HLS Student Papers

Criminal law defines the system of government of which it is the political expression; thus having a normative theory of substantive criminal law is paramount. U.S. criminal law has developed in the absence of such overarching theory, and is now plagued by overcriminalization. This Article advances a model of a minimalist criminal law grounded on strong normative principles that are presented and defended not from the perspective of metaphysics or moral philosophy, but rather in a historical and comparative perspective, as a matter of political choice. Core among those principles is the idea that in a liberal democracy the criminal law should be seen as the extrema ratio, or option of the last resort. After laying out and defending the model, the Article deals with issues related to its implementation, advancing an argument for the constitutionalization of substantive criminal law. The Article argues that, on the basis of existing yet overlooked constitutional doctrine, criminal laws should be subject to at least strict scrutiny.

Leaders in both the public and private sectors have increasingly acknowledged that society has an obligation to include the next generation in the decision-making processes that will shape their future. Young people (ages 12-18) seem to agree, and they have expressed a growing desire to be actively consulted on issues that matter to them. From environmental protection and climate change to social justice and mental health, youth are increasingly voicing their questions, concerns, and hopes about the future. Input from the next generation is particularly crucial when it comes to navigating the challenges of new technologies.

Many people, particularly in developing countries, die from curable or manageable diseases without access to medicine. After the TRIPS Agreement was brought into force, access to medicine in developing countries became worse and even deteriorated development. To solve the controversy in interpreting the TRIPS Agreement and the resulting public health crises, the Doha Declaration was adopted, recognizing the flexibilities of the TRIPS Agreement as effective and vital manners to promote access to medicines. However, there are still many difficulties encountered by developing countries in full implementation of the Doha Declaration. Therefore, this paper aims to reexamine and reaffirm access to medicine as an international human right, claiming it should be accommodated under the WTO framework, and also proposes several possible solutions to advance the accessibility of medicine.

Pharmacogenomic technologies promise to usher in an era of individualized medicine, but also pose challenges to a regulatory regime without experience dealing with the sorts of data produced by these techniques. Pharmacogenomics as a field encompasses both pharmacogenetic techniques, which tend to focus on polymorphisms in cytochromes and other proteins involved in drug metabolism, and pharmacogenomic techniques such as microarray technologies, which examine disease and drug interactions on the level of the entire genome. In 2003, the FDA produced a guidance recommending procedures for the submission of pharmacogenomic data at the IND or NDA stage. While pharmacogenomic information used in decision making; during trials is required, most pharmacogenomic data of an exploratory nature may be submitted voluntarily under a separate protocol. Though these procedures seem a reasonable means by which the FDA can open a dialogue with pharmaceutical manufacturers regarding the use of pharmacogenomic data, more action is necessary to develop the infrastructure necessary to develop the technology such that in may be incorporated in regulatory decisions with confidence.

In the context of prescription drugs, tort law is traditionally understood to providing added incentive for drug manufacturers to adhere to regulations of the Food and Drug Administration (FDA) and to account for risks unknown at the time of regulation. However, holding drug manufacturers liable for risks that were unforeseen at the time of FDA approval may lead to a suboptimally high level of risk avoidance. On the other hand, preemption of all tort liability would eliminate valuable incentives created by the tort system for the on-going, post-market monitoring of prescription drugs. I therefore propose an alternate system that would harness the resources of the private sector to invest the optimal amount in researching prescription drugs’ risks and makes this information available to the parties best suited to weigh any newly discovered risks, without holding manufacturers liable for these risks in such a way as to distort the FDA’s social utility determination.

The acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend towards the increasing emphasis in drug regulatory policy on post-marketing risk management. The Accutane experience illustrates the fundamental regulatory problems of drug safety, drug availability and individual autonomy driving this shift. Recent reform of Accutane regulation through the S.M.A.R.T. program both exemplifies the trend and suggests its limitations.

The FDA maintains almost complete control over the approval, labeling, and marketing of prescription drugs. Pharmaceutical companies are generally prohibited from promoting their products to doctors for any use other than the ones that have been explicitly approved by the FDA. However, doctors may prescribe drugs that have been approved by the FDA to their patients for any purpose for which they believe it will be beneficial. In 1997, Congress passed the Food and Drug Modernization Act (FDAMA) which created a limited exception that allows drug manufacturers who submit a supplemental new drug application to the FDA for a new use of an approved drug to send limited materials directly to doctors. In enacting the provisions, Congress sought to balance the competing interests of patient access to innovative treatments with consumer protection and patient safety.
However, these provisions and the regulations the FDA promulgated under them have drawn significant criticism. Certain critics contend that the restrictions on off-label marketing stifle innovation and keep beneficial treatments from patients who need them. Others argue that these exceptions expose patients to significant risk by encouraging them to take drugs that have not been proven safe and effective under the FDA standards. This paper argues that the regulatory scheme developed under the FDAMA represents a proper balance between patient safety and access to innovative drugs because it seeks to facilitate the education of doctors rather than the promotion of drugs. However, the FDA can go further under the current regulatory scheme to find affordable ways to get reliable information to doctors, while still protecting patient safety. By focusing on finding new means to provide doctors with reliable, unbiased information the FDA can do just that.

By the measure of its mission, the Indian Health Service is one of the most successful and productive government agencies. At the same time, it is an agency often criticized for not achieving enough. Part of this criticism undoubtedly results from the negative effects caused by a chronic lack of funding. Another part of the criticism, however, comes from a deep-seated belief that they agency’s priorities are too deeply intertwined with the federal government’s national policy agenda and are not sufficiently responsive to the needs of those who receive its services. This paper examines both of these criticisms in light of the transformation of the Indian Health Service from a dominating, centralized federal agency to an agency redefining both its cause and its structure in a time of expanding Indian sovereignty. The paper concludes with an analysis of how the Indian Health Service can support the expansion of sovereignty by pursuing policies that do not just mimic national trends, but that instead develop from cooperation and negotiation with tribal “almost-equals.â€

In the United States, $26-54 billions are spent every year on the marketing of pharmaceuticals. This article focuses on the scope and pros and cons of off-label use and marketing of pharmaceuticals, and proposes a new FDA regulatory structure to redirect the incentives to positives uses of off-label pharmaceutics. The policy concern is to encourage research, treatment, and innovation, without allowing pharmaceutical companies to leverage the exclusivity that FDA approval brings for unwarranted sales that put patients at risk. The present legal regime encourages the FDA and pharmaceutical companies into Prisoner's Dilemma, where companies have every reason to attempt to use marketing to end run the agency, and the agency has every incentive institutionally to issue regulations which does not effectively address the problem. The losers, however, are those afflicted with conditions whose treatment would be improved by medications that are presently not indicated for their population, and patients who are prescribed medications which have neutral to adverse outcomes. By expanding the tiers of labeling to encompass standard of care, experimental, and orphan uses, companies will have greater incentive to pursue research which solidly shows that particular products are beneficiary treatments for a wider range of target populations.

This paper will attempt to analyze the history of FDA’s response to the emergence of BSE and whether FDA’s actions were adequate to protect the American public and its food supply.

This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and Drug Modernization Act, which provides economic incentives for drug sponsors to include children in research studies on their products. This paper concludes that Congress should renew the pediatric exclusivity provision of the Food and Drug Modernization Act, but with modifications as to provide incentives to drug sponsors for testing products on children that are not as burdensome to the elderly and the poor. After a historical review of the ills of pediatric testing, the paper discusses the need for more studies to be conducted regarding the effects of drugs commonly prescribed in children. The paper then discusses the need for regulation in clinical trials involving children. Next, the paper discusses past efforts of Congress and the FDA to encourage drug sponsors to include the pediatric population in research trials before marketing their products and then examines the latest efforts of both to encourage such studies. In the final section, the paper proposes modifications to FDAMA Section 111 to ensure that the legislation is meeting its goal of including children in more clinical trials in efforts to provide more labeling information in therapies used on children.

This paper explores the legality and the proper limits of the FDA's rule. Part I lays out the background for the rest of the paper by exploring the complicated policy and ethical problems posed by inadequate pediatric research. Part II describes the history of FDA's response to the problem of inadequate pediatric information, culminating in the 1998 rule. Part III describes the 1998 rule's potentially dramatic expansion of FDA's power over the regulated pharmaceutical industry and analyzes whether this expansion falls within the agency's statutory authority under the FDCA. Part IV explores the legislative history behind the recently passed Food and Drug Administration Modernization Act of 1997 (FDAMA) and suggests that Congress, when confronted with the 1998 Pediatric Testing rule, intended to relegate it to a policy of last resort. As a result, congressional passage of the FDAMA should limit the rule's application to the fairly narrow set of circumstances, described in Part V, in which market incentives are inadequate to induce sufficient pediatric testing. Ultimately, although the Pediatric Testing rule is a valid exercise of administrative authority, the legislative backdrop for the rule should caution FDA against imposing the mandate except as a means of correcting "market failure."

This discussion will attempt to explore the controversy and dynamics of FDA authority over tobacco advertising and the constitutionality of the existing (although unapproved) restrictions on tobacco advertising, the two major obstacles to the firm establishment of government limitations on the tobacco industry's commercial speech.

Many companies continue to go public with takeover defenses even though institutional investors zealously oppose defenses in public companies. In this Article, I analyze the determinants of takeover defenses at IPO firms using an empirical analysis of 259 IPOs from 2008-12, interviews with numerous practitioners, and a survey of the corporate governance policies of significant investors. I find that the type of an issuer’s legal counsel’s M&A experience and the identity of pre-IPO shareholders explain much of the variation in takeover defenses at IPO firms. Companies advised by law firms with more target-side M&A experience adopt more defenses, while companies advised by law firms with more acquirer-side M&A experience adopt fewer defenses. Companies backed by venture capital funds are significantly more likely to adopt more takeover defenses. However, private equity backing has no effect on the pre-IPO adoption of staggered boards. Even though mutual funds and public pension funds are some of the most ardent opponents of takeover defenses in public companies, I find that issuers that they had invested in prior to the IPO almost always go public with robust takeover defenses in place. A comparison of issuers backed by Silicon Valley law firm Wilson Sonsini and New York law firm Simpson Thacher is particularly telling: Wilson Sonsini, a firm well known for its ties to the venture capital industry and its representation of targets, installed staggered boards in all of its IPO clients while Simpson Thacher, known for its private equity practice and acquirer representation, installed staggered boards in only 50% of its IPO clients. The lack of a consensus regarding the efficiency of defenses among the most experienced participants in the IPO market leads me to reject the idea that takeover defenses are generally optimal for pre-IPO shareholders.

This paper explores the various impediments to the development of a safe and effective AIDS vaccine, and offers suggestions to help overcome these obstacles. I begin by discussing the FDA approval process and the current state of AIDS vaccine development. I then consider the different scientific impediments to the development of a preventive vaccine. The next section addresses the logistical and ethical issues in the clinical testing of a vaccine. I discuss the ethical principles that should guide researchers, demonstrate the social harm that participation may cause volunteers, and suggest methods to resolve these ethical dilemmas. Finally, I discuss the economic impediments faced by manufacturers in the form of high costs, uncertain profit margins, and unpredictable liability. Using past legislative attempts at restructuring manufacturer incentives as models, I present recommendations to help encourage manufacturers to produce the safest and most effective vaccine they can, and make it available as quickly as possible.

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.

In evaluating the United States drug regulatory system in 1978, Richard J. Crout posed a choice between competing good values: "Do we want scientific rationality or personal freedom? And if we want the latter, are we willing to pay the price of a few frauds here and there?" While the superiority of one policy preference over the other remains uncertain, since the answer largely depends upon the perspective of the "chooser" (i.e. consumer advocate or member/representative of the drug industry), what has become clear over the intervening twenty-five years is that Crout's proposed tradeoff has materialized. Changes in the structure of the law including passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA), FDA's 1997 draft guidance addressing advertisements through broadcast media (such as radio and television communications) incorporated under final regulations promulgated in 1999, recent trends in the courts' First Amendment treatment of commercial speech concerning drugs, and the January 2002 Health and Human Services (HHS) policy requiring FDA legal review of regulatory letters before they are sent to drugmakers, all embody, either in theory or in practice, a loosening of the restrictions placed upon pharmaceutical manufacturers. At the same time, fraudulent promotional practices pervade the marketplace as manufacturers run deceptive ad campaigns marketing drugs as safer and/or more effective than they really are, obscuring and minimizing risks and/or failing to present information about adverse side effects, marketing unapproved uses for an approved drug, and commercializing experimental drugs that have not yet received NDA approval. This paper will explore the impact, if any, had by the changes in the legal landscape upon drugmakers' marketing practices, raising the issues of whether certain unlawful practices may in fact be desirable, and whether the current level of FDA enforcement is appropriate to meet these practices.

Risk assessment tools are increasingly being incorporated into all aspects of the criminal justice system. This paper focuses on the use of these tools in the sentencing process, a relatively recent development which raises fundamental legal and ethical questions about fairness, accountability, and transparency. The paper provides an overview of these issues and questions for further research that can help local policymakers who are currently implementing or considering implementing similar systems in their jurisdiction.

This paper uses fiction to illuminate anxieties associated with the substances that sustain, nourish and transform us, and to consider the impact of consumer perceptions on the regulatory balances that must be struck between nature and technology, and between cultural concerns and scientific methods. It explores as a case study the FDA’s labeling regulations as applied to food crops developed using gene manipulation techniques, and touches on the FDA’s appropriate role as a consumer advisor.

Allergies affect over 12 million Americans; that number is increasing and children are disproportionately affected. Four years ago, Congress enacted the Food Allergen Labeling and Consumer Protection Act of 2004, mandating that all foods containing the eight most common allergens be clearly labeled, and requiring the Department of Health and Human Services to prepare a report on cross-contamination throughout the food industry and on the use of and consumer preferences regarding advisory labeling. The report showed that despite widespread use of allergen control policies, cross-contamination is rampant in food manufacturing facilities. The use of advisory labeling is inconsistent and communicates little valuable information. Consumers do, however, tend to take head of advisory labels and try to interpret different meanings from differently-worded messages, which indicates they are often misled. We need an industry standard, but we need to be careful not to encourage manufacturers to label all of their products, regardless of risk. I propose a system where manufactures could choose between several levels of risk. That way, they could be shielded from liability by using at least the lowest level, but they could use their discretion to apply higher risk warnings to truly dangerous products, thus better informing consumers of real risk levels. I also propose that in addressing restaurant regulation, we bear in mind the fact that the social and professional importance of restaurant dining to many people increases as they age. Even though restaurants are currently very dangerous, many teenagers and adults with allergies eat at them, and many experience serious reactions. I propose that we impose mandatory allergy training on restaurant staff, and that we direct restaurants to develop and articulate clear allergy policies, that they communicate openly and honestly to consumers. That way, consumers would know the level of risk they are taking on when they eat at particular restaurants. Further, allergic consumers and their dining partners could more easily choose safer places to eat, which hopefully would exert market pressure restaurants to develop more accommodating policies. I see both of these proposals as necessary in the short term, but hope that eventually the consumer demand for allergy-friendly policies in food manufacturing practices and in restaurants will grow strong enough that we will see the market provide more and more accommodations for people with allergies.