Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule

Abstract

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."