by

Sharon B. Jacobs, Associate with the law firm of Covington & Burling LLC, Washington, DC

64 Food and Drug Law Journal 599-630 (2009).

At the turn of the century, newspapers across America carried reports of a handful of infant deaths in St. Louis linked to contaminated diphtheria vaccine. Congress responded to the resulting outcry with the Biologics Act of 1902, inaugurating a century of food and drug “crisis legislation.” This article explores the history of Congressional responses to high-profile safety events in the area of food and drug law, from the Biologics Act to the Food and Drug Administration Amendments Act of 2007. It suggests that this pattern may be seen as an example of what Justice Stephen Breyer has labeled the “vicious circle”: a pernicious feedback loop linking public misperception, legislative overreaction, and regulatory irrationality. But the article also argues that these findings may fit a more sympathetic paradigm, and that the refrain of crisis and response might be viewed as a natural, unavoidable, and even beneficial facet of legislative evolution.

by

Geneviève Michaux, Of Counsel with the law firm of Covington & Burling LLC,
Brussels, Belgium

64 Food and Drug Law Journal, 631-662 (2009).

This article examines the rules applicable to pediatric rewards and their interpretation by the competent European authorities, i.e. the European Commission and the EMEA, and national authorities, i.e. the national Medicines Agencies and patent offices, in particular in relation to medicinal products that are approved at the national level. Depending on the patent protection of the active substance or status of the medicinal product, the reward for pediatric development is an extension of the term of the supplementary protection certificate (“SPC,” the EU equivalent of the patent term extension) or, where the medicinal product has been designated as an orphan, an extension of the term of the market exclusivity (the EU equivalent of the orphan exclusivity). Where the active substance is not or no longer protected by a patent or an SPC, the pediatric obligation is optional and the pediatric research is rewarded by data exclusivity (the EU equivalent of market exclusivity) for the new pediatric data through the grant of a pediatric use marketing authorization (PUMA). Except for the PUMA, the pediatric rewards are subject to stringent substantive requirements, in particular the approval of the medicinal product in all the EU Member States and the so-called “PIP compliance,” i.e., the implementation of the agreed PIP.

by

Marta L. Villarraga, Principal at Exponent, Inc., Philadelphia, PA

and

Heather L. Guerin, Senior Engineer at Exponent, Inc., Philadelphia, PA

and

James M. Wood, Partner in the law firm of Reed Smith, San Francisco, CA

64 Food and Drug Law Journal 663-676 (2009).

In the current analysis, the authors have added two fiscal years of Class I recalls (up to FY 2008), and have added an evaluation of warning letters to the analysis for all five fiscal years (FY 2003-2008). The authors have examined the relationship between the recalls that occurred during this time period and warning letters issued that were deemed to be related to the recalled products. In addition, the authors included evaluations of the lay press and medical literature to examine the impact of these recalls on these communication means. The authors also examined the legal impact by determining if these recalls led to any significant product liability activity by reviewing those cases that have been consolidated for coordination by the Judicial Panel on Multidistrict Litigation.

by

Maruthi Prasad Palthur, Director of Regulatory Affairs and Quality at Indigene Pharmaceuticals, Inc., Westborough, MA

and

Sree S.S. Palthur, A Compliance Coordinator at Indigene Pharmaceuticals, Inc.,
Westborough, MA

and

Suresh Kumar Chitta, A Professor of the College of Pharmacy, S.K. University, India

64 Food and Drug Law Journal 677-692 (2009).

The world market for functional foods, nutraceuticals, and dietetic products has been expanding and is driven by demographic, economic, and social trends. Confusion over the definition of functional foods makes it difficult to estimate the exact size of this sector. The global market size has been estimated between US $30 and US $60 billion depending on the definition. Japan, the United States, and Europe are the biggest markets with an annual growth of approximately 10 percent. The functional food industry in India is strong and is a growing force in the international health foods market. The health and wellness foods market is currently estimated to be in the vicinity of US $1.6 billion and is expected to reach US $7.5 to $10 billion by the year 2015 — growing at a 25 to 30 percent compounded annual growth rate.

This article examines the current regulatory framework for functional foods and nutraceuticals in India, the development of a new regulatory regime, and speculation on the implementation of the new regime. This article attempts to provide some context on regulation, invoke debate and dialogue, and make recommendations on India’s approach to regulation of functional foods and nutraceuticals.

by

Peter Chang, Third year law student at Harvard Law School

64 Food and Drug Law Journal 693-716 (2009).

Country-of-origin labeling (COOL) is finally experiencing a second wind, nearly 120 years after it was first enacted in the United States. Congress recently passed, and the federal government is now in the process of implementing, new geographic origin labeling requirements on a variety of foods, above and beyond marking requirements already firmly established in federal law. That many aspects of the new legislation―the covered foods, the affected parties, and the method of implementation―have never before been envisioned on a national scale perhaps is not a surprise. Only the globalization of the last few decades, characterized by reduced trade barriers, rapid scientific and technological advances, and improved transportation networks, has added anything of real substance to the existing array of food and product safety concerns America has historically confronted.

by

Ricardo Carvajal, Of Counsel with the law firm of Hyman, Phelps & McNamara, PC, Washington, DC

and

David Clissold, A Director with the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

and

Jeffrey Shapiro, A Director with the law firm of Hyman, Phelps & McNamara, PC, Washington, DC

64 Food and Drug Law Journal 717-732 (2009).

Signed into law on June 22, 2009, the Family Smoking Prevention and Tobacco Control Act provides FDA with regulatory authority over virtually every aspect of the design, production, marketing, and advertising of tobacco products. Although the new law has its detractors, there is little question that the law’s enactment marks a dramatic shift in the relationship between the federal government and the tobacco industry. This article provides a summary of the new law’s major provisions and highlights some of the legal issues that implementation of the law is likely to raise.

by

Christopher-Paul Milne, Associate Director of the Tufts Center for the Study of Drug Development, Tufts University, Boston, MA

and

Joyce Tait, Scientific Advisor to the ESRC Innogen Center and a Professor at the
University of Edinburgh, Scotland

64 Food and Drug Law Journal 733-754 (2009).

In governing the life sciences, there is a need to foster innovation, but also to control risk. While the scientific complexity and public unease with new healthcare technologies typically proscribe industry self-regulation, overly burdensome regulatory regimes can thwart the speed of innovation and the diversity of innovators necessary for a high-tech field to sustain itself. The premise of this article is that FDA has two programs, the orphan product and fast track programs for biopharmaceuticals, which serve as useful models of a regulatory system evolving towards a so-called ‘governance’ approach, which is characterized by push-pull incentives and a problem-solving philosophy. However, in this case, it also demonstrates features of old-style command-and-control ‘government,’ but with more control, and less command. The authors’ analysis presents evidence that these programs are exemplars of “what works.”

by

John B. Reiss, Partner in the Business Department of the law firm of Saul Ewing, LLP, Philadelphia, PA

and

Nichole Alling, A 2009 Summer Clerk with the law firm of Saul Ewing, LLP, Philadelphia, PA

and

Stephen Chuk, A 2009 Summer Clerk with the law firm of Saul Ewing, LLP, Philadelphia, PA

and

Kristen Hall, A 2009 Summer Clerk with the law firm of Saul Ewing, LLP, Philadelphia, PA

64 Food and Drug Law Journal 755-804 (2009).

While this year is likely to bring major policy changes as a result of the potential health system reform legislation, the trends in agency activities and court decisions are likely to be maintained. The Food and Drug Administration (FDA) is expanding its staff and responsibility to engage in industry oversight. The large increase in FDA warning letters and other enforcement actions within the past year is likely to continue. The Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) are unlikely to experience significant change regarding their regulation of Manufacturers. The FTC continues to try to prevent “reverse” payments to generic drug manufacturers by Innovator Manufacturers to diminish generic drug competition, and proposed legislation is before Congress. The SEC appears more focused on the Foreign Corporate Practices Act with respect to enforcement against pharmaceutical manufacturers. Shareholder suits will be less prevalent, and Federal pre-emption of state law less common.