HLS Student Papers

The current FDA process is not well suited for the introduction of enhancement drugs that are intended to improve certain aspects of cognition or behavior to a degree beyond what is normal. Even though there are no statutory restrictions against approving these drugs, the current positioning of the FDA approval process suggests these types of drugs would have a difficult time receiving approval for an indication that covers normal, healthy adults. However, until now the FDA has not had to confront this issue directly, since despite common media hype there is little scientific evidence that any drugs are true cognitive enhancers. That said, scientific interest in this area is growing, as is the pace of understanding about the framework of the brain. It seems only a matter of time before potently effective cognitive enhancements are developed. Once this happens, the current FDA norm of approval for a specific indication, followed by large off-label use, could result in many important ethical and safety questions going unaddressed. Ultimately, if the FDA is going to satisfy its mission to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner,” a new framework will need to be developed.

Drug shortages are a growing problem in the United States. The scope and severity of drug shortages has caught the public eye and prodded the FDA into action. Among the potential causes of drug shortages are Medicare Part B reimbursement policies, the 340B federal drug rebate program, market consolidation and competition in the pharmaceutical industry, regulatory overreach by the FDA and manufacturing and supply problems at production plants. What these causes have in common is that they can all be understood as dampening profits for manufacturers in one way or another. Some causes effectively impose price caps which prevent manufacturers from charging a free-market price for their products. Other causes create cost floors which stymie cost-cutting efforts by manufacturers. Whether by elevating costs or reducing prices, these contributors dampen profits, and without profits, incentives to produce evaporate. Pulling these conclusions together, it becomes clear that the best approach to drug shortages is to make drug manufacture more attractive by removing price caps and reducing cost floors. Whether through tax subsidies, Medicare Part B and 340B drug rebate reform, or relaxed regulatory requirements, the most promising approach is one that makes drug manufacture more profitable.

In 1986, Congress passed the National Childhood Vaccine Injury Act, which established a no-fault compensation system to provide money to people who are injured by vaccines. The major impetus behind this Act was the soaring cost of tort litigation and damages awards imposed on vaccine manufacturers, which was causing many manufacturers to stop producing vaccines altogether. The resulting vaccine shortages threatened the public health of the country. In recent years, manufacturers of prescription drugs have paid large damages awards and legal fees that are akin to those costs borne by vaccine manufacturers in the 1970s and early 1980s. Pharmaceutical manufacturers can be liable for billions of dollars if patients who take a drug suffer an unexpected adverse event that was not discovered during clinical trials. The uncertainty about the extent of liability a manufacturer may face for a particular drug is causing many manufacturers to remove beneficial drugs from the market or to forego drug development altogether. As a result, Congress should establish a no-fault compensation system to replace failure-to-warn claims against prescription drug manufacturers. Such a scheme would significantly reduce the incredible costs that the current drug product liability system imposes on drug manufacturers. At the same time, patients who take a prescription drug and suffer a serious injury that was not foreseen by the drug manufacturer or the FDA will be compensated, so long as they can prove that the drug was the cause of their injury. The National Vaccine Injury Compensation Program is an excellent model that Congress can adapt to meet the needs of participants in the market for prescription drugs.

The idea that some processed foods can be addictive has gained support in recent years. Animal and human studies show extensive overlap between the neuronal signaling involved in palatable food consumption and drug addiction. A growing number of individuals also repor being unable to stop consuming certain foods despite repeated efforts, and consuming them to feel better emotionally, rather than to satisfy hunger. While food addiction can contribute to overconsumption of calories and excessive weight gain, it is not synonymous with obesity. The food addiction concept, while controversial, can have important implications for treatment and regulation. Government initiatives have focused on spreading nutrition information, but evidence indicates that most people are eating unhealthy food for emotional reasons, not due to lack of information. If the existence of food addiction gains greater acceptance, it may be particularly important in facilitating the regulation of food advertising directed to children. The model also has implications for research and treatment.

This Paper traces the history of aquaculture from ancient China until the present, highlighting the various degrees of, and reasons for, aquaculture’s popularity at different points throughout history. The history of aquaculture demonstrates that the industry is largely a manifestation of concern over environmental and economic costs of the capture fishery industry; yet the current practice of aquaculture has begun to resemble the tortured past of wild-caught fish, with mono-culture fish farms causing serious environmental and economic problems for inland and coastal human and natural environments. Thus, this Paper argues that the history of the development of the aquaculture industry can serve as a cautionary tale as the industry moves forward, using the rubric of Garrett Hardin’s The Tragedy of the Commons to delineate the ways in which aquaculture succeeds and fails at achieving one of its fundamental purposes: to provide a sustainable method of protein provision to human society. This Paper posits that aquaculture, historically viewed as a substitute for dwindling wild fish stocks, a solution to the exploitation of a global commons, should itself also be viewed as a contributor to serious tragedies of the commons by both exploitation and by pollution. However, aquaculture has never been adequately regulated holistically as an instigator of environmental and economic problems. Thus, for the aquaculture industry to realize its full, impressive potential as an environmentally beneficial, economically sound, and domestically responsible method of protein production, it must draw lessons from its history to become a sustainable, “green” blue revolution.

This paper examines and contrasts the legal framework in the United States and comparable legislation in Taiwan. Prompted by the Syntex incident, the U.S. Congress passed the Infant Formula Act of 1980, and delegated the Food and Drug Administration (FDA) the authority to establish the regulations in order to safeguard the health of infant children. In contrast to the legislation history in the United States, Taiwan enacted the comparable law and established relevant regulations late in 2008. A comparison of these two legal systems reveals that the United States has a more comprehensive regulatory scheme for infant formula, while Taiwan focuses only on the sanitary conditions for infant formula manufacture. Besides, U.S. infant formula regulations have expanded and become more stringent while Taiwan’s FDA (TFDA) only requires manufacturers to meet certain sanitary requirements, without mandating how to achieve them. Another difference is that the U.S. FDA does not require infant formula manufacturers to note that breastfeeding is more nutritious than infant formula on their product labels, but TFDA takes a firm stance and requires formula manufacturers to state on product labels that breast milk is more nutritious than formula.

Medical devices are an extraordinarily large and important component of the delivery of healthcare services. This Paper examines the manner in which they are introduced into commerce and the ways in which legal privileges and encumbrances upon medical devices affect their dynamics in the market. The usual way of regulating introduction of new products to promote innovation is through the patent system. With medical devices, a complex regulatory framework also governs their market introduction. These two independent bodies of law are occasionally in tension, producing a number of distortions and unusual incentives for manufacturers of medical devices. This Paper aims to understand the medical device regulatory context in detail and to survey these pressure points, with an emphasis on how the interaction between food and drug law and patent law relates to innovation policy.

Using Mississippi as a case study, this paper describes the potential for expanding farm to school and provides recommendations for state and local actions to encourage its growth. Part I provides a brief background of farm to school programs in the United States and the benefits of such programs to education, children’s health and economic development. Part II reviews federal regulations and statutes relevant to farm to school programs and discusses new federal legislation designed to encourage farm to school activities. Part III provides an overview of school food purchasing, including coverage of the extent to which schools currently purchase local and regional agricultural products. Part IV reviews some of the barriers that could come into play when implementing farm to school programs in Mississippi. Part V is comprised of studies of farm to school programs implemented elsewhere at the local, state and regional levels. Part VI is an overview of measures that legislatures across the country have taken to support farm to school programs. In Part VII, the paper concludes with a description of actions nonprofit organizations and the state government can take to promote farm to school activities in Mississippi.

Since the mid-1900s, rates of obesity and diabetes among Native American populations have been much higher than the rates of those disorders for Americans as a whole—and yet, before 1950 or so, diabetes was extremely rare among Native Americans. This paper suggests that the influence of Western culture in Native American communities in the last 60 years, and particularly Native American adoption of the Western diet, is the primary reason for the rapid increase in obesity and diabetes. This paper reviews the history of Native American interaction with Europeans and the U.S., and analyzes several theories regarding the specific mechanisms by which Western influence has high rates of obesity/diabetes in Native American communities. It concludes that the obesity/diabetes epidemic is driven by several factors: the historical U.S. policies of relocating Native Americans and attempting to assimilate them into Western culture; the resulting extreme poverty of Native American tribes and their reliance on government food programs; and the destruction of environmental resources that tribes depended on for sustenance, compel many tribes to adopt a Western-style diet. In turn, the Western diet, high in glucose and simple carbohydrates, causes significant obesity- and diabetes-related problems among Native Americans who possess genetic and physiological propensities to efficient energy metabolism.