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Carolyne R. Hathaway, Partner in the law firm of Latham & Watkins LLP, Washington, DC
John R. Manthei, Partner in the law firm of Latham & Watkins LLP, Washington, DC
J. Ben Haas, Associate in the law firm of Latham & Watkins LLP, Washington, DC
Elizabeth D. Meltzer, received her JD from Georgetown University Law Center, MPH from Johns Hopkins Bloomberg School of Public Health and AB from Georgetown University

64 Food and Drug Law Journal 261-276 (2009).

The web of overlapping requirements, standards, recommendations and policies governing the conduct of clinical trials highlights the intense scrutiny of the ethical, data quality and public access issues raised by human trials that are conducted to demonstrate the safety and efficacy of medical products marketed in the United States.

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Christopher Richins, 2009 JD Candidate, Hofstra University School of Law. This article was written while the author was a student at Hofstra University School of Law

64 Food and Drug Law Journal, 277-290 (2009).

There are about 50 million active cigarette smokers in the United States, and cigarette smoking accounts for almost 500,000 deaths each year. The World Health Organization (WHO) places the global total of such deaths at 5million people annually. In the United States, this high-level of cigarette smoking occurs despite the fact that 70 percent of Americans who smoke report that they want to quit the habit.

As a direct consequence of these statistics, several smoking cessation aids, some as the result of the discovery and development of new molecular entities, have been developed both domestically and abroad. While the timely development and commercialization of new molecular entities serves a vital public interest, so too do assurances of their safety and efficacy. This article proposes an integrated approach early in the clinical development of a new molecular entity to the design of premarket approval clinical studies, postmarket approval clinical studies, and Risk Evaluation and Mitigation Strategies (REMS), as a means of balancing these two important policy objectives.

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Gregory J. Wartman, Associate in the law firm of Saul Ewing LLP, Philadelphia, PA

64 Food and Drug Law Journal 291-312 (2009).

The United States Supreme Court’s landmark decision in Riegel v. Medtronic, Inc. in February 2008 altered the landscape of medical device litigation involving Class III medical devices that have received premarket approval from the Food and Drug Administration (FDA).
In Riegel, the Court ruled that the premarket approval process establishes federal requirements and that state law tort claims seeking to impose additional or different requirements on device manufacturers are preempted under the express preemption clause of the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA).

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James Chyau, May 2009 JD Candidate, Southwestern Law School

64 Food and Drug Law Journal 313-334 (2009).

In mid-March 2007, Ontario-based Menu Foods Inc. started recalling its “cuts and gravy” style pet food, after receiving information that pets that had eaten the product had fallen ill. Within a week, the company was inundated with complaints and expressions of concern from about 200,000 of its customers.

The Food and Drug Administration (FDA) determined in late March 2007 that the most likely culprit in the illness, and in some cases death of the pet animals, was contaminated wheat gluten, a vegetable protein imported from China. One of the FDA identified contaminants was an industrial chemical called melamine. Reports of widespread adulteration of animal feed with melamine in China raised concern of similar contamination in the human food supply. In response, on April 27, 2007, FDA announced the detention of all vegetable proteins imported from China, whether for animal or for human consumption. But, FDA’s action came too late. On May 1, 2007, officials from FDA and the U.S. Department of Agriculture (USDA) indicated that between 2.5 to 3 million people in the United States had consumed chickens that had been fed with contaminated vegetable proteins imported from China.

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David E. Korn, Senior Assistant General Counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC
Erika Lietzan, Partner in the law firm of Covington & Burling LLP, Washington, DC
Shaw W. Scott, Associate in the law firm of Covington & Burling LLP, Washington, DC

64 Food and Drug Law Journal 335-390 (2009).

Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended the provision substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 180-day exclusivity was to provide an incentive for generic drug applicants to challenge innovator patents, and the core of the concept—as it has been applied by the Food and Drug Administration (FDA) and the courts—is that the first generic drug applicant to challenge an innovator’s patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. 180-day exclusivity is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA.

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Joshua Cohen, Senior Research Fellow, Tufts Center for the Study of Drug Development, Tufts University, Boston, MA
Andrew Wilson, Research Analyst, Tufts Center for the Study of Drug Development, Tufts University, Boston, MA
Laura Faden, Senior Research Analyst, Tufts Center for the Study of Drug Development, Tufts University, Boston, MA

64 Food and Drug Law Journal 391-404 (2009).

In this study, the authors examine factors underlying payer off-label use reimbursement policies. Updating a study published 14 years ago, presenting the results of the survey of 179 payers administering public (Medicare and Medicaid) pharmacy benefits. The focus is on payers administering pharmacy benefits in the public sector for two reasons: First, transparency; there is a tendency for such payers to reveal more about their decisionmaking processes than payers that exclusively deal with the commercial market. Second, Medicare and Medicaid set the pace in terms of specific policies on off-label use reimbursement, particularly with regard to anti-cancer agents and biologics.

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A. Bryan Endres, Assistant Professor of Agriculture Law, University of Illinois
Jody M. Endres, Senior Regulatory Associate, Energy Biosciences Institute,
University of Illinois

64 Food and Drug Law Journal 405-440 (2009).

Two historical examples provide important insight into how federal government policies can integrate regional and local food systems to achieve food security during a time of acute crisis. During World War II, American home gardeners, through the federal government’s Victory Garden program, supplied 40 percent of the nation’s fresh produce, while simultaneously maintaining pre-war commodity production policies favoring large agricultural interests.

The recent food crisis in Cuba, precipitated by the collapse of Soviet-bloc trade in the early 1990s, is another historical example that could inform U.S. policymakers on how to achieve food self-sufficiency through reemphasis on small farmers using sustainable practices supplemented with urban gardening.