Reputation and Regulation: A Study of Pharmaceutical Policy at the FDA

Award Year: 2003	Investigator: Daniel Carpenter	Budget: $270,675	Categories: Pharmaceutical Policy, Government Agencies
Abstract: As U.S. expenditures on prescription drugs continue to rise and account for a growing share of gross national product, Daniel P. Carpenter, Ph.D. examines a major institution in American health care: the U.S. Food and Drug Administration (FDA). His project, Reputation and Regulation: A Study of Pharmaceutical Policy at the FDA, considers the power the FDA exerts and how political, social, and other considerations influence its decisions. Focusing on the Center for Drug Evaluation and Research (CDER), the agency's drug reviewing division, Dr. Carpenter dissects the FDA's reputation for protecting the American public, the evolution of that role, and its impact on regulation of new drugs. Specifically, he explores how the FDA's concerns about its image and credibility affect whether drugs are approved or rejected, and whether drug development is accelerated or slowed. His work should also reveal who wins and who loses when agency self-protection motivates the making of prescription drug policy.