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FDA’s Use of Negative Publicity as an

Enforcement Mechanism

Kelly Blevins

Harvard Law School

Third Year Paper

May 13, 2003

Table of Contents

Abstract

This paper analyzes FDA’s use of negative publicity as an enforcement mechanism, both generally and in the specific instance of the agency’s regulation of phenylpropanolamine (“PPA”). While FDA does have explicit statutory authority to issue negative publicity in limited situations, both the agency and the courts have broadly interpreted FDA’s power to extend beyond these statutory limits. In practice, while FDA has sometimes used negative publicity consistently with its statutory authority, it frequently abuses its powers, by issuing public warnings that are overbroad and that are not based on any scientific evidence, and by using very negative publicity to coerce companies to comply with the agency’s requests for voluntary recalls. When compared to the agency’s other statutory enforcement powers, negative publicity has both advantages and disadvantages: it is a cheap and fast way to protect the public from serious dangers, but it has the potential to cause undue public alarm and confusion, and it provides regulated companies with very little procedural protection. FDA’s issuance of a public advisory about the stroke risk of PPA in November 2000 highlights many of the problems of FDA’s use of negative publicity as an enforcement mechanism. The advisory caused significant financial losses to the regulated companies and consumer confusion. Instituting a rule-making proceeding to formally ban PPA would have avoided these problems and allowed PPA manufacturers to effectively challenge FDA’s actions.

I. Introduction

On November 6, 2000, the Food and Drug Administration (“FDA”) issued the following press release:

The Food and Drug Administration (FDA) is issuing a public health advisory concerning phenylpropanolamine hydrochloride. This drug is widely used as a nasal decongestant (in over-the-counter and prescription drug products) and for weight control (in over-the-counter drug products). FDA is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Phenylpropanolamine has been marketed for many years. A recent study reported that phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine.

FDA’s Nonprescription Drugs Advisory Committee (NDAC) recently discussed this study and other information on phenylpropanolamine. NDAC determined that there is an association between phenylpropanolamine and hemorrhagic stroke and recommended that phenylpropanolamine not be considered safe for over-the-counter use.

Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. FDA does not consider the conditions for which phenylpropanolamine is used (over-the-counter or by prescription) as justifying the risk of this serious event. Other products are available for use.

In the meantime, consumers can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for “phenylpropanolamine” in the list of active ingredients on the label. Consumers can check with their health care provider or pharmacist to see whether their prescription cough-cold or nasal decongestant product contains phenylpropanolamine. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.[1]

Within days of FDA’s announcement on the alleged connection between phenylpropanolamine (“PPA”) and stroke, drug stores had pulled from their shelves all nasal decongestants and weight loss pills containing PPA, including products like Triaminic, Alka-Seltzer, and Dexatrim.[2] This action confused consumers, who bought 6 billion doses of products containing PPA in 1999,[3] and left them with a limited selection of over-the-counter (“OTC”) cold remedies right at the start of the cough and cold season, as well as depriving them completely of any OTC weight loss products.[4] The depleted market conditions continued for several weeks, until manufacturers were able to reformulate their products to remove PPA.[5] These companies lost significant sales in the time between when their PPA products were pulled and when their reformulated products hit the shelves.[6]

But despite the harm suffered by these companies, they were left virtually without recourse to challenge the propriety of PPA’s removal from the market, because FDA had chosen to accomplish this goal by issuing a press release, instead of by seeking an injunction or a seizure of PPA products or by instituting a rule-making proceeding to formally ban PPA. Any public statement questioning FDA’s advisory would make the manufacturers look insensitive to consumers’ health, and any legal action challenging the advisory would fail due to the deference courts usually give to FDA’s judgments on public safety matters. So if manufacturers wanted to remain in the nasal decongestant or weight loss business, they had no choice but to remove PPA from their products.

The drug manufacturers’ forced compliance with FDA’s determination of PPA’s safety is just one example of the potential harms that can result from the FDA’s use of negative publicity as an enforcement mechanism. FDA and the courts have both broadly construed Section 705 of the Food, Drug, and Cosmetic Act (“FDCA”),[7] which allows the agency to issue negative publicity to prevent “imminent danger” to health, and Sections 301 and 310 of the Public Health Services Act (“PHSA”),[8] which gives it the power to issue general research data and other information related to public health. While the agency has effectively used its publicity power in cases that do present a real danger, it has occasionally abused its authority by issuing publicity in cases where the harm to the public is questionable, by phrasing public warnings in way that could cause undue alarm in an overbroad segment of the population, and by using negative publicity to strike back at uncooperative firms.

FDA’s choice of negative publicity over other more formal enforcement mechanisms such as seizures, injunctions, and criminal actions has its benefits: a press release (especially when it is combined with a voluntary recall) allows FDA to effect the removal of unsafe products much more quickly, since other enforcement proceedings require lengthy judicial and administrative actions. But these benefits do not come without costs to both consumers and the regulated industries, as the PPA incident demonstrates. In contrast to the generous rights afforded to regulated companies in other enforcement proceedings, manufacturers have no procedural protections in the negative publicity process: they have no right to know the content of the publicity or to have the agency hear their side of the story before the press release is issued, nor can they seek effective judicial review of FDA’s actions in this arena. In addition, an unanticipated press release can deprive consumers of a food, drug, or medical device on which they have come to rely, and it may unnecessarily alarm them about the harm that might come from their prior use of that product.

This Paper explores FDA’s growing use of negative publicity, and the benefits and drawbacks of this tool as an enforcement mechanism. Part II describes FDA’s interpretation of its statutory authority to issue negative publicity, as well as the federal courts’ response to challenges to FDA’s publicity power. It then discusses several well-known historical examples of negative publicity and examines all of FDA’s press releases and talk papers from the past five years, to determine the extent of FDA’s abuse of its publicity power. Part III of the Paper compares publicity to the other enforcement mechanisms that FDA uses to protect the public from harmful products, focusing on the expenditure of time and resources required for each mechanism; the effectiveness of each power in protecting the public from dangers; the procedural protection afforded to regulated parties by each enforcement action; and institutional and public policy considerations. Part IV explores the PPA incident in detail, focusing on the events that led to FDA’s issuance of the public health advisory and the consequences resulting from it. This Part also considers the feasibility of other enforcement mechanisms in removing PPA from the market. Finally, Part V suggests ways that FDA could reform its use of negative publicity, in order to give manufacturers more of an effective opportunity to participate in FDA’s decision-making process and to reduce confusion and panic among consumers. It also gives suggestions on how to achieve more effective judicial review of FDA’s issuance of press releases.

II. FDA’s Power of Publicity

This Part explores how FDA has used its relatively narrow statutory publicity power to greatly expand its enforcement powers and encourage the removal of products it deems unsafe. After setting out the relevant statutory language, this Part describes the publicity guidelines of the Department of Health and Human Services, and then discusses FDA’s own proposed (but never finalized) general negative publicity policies, as well as its guidelines for issuing press releases in conjunction with voluntary recalls. These guidelines indicate that FDA believes it can issue negative publicity even in cases that might not present an “imminent danger” to the public health, without affording any procedural protections to affected companies. This Part then surveys the limited court cases that have addressed the scope of FDA’s publicity power: generally, courts have held that the issuance of negative publicity is a matter left solely to the agency’s discretion, and they have consistently denied both injunctions and damages to regulated companies who have challenged FDA’s actions in this arena. This Part next discusses several historical examples where FDA has issued press releases that exaggerated product dangers, causing public panic and severe losses to the products’ manufacturers. Finally, this Part analyzes the trends in FDA’s recent use of press releases and talk papers: while FDA sometimes uses its publicity powers responsibly, it often issues press releases that are likely to cause undue alarm and that do not include evidence to support their assertions of danger, especially in cases where the manufacturer is not cooperating with the agency.

A. Statutory Language

FDA’s publicity powers are primarily derived from Section 705 of the FDCA, which states:

(a) The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this Act, including the nature of the charge and the disposition thereof.
(b) The Secretary may also cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department. [9]

Because Section 705(a) only mandates that FDA summarize and publish information already in the public record, it cannot be used as an independent mechanism to pursue unsafe products that are not already the subject of an enforcement proceeding. It is Section 705(b) that has been the source of the expansion of FDA’s authority in this field, because it gives FDA the authority to issue negative publicity that is unrelated to another statutorily authorized formal enforcement proceeding. However, the scope of this authority is limited to cases that, in the Secretary’s opinion, present an “imminent danger to health or gross deception.” Section 705(b) plainly does not give the agency full discretion to issue negative publicity whenever it chooses to do so.[10]

Two other statutory provisions may give FDA additional publicity powers. Section 301 of the PHSA gives the Secretary of the Department of Health and Human Services (“HHS”) the power to cooperate with other public authorities and scientific institutions in conducting and coordinating “research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man.”[11] In carrying out this power, the Secretary is authorized to “collect and make available through publication and appropriate means, information as to, and the practical application of, such research and other activities.”[12] In addition, Section 310(b) of the PHSA provides:

From time to time the Secretary shall issue information related to public health, in the form of publications or otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United States and other countries and other pertinent health information for the use of persons and institutions concerned with health services.[13]

The Secretary of HHS has redelegated his Sections 301 and 310 powers to the Commissioner of FDA.[14] No agency materials or judicial opinions have provided any guidance on how to interpret the extent of FDA’s authority under these provisions. However, the legislative context of these sections indicates that Congress did not intend these publicity powers to be used extensively as an enforcement mechanism against individual companies for particular statutory violations. The title of Section 301 is “Research and investigations generally,” while the subtitle of Section 310 is “Health conferences and health educational information” – both of which indicate that these sections are to be used as a means of releasing more general health information. Section 301 is codified at 21 U.S.C. § 241, while Section 301 is codified at 21 U.S.C. § 242o. All of the other provisions of § 242 all deal with the collection of health statistics and disease data,[15] the dissemination of regular reports to Congress and the President,[16] and the establishment of a task force on aging.[17] Viewed in the context of these related statutory provisions, FDA’s powers under Sections 301 and 310 seem limited to releasing generalized data on health issues of nationwide interest, with the purpose of public education.

The statutory language of these sections also supports this interpretation. The “research, investigations, experiments, demonstrations, and studies” language of Section 301(a) seems to expect that the agency will conduct broad-based, long-term inquiries into the causes and treatment of physical and mental diseases, and thus the publicity power provided in Section 301(a)(1) relates only to this large-scale research – not to individualized investigations of a particular company whose products might affect physical and mental diseases.[18] In addition, the “from time to time” language of Section 310(b) seems to anticipate that the agency will release public health information on a somewhat regular basis – not anytime a threat to the public health arises.[19] Thus, these provisions probably do not expand FDA’s ability to use negative publicity as an enforcement mechanism against particular dangers beyond the limits provided in Section 705(b) of the FDCA, except possibly to reach problems which affect a broad class of people or about which the agency had conducted extensive research.

B. HHS and FDA Guidelines on Publicity

While FDA has never formalized its own guidelines of its own spelling out the procedures to follow when issuing negative publicity, the Department of Health and Human Services (HHS) has adopted a publicity policy, codified in the Code of Federal Regulations, which is applicable to all of its subdivisions including FDA.[20] In addition, in 1977 FDA proposed regulations to limit its issuance of publicity, and while these regulations were never finalized, they provide some insight into how the agency has broadly interpreted its statutory authority.[21] FDA has formally addressed the more narrow issue of when it issues press releases related to a voluntary recall, and these guidelines also shed light on FDA’s broad interpretation of its publicity powers.

1. HHS Guidelines

The HHS publicity policy is generally a conservative statement about the scope of the agency’s powers to issue publicity. It broadly defines adverse publicity as any statement to the news media “which may adversely affect persons or organizations identified therein.”[22] The policy provides that adverse information released to the news media must be “factual in content and accurate in description,” and may not include disparaging terminology that is not essential to the content and purpose of the publicity.[23] The agency must take “reasonable precautions” to verify the accuracy of the information, and the press release must include the source of the information and explain the nature of any studies relied upon in the release.[24] If the information relates to a regulatory investigation or criminal or civil trial, it may only be released if “there is a significant risk that public safety may be impaired or substantial economic harm may occur,” and the respondent in the proceeding must be given advance notice of the information to be released and a chance to prepare a response to it.[25] If information released by an agency is later determined to be misleading, the agency must issue a correction.[26]

2. FDA’s Proposed Publicity Guidelines

In its proposed publicity rules, FDA interpreted its authority to issue negative publicity as broader than what is allowed by either the literal language of the relevant statutory provisions or the HHS guidelines. These proposed regulations were published in the Federal Register in March 1977, along with FDA’s comments on the purpose and effect of these rules.[27] As the statutory bases for FDA’s publicity power, the guidelines cite Section 705 of the FDCA and Sections 301 and 310 of the PHSA. The rules provide that FDA may issue publicity whenever it is “necessary or appropriate” to carry out the agency’s responsibilities under the statutes it administers.[28] The agency’s comments give several examples of when negative publicity might be “necessary or appropriate,” the most relevant of which is “to warn against the use of marketed products that may be hazardous.”[29] However, Section 705(b) gives FDA the power to issue publicity only when the Secretary determines there is an “imminent threat to health,”[30] not anytime a product “may be hazardous.” And, as described above, Sections 301 and 310 probably only extend to the release of general health research and information, not to the release of warnings about particular products that might pose a limited threat. Thus, the language in the publicity policy may encourage FDA to reach a wider scope of products through the use of negative publicity than Congress originally intended.

The proposed regulations provide detailed standards to which publicity concerning litigation, administrative hearings, and law enforcement investigations should conform,[31] but they do not specifically address the content of publicity that is unrelated to formal enforcement proceedings. The proposal generally states that publicity must be “accurate and relevant to the purpose for which it is released and shall reflect the context fairly...The manner in which such publicity is issued will be commensurate with the purpose it is to achieve, the urgency and importance of the need to publicize, and the public interest in the matter.”[32] This very general, vague statement would not provide agency staff with much guidance on what information to include in a press release that FDA intends to use as an enforcement mechanism, which is likely to lead to inconsistency in the content of press releases. The policy does provide for a limited amount of centralization: while different field offices and headquarters offices may write and issue press releases, the Office of Public Affairs has responsibility for authorizing all releases.[33]

Beyond requiring that publicity be “accurate,” the proposed regulations do not require that the information on which publicity is based be subject to scientific verification, nor do the regulations require the agency to reveal the sources of the information in the publicity itself, contrary to the requirements of the HHS publicity guidelines.[34] Although FDA’s proposed rules state that “disparaging comments should be avoided,”[35] the agency’s comments accompanying the regulations indicate that disparaging comments would be allowed “when the purpose of the publicity is to warn of a threat to the public health or report to the public about an action taken by FDA against a firm or product.” [36] Since all publicity that FDA uses as an enforcement mechanism relates to threats to health, this language would permit the agency to make disparaging statements that could harm a manufacturer’s reputation in all such publicity.

The proposed regulations also provide very limited procedural protections to parties that may be affected by adverse publicity. They only require, in language different from the HHS guidelines, that advance notice of the publicity’s subject matter – but not the exact text – be given to individuals who might be adversely affected by the publicity.[37] However, advance notice is not required when the publicity involves an entire class of products or a large segment of an industry.[38] Advance notice is the extent of the procedural protections given to affected parties under the proposed guidelines: the parties have no right to convince the agency, through either oral or written submissions, that the information contained in the release is inaccurate or materially misleading.[39]

The agency’s comments accompanying the proposed regulations somewhat curiously state that the fact that the “information may be ignored, misinterpreted, oversimplified, overstated, or misunderstood by the media or public” would not deter FDA from seeking publicity.[40] This statement seems to indicate that the potential that the public might become unnecessarily alarmed about an announced health risk is irrelevant to the agency’s decision whether to make this announcement. In addition, the comments provide that the possibility of prejudicing an ongoing or future litigation, administrative hearing, or investigation would not bar the issuance of adverse publicity, if such publicity is necessary to protect public health or avoid economic harm.[41] This excerpt indicates that FDA may prioritize its power to enforce the FDCA and protect the public health through its publicity powers above its other statutorily authorized enforcement mechanisms, which are described in Part III.A. of this Paper.

Finally, the agency’s comments on the proposed regulations delineate the types of negative publicity issued by the agency: press releases, press conferences, and mass media interviews.[42] The comments explicitly state that talk papers – which are internal documents that discuss the responses that FDA personnel should give to public inquiries on specific matters – are not considered negative publicity, because they are not distributed to the media or anyone else except in response to a Freedom of Information Act request.[43] While this distinction may have been true in 1977, it is clearly no longer applicable: talk papers are available to any member of the public through FDA’s website, where they are listed right underneath the press releases.[44]

In sum, while FDA’s proposed general publicity regulations have not been finalized, they are helpful in demonstrating that FDA believes it has authority to issue negative publicity whenever a product “may be harmful,” and that the agency does not follow any formalized procedures or give affected parties any procedural rights.

3. FDA Publicity Policy for Voluntary Recalls

Although it has not finalized general guidelines for the issuance of negative publicity, FDA has adopted final rules governing its use of publicity in connection with voluntary recalls.[45] While FDA has very limited statutory authority to “order” recalls for medical devices and infant formulas,[46] FDA often requests that firms recall products that “present a risk of injury or gross deception.”[47] Because the agency does not have explicit statutory power to conduct these voluntary recalls, they cannot be considered “judgments, decrees [or] court order which have been rendered under” the FDCA,[48] and thus FDA’s power to issue publicity in conjunction with voluntary recalls is derived not from Section 705(a), but from Section 705(b).[49] It is unlikely that Sections 301 and 310 of the PHSA could serve as the basis for FDA’s power to issue publicity in conjunction with voluntary recalls, since these sections only seem to cover the release of generalized health information, not specific information related to the actions of a particular company.

The final regulations on voluntary recalls give FDA the power to issue two types of public statements related to recalls: Enforcement Reports and public warnings. FDA’s weekly Enforcement Report must give information about each new recall, including its classification (Class I, II, or III, based on the relative degree of health hazard of the product), whether it was initiated by FDA or the firm, and the remedial actions taken by the firm.[50] Enforcement Reports are a limited form of publicity: they are available to the public on request and are posted on FDA’s website, but they are not widely distributed to the media.[51] The recall regulations provide that FDA may delay publishing information about recalls of drugs or devices in the Enforcement Report, if it determines that public notification may cause undue, harmful anxiety in patients.[52] This policy seems to reflect a sensible consideration of the potential harmful effects that can come from recalls, though it also contradicts the statement in FDA’s proposed publicity policy that the fact that the public may misunderstand or overstate the content of the public statement would not stop the agency from issuing negative publicity.[53]

In addition to publication in the Enforcement Report, FDA, may “in consultation with the recalling firm,” issue a public warning about a voluntary recall.[54] The recall guidelines state that public warnings are “reserved for urgent situations where other means for preventing use of the recalled product appear inadequate.”[55] In practice, public warnings are only issued for recalls categorized as Class I, which represents the highest degree of health hazard.[56] This public warning may come in several different forms: FDA sometimes issues general public warning through the general news media, while in other cases it works through specialized media outlets such as a trade press.[57] However, all public warnings related to recalls are posted on FDA’s website, so even if FDA targets particular segments of the population through its press releases, the information is theoretically available to everyone.[58] In a description of its recall policies, FDA gives the following example of when a public warning may be used: “if a canned food product, purchased by a consumer at a retail store, were found by FDA to contain botulinal toxin, an effort would be made to retrieve all the cans in circulation, including those in the hands of consumers. As part of this effort, the Agency could also issue a public warning via the news media to alert as many consumers as possible to the potential hazard.”[59]

By using words such as “urgent” and stressing that “other means for preventing use of the recalled product must be inadequate,” the recall guidelines do attempt to limit the situations in which negative publicity can be used. However, just like FDA’s proposed publicity guidelines, the recall guidelines do not track the language of Section 705(b) of the FDCA: they do not require that recall-related negative publicity only be used in situations presenting an imminent danger to public health or gross deception, which also may demonstrate that FDA interprets its power to issue negative publicity as reaching beyond the statutory text. The recall guidelines also do not seem to be in line with FDA’s publicity powers under Sections 301 and 310 of the PHSA, since those sections seem to give FDA the power to release general health information, not specific information related to the compliance actions of a particular company. These inconsistencies may demonstrate that FDA views its authority to issue recall-related publicity as extending beyond the statutory texts, but unlike the proposed publicity guidelines, the recall rules do give the regulated firm a right to participate in the publicity process, by stating that FDA will issue public warnings “in consultation with the recalling firm.”[60]

C. Courts’ Interpretation of FDA’s Publicity Power

Although few companies have brought legal challenges to FDA’s authority to issue negative publicity, those courts that have addressed the issue have consistently upheld FDA’s publicity powers. All of these cases have recognized that FDA’s power to issue negatively publicity about particular threats to public health is derived from Section 705(b) of the FDCA; none of them have mentioned Sections 301 and 310 of the PHSA as a source for FDA’s authority to issue negative publicity. Only one court has ever issued an injunction to prevent FDA from issuing publicity, and courts have consistently denied recovery to plaintiffs who have sought damages for harm suffered by FDA’s release of negative publicity. In all cases dealing with FDA’s use of negative publicity, courts have shown great deference to the agency, without explicitly considering whether the agency acted within the bounds of its limited statutory authority. Courts have also refused to recognize the harm that negative publicity causes to regulated individuals as a cognizable legal injury. Thus, both pre- and post-publicity judicial review has done nothing to narrow the scope of FDA’s broad interpretation of its statutory authority to issue publicity.

1. Pre-Publicity Review

Courts have consistently refused to issue injunctions to companies seeking to prevent FDA from issuing negative statements about their products. In the first case to consider the constitutionality of Section 705, [61] the Hoxsey Cancer Clinic sought an injunction to stop FDA from disseminating a poster stating that the Hoxsey cancer treatment was worthless. The clinic also challenged the constitutionality of Section 705 on the grounds that it violated due process by not providing a notice or hearing to affected individuals. The district court upheld the constitutionality of Section 705, holding that the plaintiffs were not entitled to due process because FDA officials had “made no order; they are adjudicating no rights; they are issuing no directions.”[62] The court did not acknowledge that companies might suffer a similar economic and reputational injury after the dissemination of negative publicity as they would after the issuance of a negative adverse order or decision, which could entitle them to due process rights.[63] The court also stated in dicta that even if the FDCA did not give FDA explicit authority to use publicity, the defendants would still be able to issue a public warning in this case because they “are performing a public duty when they are urging the use of certain treatments.”[64] This statement indicates that the agency’s publicity power might extend beyond the literal language of Section 705(b), to include every instance where FDA is performing a public duty. The court denied also the injunction, because an injunction would not be appropriate even if the statements in the press release were false, although false statements could entitle the plaintiffs to damages for libel and slander after the fact.[65] The Hoxsey decision would thus preclude all actions for pre-publicity review and limit recovery in post-publicity cases to false public statements, which would provide FDA with much more discretion than the literal language of Section 705.

The district court in Ajay Nutrition Foods, Inc. v. FDA [66] reached a similar result as the court in Hoxsey . In that case, FDA wrote a press release about new regulations governing the health food industry, and health food companies sought an injunction to stop the dissemination of the press release because it allegedly referred to them as “nutrition quacks.”[67] Like the clinic in Hoxsey , the plaintiffs claimed that the press release resulted in a denial of due process. The court held that the government’s actions were privileged because “the issuance of press releases is a duty mandated by Congress,” unless the plaintiffs could show that the press release, even if true, violated the defendant’s executive authority.[68] The plaintiffs did not meet this burden, because there was no showing in the complaint that the issuance of the press release deviated from standard agency practice (although the court did not discuss what “standard agency practice” for issuing press releases is or should be).[69] But the court went on to state that even if the press release was not protected by privilege, the plaintiffs could not get an injunction because “there is decidedly no complaint...that the Government has singled out any party for discriminatory treatment...The class involved is...much too broad to require the protection of a court order, particularly in view of the legitimate function of Government to inform the public of business abuses.”[70] The court did not consider, however, the fact that the publicity duty imposed by Section 705 is limited to cases of imminent danger to health or gross deception, or that the Sections 301 and 310 seem to authorize the release only of general statistics and research; however, unlike Hoxsey , Ajay leaves some room for plaintiffs to obtains injunctions if FDA singles out one party for discriminatory treatment.

In United States v. Diapulse Manufacturing Corp. ,[71] the defendants in a prosecution for drug misbranding sought an order preventing FDA from issuing news releases and other public statements related to the criminal proceeding against the company. The agency had previously included a factual description of the Diapulse product in its Report on Enforcement and Compliance, and the FDA commissioner had mentioned Diapulse in a speech. The court denied the order because the defendant had not demonstrated that it would suffer irreparable injury from any future public statements.[72] The court also discussed the policy reasons behind its decision: it would be inappropriate for the federal judiciary to “muzzle an agency of the executive branch of government in performing a duty expressly entrusted to it by Congress.”[73] Like Hoxsey andAjay , the Ajay decision demonstrates courts’ complete deference to FDA in light of the agency’s duty to protect the public.

In the last reported case denying a pre-publicity injunction, Durovic v. Palmer ,[74] the Seventh Circuit upheld the district court’s dismissal of a request for an injunction to prevent FDA from uttering misleading statements discrediting the plaintiff drug manufacturer and his product. Because the plaintiff did not raise specific arguments on appeal about why he was seeking an injunction against the use of negative publicity, the Seventh Circuit did not address this issue on appeal, but instead concentrated on the plaintiff’s other claims.[75]

One unpublished opinion goes against this general judicial trend of denying requests for injunctions to stop FDA from using negative publicity. In United States v. International Medication Systems , FDA sent a letter to all hospitals that IMS products presented a public health hazard because their sterility was compromised.[76] The district court found that this letter was outside the agency’s Section 705 authority because FDA did not demonstrate that IMS had so violated good manufacturing practices that its products presented a potential hazard to public health.[77] The court enjoined FDA from issuing statements similar to its first letter and ordered FDA to send another letter to hospitals retracting its original allegations.[78] Unlike the other decisions described above, the court in IMS did analyze whether the press release was within the precise language of Section 705. It also implicitly recognized that publicity can and does injure its subjects, so courts cannot show complete deference to FDA at the expense of the rights of these corporations. However, the fact that there have been no published opinions in cases seeking pre-publicity review since the 1960’s indicates that IMS is the exception and not the rule. Firms have realized that seeking injunctions to stop the dissemination of negative publicity is futile because of courts’ overwhelming deference to FDA’s discretion, so they no longer file these actions.

2. Post-Publicity Review

Courts have been equally hostile to actions by companies seeking damages for harm caused by FDA’s use of publicity. Though plaintiffs have employed a variety of legal theories, courts have rejected all of these claims due to their reluctance to second-guess FDA’s determination of what is necessary to protect public health. In Sperling & Schwartz, Inc. v. United States ,[79] the court dismissed a libel action against FDA for issuing a negative press release about the plaintiff’s dinnerware, after a child became ill after using the product and a test revealed high levels of lead content. The court held that even though there was no evidence that the child became ill because of lead poisoning, the libelous nature of the release was “at best murky.”[80] The court pointed out that “FDA’s charter and purpose dictate that the public be alerted to any situation presenting imminent danger to health,”[81] but, like the injunction cases discussed above, it did not expressly find that this situation presented such a danger.

In California Canners & Growers Association v. United States ,[82] the Court of Claims denied recovery for injuries resulting from the Secretary of Health and Human Services’ statements at a press conference that the artificial sweetener cyclamate had been found to cause bladder tumors in animals and that the use of cylcamate should be discontinued immediately.[83] The court held that the plaintiffs had not established that FDA had acted negligently because there was substantial evidence (in the form of a determination by a panel of scientific experts that cyclamate was carcinogenic) supporting FDA’s statements. Like the court in Sperling & Schwartz, the court stated that FDA officials “were exercising their congressionally delegated discretion,” without analyzing whether this situation presented an imminent danger to health under Section 705(b) or whether the press release fell under the types of information authorized in Sections 301 and 310.[84] The court also stated that the officials “did not have the luxury of deferring action and explanation indefinitely. Hesitation might have had adverse effects on the health of countless people.”[85] This conclusion might defer a bit too much to FDA’s discretion, since it is doubtful that people could consume enough artificial sweetener to cause brain tumors in the several months it would have taken FDA to pursue a more formal enforcement action.

The Court of Claims showed similar deference to FDA in Lance Industries v. United States ,[86] in which it dismissed a disparagement and negligence action against several federal agencies, including FDA, for circulating a warning that the plaintiff’s product was being used as a heroin or cocaine substitute – a claim that later turned out to be entirely false. The court held that the plaintiff could not make a case for disparagement because there was no evidence that “any government player knew of the falsity of the rumor, or that its actions could be characterized as showing reckless disregard.”[87] The plaintiffs’ negligence claim failed because the fact that the agencies did not verify the warnings did not amount to a lack of due care, and FDA’s prompt issuance of a retraction after it discovered the falsity of the allegation supported that the agencies acted with due care.[88] This case holds FDA to a very low standard of care in its dissemination of negative publicity, because it imposes no requirement that the agency attempt to verify the accuracy of its publications: FDA can avoid liability merely by showing that it did not know its allegations were false.

In the most recent challenge to FDA’s use of publicity, [89] the plaintiffs sought damages under the Federal Tort Claims Act (“FTCA”) against FDA for issuing an order refusing the entry of fruit from Chile and a press release publicizing the order and encouraging consumers to destroy any Chilean fruit in their possession, after some Chilean grapes tested positive for cyanide. The Third Circuit upheld the lower court’s dismissal of the case, because FDA’s actions were policy decisions protected by the discretionary function exception to the FTCA.[90] The court justified its decision on broader policy grounds than courts’ typical reliance on FDA’s Congressionally delegated duty to protect the public health: “if plaintiffs injured by regulatory policy decisions were permitted to prosecute damage actions by challenging the manner in which the underlying data was collected, federal courts, of necessity, would be required to examine in detail the decision-making process of the policy maker...The social cost of permitting the[se] inquiries...are prohibitive.”[91] While the court’s reasoning seems right, it may be a stretch to call a decision that only temporarily affected the importation of fruit from one country a “policy” decision. Negative publicity affecting a limited class of products may be more amenable to judicial review than broader policy decisions, because it is typically based on a particular finding by agency officials, like the positive cyanide test in this case.

In addition to denying monetary recovery for negative publicity, courts have been equally hostile to claims by defendants that negative FDA publicity prejudiced an ongoing criminal proceeding. In United States v. Abbott Labs ,[92] FDA and DOJ brought an indictment against the defendant for misbranding and adulterating an intravenous solution, and then FDA issued a press release stating that fifty deaths resulted from the use of the solution. The Fourth Circuit reversed the district court’s dismissal of the indictment, even though the court stated that it joined in the “district court’s condemnation of this conduct and express our strongest disapproval that...the FDA...would issue a press release containing such prejudicial material.”[93] Dismissing the indictment was not necessary, however, because a change of venue and a continuance would diminish any prejudice, and the information in the press release was relevant to the proceedings.[94] Despite the court’s condemnation of FDA’s actions in this case, the Abbott Labs decision gives the agency no incentive to stop issuing this type of publicity, since it suffered no negative consequences from its actions. In sum, these cases make it clear that courts do not serve as a meaningful check on FDA’s use of its publicity power: courts consistently have failed to analyze whether the FDA is acting within its statutory authority to issue publicity, nor do they require the agency to verify its public statements or consider input from the affected parties.

D. Historical Examples of Negative Publicity

Given FDA’s broad interpretation of its statutory authority to issue publicity and the courts’ hostility to challenges to FDA’s publicity power, it is no surprise that FDA has historically used negative publicity to influence regulated companies to take specific actions that the agency could have achieved through formal enforcement mechanisms. The instances of negative publicity that have traditionally received the most attention from practitioners and scholars are, not surprisingly, those that in hindsight appear to be gross errors in the agency’s judgment and that have resulted in substantial, unjustified losses to regulated companies.

The most famous of these situations involves a press conference held by the Secretary of the Department of Health, Education, and Welfare in October 1959, where the Secretary told reporters that part of the nation’s cranberry crop had been contaminated with a carcinogenic weed killer that had caused cancer in laboratory rats.[95] The Secretary would not confirm that the part of the crop not affected by the weed killer was safe, despite the fact that FDA had no information indicating that these cranberries were dangerous.[96] The Secretary even stated that he personally would not be eating cranberries for Thanksgiving that year.[97] His statements caused a huge decrease in the sales of cranberries during the busy Thanksgiving and Christmas season, so that cranberry sales for 1959 were 67 percent lower than the previous year’s sales.[98] Congress responded by providing emergency loans to the cranberry industry and by indemnifying growers for $9 million.[99] However, the danger that these cranberries presented to the public health probably did not warrant such catastrophic losses, because it would have taken years for a consumer to eat enough cranberries to cause a carcinogenic response.[100] In addition, cranberry growers were cooperating with the industry, so a recall, seizure or injunction that targeted only the affected lots would probably have been just as effective, without causing undue public panic about the safety of all cranberries.[101]

A second example of possibly unwarranted negative publicity that caused significant losses occurred in July 1971, when FDA learned that a man had died of botulism after eating Bon Vivan vichyssoise.[102] FDA announced a Class I recall of all cans of Bon Vivan vichyssoise that were produced in the same batch as the can consumed by the man, then extended this recall to all Bon Vivan products. FDA also released public statements that accused the company of maintaining unsanitary conditions, using defective equipment, and keeping poor records.[103] The agency later determined that only five cans of vichyssoise were contaminated with botulism, thus indicating that its statements condemning all Bon Vivan products were probably overbroad.[104] But by the time the agency made this determination, its dramatic statements had already had dramatic effects: the public almost completely stopped buying Bon Vivan’s products, and the company was forced to file for bankruptcy less than a month after the recall.[105]

FDA did not appear to learn from its mistakes in releasing an overbroad warning about botulism in Bon Vivan products, because in October 1971, it issued a warning that cans of Stokley-Van Camp French-style sliced green beans might be contaminated with botulism.[106] The warning was based on preliminary tests performed by another government agency. Confirmatory tests then revealed that the cans were not contaminated with botulism, and FDA had to issue another press release retracting the warning.[107] The agency expressed no real regret for its mistake in the retraction; instead, the press release stated that “there are times when the public interest demands action before the scientific case is complete. The decision always must be made in favor of consumer protection.”[108] Thus, these few historical examples demonstrate that the procedures the agency follows in issuing negative publicity are not infallible in preventing the release of incorrect information, which can cause needless alarm among consumers and significant financial losses to regulated companies.

E. Current Trends in FDA’s Use of Negative Publicity

A survey of the press releases and talk papers posted on FDA’s website from 1997 to 2002 indicates that the abuses demonstrated by the above historical examples may continue today. These press releases and talk papers reveal the following trends in the agency’s use of negative publicity: while FDA sometimes uses negative publicity in a manner totally consistent with its statutory authority, it occasionally phrases public warnings in a way that is likely to cause undue alarm in an overbroad segment of the population; it sometimes issues negative publicity based on scant scientific evidence; and it can use negative publicity to strike back at uncooperative firms.

Before discussing these trends, it is important to recognize that the type of negative publicity that is the focus of this paper – publicity that is used as an independent enforcement mechanism or in conjunction with a voluntary recall, but is otherwise unrelated to an ongoing statutorily authorized formal enforcement proceedings – makes up only a small portion of the information FDA formally releases to the public.[109] Many of the press releases and talk papers involve issues such as FDA’s approval of new drugs and medical devices;[110] ongoing criminal and civil enforcement proceedings;[111] rulemaking proceedings;[112] and general public relations/public interest stories.[113] Each year, however, there are a significant number of press releases and talk papers that contain negative information about a particular product or class of products and that are intended to get at least a portion of the public to stop using these products, even though FDA has not initiated a formal regulatory action against the items in question. Some of these public statements are issued in conjunction with voluntary Class I recalls initiated by specific companies,[114] but others are targeted at an entire class of products and are not accompanied by any action on the part of the industry.[115]

The table below gives the total number of press releases and talk papers issued each year from 1997-2002, as well the number of these press releases and talk papers that could be as designed to achieve a negative enforcement purpose, either independently or in conjunction with a recall:[116]


1997
1998
1999
2000
2001
2002
Total # Press Releases
43
57
20
35
41
75
# Negative Press Releases (% of Total)
12
(28%)
11
(19%)
9
(45%)
9
(28%)
11
(27%)
23
(31%)
Total # Talk Papers
65
88
61
68
65
59
# Negative Talk Papers
(% of Total
13
(20%)
10
(11%)
10
(16%)
8
(12%)
9
(14%)
7
(12%)
Total # of Press Releases + Talk Papers
108
145
81
103
106
134
# Negative Press Releases + Negative Talk Papers
( % of Total)
25
(23%)
21
(14%)
19
(23%)
17
(17%)
20
(19%)
30
(22%)

These numbers demonstrate that over the past six years, FDA’s use of negative press releases and talk papers has varied from year to year, ranging from a low of 17 negative public statements in 2000 to a high of 30 public statements in 2002. It is possible that the increase in negative public statements from 2000 to 20002 indicates that FDA is becoming more and more dependent on the use of negative publicity as an enforcement mechanism (possibly at the expense of other more formal enforcement tools), but we would probably need to see if these numbers continue to increase over the next few years before drawing any definite conclusions. This table also shows that FDA uses press releases more often than talk papers to communicate negative information about products: although more total talk papers than press releases were issued in every year except 2002, a much higher percentage of press releases were negative in each of these years, especially in 1999 and 2002. Since press releases have traditionally been used to reach a broader segment of the population than talk papers, these statistics indicate that FDA often consciously chooses to spread negative information about products to as many people as it can possibly reach.[117]

A study of the content of the negative press releases and talk papers issued between 1997 and 2002 demonstrates that issuing a negative press release about the potential hazards of a product is often completely justified to protect the public from imminent danger, even if these negative statements cause injury to the regulated company. For example, FDA understandably issued a press release telling consumers to avoid eating a certain type of plant, on which a nursery in Canada had placed a label saying “all parts of this plant are tasty in soup,” when the plant was actually poisonous.[118] Though the nursery had notified all of its distributors of the mistake,[119] that notification might not have been sufficient to warn the end purchasers of the incorrect labeling, so a press release seems necessary in this situation. In addition, after several outbreaks of Salmonella Poona that resulted in numerous illnesses and two deaths were connected to a particular brand of cantaloupes imported from Mexico, FDA issued a press release advising consumers not to eat this brand of cantaloupe and telling retail establishments to stop selling that brand.[120] The widespread nature of the illnesses associated with this product seemed to indicate that it did present an imminent danger to public health, and the warning was no broader than necessary to prevent this danger, since it was targeted only at the particular brand of fruit that was responsible for these injuries.[121]

There have been several instances in which FDA has disseminated negative information about a product but has either targeted the information to a narrow class of health care professionals, or has attempted to downplay the risk presented by the product, so as not to alarm the public unnecessarily. For example, when several firms voluntarily recalled hip implants due to higher-than-expected fracture rates, FDA did not recommend that patients who had already received the implants have surgery to correct the problem, because it recognized that the risk of failure was still very low.[122] In addition, FDA’s press releases related to a voluntary recall of powdered infant formula that was possibly contaminated with Enterobacter sazakazii stated that the formula presented hazards only to immuno-deficient infants in neonatal intensive care units; healthy babies were not at risk.[123] Finally, in a talk paper about the possible risks of heart failure and liver disease connected with certain fungal nail treatments, FDA alerted health care professionals to these potential adverse events and recommended that they confirm the diagnosis before prescribing either of these products, but it did not tell consumers not to use these products, because the risks were very low.[124]

Despite the above examples of FDA’s responsible use of negative publicity to target a particular product or a subset of the population, in many instances FDA has issued overbroad, strongly-worded warnings that seem likely to cause undue public alarm. For example, FDA advised pregnant women and women of child-bearing age, as a matter of “prudent public health,” not to eat four types of fish (including swordfish) with high mercury levels.[125] It is conceivable that many pregnant women who had eaten these fish before the press release was issued – and even women who had already delivered their babies but had consumed these fish during pregnancy – would panic when they heard that their actions might have endangered their children. Telling such a large subset of the population to avoid a broad class of common foods would seem justified only when the agency has abundant evidence of the dangers of these products, but the press release also states that FDA is just beginning to develop an “overall regulatory strategy” for dealing with mercury in fish, which indicates that the agency has yet to really explore the mercury risks of fish.[126]

FDA’s repeated warnings about sprouts also seem unnecessarily vague and broad. In 2002, the agency issued a talk paper advising all children and the elderly not to eat raw or lightly cooked sprouts at all, due to several outbreaks of food-borne illnesses connected to sprouts.[127] The talk paper acknowledged that many sectors of the sprout industry had made great strides to enhance the safety of their products since FDA originally issued a sprout advisory in 1999, but the agency made no attempt to narrow the warning to apply only to those sprouts that were not subjected to rigorous safety standards.[128] Similarly, FDA issued a warning that consumers should totally avoid using decorative contact lenses obtained without a prescription, stating in graphic terms the eye damage that these lenses could cause.[129] However, the products only caused problems when they were worn beyond the recommended usage period, and thus a more targeted warning that advised consumers to follow the package’s labeling would probably have been sufficient to protect the public health.[130]

Perhaps the most general negative press release issued between 1997 and 2002 related to the dangers of listeria, following an increase of listeria cases in Pennsylvania.[131] Listeria can result in miscarriages and stillbirth in pregnant women and can cause fatal infections in newborns and the elderly, and the press release warned these large risk groups to avoid a whole range of common food items, such as hot dogs, soft cheeses, pate, smoked seafood, and raw milk, without specifying what dangers each of these foods posed.[132] Although only one state had experienced an increase in listeria cases, the advisory was not limited to Pennsylvania, but extended to the whole nation.[133] When FDA issues such overbroad and inflammatory press releases that are not narrowly tailored to the evidence of the product’s dangers, the agency is arguably acting outside its Section 705(b) authority, because the statute should only give FDA the power to do what is necessary to prevent an imminent danger to health.

Such general press releases may be more justified under Section 301 and 310, since these provisions seem to give the agency the power to release more generalized statistics and information about diseases and other health matters. However, Section 301 comprehends that the agency will conduct research related to human diseases before releasing information, and the lack of details about what causes and how to prevent listeria in this press release indicates that FDA did not carry out a thorough inquiry.

In addition to often being overbroad and inflammatory, FDA’s negative press releases and talk papers also frequently fail to provide any sort of scientific evidence to justify the product warnings. For example, FDA alerted health care professionals that certain OB/GYN devices manufactured by a particular company may not have undergone a sterilization process, but the agency did not give any reasons to explain why it had reached that conclusion.[134] Another press release alerted cancer patients who had received treatment at a certain Florida urology clinic that they might have been given inadequate doses of Lupron and that they should contact their primary care physician immediately – but the release does not indicate how FDA reached the conclusion that some patients might have received improper treatments.[135] Similarly, a press release that warned consumers not to use a particular brand of chopped clams because they had the potential to be contaminated with a bacterium that may cause life-threatening illness or death, but it provided no explanation as to why FDA believed these products could be contaminated.[136] FDA’s failure to provide the evidence behind its allegations makes it difficult to determine whether the agency is acting within either its Section 705(b) authority or its Sections 301 and 310 powers, and it also impedes regulated companies to effectively respond to FDA’s concerns.

Another aspect of FDA’s use of negative publicity that becomes apparent from surveying the press releases and talk papers from 1997-2002 is that FDA uses negative publicity as a punishment against uncooperative companies. While agreeing to conduct a voluntary recall does not prevent FDA from issuing negative public statements about a company’s product, press releases in conjunction with voluntary recalls tend to be phrased in less dramatic language, to be less overbroad, to reflect less negatively on the company, and to have more complete and accurate information. For example, despite the fact that 31 deaths were related to the drug Baycol, FDA permitted the manufacturer to recall at the pharmacy level only, and in a press release related to the recall, the agency stated that it “agrees with and supports this decision.” [137] And after a kidney dialysis company notified dialysis centers to discontinue using blood tubing that may have been linked to five deaths and two injuries, FDA stated it was working with the company to identify the source of the problem and all parties were acting in the interest of public safety.[138]

In contrast, firms that have not agreed to FDA’s requests that they take corrective actions are treated much more harshly in press releases. For example, FDA issued a strongly worded press release after a distributor did not comply with FDA’s request to hold lots of avocado pulp that had tested positive for listeria.[139] The press release told consumers not to eat this avocado pulp and restaurants to discontinue use of the product if they had it in stock, because of listeria’s potential to cause “severe illnesses.”[140] When one pharmaceutical company agreed to recall some – but not all – of its injectable drug products after FDA inspections found violations of good manufacturing practices, FDA issued a press release warning the public about the dangers of the non-recalled products.[141] The press release stated that FDA “strongly recommends that the product not be used, and that it be disposed of in a manner that makes it unusable.” A similar press release, about another company’s failure to recall all of its injectable drugs after one type of drug was linked to four cases of fungal meningitis, pointedly stated that the company “refuse[d]” to voluntarily recall its products, and warned all consumers, physicians, and health care workers to examine their drug supplies and discontinue the use of all products manufactured by this company.[142]

This brief survey of press release and talk papers demonstrates that while negative publicity has the potential to be used as a effective means of warning the public in cases of imminent harm, FDA often abuses its publicity power by making product warnings overbroad and inflammatory, by failing to include evidence to support its allegations, and by coercing companies to conduct voluntary recalls.

III. Comparison of Publicity to FDA’s Other Enforcement Powers

This Part compares the benefits and drawback of using negative publicity to effect the removal of products from the market, as compared to using other statutorily authorized enforcement mechanisms. This section first gives a brief description of the primary formal enforcement mechanisms commonly used by FDA to stop manufacturers from taking actions that threaten the public health and to remove dangerous products from the market: injunctions, product seizures, warning letters, statutory recalls, criminal prosecutions, and rule-making. It then compares each of these enforcement mechanisms to negative publicity in several different respects. When compared to FDA’s other enforcement mechanisms, the use of negative publicity has several benefits for FDA, regulated companies, and the public: it is very cheap and fast; it is the most effective means the agency has of warning the public of serious dangers; and it can allow companies to avoid a potential civil or criminal proceeding. However, negative publicity also has several serious drawbacks: the publicity process gives regulated companies almost no procedural protections; it can create unnecessary alarm and confusion among the public; it can have severe financial consequences for regulated companies; and there is a lack of transparency about FDA’s decision-making process with respect to the issuance of negative publicity. Each of these advantages and disadvantages will be discussed in detail in this Part.

A. Overview of FDA’s Enforcement Powers

Section 301 of the FDCA prohibits a broad range of acts and the “causing thereof,”[143] including the manufacture, sale, delivery or receipt in commerce of an adulterated or misbranded food, drug, device or cosmetic, as well as the introduction or delivery into interstate commerce of unapproved new drugs, Category III medical devices, animal drugs, or antibiotics.[144] The Act also authorizes FDA to use a broad range of tools to interpret and enforce its prohibitions, including injunctions, product seizures, warning letters, statutory recalls, criminal prosecutions, and rule-making.[145]

1. Injunctions

Section 302 of the FDCA gives district courts the power to restrain violations of Section 301 for “cause shown,”[146] and provides for a court or jury trial if a defendant violates an injunction or restraining order.[147] FDA can seek injunctions that are as limited as prohibiting the introduction of new products, or as broad as closing down the operations of a business.[148] Injunctions are typically utilized where a “current and definite health hazard requires immediate action;” multiple seizures are impractical or uneconomical; and the company has not voluntarily corrected numerous violations.[149] The agency usually attempts to get the company to voluntarily correct the violative procedure or practice before seeking court intervention.[150] To prevail in an injunction action, FDA need not show that the FDCA has been violated, just that it is likely the law will be violated if the defendant’s behavior continues.[151] Courts have not required FDA to prove irreparable injury or the “precise way in which violation of the law will result in public harm” before granting preliminary injunctions or temporary restraining orders.[152]

FDA also sometimes requests that a court order an involuntary recall as part of an injunction suit.[153] While some courts have found that they have the power to issue such recalls under their general equity jurisdiction,[154] others have held that by explicitly providing an enforcement scheme of injunctions, seizure, and criminal prosecutions in the FDCA, Congress did not intend to authorize judicial recalls for violations of the Act.[155]

2. Seizures

Section 304 of the FDCA gives FDA the authority to file suit in district court for the seizure of any adulterated or misbranded food, drug, or cosmetic that is in interstate commerce, or any medical device.[156] FDA usually begins seizure actions in situations where the owner of the article could not have easily corrected the violation without litigation.[157] It refers seizure actions to the Department of Justice, which then brings a Complaint for Forfeiture and a warrant for arrest, directing the United States Marshal to take actual possession of the article or place it in constructive custody of the court.[158] After the article is seized, persons with an interest in the article may file a Notice of Claim and a Verified Answer,[159] and then the seizure action proceeds as if it were an injunction action. The claimant does not have a right to a jury trial in seizure proceedings.[160] Instead, the judge issues a decree of condemnation and an order directing FDA to destroy or sell the offending articles, if he determines that the government has proved its case by a preponderance of the evidence.[161]

Section 304 also allows FDA to file multiple seizure actions simultaneously in different jurisdictions against different lots of the same adulterated or misbranded product.[162] In these cases, the claimant may choose in which of these jurisdiction all proceedings will be consolidated.[163] Multiple seizures are often used by FDA to achieve a nationwide cessation of sales. [164]

3. Warning Letters

Section 306 of the Act gives FDA authority to issue a written notice or warning for violations of the statute, if FDA believes that “the public interest will be adequately served” by utilizing this enforcement mechanism instead of prosecutions, injunctions, or seizures.[165] The agency’s policy is that warning letters should only be issued for violations of “regulatory significance,” i.e., where a company’s “failure to adequately and promptly correct violations contained in the Warning Letter may be expected to result in enforcement action.”[166] Thus, warning letters give companies the opportunity to remedy violations voluntarily, before subjecting them to civil or criminal enforcement actions. Companies have fifteen days to respond to a Warning Letter before FDA will consider formal enforcement action.[167]

4. Statutory Recalls

While, as described in Part II, FDA has increasingly used extrastatutory “voluntary” recalls in conjunction with negative publicity to remove harmful products from the market, the agency has explicit statutory authority to require a company to recall its products in a very narrow set of circumstances. Section 412 of the FDCA gives the agency the authority to mandate the recall of infant formula that present risks to human health.[168] To implement a recall of formula, FDA must issue regulations detailing the “scope and extent of recalls necessary and appropriate for the degree of risks to human health presented by the formula.”[169] The manufacturer must then request that all stores that sold the formula post a notice about the recall,[170] and every two weeks it must inform FDA of the actions it is taking to carry out the recall.[171] Section 8 of the Safe Medical Devices Act of 1990 also gives FDA the authority to issue an order requiring manufacturers, importers, distributors, or retailers to stop distributing a medical device immediately and to notify health professionals and consumers of the order, when the agency determines that there is a reasonable probability the device would cause “serious, adverse health consequences or death.”[172]

5. Criminal Actions

Section 303 of the FDCA provides a variety of criminal sanctions for violations of the Act.[173] In theory, anyone who violates a provision of Section 301 is subject to imprisonment for up to one year and/or a fine of $1000, and repeat offenders, as well as those who violate the statute with the intent to defraud or mislead, can be imprisoned for up to three years or fined up to $10,000.[174] However, the Act itself establishes several exceptions under which even those who violate section 301 cannot be criminally prosecuted,[175] and FDA certainly does not prosecute every violation of the Act. Instead, it concentrates on cases where (1) the violations have been ongoing; (2) a reasonable person would have concluded that management would have known of the violation (such as a rat-infested warehouse); (3) normal attention from management could have prevented the violations; (4) the violations are life-threatening or have caused injuries; or (5) the violations are “deliberate attempts to circumvent the law.”[176] Defendants are entitled to a jury trial in prosecutions for FDCA violations, but they are held to be strictly liable for these violations. The government does not need to prove that the defendant had any awareness of wrongdoing, [177] though defendants may be able to avoid liability by proving that they had no power to prevent the violation from occurring.[178]

6. Rule-Making Authority

All of the above-described enforcement mechanisms require FDA to pursue violations of the statute on a case-by-case basis, but rule-making allows FDA to deal with industry-wide practices that it determines to be in violation of the FDCA.[179] These regulations inform the industry of the specific practices FDA considers to violate the FDCA, and if an individual company fails to comply with these regulations, FDA can then initiate one of the enforcement actions described above.[180] The procedures that FDA must follow when exercising its rule-making authority are governed by the Administrative Procedure Act.[181] The agency must first publish a Notice of Proposed Rule Making (“NPRM”) in the Federal Register, informing the public of the time, place, and nature of the rule-making proceedings; the legal authority under which the agency is acting; and the terms of the proposed rule.[182] The agency must give all interested persons the chance to submit written data or arguments, and it can also extend the opportunity for oral hearings if it chooses.[183] After considering the comments submitted to it, the agency can publish a final rule, which usually takes effect 30 days after publication.[184] Any person “suffering legal wrong” or “adversely affected or aggrieved” by a final rule may seek judicial review of the agency’s actions, normally in a Court of Appeals.[185]

B. Expenditures of Time and Resources Required for Each Mechanism

One of the most significant benefits of negative publicity as an enforcement mechanism is that it is much cheaper and faster than injunctions, seizures, criminal actions, and rule-making proceedings.[186] Injunctions, seizures, and criminal actions can all take a long time to complete: all three of these actions must be approved by several levels of administration at both FDA and the Department of Justice before they even can be brought in federal court.[187] In addition, the agency usually attempts to get the offending firm to voluntarily correct the violative procedure or practice before seeking court intervention, which further delays the amount of time it takes to complete these enforcement actions.[188] Once an injunction, seizure, or criminal action is finally brought in court, it can take years to get a final ruling: federal district courts are extremely busy, and they obviously cannot devote all of their time to processing FDA’s enforcement actions. Injunctions in particular can take a longer time to resolve at the district court level than most other enforcement actions, due to the availability of temporary restraining orders, preliminary injunctions, and permanent injunctions.[189] And even after a district court reaches a decision in an injunction, seizure, or criminal enforcement action, its ruling can be appealed by either party to the appropriate Court of Appeals and the Supreme Court, which can be another lengthy process.[190] Injunctions, seizures, and criminal actions are also quite expensive for FDA, for they require the involvement of multiple attorneys and experts, who must collect evidence to be presented to the court or jury.[191]

Rule-making proceedings also require several stages before completion, for the agency must first publish an NPRM in the Federal Register, give interested parties time to submit comments, and respond to those comments before publishing a final rule.[192] Even after a final rule is published, it cannot take effect for 30 days. Because rules do not require court approval before they become final (although they are subject to judicial review after they are finalized), FDA can complete rule-making actions entirely on its own time table, unlike seizures, criminal actions, and injunctions. However, it typically takes FDA several years to complete a rule-making, and this enforcement mechanism requires the expenditure of significant agency resources, because FDA personnel must summarize and respond to all of the comments submitted, and must explain the agency’s reasoning in promulgating the rule.[193]

Statutorily authorized recalls are similar to rule-making proceedings in that while FDA must conduct internal proceedings either before or after ordering a recall of infant formula or medical devices, no court authorization is required before the recall goes into effect.[194] Warning letters are probably the fastest and cheapest of the statutorily authorized enforcement mechanisms: they require no court intervention, and recipients of letters must respond within fifteen days before FDA will consider other enforcement actions.[195] The only resources that FDA must expend in issuing warning letters is the collection of evidence establishing that the recipient has committed a violation of “regulatory significance.”[196]

Issuing negative publicity is even less resource- and time-intensive than issuing warning letters, and is far less burdensome on the agency than injunctions, seizures, criminal actions, and rule-making proceedings, because of the complete lack of procedures that the agency must follow. Negative publicity does not require the involvement of the court or even of the parties that are the subject of the publicity, so FDA can act on its own timetable. Because FDA does not have to make a formal presentation to a court or explain its reasoning in the Federal Register, the agency does not have to expend money or time in gathering evidence to back up the statements in its press releases or in formulating reasons for why it is issuing the negative publicity. Thus, publicity can be utilized almost as soon as FDA finds out about a dangerous product, and at virtually no cost to the agency. After the press release is issued, FDA also does not have to spend time or money monitoring compliance, as it does with injunctions and statutorily authorized recalls.

C. Effectiveness of Each Power in Protecting Public from Product Dangers

Because negative publicity is cheaper and faster than all other enforcement mechanisms, it is typically thought to be the most effective means that FDA has of protecting the public’s safety, especially when it is combined with a voluntary recall.[197] Injunctions, seizures, statutorily authorized recalls, and rulemaking proceedings can end violative behavior on the part of regulated firms and remove unsafe products from the market, but only after the completion of lengthy administrative or court proceedings, as described above. Seizures are a particularly limited tool to remove dangerous products: an order of condemnation in a seizure proceeding affects only the specific items seized, so the company may produce and sell other lots of the same product even after a condemnation judgment is rendered against it.[198] In addition, seizures, injunctions, and rule-making proceedings do not reach products that have already been sold, so in the absence of publicity, consumers could continue to use hazardous products that they purchased before the initiation of the enforcement proceeding without knowing of their potential risks. While it is possible that the media could disseminate information about dangerous products that are the subject of court or administrative proceedings, these proceedings do not typically receive much media attention unless they involve a very heinous offense or famous defendants.[199]

The connection between criminal proceedings and protecting the public health is even more attenuated. A “guilty” verdict does not, in and of itself, prevent defendants from engaging in the same violative behavior in the future, although steep fines that bankrupt a corporate defendant or imprisoning of individual defendants could accomplish this result. Warning letters are also not always effective means of protecting the public from dangers, since they merely request, but do not require, that firms take actions to end violative practices that endanger the public interest.[200]

In contrast to these other enforcement mechanisms, publicity allows FDA to carry out its mission of consumer protection by enabling the agency to quickly warn the public about products that pose a serious threat to their safety.[201] When negative publicity is coupled with a voluntary recall, unsafe products are quickly removed from the market, so they can no longer endanger future purchasers. And even if individuals have already bought unsafe products, negative publicity allows FDA to warn these consumers to stop using these items and to take appropriate remedial actions. In addition, Section 705(b) of the FDCA and Sections 301 and 310 of the PHSA may allow FDA to target a broader class of products than the other enforcement mechanisms: publicity allows FDA to act in situations that present an imminent danger to the public health, even if there have been no violations of the FDCA, while an FDCA violation is a prerequisite for all of the other enforcement mechanisms.[202]

However, when FDA does not use its publicity powers consistently with the limits of Section 705(b) and Sections 301 and 310 as described in Part II.E., publicity can cause unnecessary alarm and confusion among the public, which is not really an issue with the other enforcement mechanisms. Some products, such as the contaminated cranberries described in Part II.D., are harmful to consumers only if they are consumed in large quantities over a long period of time. But consumers do not always understand these subtleties, so when they hear that a product has the potential to cause cancer or other serious illnesses, they may just panic. In addition, FDA can only issue a limited amount of information in press releases, and it cannot control how the media interprets that information and presents it to consumers. For products that do not present grave, immediate dangers, consumers might be better informed of health risks through other avenues of communication, such as through their doctors or pharmacists.[203]

Finally, the frequent use of negative publicity could result in a “crying wolf”-like problem: as one commentator has stated, a “constant stream of relatively minor product defects announced by FDA could jade the consumer and not prepare them to act in cases of real emergency.”[204] Several of the other enforcement mechanisms are often superior ways to deal with these relatively minor defects, and to prevent both consumer alarm and malaise. Injunctions and seizures prevent companies from selling products that they have already manufactured but not yet sold, so any future harm from these products is avoided without causing people to worry that their past use of the product is going to cause severe injuries. Rulemaking also prospectively prevents injury, by giving companies advance notice that their products must conform to certain requirements by a certain date, without alarming the public that their past use of the products might have been unsafe. Thus, while negative publicity may be the most effective means of protecting the public from serious dangers, it may be an inferior mechanism to deal with more minor threats to the public health.

D. Procedural Protections Afforded to Regulated Parties by Each Mechanism

In contrast to the other enforcement mechanisms, which provide regulated firms with a wide range of procedural protections, companies have almost no rights in the publicity process; they are wholly subject to the agency’s discretion to issue press releases and determine their content.[205] While notice, opportunity to be heard, and rulings by an independent decision-making or judicial review of the agency’s ruling are crucial parts of all of the other enforcement actions, they have almost no role in the publicity process.

1. Notice

In injunctions, seizures, and criminal actions, regulated parties all receive notice of the enforcement actions being taken against them in the form of a complaint, which FDA must file with the court and serve on the defendant. In addition, most parties subject to one of these enforcement actions are aware that such action is pending even before the complaint is filed. FDA usually attempts to get the company to voluntarily correct the violative procedure or practice before pursuing injunctions,[206] and the agency is required to give most potential defendants in criminal actions a hearing before going to court, which provides them with notice that the agency is considering a prosecution.[207] Parties affected by rule-making proceedings also receive notice through the NPRM published in the Federal Register. Finally, a warning letter itself provides notice to its recipients of FDA’s contemplated enforcement action.

The notice given to parties affected by negative publicity is similar to the notice given to participants in other enforcement proceedings. Under its proposed guidelines, FDA is supposed to inform affected firms of the subject matter of negative publicity, although it does not tell them in advance about the specific content of its public statements or the evidence on which the negative warning is based.[208]

2. Opportunity to Be Heard

While the agency gives some form of notice to affected parties in issuing negative publicity just as it does in conducting other enforcement mechanisms, it provides these parties with much less of an opportunity to be heard. Firms that do not conduct a voluntary recall have no right to collect and submit data to attempt to convince the agency not to release the negative statements, although FDA is supposed to develop public statements in conjunction with firms that agree to conduct a voluntary recall to of its products.[209] In contrast, defendants in injunctions, seizures, and criminal actions all have the right to participate in the court proceedings related to the these actions.[210] The Supreme Court has emphasized the importance of defendants’ participation in these court proceedings: “These proceedings for the seizure and condemnation of property which is impure or adulterated are intended to be in a sense summary, and yet the statute as we have construed it gives the owner a right to a hearing in a court of record a right of review upon questions of law by writ of error in the Circuit Court of Appeals, and...finally, in this Court.”[211] In addition, in the informal hearing held before FDA files a criminal action, a potential defendant has the right to “present his views, either orally or in writing, with regard to such contemplated proceeding.”[212]

In rule-making proceedings, companies who will be affected by the proposed rule may submit comments after the NPRM is published, and FDA is obligated to read and respond to all comments. These parties can also submit petitions to amend or repeal a finalized rule.[213] Parties affected by statutory recall orders for medical devices have the right to an informal hearing within ten days of the issuance of the order.[214]

3. Decision by Independent Decision-Maker and Judicial Review

In all of the other enforcement actions, either the ultimate decision that determines the rights of the regulated party is made by a neutral decision-maker (such as a judge or jury), or if FDA makes the ultimate decision, its decision is subject to judicial review by a court . Injunctions, seizures, and criminal actions fall into the first of these categories, and rulemaking proceedings and statutory recalls fall into the latter category. Warning letters are a bit more difficult to classify: the agency and the courts do not consider warning letters to be final agency actions which are subject to judicial review,[215] but recipients can effectively get the agency’s position in the letter reviewed by a court if they do not comply with the agency’s request and are subjected to a seizure, injunction, or criminal action.

In contrast, negative publicity clearly does not fall into either of these categories. The agency itself is the final arbiter of whether a press release is reasonably necessary to protect imminent harm to the public health or gross deception – FDA is, in effect, the prosecutor, judge, and jury. And the agency’s decision to issue negative publicity is, as explained in Part II.C., not subject to meaningful judicial review, because courts rarely analyze whether the information released meets the narrow requirements of Section 705(b) or Sections 301 and 310. Instead, courts seem reluctant to question FDA’s claims that its actions were necessary to protect the public, even in cases where it becomes clear after the fact that such extreme measures were not necessary. Judicial review of publicity decisions is also difficult because no record exists and the agency’s decision-making procedures are vague.[216] Thus, the procedural protections that regulated companies receive in the negative publicity process are much lower than the rights to which they are entitled in any other enforcement proceeding, which makes it easier for FDA to abuse its powers and to act outside its statutory authority.

E. Other Effects on Regulated Parties

Besides infringing on their procedural rights, negative publicity can have several other effects – some of which are beneficial, some of which are harmful – on regulated companies when compared to FDA’s other enforcement mechanisms. First, negative publicity allows regulated companies to avoid the official penal or civil fees and other sanctions that are associated with more formal enforcement actions.[217] For example, in seizure actions, companies who are unsuccessful in challenging the seizure of their products must pay the costs and fees for the storage or destruction of the offending article,[218] and criminal actions can result in large fines and possibly imprisonment for corporate officers.[219] There is also a stigma associated with being a defendant in an action brought by the government, but companies whose products are merely the subject of a negative press release are not subject to the official imprimatur of wrongdoing.

While companies whose products are the subject of negative publicity can avoid court-ordered penalties and stigma, negative publicity does have the potential to cause much greater financial harm to regulated companies than any other enforcement action. The media is much more likely to report FDA’s public statements that a certain product is harmful than it is to report on FDA’s institution of a criminal or civil enforcement action or a rulemaking proceeding – even though in all instances the agency has determined that a particular product is unsafe. The reputational harm is thus potentially greater with negative publicity, and it can extend beyond the particular products that are the subject of the press release, to tarnish and reduce sales of the company’s entire product line, as demonstrated by the Bon Vivan incident described in Part II.D.[220] In contrast, even though seizures cause companies to lose money on products they have already produced but can no longer sell, the sales of a company’s other products are likely to be unaffected if the public does not learn about the enforcement action. Rulemaking proceedings impose even more limited costs on the regulated parties: since companies receive advance warning of the rule, they can take measures to bring their products in compliance before the rule becomes finalized and avoid lost sales completely.

The lack of procedural protections and meaningful review, combined with the severe harm that can come from press releases, can coerce companies into accepting FDA’s determination of whether a product is harmful and to go along with the agency’s request to remove or stop producing a product. As discussed in Part II.E., the press releases that FDA issues about the products of uncooperative companies are often much more negative and inflammatory than the press releases issued in conjunction with a company’s voluntary recall of a product. Companies thus have a strong incentive to comply with the agency’s demands for a voluntary recall, so they can avoid the reputational harm that might come from a very negative press release.[221] One commentator has labeled this practice of threatening negative publicity as “administrative arm-twisting,” and he offers the following description of the harms of this practice:

Arm-twisting succeeds and evades judicial scrutiny in part because companies in pervasively regulated industries believe that they cannot afford to resist agency demands. For instance, some critics have accused the FDA of retaliating against firms that fail to cooperate. Whether or not such charges are accurate, the perception leads companies to accede to the Agency’s demands even though they may lack basis in law or fact.[222]

Thus, the “arm-twisting” power of negative publicity can allow the agency to target actions that may not actually violate the statute, because they know that affected companies will not fight back.[223] In contrast, FDA must carefully decide when to bring a formal enforcement proceeding or initiate a rule-making action, because it knows that the regulated party has the opportunity to vigorously argue that its actions do not violate the statute, and that an independent party will ultimately decide whether a violation exists.

E. Institutional and Public Policy Considerations

Another problem with the agency’s use of negative publicity as an enforcement mechanism is that its decision-making process in this field completely lacks transparency, especially when compared to FDA’s other enforcement mechanisms. In presenting its injunction, seizure, or criminal case to a judge or jury, FDA must continually explain why it believes there is a statutory violation and present evidence to support its position. Similarly, in rulemaking proceedings, the agency must offer justifications for its actions when it issues both the NPRM and the final rules. But there are no such requirements before FDA issues negative publicity, and, as demonstrated in Part II.E., press releases and talk papers frequently fail to provide the evidence on which a product warning is based Even the procedures that FDA follows in deciding whether to issue a press release and its content are basically secret: FDA never finalized its proposed publicity policy, and it has not given any indication whether it actually adheres to those guidelines. In contrast, the procedures that FDA follows in carrying out injunctions, seizures, rulemaking proceedings, warning letters, statutory recalls, and criminal actions are readily available to the public in either the Code of Federal Regulations or the Regulatory Procedures Manual. This lack of transparency in FDA’s use of negative publicity contradicts the fundamental democratic principle that voters are entitled to have full information about the operations of their government. Thus, even though the informality of negative publicity often makes it an attractive enforcement mechanism, this informality also can have grave consequences both for the regulated companies and the public.

IV. Case Study: Phenylpropanolamine (PPA) Public Warning

In order to highlight some of the issues described in the previous sections, this Part examines in detail one particular use of negative publicity by FDA: its issuance of a public advisory in November 2000 about the safety of PPA, a chemical compound that had been widely used in OTC nasal decongestants and weight loss pills since 1938. This Part begins by outlining the procedures that FDA usually follows in regulating substances used in OTC products, then discusses FDA’s regulation of PPA prior to November 2000. It then presents the findings of the Hemorrhagic Stroke Project (“HSP”) study, which found a connection between PPA and stroke in some subgroups of the population, and FDA’s consideration of this study, which ultimately led to the public advisory. After discussing the effects of the public advisory on regulated companies and consumers, this Part then analyzes whether FDA’s issuance of the PPA advisory was within its statutory powers, and whether any other enforcement mechanisms would have been preferable to a press release in this situation. I conclude that it is questionable whether the agency had statutory authority to issue publicity in this situation, since the HSP study did not conclusively find that PPA presented a safety risk, and a rule-making proceeding would have better protected the rights of regulated companies without causing the same inconveniences and confusion both to consumers and the industry.

A. General Description of the OTC Drug Review Process

In order to understand FDA’s regulatory actions related to PPA, it is necessary to consider FDA’s overall regulatory strategy for dealing with OTC drugs. After the 1962 amendments to the FDCA required the agency to consider the safety and effectiveness of all currently marketed OTC drugs, FDA had the option of either “initiating a separate court action with respect to each violative OTC drug or to deal with all OTC drugs through rulemaking by therapeutic classes on an industry-wide basis.”[224] It chose the latter option, because of the expensive and time-consuming nature of case-by-case litigation, and the inadequate consumer protection that would result from leaving violative drugs on the market until FDA could evaluate and initiate court action against each of these products.[225] FDA thus decided to issue regulations to establish whether each of the 200 ingredients commonly found in most OTC products were safe and effective.[226] The agency divided the ingredients by therapeutic class, and appointed an advisory review panel of experts to evaluate the safety and effectiveness of drugs in a given therapeutic class.[227] The panels have the authority to consult with any individual or group, and any interested person can present written or oral data to the panel.[228]

After evaluating all available information about the drugs in a particular therapeutic class, the panel makes a report to the FDA commissioner with three sections: (1) a recommended monograph covering the ingredients that the panel determined to be generally recognized as safe and effective (“GRASE”) and the conditions under which these ingredients should be used (Category I); (2) a statement of ingredients and conditions that the panel has determined to be not GRASE (Category II); and (3) a statement of ingredients and conditions that the panel excluded from the monograph due to insufficient data to determine their GRASE status (Category III).[229] The Commissioner reviews the panel’s report, and then publishes in the Federal Register a proposed monograph establishing the conditions under which OTC drugs in that therapeutic class will be considered to be GRASE, as well as a statement of conditions excluded from the monograph either because they are not GRASE or due to insufficient data.[230] Interested parties are then given the opportunity to submit comments about the proposed monograph, and after reviewing the comments, the Commissioner must publish a tentative monograph containing the conditions under which OTC drugs are GRASE.[231] The agency must then again give interested parties an opportunity to file written objections and also to request an oral hearing, which FDA must grant if it finds reasonable cause.[232]

After reviewing any objections, FDA then publishes a final order containing a monograph establishing conditions under which a category of OTC drugs is considered to be GRASE. [233] This final monograph is considered final agency action and is subject to judicial review by the federal Courts of Appeals.[234] While FDA allows continued marketing of most OTC products during this lengthy process of developing a final monograph, once an OTC drug monograph became final, manufacturers must submit a new drug application (NDA) for any drug that deviates from the monograph or else be subject to formal enforcement action.[235]

B. FDA Regulation of PPA Prior to May 2000

PPA was part of the OTC monograph process for two categories of OTC drugs: nasal decongestants and weight control products. In 1976, the advisory panel for nasal decongestants recommended that PPA be classified as GRASE.[236] The advisory panel for weight control products made a similar recommendation, but in its publication of an advanced NPRM to establish a monograph for weight control products, FDA noted that since the panel made its recommendation, studies had been released that demonstrated that PPA may increase blood pressure.[237] The agency requested comments and further study on this issue, but stated that it would not remove products with PPA dosage levels that had a marketing history of use until the safety questions were resolved.[238]

FDA published this advance NPRM for the weight control monograph in 1982, but it apparently took no further regulatory action on the monograph until 1990, when it published an NPRM that 111 weight control ingredients were to be classified as not GRASE.[239] This NPRM did not include the ingredients that would be classified as GRASE; FDA stated that it chose to release an NPRM relating solely to the Category II and III ingredients in order to give manufacturers the opportunity to reformulate their products before the promulgation of the final monograph.[240] The final rule mandating that the presence of these 111 active ingredients in weight control drugs would result in the products being misbranded was issued in August 1991.[241] Because PPA was originally classified as GRASE, it was not affected by this rule, and manufacturers were allowed to continue using it in their products.

In 1991 FDA announced that it was reopening the administrative record and holding a public meeting to discuss the safety and effectiveness of PPA for use in weight control products, due to the data and comments it had received about the effects of PPA on the central nervous system.[242] After reviewing these comments, the agency stated that it had concluded that the evidence linking PPA to strokes and other adverse events was inconclusive.[243] Because PPA users rapidly develop a tolerance to PPA’s hypertensive response, it is most plausible that PPA would cause an adverse reaction after the first day or first dose of use, but very few reported stroke incidents were first day/first dose cases.[244] In addition, most of the serious cases occurred after the ingestion of a single dose of weight loss medication that was above the recommended dosage, suggesting that normal use of these products might not be problematic. FDA had received very few reports of negative effects after using cough-cold medicines containing PPA, which seemed to indicate that PPA was not the cause of increased hypertension in patients taking weight control products.[245] FDA’s decision to reopen the administrative record was based in part on a hearing held by the House Small Business Subcommittee on Regulation, Business Opportunities, and Energy, chaired by Rep. Ron Wyden, on September 24, 1990. At that hearing, witnesses presented testimony showing that OTC drugs containing PPA had more serious adverse effects in people under 29 years old than any other OTC products, and that clinical trials confirmed the increase in blood pressure.[246] Witnesses also testified that most people who use weight control products with PPA misuse these drugs.[247]

FDA’s next action related to the regulation of PPA was to ask outside epidemiologists to review the data relating to the use of PPA and subsequent adverse effects.[248] The findings of these epidemiologists were mixed: one scientist concluded that the “reports indicated the need for a population-based case-control study of PPA use and intracranial bleeding,” because the reports in the current medical literature and FDA’s analysis did not support or refute an association.[249] But another epidemiologist determined that the data did not support an association, because there was no evidence about what percentage of hypertensive incidents had been reported or what the background rate for stroke incidence was. This scientist also stated that a case control study would be inconclusive because it would be difficult to get a large number of cases, and cases would be more likely to recall some possible association with an event or drug than the controls.[250]

Soon after these epidemiologists reported their findings to FDA in 1992, the Nonprescription Drug Manufacturers Association (“NDMA”), the trade association for OTC manufacturers, proposed a large-scale epidemiologic case-control study of PPA and stroke. NDMA’s proposal was based in part on a concern that FDA would classify PPA as GRASE, thus requiring these companies to take their PPA products off the market.[251] FDA officials then sent a letter to NDMA in March 1993, stating that it was critical that this proposed study be carried out promptly, and that it “provide a large enough database to determine if the incidence of stroke association with ingestion of PPA is greater than the spontaneous rate of stroke.”[252] The letter also stated that the agency intended to classify PPA as not GRASE in its proposed rules, but that it was not necessary to remove PPA products from the OTC market while the study was being conducted.[253] Over the next few months, FDA and NDMA worked together to revise the protocol for the stroke study, which began in 1994.[254]

Around this time NDMA also proposed voluntary changes in the package labeling, advertising, and promotion of PPA weight control products to inform consumers that taking more than the recommended dosage will not increase weight loss and may be effective. FDA informed NDMA that these changes met the agency’s safety concerns, but that the agency still intended to classify PPA as not GRASE until additional studies could prove that an immediate-release dosage form was safe and effective.[255] Yet in spite of FDA’s repeated statements to NDMA that it would classify PPA as not GRASE, the agency never published a proposed or final rule about the safety and effectiveness status for PPA.[256]

C. The Hemorrhagic Stroke Project Study

The study proposed by NDMA was carried out by the HSP between December 1994 and July 1999.[257] The study had three goals: (1) to determine the association between PPA and stroke; (2) to estimate the association by type of PPA exposure; and (3) to estimate the association between first use of PPA and stroke, as well as the association between PPA in appetite suppressants and stroke, among women ages 18-49.[258] The researchers located 702 case subjects – men and women between the ages of 18 and 49 who were hospitalized with subarachnoid hemorrhage or intracerebral hemorrhage and who had no prior history of stroke and were able to participate in an interview within 30 days of suffering the stroke.[259] The researchers then matched, through random digit dialing, each case subject with two control subjects who had the same age, gender, race, and telephone exchange.[260] Both the cases and controls were asked a series of questions about their prior medical history, personal habits, and their use of prescription and over-the-counter drugs (including drugs containing PPA). A subject was classified as having been exposed to PPA if he or she reported using a PPA product within 3 days of the stroke event (or a corresponding date for control subjects) and if the exposure was verified.[261] There were 28 reported PPA uses for case subjects and 35 reported uses for control subjects.

After performing statistical analyses, the researchers found statistically significant odds ratios for the association between stroke and PPA use in appetite suppressants.[262] This association was even higher for women than for the general population, and there was a statistically significant association between first use of PPA and stroke for women.[263] However, the odds ratio for the association between any PPA use in three days and stroke was not statistically significant.[264] Nevertheless, the researchers concluded that the results of their study “suggest that PPA increases the risk for hemorrhagic stroke.”[265] They acknowledged that there could have been recall and selection bias in the design of the study, but concluded that none of these variables were likely to affect the study’s outcome. The researchers also pointed out several potential limits to their research: (1) they excluded dead and non-communicative stroke patients, so they did not know the association between PPA and stroke for these patients; (2) the low number of case and control subjects with PPA exposure limited the opportunity for sub-group analysis; and (3) the interviewers knew the case or control status of subjects and some were aware of the study’s purpose.[266]

D. FDA’s Consideration of HSP Study and Subsequent Regulatory Action

HSP released its findings on May 20, 2000, but FDA did not immediately issue the public health advisory; instead, it first took several steps that were initially consistent with the OTC drug review protocol. First, FDA’s Office of Post-Marketing Drug Risk Assessment performed its own analysis of the stroke project survey. FDA’s researchers found it to be well-designed and executed, with “all reasonable steps taken to minimize bias and confounding variables.”[267] The researchers concluded that the “weight of the evidence” from the study, along with the 37 spontaneous reports of PPA-related stroke to FDA since 1991 and the reports in the published literature, indicated that PPA products should be taken off the market.[268]

Second, even though FDA did not formally solicit comments about the study as it did throughout the rest of the OTC protocol review process, it did receive information critical of the study from NDMA’s successor organization, the Consumer Healthcare Products Association (“CHPA”). In a letter to FDA’s Dockets Management Branch, CHPA said that no broad conclusions could be drawn from the study, since the overall odds ratio for PPA use and stroke was not statistically significant, and there were not enough cases and controls to control the sub-group associations for confounding factors.[269] In addition, the reported association could arise from the comparison of subjects already at a high risk for stroke (as evidenced by their higher levels of hypertension, cocaine and alcohol abuse, caffeine consumption, family history, and obesity), with subjects from the general population.[270] CHPA also criticized the study for its choice of statistical analysis and for not providing a biological explanation for the relationship.[271] CHPA subsequently convened its own panel of experts to review the stroke study, and that panel concluded that because of the study’s small number of PPA cases and high number of confounding variables, the study could do no more provide “supportive evidence” of an association if “there are other scientifically valid confirmatory data.”[272] The experts also found that because stroke was a rare event even among users of PPA, any risk of stroke to PPA users in the general population – even if real – would be very small.[273] Although FDA accepted this information from CHPA, it is unclear to what extent it influenced the agency’s decision to issue a public advisory.

Third, the Nonprescription Drug Advisory Committee (NDAC) held a meeting on October 19, 2000, at which they reviewed the regulatory history of PPA and heard from representatives of the Hemorrhagic Stroke Project, CHPA, and the Office of Post-Marketing Drug Risk Assessment. The 14 NDAC members then voted on whether they believed there was a general association between PPA and stroke. [274] Despite the fact that the stroke project did not find a statistically significant relationship between all PPA use and stroke, 13 members said that they believed such an association existed, while only one member found the data inconclusive. Twelve members of the committee said that PPA should not be considered generally recognized as safe for use as a decongestant, and 13 recommended that it not be considered GRAS for use as an appetite suppressant.[275]

After FDA receives a recommendation from the NDAC on an OTC ingredient’s safety and effectiveness, the next step in the OTC protocol would typically be to initiate a rule-making procedure to classify the ingredient as GRASE or not GRASE. However, FDA did not engage in this formal regulatory action after the NDAC’s determination on the GRAS status of PPA. Instead, it first sent a letter to all manufacturers of PPA products, stating its intention to issue a public health advisory and requesting that these companies “voluntarily discontinue marketing any drug products containing PPA” and reformulate their products to remove PPA, if possible.[276] The letter described these requests as “interim measure[s] to protect the public health” until FDA could initiate a rule-making proceeding to classify PPA as nonmonograph.[277] In this letter, FDA did not request that manufacturers recall PPA products already on the market, just that they not sell any more of these products.

On November 6, 2000 – a mere three days after it sent the letter to PPA manufacturers – FDA issued the public health advisory, set forth in the Introduction, about the stroke risk of PPA. The health advisory slightly overstated the findings of the stroke project study: while it correctly reported that the study determined that PPA increases the risk of stroke in women, it indicated that the study found a connection between PPA and stroke in men as well, even though the odds ratio for men was not statistically significant.[278] Despite twice acknowledging that the risk of stroke was very low, the advisory still gives the overall impression that PPA presents serious health risks to the general population: the advisory states that FDA has “significant concerns” about the inability to predict who is at risk, and it recommends that all consumers stop using products containing PPA and gives instructions about how to identify these products.[279] These statements are slightly misleading: because the study did not find a general statistically significant association between any PPA use and stroke, the entire population is most likely not at risk. Since the study did find that stroke victims were more likely to present certain confounding factors (like cigarette smoking, family history, and obesity) than the general population, it would have been possible for FDA to identify subsets of the population that were at greater risk.[280]

The health advisory also does not refer to any of the limitations that the study’s authors recognized in their report, nor does it present the alternative interpretations of the study by CHPA experts; it instead treats the study as infallible scientific evidence of PPA’s health risks.[281] In addition, only sophisticated consumers would realize – based on the statement that “FDA is taking steps to remove [PPA] from all drug products and has requested that all drug companies discontinue marketing products containing PPA” – that FDA had not yet made the use of PPA illegal at the time of the health advisory.[282] However, the health advisory does at least briefly explain the cost-benefit analysis behind FDA’s decision to issue the health advisory about PPA, by stating that “FDA does not consider the conditions for which [PPA] is used as justifying the risk of this serious event. Other products are available for use.”[283] In this respect, and in this respect alone, the advisory is similar to a notice of proposed or final rule-making in the Federal Register, in which FDA must explain the reasons why it is undertaking a regulatory action.

E. Effects of the PPA Public Advisory

The public health advisory about the safety of PPA had significant short-term effects on consumers, pharmacies, and OTC manufacturers. First, even though FDA did not initiate a voluntary manufacturer recall of PPA, products containing PPA quickly came off the shelves: within hours of the issuance of the advisory, large drug store chains such as Walgreens, CVS, and Rite-Aid announced that they would remove products containing PPA from their shelves.[284] While major pharmaceutical companies such as Smith-Kline Beecham and Bristol Myers Squibb simultaneously announced that they would reformulate their products to remove PPA in order to comply with FDA’s request,[285] it took several weeks (until mid-December) for companies to complete this reformulation and ship products to stores.[286] In the meantime, consumers had few cough-cold and weight loss products available to them in the stores that decided to remove PPA products, and in the stores that did not remove the products, customers had to make the decision whether to heed the FDA’s dire warnings or to use these familiar products anyway. One reporter described the following scene in New York pharmacies in the days after the issuance of the health advisory:

When her coughing and congestion got to be too much yesterday morning, Cindy Moona dragged herself to the Rite-Aid pharmacy on Amsterdam Avenue near West 69th Street in Manhattan. She squinted her watery eyes to read labels, looking for just the right medicine for her many annoying symptoms. She found a Rite-Aid cold medicine and hurried to the checkout with money in hand, minutes away from breathing easily, she thought. But that is when a clerk waylaid Ms. Moona’s relief plains, confiscating her cough syrup....In the wake of the F.D.A.’s advisory against [PPA], an ingredient used as a decongestant in many cold remedies and in appetite suppressants, the exasperating scenario that confronted Ms. Moona was commonplace across the city and the country as consumers and druggists sought to make sense of the new advisory...In certain stores there was outright confusion. In others, consumers found cleared shelves and direct warnings. But the atmosphere in most pharmacies fell somewhere in between, and customers used their own calculations of personal risk to decide whether to buy the product...[One pharmacy owner] said that as long as the F.D.A. had not ordered a ban on the products, he still considered them safe. “What happens is that this flood of information is confusing,” he said. “I don’t think people should be too alarmed.”[287]

In addition to the confusion among consumers during the month-long interlude between the issuance of the advisory and the completion of the reformulation, both manufacturers and pharmacies lost money because they did not sell any cough-cold remedies or weight loss supplements that had previously contained PPA during this time. Though no precise figures about how much companies lost could be located, it is logical to assume that manufacturers sold about 10 percent fewer doses of PPA products in 2000 than they had in 1999. If that assumption is correct, since 6 billion doses of PPA were sold in 1999,[288] manufacturers and pharmacies lost the revenues from the sales of 60 million doses. In addition, some manufacturers set up toll-free numbers and websites to offer consumers refunds and exchanges for PPA products that they had previously purchased, which means that these companies incurred the costs of those refunds and exchanges as well.[289] Because most PPA product manufacturers are huge companies with many other products – for example, Bayer’s $110 million in sales of its PPA product, Alka-Seltzer Plus, accounted for only 1 percent of the company’s total revenues in 1999 – these losses did not have too great of an impact on their revenues for the year.[290] However, for some smaller manufacturers, the advisory was quite costly: 7 percent of Chattem Pharmaceuticals’ sales came from the PPA weight loss product Dexatrim, and reformulation was more difficult and time-consuming for weight loss products than for cough-cold remedies because there was no ready substitute for PPA in appetite suppressants.[291]

After companies were able to replace PPA with other ingredients and ship the reformulated products to stores, they presumably stopped losing sales, because there is no evidence that consumers bought these new non-PPA products less often than they had bought PPA products before the issuance of the advisory. But companies have incurred significant litigation expenses related to PPA: since the advisory was issued, hundreds of lawsuits have been filed across the country against PPA manufacturers, alleging that PPA caused death or serious injury.[292]

The health advisory’s most significant effect was its ultimate goal: to remove PPA from cough-cold and weight loss products. Today, PPA is not found in any OTC products, despite the fact that FDA has yet to formally classify PPA as GRASE, so manufacturers are technically allowed to sell products containing PPA without being subject to a formal enforcement action. Since the issuance of the health advisory, the only formal regulatory action that FDA has taken against PPA is to issue a proposal to withdraw approval of NDA’s and abbreviated NDA’s for products containing PPA.[293] This proposal, which apparently has never been finalized, did not apply to products marketed under the OTC drug monograph system, however. In the most recent semi-annual regulatory agenda for the Department of Health and Human Services, FDA stated that it planned on issuing an NPRM to classify PPA as not GRASE in April 2003.[294] However, since FDA has missed several other self-imposed deadlines about when it will issue this NPRM for PPA, it is unlikely that FDA will take formal regulatory action anytime soon.[295] Since PPA has already been removed from the market, this NPRM, and any subsequent final rule, would be a mere formality anyway.

F. Analysis of PPA Public Advisory and Other Potential Enforcement Options

In retrospect, FDA’s issuance of the public health advisory about PPA most likely exceeded its Section 705(b) and Sections 301 and 310 publicity powers, and issuing negative publicity was not the most effective enforcement mechanism the agency could have employed to remove PPA products from the market. Instituting a rule-making procedure to formally declare PPA non-monograph would have given PPA product manufacturers more procedural rights, and it would have created less public confusion and guaranteed that the public had continual access to cough and cold and weight loss products. Even if this situation was one in which negative publicity was warranted, FDA could have acted more responsibly in issuing the PPA public advisory: it could have given manufacturers more notice of its intention to issue a press release, and it could have worded the advisory differently to more accurately reflect the results of the HSP study and reduce unnecessary public alarm.

The public advisory about PPA was most likely not within FDA’s Section 705(b) powers. In this situation, it may have been unreasonable for FDA to conclude that PPA posed an imminent danger to the public health. Even assuming the validity of the HSP study (which is a generous assumption, given the criticisms by CHPA and other independent epidemiologists), the study found only a slightly increased stroke risk in women, most of whom were already at risk for stroke due to obesity, family history, smoking, or other confounding variables. Merriam-Webster’s Dictionary defines “imminent” to mean “ready to take place, especially hanging threateningly over one’s head.”[296] The fact that the risk of stroke remained so low, even after factoring in the increased risk from PPA, makes it almost ludicrous to apply this definition to PPA.

In addition, the public advisory does not seem warranted under Sections 301 or 310 of the PHSA. Section 301 gives FDA the power to conduct research and investigations relating to “physical and mental diseases and impairments of man,” and to “collect and make available through publications...information as to, and the practical application of, such research and other activities.”[297] PPA does relate to the treatment of “physical and mental diseases and impairments of man,” and FDA did cooperate with CHPA in designing the HSP study, so several of the requirements of Section 301 are met. However, the language of the advisory – which warns the public as a whole to stop using PPA and tells manufacturers to remove the ingredient from their products – seems to go beyond just “collecting and making available” the results of the HSP study. Perhaps if FDA had merely released the results of the HSP study and indicated that the study raises serious issues about the safety of PPA, without including such a strongly worded warning that prompted pharmacies to take PPA products off the shelves, it would be able to claim that it was acting within the scope of Section 301. Finally, a public advisory is not the type of regular, comprehensive publication that seems anticipated by the “from time to time” language of Section 310(b).[298] If FDA had instead released the results of the HSP survey in a publication that dealt with a number of other public health issues, it would probably have a valid argument that it was acting under Section 310(b).

Even though FDA might have been acting outside its statutory authority in issuing a public advisory about PPA, its ultimate determination that PPA should be removed from the market seems correct, in light of the limited efficacy of PPA in either cough-cold or weight loss products and the existence of other chemical compounds that produced the same results without increased risks. But there were numerous other enforcement mechanisms, besides issuing a public advisory, to accomplish this goal: FDA could have instituted seizures, injunctions, or a rule-making proceeding. However, because countless PPA products could be found in virtually every pharmacy across the country, a seizure of all of these products seems infeasible. It would have required the cooperation of the entire U.S. Marshal staff to take possession of these items. In addition, it is unclear whether a judge would have granted FDA’s request to issue an order of condemnation of the seized products: without a formal FDA determination that PPA was not GRASE, FDA would have difficulty arguing that products containing PPA violated the FDCA.

Injunctions would have been impractical for many of the same reasons. Without a formal determination that PPA was unsafe, FDA would not have had a very convincing argument that the manufacturers’ actions in producing and distributing these products needed to be enjoined. Asking for an injunction in this situation probably would have gone against the guidelines in FDA’s Regulatory Procedures Manual, which provides that injunctions should be utilized where a “current and definite health hazard requires immediate action” and the company has declined to voluntarily correct numerous violations.[299] As explained above, it is difficult to characterize the stroke risk from PPA as “definite,” given the findings of the HSP study that the risk was so small. Also, FDA had never formally asked the manufacturers to remove PPA from their products. Finally, although injunctions are typically used when multiple seizures would be infeasible, asking for an injunction against every single manufacturer of PPA products would have been a huge drain on the agency’s and the court’s resources.

FDA could have easily instituted a rule-making proceeding, however, to formally declare that PPA was not GRASE, which would have prohibited the use of PPA without an approved NDA. This regulatory option would have greatly increased the procedural rights of the drug manufacturers. First, by allowing them to submit comments after the publication of the NPRM, rule-making would have given them a greater chance to voice their concerns about the HSP study. Although CHPA submitted some comments to FDA right after the HSP study was released, the industry fell silent after the advisory was issued: CHPA apparently stopped questioning the results of the stroke project study, while individual manufacturers did not publicly challenge FDA’s attacks on their products but instead complied completely with FDA’s requests. One potential explanation of this new silence is that manufacturers feared that if they questioned FDA’s decision, consumers would think they did not care about the safety of their products, which would undermine their public image. The issuance of the health advisory thus completely ended, without any formal regulatory action, the scientific debate about the safety of PPA, which had been active since the early 1980’s. Through its notice-and-comment procedures, rule-making would have allowed this debate to continue.

Second, issuing a public health advisory deprived the manufacturers of the opportunity to hear FDA’s responses to their criticisms or to learn the basis for FDA’s decision. If the agency had instituted a rule-making procedure instead, it would have been forced to respond to the manufacturers’ comments in the publication of the final rule, and it also would have had to explain in detail why it was taking this regulatory action. While the public health advisory seems to indicate that FDA’s decision was primarily based on the HSP study, it does not give any clue as to whether other factors – such as the spontaneous reports that FDA had received over the years about strokes following ingestion of PPA – affected either the NDAC’s recommendation or FDA’s final decision. The typical publication of a tentative or final monograph in the OTC drug review goes into much greater detail about the evidentiary foundation for declaring that a drug is GRASE or not GRASE, with an extensive analysis of the scientific merits of the research studies on that product.[300] The manufacturers did not get the benefit of knowing precisely why the agency was issuing a public health advisory, which seems only fair given the tremendous effect that the advisory had on their products. This lack of transparency about FDA’s decision-making process could also give the agency the reputation as an arbitrary decision-maker and undermine its credibility in knowing what is best to protect the public health.

Third, FDA’s failure to implement a rule-making procedure to declare the non-monograph status of PPA deprived the manufacturers of any meaningful opportunity to challenge FDA’s decision that its products were unsafe. CHPA would have had to act very fast to file for an injunction to halt FDA from issuing the public advisory, since FDA informed manufacturers of its intentions a mere three days before it issued the warning. Even if the manufacturers would have gotten to court on time, the court would most likely have summarily dismissed the action, due to courts’ reluctance to question FDA’s judgment about what is necessary to protect the public health. Meaningful court review would have been equally infeasible after the public advisory issued: manufacturers would be unwilling to file a court action after FDA publicly declared their products unsafe, for fear of conveying the impression that they did not care about the public’s health. As explained in Part II.C., courts are equally hostile to post-publicity challenges to negative publicity, and even if the manufacturers had succeeded in their court action, any remedies they received could not have erased the harm to their reputation caused by the press release.

However, if FDA had instituted a rule-making proceeding, manufacturers could have brought a court challenge to the rule after it became final. They would probably have been more likely to take such action after rulemaking than after the issuance of negative publicity, because filing a lawsuit to challenge a rule would probably not receive extensive media coverage and affect the companies’ reputations. Rulemaking also would have prevented the economic loss to manufacturers and consumer confusion. There is typically a gap of 30 days between when a final rule is published in the Federal Register and when it goes into effect. During this time, manufacturers could have removed PPA from their products and shipped the reformulated products out to retailers, so that there would not have been a period of time in which no cough-cold and weight loss remedies were being sold. This alternative would have prevented the lost sales incurred by manufacturers and retailers, and it would have been preferable for consumers, who were left without any cough-cold remedies and weight loss products for a significant period of time after the PPA advisory was issued.

In addition, a rulemaking would have prevented alarming the public that they were putting themselves in grave danger from consuming these common household products. Taking the products off the shelves via rulemaking would have prevented any future harm that could have occurred from the products, since the study found that the increased risk of stroke from PPA occurred most often after the first use, and always within 1-3 days of use. If the study had found significant long-term effects from using PPA, a public warning to inform people that their past behavior could have future effects might have been more justifiable, so they could take actions to minimize the chance that these harms might result. But that was not the case here: the only people who were in danger of suffering a stroke caused by PPA were those might consume PPA in the future, not those who consumed it in the past.

Finally, instituting a rulemaking instead of issuing a press release would have been more consistent with the agency’s past practices in the OTC drug review and its treatment of drugs generally. FDA had already issued final regulations about the ingredients that were not GRASE for use in weight loss products, which meant that these ingredients could not be used without an approved New Drug Application. Issuing a press release to deal with PPA thus created a lack of uniform regulation of OTC drugs. In addition, it is very rare that FDA removes a drug from the market in such a dramatic way.[301] When the agency does take this drastic measure, it is typically when there is overwhelming scientific evidence that the drug is unsafe, or when the manufacturer has not responded to repeated requests to voluntarily remove the drug itself.[302] Neither of these conditions was met in the case of PPA.

Instituting a rulemaking instead of issuing a press release would certainly have had one drawback: it would have taken a much longer time to complete, so PPA products would have remained on the shelves for an additional period of time. The OTC drug review is notorious for how long it has taken to complete: typically several years have passed from the publication of a tentative monograph to the publication of a final monograph.[303] However, there is no requirement that rulemaking has to take that much time; FDA could have expedited the processing of a rule declaring PPA to be not GRASE, since only one ingredient (instead of the 111 involved in the original weight loss monograph) was at issue, and much of the scientific evidence was already compiled. FDA had known of the potential risks of PPA since the early 1980’s, and the HSP study had taken 7 years to complete. Thus, it is unclear how much more harm could have come from waiting an extra year to remove PPA from the market entirely, especially given the very low risk of stroke presented by the product. Any benefits that could have accrued from issuing the press release seem to be outweighed by the negative impact on the manufacturers and the public as a whole.

Even if this cost-benefit analysis is incorrect, and a press release was necessary to deal with the dangers presented by PPA, FDA could have done a much better job in how it handled the public advisory. First, it could have given manufacturers more notice of its intention to issue an advisory: even waiting a week would have given them additional time to begin reformulating their products and could have assured a more smooth transition from PPA to non-PPA products. In addition, the wording of the advisory could have made it clearer exactly who was at increased risk from taking PPA: women between the ages of 18-32 who presented certain risk factors. Instead of recommending that all consumers not use products containing PPA, FDA could have targeted its recommendations towards this particular subgroup. This targeted warning may have prevented retailers from pulling the products and creating mass confusion in the stores, while at the same time putting manufacturers on notice that FDA expected them to reformulate their products. In the meantime, the most at-risk consumers would have had the information they needed to make an informed decision about whether to take PPA products. Thus, it is clear that there were several better alternatives available to deal with the risks presented by PPA than issuing the particular public advisory actually released.

V. Conclusion

The foregoing discussion of FDA’s use of publicity generally and the PPA public advisory in particular has highlighted some of the problems with this enforcement mechanism. First, FDA has not issued any final guidelines that proscribe when it will use negative publicity and what the content of its public statements will be, and the proposed guidelines give the agency much discretion. Second, FDA often issues public warnings that are overbroad and likely to cause undue alarm in the general public, and press releases often do not back up their assertions of product dangers with scientific evidence. Third, the procedural rights of regulated companies who will be affected by negative publicity are very limited, especially when compared to FDA’s other enforcement alternatives: individuals do not have the right to submit information to FDA before the press release is published, and due to courts’ deference to FDA, they have no opportunity for meaningful judicial review of the agency’s decisions in this field. Due to these lack of procedural protections, FDA has the potential to use negative publicity in situations when its statutory authority is questionable and as a means to punish uncooperative companies. Finally, FDA often acts outside the explicit statutory authority to issue publicity given to it by Section 705(b) of the FDCA and Sections 301 and 310 of the PHSA.

The solution to these problems is certainly not to amend the FDCA to prohibit FDA from ever issuing negative publicity. Press releases and talk papers are necessary in cases where products present a grave, immediate danger to large numbers of people, and the only way to inform those at risk is to give the public the information they need to protect themselves. However, several reforms of the current system are necessary in order to prevent the abuses described above and to ensure the rights of both regulated companies and the public. First, FDA should finalize new guidelines about the procedures that agency follows in issuing publicity, in order to make the entire process less secretive. These guidelines should include the following mandates: (1) the agency will only issue negative publicity when there is a grave and immediate risk to the public health that cannot reasonably be prevented through any other enforcement mechanism; (2) the agency will gives adversely affected parties advance notice (at least 24 hours) and an opportunity to comment on the content of the proposed publicity;[304] (3) the content all press releases must be approved by the Office of Public Affairs; (4) the agency will create an internal appeals procedure through which persons wrongly aggrieved by adverse publicity could seek redress;[305] and (5) the agency must provide a detailed description of the reasons why it believes a grave and immediate risk to the public health exists. The attitude of the agency towards negative publicity also needs to change: as one commentator has stated, FDA officials must have a “constant awareness...of the potential impact of [their] actions and a scrupulous and extensive review of the facts of each case.”[306]

More effective judicial review is also necessary to deter FDA from abusing its negative publicity power. Courts’ hesitancy to issue injunctions to prevent the agency from issuing negative publicity is understandable, because if they are incorrect and the product actually is very dangerous, then an injunction could result in great harm to the public. But there is no reason why a post-publicity negligence action seeking to recover for the harm caused by the agency’s unreasonable publicity should be treated any differently than a normal negligence action. In his seminal article on agency use of adverse publicity, Ernest Gellhorn proposed that the Administrative Procedure Act be amended to allow judicial review of agency publicity, and that the Federal Tort Claims Act should permit recovery for defamation and slander by government agents.[307] In light of the increase in FDA’s use of negative publicity since Gellhorn’s article was published, these reforms seem even more necessary today than when he originally proposed them. But changes in the courts’ review of FDA’s use of negative publicity could occur without Congressional action, if courts perform a more critical, less deferential analysis of FDA’s actions in cases where companies seek to recover for harm caused by negative publicity. The inquiry in these cases should be whether FDA acted reasonably in determining that publicity was necessary to prevent an imminent risk to health or gross deception.

With these reforms to FDA’s internal publicity process and to the judicial review process, FDA’s power of negative publicity could better serve its original purpose – to warn the public of grave and immediate dangers – without infringing on the rights of regulated companies and presenting the potential for abuse. Such reforms could improve the relationship between the agency and the companies it regulates, allowing for the two parties to more effectively protect the public welfare.


[1] Public Health Advisory, Subject: Safety of Phenylpropanolamine, www.fda.gov/cder/drug/infopage/ppa/ advisory.htm (Nov. 6, 2000).

[2] Sheryl Gay Stolberg, Popular Cold Medicines are Pulled from the Market , N.Y. TIMES , Nov. 7, 2000, at A1.

[3] David Noonan, An Ingredient Under Fire , NEWSWEEK , Oct. 30, 2000, at 59.

[4] Susan Saulny, Aisles of Confusion as Medicines are Pulled , N.Y. TIMES , Nov. 8, 2000, at D1; Nancy A. Youssef, Voluntary Pullback of Cold Drug Confuses Consumers , L.A. TIMES , Dec. 4, 2000, at S6.

[5] Jeff Gerth and Sheryl Gay Stolberg, Another Part of the Battle: Keeping a Drug on the Shelves of Stores , N.Y. TIMES , Dec. 13, 2000, at A31.

[6] Greg Winter, Drug Makers Have New Versions of Cold Remedies , N.Y. TIMES , Nov. 8, 2000, at D1.

[7] 21 U.S.C. § 375(b)(2000).

[8] 42 U.S.C. §§ 241, 242o(b).

[9] 21 U.S.C. § 375(b) (2000).

[10] See Richard Morey, Publicity as a Regulatory Tool , 30 FOOD DRUG COSM. L.J. 469, 474 (1975)(stating that “unless the first sentence of Section 705(b) is read as a limitation on FDA authority to issue publicity, the second sentence is a surplusage”).

[11] 42 U.S.C. § 241(a).

[12] Id . § 241(a)(1).

[13] 42 U.S.C. § 242o(b).

[14] 21 C.F.R. § 5.10(a)(2)(2003).

[15] Id . §§ 242b, 242k, 242p.

[16] Id . §§ 242, 242m.

[17] Id . § 242q.

[18] Id . § 241(a).

[19] Id . § 241o(b).

[20] 45 C.F.R. § 17.

[21] Administrative Practices and Procedures: Publicity Policy, 42 Fed. Reg. 12,436 (Mar. 4, 1977); see also Lars Noah, Administrative Arm Twisting in the Shadow of Congressional Delegations of Authority , 1997 WIS. L. REV. 873, 890.

[22] 45 C.F.R. § 17.1.

[23] Id . § 17.2.

[24] Id . §§ 17.3 – 17.5.

[25] Id . §§ 17.4 – 17.6.

[26] Id . § 17.7.

[27] Publicity Policy, supra note 21, at 12,436-41.

[28] Id . at 12,440 (to be codified at 21 C.F.R. § 2.741(b)).

[29] Id . at 12,436.

[30] 21 U.S.C. § 375(b);see supra text accompanying note 10.

[31] Publicity Policy, supra note 21, at 12,440 (to be codified at 21 C.F.R. § 2.744).

[32] Id . at 12440 (to be codified at 21 C.F.R. § 2.742).

[33] Id . at 12,437.

[34] See supra text accompanying note 24.

[35] Publicity Policy, supra note 21, at 12,440 (to be codified at 21 C.F.R. § 2.741(b).

[36] Id . at 12,437.

[37] Id . at 12,441 (to be codified at 21 C.F.R. § 2.745).

[38] Id .

[39] See Ernest Gellhorn, Adverse Publicity by Administrative Agencies , 86 HARV. L. REV. 1380, 1410 (FDA is not required to hold hearings or get judicial approval before issuing publicity).

[40] Publicity Policy, supra note 21, at 12,437.

[41] Id . at 12,438.

[42] Id . at 12,437.

[43] Id .

[44] See FDA Press Releases and Talk Papers, http://www.fda.gov/opacom.hpnews.htm l (last visited April 23, 2003).

[45] 21 C.F.R. § 7.40.

[46] 21 U.S.C. §§ 350a(f)(2), 360h(e).

[47] 21 C.F.R. § 7.40.

[48] 21 U.S.C. § 375(a).

[49] See Gellhorn, supra note 39, at 1410 (providing three potential bases for FDA’s power to issue publicity in conjunction with voluntary recalls: (1) this publicity serves as an interstitial supplement to FDA’s formally authorized sanctions; (2) FDA’s authority to issue publicity is implicit in the statutory framework; and (3) recall-related publicity is consistent with Section 705(b)).

[50] 21 C.F.R. § 7.50 (2003).

[51] See FDA Enforcement Report Index, http://www.fda.gov/opacom/Enforce.html (last visited March 23, 2003).

[52] 21 C.F.R. § 7.50.

[53] See supra text accompanying note 40.

[54] 21 C.F.R. § 7.41.

[55] Id .

[56] Gellhorn, supra note 39, at 1411.

[57] Id . § 7.42(b)(2).

[58] See Product Recalls, Alerts, and Warning Archives, at http://www.fda.gov/oc/ po/firmrecalls/ archive.html (last visited March 23, 2003).

[59] FDA Recall Policies, at http://vm.cfsan.fda.gov/~lrd/recall2.html (last visited March 23, 2003).

[60] 21 C.F.R. § 7.41.

[61] Hoxsey Cancer Clinic v. Folsom, 155 F. Supp. 376 (D.D.C. 1957).

[62] Id . at 378.

[63] See Joint Anti-Fascist Refugee Committee v. McGrath, 341 U.S. 123, 168 (1951)(Frankfurter, J. concurring) (“This Court is not alone in recognizing that the right to be heard before being condemned to suffer grievous loss of any kind, even though it may not involve the stigma and hardships of a criminal conviction, is a principle basic to our society.”).

[64] Hoxsey, 144 F. Supp. at 378.

[65] Id .

[66] 378 F.Supp. 210 (D.N.J. 1974).

[67] Id . at 212.

[68] Id . at 217. The court held that while it did not have jurisdiction over the claims against FDA, it did have jurisdiction over the claim for injunctive relief against the individual FDA officials. Id. at 212-16.

[69] Id . at 218.

[70] Id . at 219.

[71] 262 F. Supp. 728 (D. Conn. 1967).

[72] Id . at 730.

[73] Id .

[74] 342 F.2d 634 (7th Cir. 1965).

[75] Id . at 637.

[76] Morey, supra note 10, at 476.

[77] Id .

[78] Id .

[79] 1977 U.S.Cl.Ct. LEXIS 336 (Ct. Cl. 1977).

[80] Id . at *14.

[81] Id . at *14-15.

[82] 9 Cl. Ct. 774 (Ct. Cl. 1986).

[83] Id . at 783.

[84] Id .

[85] Id.

[86] 3 Ct. Cl. 762 (Ct. of Claims 1983).

[87] Id . at 780.

[88] Id .

[89] Fisher Bros. Sales, Inc. v. United States, 46 F.3d 279 (3d Cir. 1995)

[90] Id . at 285.

[91] Id . at 286.

[92] 505 F.2d 565 (4th Cir. 1974).

[93] Id . at 571.

[94] Id . at 572-73.

[95] Scott Fisher, Publicity and the FDA , 28 FOOD DRUG COSM. L. J . 436, 440 (1973); Gellhorn, supra note 39, at 1408.

[96] Id .

[97] Id .

[98] Fisher, supra note 95, at 440.

[99] Gellhorn, supra note 39, at 1409.

[100] Id .

[101] Id .

[102] Id . at 1413.

[103] Id .

[104] Id .

[105] Id .

[106] Morey, supra note 10, at 472.

[107] Id .

[108] Id . at 472.

[109] It is also important to recognize that FDA personnel may make other public statements during press conferences, interviews with the media, and public appearances. Because not all of these statements are recorded or readily available, it is difficult to systematically analyze them in the same manner that press releases and talk papers can be analyzed.

[110] See, e.g., FDA Approves Non-Stimulant ADHD Drug, at http://www.fda.gov/bbs/topics/ANSWERS/ 2002/ ANS01177.html (Nov. 26, 2002); FDA Approves New Indication for Implantable Cardioverter Defribrillators, at http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01159.html (July 17, 2002).

[111] See, e.g., FDA, FBI Make Arrest in Tampering Incident in Texas, at http://www.fda.gov/bbs/topics/NEWS/ 2002/NEW00847.html (Oct. 25, 2002); FDA Seizes Dietary Supplements with Drug Claims, at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00845.html (Oct. 17, 2002); Christian Brothers Contracting Corporation Signs Consent Decree with FDA; Agrees to Stop Selling all Amygdalin/Laetrile Products, at http://www.fda.gov/bbs/topics/ANSWERS/ANS01055.html (Nov. 17, 2000).

[112] See, e.g., FDA Amends Its Regulations to Provide for Approval of Certain New Pharmaceutical Products Based on Animal Efficacy Data (May 30, 2002), at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00811.html.

[113] See, e.g ., FDA and NSTA To Release New Program that Uses Science to Educate Students about Food Safety, at http://www.fda.gov/bbs/topics/NEWS/2001/NEW00769.html (Sept. 5, 2001); FDA Scientists Discover Key Mechanism Regulating Immune Cell Activity, at http://www.fda.gov/bbs/ topics/NEWS/ NEW00605.html (Dec. 2, 1997).

[114] See, e.g., Nationwide Alert on Injectable Drugs Prepared by Urgent Care Pharmacy, at http://www.fda.gov/bba/ topics/ANSWERS/2002/ANS01171.html (Nov. 15, 2002); Gonorrhea Test Kits Recalled by Abbott Laboratories, at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00832.html (Aug. 30, 2002).

[115] See, e.g., FDA Updates Consumer Advisory about Raw and Lightly Cooked Sprouts; at http://www.fda.gov/ bbs/topics/ANSWERS/2002/ANS01164.html (Oct. 2, 2002); FDA Announces Advisory on Methyl Mercury in Fish, at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01065.html (Jan. 12, 2001).

[116] The information in this table is compiled from FDA’s online collection of press releases and talk papers. FDA Press Releases and Talk Papers, http://www.fda.gov/opacom/hpnews.html (last visited April 24, 2003).

[117] Now that both press releases and talk papers are available from the same page on FDA’s website, the distinction between the two forms of publicity may be less important. However, the fact that FDA continues to employ press releases instead of talk papers to disseminate negative information gives even stronger support to the argument that the agency wants this negative information to reach a large percentage of the population.

[118] FDA and Canadian Food Inspections Agency Warn Against Consuming Mislabeled Poisonous Plant Called Autumn Monkshood, at www.fda.gov/bbs/topics/ANSWERS/2001/ANS01080.html (Apr. 25, 2001).

[119] Id .

[120] FDA Warns Consumers about VIVA Brand Imported Cantaloupe, at http://www.fda.gov/bbs/ topics/NEWS/2001/NEW00760.html (May 25, 2001).

[121] Id .

[122] Hip Implants Being Recalled; Possible Fracture Problem, at http://www.fda.gov/bbs/topics/ANSWERS/2001/ ANS01102.html (Sept. 14, 2001).

[123] FDA Alerts Public Regarding Recall of Powdered Infant Formula, at http://www.fda.gov/bbs/topics/NEWS/ 2002/NEW00849.html (Nov. 1, 2002); FDA Warns about Possible Enterbacter Sakazakii Infections in Hospitalized Newborns Fed Powdered Infant Formulas, at http://www.fda.gov/bbs/topics/ANSWERS/2002?ANS01146.htm (April 12, 2002).

[124] FDA Issues Health Advisory Regarding the Safety of Sporanox Products and Lamisil Tablets to Treat Fungal Nail Infections, at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01083.html (May 9, 2001).

[125] FDA Announces Advisory on Methyl Mercury in Fish, at http://www.fda.gov/bbs/topics/ANSWERS/ 2001/ANS01065.html (Jan. 12, 2001).

[126] Id .

[127] FDA Updates Consumer Advisory about Raw and Lightly Cooked Sprouts, at http://www.fda.gov/bbs/topics/ ANSWERS/2002/ANS01164 (Oct. 2, 2002).

[128] Id .

[129] FDA Warns Consumers Against Using Decorate Contact Lenses Obtained Without a Prescription or Professional Fitting, at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00846.html (Oct. 21, 2002).

[130] Id .

[131] FDA and FSIS Issue Health Advisory about Listeria at http://fda.gov/bbs/topics/NEWS/2002/NEW00836.html . (Sept. 13, 2002).

[132] Id .

[133] Id .

[134] FDA Issues Nationwide/International Alert on Potentially Dangerous OB/GYN Surgical Devices, at http://www.fda.gov/bbs/topics/NEWS?2002/NEW0799.html (March 14, 2002).

[135] FDA Alerts Southern Florida Patients to Possibly Inadequate Prostate Cancer Treatments, at http:// www.fda.gov/bbs/topics/NEWS/2001/NEW00781.html . (Nov. 27, 2001).

[136] Cape May Foods Recalls Chopped Clams Because of Potential Health Risk, at http://www.fda.gov/bbs/topics/ NEWS/2002/NEW00788.html (Jan. 10, 2002).

[137] Bayer Voluntarily Withdraws Baycol, at http://fda.gov/bbs/topcs/ANSWERS/2001/ANS01095.html (Aug. 8, 2001).

[138] Five Kidney Dialysis Deaths Prompt Baxter/FDA Action, at http://www.fda.gov/bbs/topics/NEWS/ 2002/NEW00835.html (Sept. 12, 2002).

[139] FDA Issues Health Warnings about Avocado Pulp in Southern California, at http://www.fda.gov/bbs/ topics/NEWS/2001/NEW00755.html (Feb. 9, 2001).

[140] Id .

[141] Phyne Pharmacueticals is Not Recalling Adrenal Cortex Extract; Product Remains a Concern to FDA, at http://www.fda.gov/bbs/topics/NEWS2001/NEW00751.html (Jan. 29, 2001).

[142] Nationwide Alert on Injectable Drugs Prepared by Urgent Care Pharmacy, at http://www.fda.gov/bbs/topics/ ANSWERS/2002/ANS01171.html (Nov. 15, 2002).

[143] 21 U.S.C. § 331.

[144] Id . § 331(a), (b), (c), (d), (g), (k).

[145] FDA also has the power to inspect records of interstate shipment under Section 703 of the Act; the power to inspect factory, warehouses, and other establishments where food, drugs, devices or cosmetics are held under Section 704; to examine and detain imports and exports under Sections 801 and 802. 21 U.S.C. §§ 373, 374, 381, 382. However, FDA often uses these powers to gather information for subsequent enforcement proceedings; they are not in and of themselves methods to impose penalties for violations of the Act on defendants. Thus, these powers cannot be considered alternatives to the use of negative publicity, like the other enforcement mechanisms discussed in this Part. In addition, FDA has the power to levy civil penalties against companies for violating the medical device requirements of the Safe Medical Devices Act or the drug sample provisions of the Prescription Drug Marketing Act. 21 U.S.C. § 333(b), (g). These penalties could be considered to be alternative enforcement mechanisms, but they are fairly recent additions to FDA’s enforcement powers, and it is not clear to what extent and in what circumstances they will be used by the agency.

[146] Id . § 332(a)

[147] Id . § 332(b).

[148] I. Scott Bass, Enforcement Powers of the Food and Drug Administration , in FOOD AND DRUG LAW 61, 74 (Richard M. Cooper ed., 1991).

[149] REGULATORY PROCEDURES MANUAL ch. 6 (1997), available at http://www.fda.gov/ora/compliance_ref/ rpm_new2 .

[150] Bass, supra note 148, at 81.

[151] Id .

[152] United States v. Odessa Union Warehouse, 833 F.2d 172, 175 (1987); see also Bass, supra note 148, at 82.

[153] Bass, supra note 148, at 74.

[154] United States v. K-N Enterprises, Inc., 461 F. Supp. 988, 990-91 (N.D. Ill. 1978).

[155] United States v. C.E.B. Products, Inc., 380 F. Supp. 664, 671 (N.D. Ill. 1974)(stating that “[i]n seeking this recall, the government is asking for judicial sanction of an additional arrow for its already well-equipped bow”).

[156] 21 U.S.C. §§ 304(a)(1). FDA may also institute seizure actions against products which may not be introduced in interstate commerce because they are contaminated with microorganisms and are injurious to the public health, or because they violates the new drug provisions. Id .

[157] REGULATORY PROCEDURES MANUAL ch. 6 , supra note 149.

[158] Id . Seizure actions are in rem proceedings, and are governed by the Supplemental Rules for Certain Admiralty and Maritime Claims. 21 U.S.C. § 334(b).

[159] Bass, supra note 148, at 79.

[160] See Four Hundred and Forty-Three Cans of Frozen Egg Products v. United States, 226 U.S. 172, 183-84 (1912); Bass, supra note 148, at 79.

[161] Peter Barton Hutt and Richard Merrill, FOOD AND DRUG LAW 1130 (2d ed. 1991)(citing United States v. 60 28-Capsule Bottles... “Unitrol,” 325 F.2d 513 (3d Cir. 1963)).

[162] 21 U.S.C. § 334(a)(1); Bass, supra note 148, at 79. FDA may only file multiple seizure actions against misbranded products if it has probable cause to believe that the product is dangerous; or that the labeling of the product is fraudulent or “materially misleading to the injury or damage of the purchaser or consumer.” 21 U.S.C. § 334(a)(1).

[163] Id . § 334(b).

[164] Bass, supra note 148, at 80.

[165] 21 U.S.C. § 336.

[166] REGULATORY PROCEDURES MANUAL ch. 4, supra note 149.

[167] Id.

[168] 21 U.S.C. § 350a(f)(2).

[169] Id .

[170] Id . § 350(a)(f)(3).

[171] Id . § 350(a)(f)(1).

[172] Id . § 360h(e).

[173] Id . § 333.

[174] Id . § 333(a).

[175] Id . § 333(c)(exception for receiving and later delivering an illegal article in good faith, and for introducing an illegal article into interstate commerce if person has received guaranty that it is not illegal); Id . § 333(d)(exceptions involving misbranded food).

[176] Sam D. Fine, The Philosophy of Enforcement , 31 FOOD DRUG COSM. L.J . 324, 329-31 (1976).

[177] United States v. Dotterweich, 320 U.S. 277, 280 (1943).

[178] See United States v. Park, 421 U.S. 658, 675-77 (1975); Bass, supra note 148, at 88.

[179] See Peter Barton Hutt, Philosophy of Regulation Under the Federal Food, Drug, and Cosmetic Act , 28 FOOD DRUG COSM. L. J. 177, 183 (1973).

[180] See id .

[181] Public Law 404-79th Congress, approved June 11, 1946, 60 Stat. 237-244 (codified at 5 U.S.C. §§ 500 et seq.).

[182] 5 U.S.C. § 553(b). These requirements do not apply to interpretative rules, general policy statements, or rules of agency organization, or when following the requirements would be “impracticable, unnecessary, or contrary to the public interest.” Id .

[183] Id . § 553(c). If the statute which delegates authority to the agency requires that the rules be made on the record after the opportunity for an agency hearing, sections 556 and 557 of the APA apply and mandate complicated procedures to be followed in a formal hearing. Id . The FDCA does not appear to make any such requirements for rule-making by the FDA.

[184] Id . § 553(c), (d).

[185] Id . § 702.

[186] See Noah, supra note 21, at 911.

[187] REGULATORY PROCEDURES MANUAL ch. 6, supra note 149. Injunctions and seizures require thirteen levels of bureaucratic approval at FDA alone. Mary Olson, Substitution in Regulatory Agencies, FDA Enforcement Alternatives , 12 J.L. ECON. & ORG . 376, 385 (1996).

[188] REGULATORY PROCEDURES MANUAL ch. 6, supra note 149.

[189] Bass, supra note 148, at 138.

[190] See Four Hundred and Forty-Three Cans of Frozen Egg Products v. United States, 26 U.S. 172, 182 (1912).

[191] See Olson, supra note 187, at 384-86.

[192] See 5 U.S.C. § 533.

[193] See Part III infra for a discussion of the time it has taken FDA to complete one rule-making proceeding, the OTC drug review process.

[194] To implement a recall of formula, FDA must issue regulations detailing the “scope and extent of recalls necessary and appropriate for the degree of risks to human health presented by the formula.” 21 U.S.C. § 350a(f)(2). Within ten days after issuing an order for a recall of medical devices, FDA must give affected parties an informal hearing. Id . § 360h(e)(2)(A).

[195] REGULATORY COMPLIANCE MANUAL ch. 4, supra note 149.

[196] Id .

[197] See Olson, supra note 187, at 384-86.

[198] Bass, supra note 148, at 81.

[199] It is true that FDA must place notices of its rule-making proceedings in the Federal Register, which could potentially alert the media and the public to the dangers of products affected by the rule-making proceedings. However, the Federal Register is tens of thousands of pages long every year, and it is unlikely that many members of the public or the media has the time to comb through it, looking for information about dangerous products.

[200] REGULATORY PROCEDURES MANUAL ch. 4, supra note 149.

[201] Morey, supra note 10, at 471; Fisher, supra note 95, at 440.

[202] See Gellhorn, supra note 39, at 1411.

[203] Morey, supra note 10, at 471.

[204] Id . at 472.

[205] See generally Eugene Lambert, Recalls, Regulatory Letters, and Publicity – Quasi-Statutory Remedies , 31 FOOD DRUG COSM. L. J . 360, 364 (1976).

[206] REGULATORY PROCEDURES MANUAL ch. 6, supra note 149.

[207] 21 U.S.C. § 335. FDA does not provide this hearing if the prosecution is brought under Title 18 of the U.S. Code, or if notice of the hearing might “result in alteration or destruction of evidence or flight to avoid prosecution.” REGULATORY PROCEDURES MANUAL ch. 6, supra note 149.

[208] Publicity Policy, supra note 11, at 12,441.

[209] 21 C.F.R. § 7.41.

[210] See United States v. Odessa Union Warehouse, 833 F.2d 172 (1987) (defendant’s general manager testified about the defendant’s attempts to voluntarily comply with FDA’s requests).

[211] Four Hundred and Forty-Three Cans of Frozen Egg Products v. United States, 226 U.S. 172, 183 (1912).

[212] Bass, supra note 148, at 89.

[213] 5 U.S.C. § 553.

[214] 21 U.S.C. § 360h(e)(2)(A).

[215] REGULATORY PROCEDURES MANUAL ch. 4, supra note 149; Estee Lauder v. FDA, 727 F. Supp. 1 (D.D.C. 1989).

[216] Gellhorn, supra note 39, at 1433.

[217] Fisher, supra note 95, at 440.

[218] 21 U.S.C. § 334(e).

[219] Id . § 333(a).

[220] See Fisher, supra note 95, at 441(damaging publicity is “often a greater threat to many agency respondents than any official agency action”).

[221] See Noah, supra note 21, at 889; Morey, supra note 10, at 471.

[222] Noah, supra note 21, at 922-23.

[223] See Fisher, supra note 95, at 441.

[224] Over-the-Counter Drugs: Proposal Establishing Rule Making Procedures for Classification, 37 Fed. Reg. 85, 86 (Jan. 5, 1972).

[225] Id.

[226] Id.

[227] 21 C.F.R. § 330.10.

[228] Id . § 330.10(b).

[229] Id . § 330.10(5). The Code of Federal Regulations defines “safety” as “low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse under conditions of widespread availability. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use.” Id . § 330.10(4). The regulations also provide that the benefit-to-risk ratio of a drug can be considered in determining safety and effectiveness. Id.

[230] Id . § 330.10(6).

[231] Id . § 330.10(7).

[232] Id . § 330.10(8).

[233] Id . § 330.10(9).

[234] Id . § 330.10(11).

[235] Id . § 330.11.

[236] Over the Counter Drugs: Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Products, 41 Fed. Reg. 38,312 (Sept. 9, 1976).

[237] Weight Control Drug Products for Over-the-Counter Human Use; Establishment of a Monograph, 47 Fed. Reg. 8466, 8455-69 (Feb. 26, 1982).

[238] Id . at 8467.

[239] Weight Control Drug Products for Over-the-Counter Human Use; Proposed Rule-Making, 55 Fed. Reg. 45,788 (Oct. 30, 1990).

[240] Id .

[241] Weight Control Products for Over-the-Counter Human Use; Certain Active Ingredients, 56 Fed. Reg. 37,792 (Aug. 8, 1991). This rule is codified at 21 C.F.R. § 310.545(a)(20).

[242] Phenylpropanolamine Hydrochloride for Over-the-Counter Weight Control Use; Safety and Effectiveness Discussion; Public Meeting and Reopening of the Administrative Record, 56 Fed. Reg. 13,295 (Apr. 1, 1991).

[243] Id . at 13,297.

[244] Id .

[245] Id .

[246] Id . at 13,296.

[247] Id .

[248] OTC Weight Control Rule-Making Chronology, at http://www.fda.gov/cder/infopage/ppa/default.html (last visited Feb. 15, 2003).

[249] Letter from Janet Daling, Fred Hutchinson Cancer Research Center, to Paula Bolstein, Acting Director, Office of OTC Drug Evaluation (July 31, 1992)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[250] Letter from Jack Whisnat, Mayo Clinic, to Robert Sherman, Office of OTC Drug Evaluation (Aug. 3, 1992)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[251] Gerth & Stolberg, supra note 5.

[252] Letter from Williams E. Gilbertson, Monograph Review Director, FDA, to R. William Soller, Senior Vice-President, NDMA (Mar. 9, 2003)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[253] Id .

[254] OTC Weight Control Rule-Making Chronology, supra note 248.

[255] Letter from William E. Gillbertson, Monograph Review Director, FDA, to R. William Soller, Senior Vice-President, NDMA (May 20, 1994)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[256] Ralph I. Horwitz et al., Phenylpropanolamine and Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Proejct (May 10, 2000), available at http://www.fda.gov/cder/infopage/ppa/default.html .

[257] Id.

[258] Id . at 5.

[259] Id . at 2.

[260] Id . Despite the researchers’ attempts to match certain characteristics of the cases and controls, the cases were more likely to report lower educational achievement, current cigarette smoking, a history of hypertension, a family history of stroke, heavy alcohol use, and recent cocaine use. Id . at 17.

[261] Id . at 2.

[262] Id . at 25. The odds ratio for appetite suppressant use was 15.92. Id . at 2-3.

[263] Id . The odds ratio for appetite suppressant use among women was 16.58, and the odds ratio for first dose PPA use was 3.13. Id .

[264] Id . at 25. The odds ratio for the association between stroke and any use of PPA within 3 days was 1.49. Id . at 2.

[265] Id . at 3.

[266] Id . at 25-27.

[267] Memorandum from Office of Post-Marketing Drug Risk Assessment, FDA, to Charles Ganley, Director of Division of OTC Drug Products, FDA (Sept. 27, 2000)(available at http://www.fda.gov/cder/infopage/ppa/ default.html ).

[268] Id .

[269] Letter from R. William Soller, Senior Vice-President, Consumer Healthcare Products Association, to Dockets Management Branch, FDA (May 24, 2000)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[270] Id.

[271] Id .

[272] Letter from Lorna C. Totman, Director of Scientific Affairs, Consumer Healthcare Products Association, to Dockets Management Branch, FDA (Sept. 22, 2000)(available at http://www.fda.gov/cder/infopage/ppa/ default.html ).

[273] Id . A CHPA member also performed an analysis in which he used the National Hospital Discharge Survey to estimate the background rate of strokes, then compared the number of strokes in the PPA diet aid user popultion to the expected number of strokes. This analysis did “not suggest or even signal a trend towards an increase in the risk of stroke.” Id .

[274] Final Meeting Minutes of the Nonprescription Drug Advisory Committee (Oct. 19, 2000) (available at http://www.fda.gov/ cder/infopage/ppa/default.html ). The committee also voted on a number of sub-issues, such as whether there was an association for females ages 18-49 using PPA as an appetite suppressant (13 yes, 1 inconclusive); whether there was a relationship for females ages 18-49 using PPA as a decongestant (6 yes, 8 inconclusive); whether there was a relationship for females using PPA on first exposure (13 yes, 1 inconclusive); and whether there was a relationship for use by men (14 inconclusive). Id .

[275] Id .

[276] Letter from Center for Drug Evaluation and Research, FDA, to CEO/President, Manufacturers of Drug Products Containing PPA (Nov. 3, 2000)(available at http://www.fda.gov/cder/infopage/ppa/default.html ).

[277] Id .

[278] Public Health Advisory, supra note 1.

[279] Id.

[280] Horwitz et al., supra note 256, at 17.

[281] Public Health Advisory, supra note 1.

[282] Id .

[283] Id .

[284] Stolberg, supra note 2.

[285] Id .

[286] Youssef, supra note 4. To reformulate cold products, manufacturers typically replaced PPA with psuedoephedrine, and to reformulate weight loss products, they replaced PPA with ephedra. Id .

[287] Saulny, supra note 4.

[288] Noonan, supra note 3.

[289] Youssef, supra note 4.

[290] Winter, supra note 6.

[291] Id .

[292] Rosanna Ruiz, Lawsuits Target Cold Remedy Ingredient , HOUSTON CHRONICLE , Feb. 12, 2003, at A29. Even before the health advisory, there were about 24 lawsuits filed against companies alleging that PPA had caused strokes. Gerth & Stolberg, supra note 5. However, it is clear that since the health advisory was issued, PPA-related litigation has skyrocketed. There is even a website called the Phenylpropanolamine Legal Network, which is dedicated to assisting consumers who have feel they have been injured by PPA. Phenylpropanolamine Legal Network, http://www.phenylpropanolamine-ppa.com/pages/ppa-list.htm (last visited Feb. 15, 2003).

[293] Phenylpropanolamine: Proposal to Withdraw Applications of New Drug Applications and Abbreviated New Drug Applications; Opportunity for a Hearing, 66 Fed. Reg. 42,665 (Aug. 14, 2001).

[294] Department of Health and Human Services Unified Agenda, 67 Fed. Reg. 74,491 (Dec. 9, 2002).

[295] See Department of Health and Human Services Unified Agenda, 66 Fed. Reg. 25,387 (May 14, 2001)(NPRM scheduled to begin in June 2001); Department of Health and Human Services Unified Agenda, 66 Fed. Reg. 61,555 (Dec. 3, 2001)(NPRM scheduled to begin in April 2002); Department of Health and Human Services Unified Agenda, 67 Fed. Reg. 33,039 (May 13, 2002)(NPRM scheduled to begin in October 2002).

[296] Merriam Webster Online, http://www.m-w.com (last visited April 16, 2003).

[297] 42 U.S.C. § 241(a).

[298] Id . § 242o(b).

[299] REGULATORY PROCEDURES MANUAL ch. 6, supra note 149.

[300] See, e.g., Weight Control Drug Products, supra note 239.

[301] Michelle Meadows, Why Drugs Get Pulled from the Market , FDA CONSUMER, Jan. 1, 2002, at 11.

[302] Id.

[303] The advance NPRM for the weight control monograph was published in 1982, and the final monograph declaring 111 ingredients as not GRASE was published in 1991. OTC Weight Control Chronology, supra note 248.

[304] See Gellhorn, supra note 39, at 1430.

[305] Id .

[306] Fisher, supra note 95, at 446.

[307] Gellhorn, supra note 39, at 1431.