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

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.