American University Law Review
February 2000

COMMENT

Kurt R. Karst*

INTRODUCTION

For more than twenty years, the Food and Drug Administration ("FDA"), the pharmaceutical industry ("Industry"), Congress, and the American Academy of Pediatrics ("AAP") have worked to craft substantive and effective proposals to provide better pediatric drug labeling and pediatric drug formulations to reduce off-label drug use. Efforts have focused on three distinct classes of drugs regulated by the Food, Drug, and Cosmetic Act of 1938 ("FDCA"): (1) new drugs; (2) currently marketed drugs; and (3) off-patent drugs. As a result of the efforts of the FDA, Industry, and the AAP, Congress has implemented two major policies. First, in November 1997, Congress passed the Food and Drug Administration Modernization Act ("FDAMA"), which included Section 111, Pediatric Exclusivity ("FDAMA Section 111"). Second, on December 2, 1998, the FDA promulgated a final rule, "Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients" ("Final Rule").

FDAMA Section 111 offers six months of extended patent life to innovator drug sponsors who conduct pediatric studies on new and currently-marketed drugs. This provision sunsets in 2002. In contrast, the FDA's Final Rule compels drug sponsors to assess the safety and efficacy of new and currently-marketed drugs and biological products in pediatric populations.

The carrot offered in the FDAMA to innovator drug sponsors who conduct pediatric studies complements the FDA's mandatory Final Rule. The former affords the Industry the opportunity to provide new and currently-marketed drug products that should be tested for use among pediatric patients in exchange for patent exclusivity, and the latter allows the FDA to require that all drugs and indications are tested in pediatric populations regardless of their market potential. Numerous questions abound, however, as to the future status and implementation of the Final Rule after the FDAMA Section 111 marketing exclusivity incentive expires in 2002. The Industry fears that once it demonstrates an ability to conduct pediatric studies with a market incentive, and after FDAMA Section 111 sunsets, the FDA will possess only the stick-like Final Rule with which to mandate further pediatric testing. Conversely, the FDA is concerned that once FDAMA Section 111 expires, mandatory testing will remain as the only alternative to continue and enhance the availability of drugs for pediatric patients. The FDA's goal, which is to increase the availability of drugs to pediatric patients, does not justify the means chosen by it to reach that end. The implementation of the Final Rule will not increase the availability of drugs to pediatric patients, but rather will stymie the growth of pediatric formulations.

This Comment argues that the FDA lacks the authority to mandate pediatric testing via the Final Rule. Further, this Comment demonstrates that the FDA intends to use FDAMA Section 111 market exclusivity as a carrot for Industry compliance with the Final Rule. This objective is made apparent in the similarity of the FDA's criteria for a drug to qualify for market exclusivity under FDAMA Section 111 and the criteria that would invoke mandatory testing under the Final Rule, the definition of "drug" as active moiety, and the lack of expedience the FDA shows in granting market exclusivity from a rather long list of drugs that qualify for pediatric exclusivity under FDAMA Section 111. In addition, this Comment explains that an Industry challenge to the FDA's authority to mandate pediatric studies will coalesce and exacerbate negative public sentiment against the Industry. Finally, this Comment recommends that the most prudent option, and the option that best serves the interest of pediatric patients, is a compromise between the Industry and the FDA, whereby the Industry contributes to pediatric studies for off-patent drugs and the FDA agrees to recommend that the United States Congress reauthorize FDAMA Section 111 incentives for an additional five years.

This Comment begins by providing historical information on both the legislative and regulatory attempts to find parents for the "therapeutic orphan" that resulted in the passage of FDAMA Section 111 and the promulgation and implementation of the Final Rule. In addition, Part II addresses the unstable statutory foundation upon which the FDA bases its authority to mandate pediatric testing and the difficulty the Industry faces in its challenge of the FDA's authority. Part II examines the consequences the Industry likely will confront when FDAMA Section 111 sunsets in 2002. Part III recommends that the Industry and the FDA reach a compromise to fulfill the needs and goals of the Industry, the FDA, and most importantly the children, which is to ensure that the entire universe of available drugs are available to pediatric populations.

* Junior Staff, American University Law Review, J.D. Candidate, May 2001, American University, Washington College of Law; B.A., 1995, Marquette University. I am grateful to Sara Young, David Chavkin, Scott Furst, and Kim Maraviglia for their thoughtful comments on earlier drafts of this Comment. I would especially like to thank my wife, Amanda, my parents, Ralph and Cheryl, my brother, Erik, and most importantly, the Lord Almighty-Omnia ad majorem Dei gloriam.

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