Rethinking Innovation at FDA

Abstract

In several controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the agency has come to make many innovation-related judgments as part of its regulation of drugs. In this Article, we investigate the broad set of innovation-related judgments that FDA has been making and argue that there are serious concerns with the major innovation role FDA has been playing, at least as the agency is currently constituted. We conclude that FDA should not separately weigh innovation in decisions about a product’s safety and effectiveness. In other areas, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in shaping the development of novel drugs. But agency officials should do so thoughtfully considering both the opportunities and challenges of FDA actively considering innovation incentives in its decisions; those challenges have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit the ways that FDA considers innovation in its regulatory decisions, changes are needed to the agency’s structure to support its ability to make reasoned judgments, based on relevant expertise.

Note:
Funding Information: None to declare.

Conflict of Interests: Rachel E. Sachs, JD, MPH is the Treiman Professor of Law at Washington University in St. Louis School of Law. W. Nicholson Price II, JD, PhD is a Professor of Law at Michigan Law School. Patricia J. Zettler, JD, is an Associate Professor of Law at The Ohio State University Moritz College of Law, and a faculty member of Ohio State’s Drug Enforcement and Policy Center and its Comprehensive Cancer Center. Zettler reports serving as consultant to the World Health Organization, U.S. Food and Drug Administration, and Hopewell Fund, as an expert witness retained by the Direct Purchaser Class Plaintiffs in In re Suboxone Antitrust Litigation, No. 2:13-MD-2445 (E.D. Pa) and as expert witness retained by the Direct Purchaser Class, End Payor Class, and Retailer Plaintiffs in In re Opana Antitrust Litigation, No. 14cv-10150 (N.D. Ill.).

Keywords: Innovation, FDA, pharmaceutical policy