Efforts by the Food and Drug Administration (FDA) to ensure the safety of prescription medicines historically have focused on the requirements for therapies to gain market approval. However, many safety risks are discovered only after a medication reaches the market.1 During the past decade, reports by the Institute of Medicine2 and calls from policy experts have provided momentum to improve the US drug regulation system. One major step in this direction was achieved in 2007 when Congress passed the FDA Amendments Act (FDAAA).3 Although the FDA has frequently sought to avoid a focus on postmarketing regulation by emphasizing that it “does not regulate the practice of medicine,” the FDAAA language suggests increasing involvement of the agency in shaping clinical practice to ensure safe medication use.
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