Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

Abstract #105982

Robert Field, JD, MPH, PhD, Health Policy Program, University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, PA PA, 215-596-7618, r.field@usip.edu

Recent revelations linking COX-2 inhibitors with cardiac risks have raised questions about FDA post-market oversight, which is much less rigorous than the pre-market vetting procedure. It is mostly voluntary and unsystematic, even though pre-market clinical trials are often too small and brief to catch rare or long-term side effects. Regulatory impediments to better oversight are not the only concern. Post-market surveillance presents an inherent institutional conflict for the FDA in that acknowledgement of previously undetected risks could be perceived as a failure of its pre-market vigilance. Historically, significant extensions of FDA authority followed safety scandals in 1906, 1938 and 1962. The COX-2s may represent another one that requires a response. Each time, the pharmaceutical industry feared new regulatory burdens, but each time it not only survived but thrived on enhanced public confidence. Present options for reform include the European Union's approach of reassessing all approved drugs after five years, and a Senate proposal for a second drug safety agency. However, a major new program seems unlikely in the present political climate. An alternative first step could promote greater transparency of information to influence market forces. Several recent initiatives seek comprehensive registries of pre-market clinical trials to insure that all results, both positive and negative, are disseminated. A similar registry could include post-market trials. A requirement for listing all such tests and their results would alert the public and the FDA to problems without the need, at least initially, for a major bureaucratic expansion.

Learning Objectives:

• To understand the existing post-market drug surveillance process.
• To review and evaluate reform options in light of the COX-2 revelations.
• To consider a modest reform approach.

Keywords: Drug Safety, Health Law

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Recorded presentation