The Food and Drug Administration Amendments Act and Postmarketing Commitments

JAMA: 7/10/13

Because rare but potentially serious adverse events of prescription drugs are often discovered only after market approval,1 observational postmarketing studies constitute an important part of the US drug safety system.2 In most instances prior to 2007, the US Food and Drug Administration (FDA) could only request that drug manufacturers voluntarily agree to conduct postmarketing safety studies.2 An Office of Inspector General report3 in 2006 found inadequacies in drug companies’ fulfillment of these postmarketing studies and weaknesses in FDA’s regulatory authority to enforce these commitments. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA), which authorized the FDA to require postmarketing studies for a prescription drug’s approval and mandate adherence to study deadlines.2,4 We examined how fulfillment of these postmarketing studies has changed over time. Read more