October 10, 2012

The FDA Safety and Innovation Act

Author Affiliations

Author Affiliations: Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut (Dr Steinbrook); and Maryland Department of Health and Mental Hygiene, Baltimore (Dr Sharfstein).

JAMA. 2012;308(14):1437-1438. doi:10.1001/jama.2012.12829

In the midst of a rancorous election year, bipartisan accord in Congress is infrequent. A notable exception is the broad agreement on the US Food and Drug Administration (FDA) Safety and Innovation Act, approved by overwhelming majorities in the House of Representatives and the Senate, and signed into law by President Barack Obama in July 2012.1 Effective October 1, 2012, the legislation reauthorizes for 5 years the collection of user fees from industry for the reviews of prescription drugs and medical devices and establishes new user fee programs for generic drugs and “biosimilar” biological products.

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