HLS Student Papers

In 1993, the California Supreme Court handed down a decision in the case Ramirez v. Plough. Inc.1 holding that manufacturers of nonprescription drugs in that state have no duty under the tort law to print mandatory warnings in any language other than English. It was a question of first impression not only for California, but for the nation, and the public policy issues it raised were among the most difficult in food and drug law: whom should our food and drug laws protect, and is a gain in efficiency worth even a small cost in human life? Further, this case raised a broader, equally difficult question about the very identity of our immigrant nation: when an immigrant chooses not to learn English, how willing are we to change our institutions to accommodate that decision?

For the average American. the words "radiation" and "irradiation" are apt to conjure up images of nuclear weapons. radioactive waste, x-rays. and other unpleasant materials associated with health dangers. Yet these words are also displayed on the labels of food products treated with a irradiation process which made the foods safer for consumers to eat. Food irradiation. currently approved for use on several foods, kills microorganisms and insects which could pose substantial health risks to consumers. Irradiation can also be used to retard spoilage and ripening of fruits and ~'egetables to increase their shelf life. Despite its potential benefits, irradiation and the labeling of irradiated foods has been a subject of controversy since its inception. Since 1966, the Food and Drug Administration ("FDA") has required irradiated foods to be labeled as such, but because the initial foods approved for irradiation treatment were limited to potatoes and wheat, the process was not widely publicized. In 1986. however, FDA expanded the list of approved foods to include fruits. vegetables, and spices, and revised its labeling regulations to require that irradiated products be labeled at both the wholesale and the retail level. The promulgation of these guidelines drew criticism from the food industry. Congressmen, and several consumer groups and remains a hotly debated topic today.

Americans dole out $33 billion dollars a year to cure their weight problems, as every year the market is flooded with food and drug products that promise a fast, easy way to a new, slimmer you. Unfortunately, while there is not a fast and easy solution to regulating America's weight problem, something must be done by the Federal Drug Administration ("F.D.A.") to better regulate the weight-loss industry.

Genetic engineering technology has recently generated techniques for making specific and precise alterations to the genetic composition of crops grown as food for humans and animals. These advances should facilitate the development of crops with enhanced resistance to diseases, pests and bad weather, improved tolerance of environmentally safer herbicides, and greater nutritional value. However, the very power of these techniques has raised fears of potential ecological catastrophe, as well as religious and aesthetic questions that arise from the prospect of vegetables containing genes ultimately derived from fish and animals. This essay briefly reviews the nature of the technology and its potential benefits and risks. It then discusses the regulatory framework with particular emphasis on the regulatory strategy adopted by FDA. Finally, it suggests that FDA's stance, while legally and scientifically defensible, is strategically misconceived in that stricter regulation would promote public acceptance of this technology.

Food and drug law, like all areas of administrative law, is rife with tension among countervailing principles. The Food and Drug Administration is charged with protecting the health and safety of the American public. This mandate involves competing considerations. First, the FDA must ensure that drug innovation is promoted so that effective new treatments are introduced as quickly as possible and at the lowest cost possible; but, FDA must also ensure that no drugs are allowed to be marketed which may cause injury or death to a patient or which are ineffective in treating the disease for which claims are made. To allow FDA to achieve this difficult mission, Congress and the courts have given the Agency unprecedented discretion over private drug manufacturers and health care practitioners. This bureaucratic discretion is in tension with our democratic notions of due process and fairness that government should be restrained by pre-existing rules and legal principles and that each person, or drug manufacturer, should have the opportunity to participate in government actions which affect a personal, professional or financial interest.

Prior to passage of the National Childhood Vaccine Act in November 1986, manufacturers could be held strictly liable in tort for vaccine-related injuries, a lamentable situation which allegedly caused increasing prices, discontinuation of childhood vaccine production, and a reduction in vaccine innovation.2 To solve this "liability crisis"--which industry officials, legal commentators, and policymakers contended had plagued the vaccine industry since the late 1960s--Congress enacted a law which eschews state tort law as a compensatory mechanism, and instead shifts the product liability burden from manufacturers to a public National Vaccine Injury Compensation Fund. While this innovation fairly compensates the innocent victims of our compulsory vaccination laws, it assumed that the opponents of strict liability had correctly explained why vaccines were being removed from the market; if this assumption was erroneous, the pre-existing manufacturer tort liability regime should have been left intact, thereby preserving market incentives for investment in product innovation and additional safety.

The Food and Drug Administration's purpose is to serve the public and protect the public health. There's a general standard of safety and effectiveness for drugs and devices set by the Food and Drug Administration. In everyday life, individuals eat food, take medications and use medical devices and these activities are done for the most part voluntarily. Physicians, nutritionists, advertisers, and labelling may advise the public about what foods to eat, drugs to take, and devices to use, however the choice is still ultimately left to the consumer.

Medical devices that presented substantial deception or an unreasonable and substantial risk of illness or injury have existed since the inception of this country. Even our forefathers such as Ben Franklin were subjected to these "quack" devices. It was not until the country's bicentennial, however, that explicit statutory provisions were enacted to allow the Food and Drug Administration ("the FDA") to ban quack devices. Even though active legislative steps have now been taken to regulate these useless medical devices, the problem continues to grow. This paper is an examination of the steps Congress and FDA have taken to regulate quack devices, where the organizations went wrong, and what should be done in the future.

The area of disease-prevention claims ("health claims") for food poses a broad spectrum of dilemmas that often arise in the food and drug law area and in other regulatory situations. These recurring questions include: How does an agency balance the public's right to information with the agency's desire to prevent consumer deception? Given an agency's broad mandate to protect public health, what type of consumer should it aim to protect with its limited resources? What should an agency do in the face of uncertainty? To what extent, and under what conditions, is informed choice desirable? How much of an agency's role is or should be educational? How should an agency balance consumers' need for information with the problem of information overload?

The current controversy surrounding the introduction of the French abortifacient, RU 486, into the U.S. should not be simplistically characterized as the FDA’s failure to admit a promising new drug for women. Rather, the furious debate over this drug derives from an entire systemic failure -- a failure to take responsibility. A failure by the medical and scientific community to fully and objectively assess the known and unknown dangers to woments health and safety. A failure by purveyors of information in the manipulation of theoretical and highly preliminary evidence regarding potential uses for this drug in the treatment of several tragic diseases. A failure of the Food and Drug Agency itself to make clear both to itself and to the public its policies, and its justifications for its policies. A failure of Congress to providing leadership and guidance from a democratic majority on this issue which affects our entire country. And, most of all, a failure of the American public to truthfully scrutinize the choices we are making for ourselves and to take responsibility for their implications and consequences. Many of us would rather place the burden on deciding the correct course of action solely on the manufacturer of the drug. RU486 is merely another tool which may be used to bring life or death, suffering or its alleviation in the hands of men and women. In order to decide how to use that tool wisely, or to abstain from using it all, we must look closely at facts and the nature of what is at stake, and each of us take responsibility for arriving at reasoned solutions.

This paper has been written with future vaccines in mind. It is true, of course, that most vaccines currently available are extremely safe and not prohibitively expensive. For the few injuries caused by these vaccines, an insurance system paid for by their manufacturers might be feasible and reasonable. The small increase in a manufacturer's cost of doing business could be offset by a similarly small increase in the price of the particular vaccine. Disincentive to create new vaccines would be minimal. But vaccines of the future may only become this safe if government insures them during their earliest stages of development. In this light, a government-paid system may be a necessary bridge between the riskier and safer periods of a vaccine's life.

A recent trend in the pharmaceutical industry has been for large pharmaceutical companies to acquire or merge with PBMs (prescriptionlpharmacy-benefits-management companies). Merck started this trend in November 1993 by merging with a PBM named Medco; two other pharmaceutical giants have followed suit. Since such mergers are a recent phenomenon, their full-scale implications are as yet unknown and there is little regulation in place specifically to address their potential effects. This essay describes the current state of affairs of PBM-pharmaceutical company alliances and explores their implications for the pharmaceutical and health care industries and the players involved. It further discusses the regulatory bodies involved, the measures they have taken to date, and possible future courses of action.

Given the emphasis on private, confidential and voluntary testing, the idea of an AIDS home test kit was inevitable. What could be more private, confidential and voluntary (and profitable) than buying a test kit at a drug store to take home and use? in 1986 the Food and Drug Administration (FDA) began receiving applications for various kinds of AIDS home test kits and immediately found itself at the center of a political maelstrom. Congressional subcommittees, AIDS activists, the gay community, doctors and scientists were quickly pitted against several entrepreneurs interested in bringing these products to market. FDA responded by refusing to even consider and evaluate any applications for AIDS home test kits for several years. Finally, in 1990 the FDA effectively reversed this policy and with little controversy began accepting applications for the kits. In this paper I want to assess the FDA's and the public's evolving response to the idea of AIDS home tests. Additionally, what is the FDA's role in a public health crisis such as the AIDS epidemic? What are legitimate criteria for FDA to weigh when evaluating a product such as an AIDS home test kit? More generally, are AIDS home test kits good public policy? I begin by sketching a brief history of the FDA's regulation of the product. Next I discuss the various arguments for and against an AIDS home test. I conclude with an analysis of the FDA's role in a debate such as this and some thoughts on the politics of AIDS.

The debate over whether to label milk and other dairy products as coming from cows injected with the milk production hormone bovine somatotropin (BST or rBGH--recombinant bovine growth hormone) pits consumers, like Darlene Lynwood, who see milk as that wholesome and pure liquid you give your children against biotechnology entrepreneurs who want to move the United States into the Twenty-first Century. As one of the first agricultural biotechnology products to come to market, BST milk is seen as a test case for bioengineered foods. The outcome of the labeling debate and the degree of public acceptance of the product will send a message to the developers of a range of other genetically engineered foods (including vegetables, pork, and poultry) waiting in the wings.

Cardiac catheters have become an essential element of current cardiovascular practice with several hundred thousand used each year in both diagnostic and angioplasty procedures. Uke many other disposable devices they are also increasingly being reused as hospitals attempt to cut costs.' The general progression of device reuse seems to follow rather directly the rise in the expense of medical equipment and procedures. For example, in 1976, only 14% of United States' hospitals reported reusing single-use devices, while in 1982, 90% of hospitals admitted practicing reuse.2 As for the government's regulation of such reuse, 1981 saw the FDA issuing guidelines practically proscribing the reuse of catheters when their average cost was only $10-$25.~ Even as late as 1987, however, only 2.4 full-time FDA employees and $19,000 were dedicated to monitoring the reuse of nondurable devices.4 The General Accounting Office concluded that the FDA knew of less than 1% of medical device problems occurring in hospitals.5 On the heels of the longstanding debate about the reuse of hemodialyzers and the Safe Medical Devices Act of 1990 and 1992 Medical Device Amendments, it appears as if the FDA is more receptive to tightening regulatory control over medical device reuse.

The Orphan Drug Act is a statute with a noble purpose but a controversial history. Originally designed to spur research into drugs for conditions with extremely limited patient populations,~ the Act has become a highly successful means of developing new drugs for rare diseases and conditions. In total, these conditions affect a significant percentage of the population -- as many as 1 out of every 13 Americans. In the ten years prior to the Act's passage, only ten drugs had been approved for these conditions, but by December 31, 1993, 569 drugs had received designation as orphan drugs under the Act; of these, over 65 had been approved. Few, then, would dispute that for its intended purpose -- benefit to patients suffering from rare conditions -- the Act has worked successfully.

While food and drug law has made its greatest contributions to the health and welfare of society over the past two centuries, it is indisputable that the history of this body of law is much older than two hundred years.1 Soon after man realized he needed to eat, he recognized a need to establish rules and regulations governing the sale, preparation and handling of food. Perhaps the oldest documented set of food laws are the Jewish dietary laws, also known by the Hebrew term, kashrut, from which the word "kosher" is derived.
Unlike most laws related to food, which are enacted by society through government or other rule-making bodies, Jewish dietary laws are believed to be conceptualizations of divine will that were expressed to Moses at Mount Sinai and transcribed in the Old Testament.2 Intellectual curiosity and an interest in the evolution of food and drug law compel both Jews and Gentiles to study the Jewish dietary laws. For observant Jews, however, Jewish dietary laws possess unique significance. Kashrut is one of the pillars of Jewish religious life and virtually every aspect of eating and preparing food implicates some Jewish dietary law. While the First Amendment prevents any governmental enforcement of religious law, for those who are strict practitioners of the Jewish religion, the observance of Jewish dietary laws is every bit as important and compelling as is the observance of secular law. Despite the important role Jewish dietary laws play in the lives of many, few give much thought to the foundations of and rationales for kashruz.
After describing the Jewish dietary laws and their origin, this paper will present and analyze some Judaic and secular scholarly attempts at explaining the underpinnings of these laws. The Pentateuch does not explicitly explain the reasons for the laws, which has made this issue a popular topic for debate among Biblical scholars. While the arguments these scholars make for their positions are logical and often convincing, it is important to remember that an accepted principle of jurisprudence and legal philosophy is that "unless a code of law itself states the underlying idea of a law, any theory about that idea remains conjecture.

The FDA's proposed advertising restrictions, described in greater detail infra part II, would ban outdoor advertising for tobacco products within a specified distance of schools and playgrounds; require print advertising to be in black and white text-only format except in publications with a sufficiently high adult readership; ban the sale or distribution of promotional items containing the name or logo of branded non-tobacco items; and prohibit brand sponsorship of events such as concerts and auto races. The FDA also proposes to "require manufacturers to establish and maintain a national public education campaign aimed at children and adolescents to counter the pervasive imagery and reduce the appeal created by decades of pro-tobacco messages."

This paper begins with a brief discussion, for illustrative purposes, of the evolution of regulations for reconditioning in the food salvage industry, and present requirements for reconditioning adulterated food. It then describes the current FDA policy with regard to blending, and the theory behind the prohibition of this particular method of reconditioning adulterated food. Part B shows the application of the rule against blending to individual cases. It begins with several cases in which the general rule was followed and blending was not allowed. It then dexcribes a case in which FDA discretion to prohibit blending was questioned in the context of exports. Part C describes a situation which occurred in the late 1970s, when corn produced in the southeastern part of the country became widely contaminated with aflatoxin, a carcinogen. FDA made an exception to the blending policy in the aflatoxin case, allowing contaminated corn to be blended with pure corn for feeding to animals. This ignited a controversy which still exists today. Part D takes a more detailed look at the increasing controversy over the blending policy, and its effect on the perception of FDA regulations. Courts have concluded that FDA has the power to grant such exceptions, but the prospect of case by case analysis has prompted strenuous arguments for change. Some have called for an end to DALs, or at the very least some clarity as to the meaning of compliance guidelines. Others have argued that regardless of whether FDA's power to grant exceptions in individual cases may be deemed arbitrary, it may be more important to look at procedures for blending so that food will not be wasted when so many are starving around the world.