Report: Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Report: Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Institute of Medicine (IOM); 1 May 2012

Abstract
Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed. The FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM recommends implementing a life cycle approach to drug safety oversight that could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.

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