Synthetic Drug Abuse Prevention Act of 2012

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.

Title I extends through FY2017 the authority of the FDA, through the authority of the Secretary of Health and Human Services, to collect drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA process for reviewing human drug applications.

It requires the FDA to submit annually to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions, a report on the progress of the FDA in achieving the goals of the administration, future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research in achieving such goals. The report should include the number of: (1) new drug applications and biologics license applications filed, (2) priority new drug and biologics applications filed, (3) standard efficacy supplements, (4) priority efficacy supplements, (5) applications filed for review under accelerated approval, (6) applications filed for review as fast track products, (7) applications filed for orphan-designated products, and (8) breakthrough designations.

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