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Bruce M. Psaty, MD, PhD; David Korn, MD

JAMA. 2007;298(18):2185-2187.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US drug safety system developed fitfully through a series of historical accretions, typically in the wake of major drug safety scandals. In 1962, largely precipitated by the thalidomide tragedy, the Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act required the sponsor to provide "substantial evidence" of both safety and efficacy during a premarket evaluation. The resulting multistage approval process improved the evidence base for premarket regulatory decision making about drugs, but it also created, as an unintended consequence, a postapproval environment in which sponsors were largely free from requirements for additional evaluations. At approval, the sponsor's scientific teams responsible for meeting US Food and Drug Administration (FDA) requirements were generally replaced by marketing teams, and the manufacturer's efforts, energies, and studies were generally directed toward marketing its drugs.^1-2

The formulaic preapproval evaluation process, even though usually of high quality, . . . [Full Text of this Article]

Selected Drug Safety Provisions of the FDA Amendments Act

New Authorities and Enforcement Tools (IOM Recommendations 5.1 and 5.2)

Access to Data and Active Surveillance (IOM 4.2 and 4.6)

Clinical Trials Registration, Results Database, and Conflict of Interest (IOM 4.11 and 4.10)

Risk Communication (IOM 6.1, 6.2, and 4.12)

Other Provisions

Resources (IOM 7.1)

Author Affiliations: Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, and Center for Health Studies, Group Health Cooperative, Seattle (Dr Psaty); and Division of Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, DC (Dr Korn).

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