Online Program

Drug safety and the food and drug administration: The past, present, and future

Tuesday, November 5, 2013

Brian Chen, JD, PhD, Arnold School of Public Health, University of South Carolina, Columbia, SC
Several high-profile recalls have called into question the safety of prescription drugs in the United States. In this article, we describe the regulatory and market factors that contribute to these safety concerns, review proposals to address the challenges, and highlight the essential elements that must be incorporated into a successful agenda to repair the failures in the American drug safety net. We show that at the root of the drug safety problem lies the tension between the need for a quick, efficient drug approval process and the need for a long-term adverse event surveillance system. The current regulatory environment is a product of an era that emphasized speed as a result of major health crises (particularly AIDS and cancer) in the 1990s. Yet, despite a much faster approval process today, there is insufficient increase in the ability to monitor adverse events and take safety-related actions after a drug has been approved even with new FDA regulatory powers under the 2007 Food and Drug Administration Amendments Act. Moving forward, policymakers must consider ways to address the current weaknesses in post-approval drug surveillance and drug safety without unduly affecting the efficiency of new drug application review.

Learning Areas:

Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
Describe legal and economic factors contributing to pharmaceutical safety concerns in the United States. Discuss legislation enacted to address adverse drug reactions that surface in the postmarket. Assess and analyze proposals under the law for future Food and Drug Administration actions to improve the safety of prescription drugs.

Keyword(s): Law, Drug Safety

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have a J.D. from Stanford Law School and am admitted to the California State Bar. I am also a co-investigator on an National Cancer Institute-funded R01 grant investigating drug safety and adverse drug detection.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.