Food and Drug Administration Safety and Innovation Act

Food and Drug Administration Safety and Innovation Act
Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.
Enacted by	the 112th United States Congress
Citations
Public law	Pub. L. 112–144 (text) (PDF)
Statutes at Large	126 Stat. 993 through 126 Stat. 1132 (140 pages)
Codification
Agencies affected	Food and Drug Administration
Legislative history
	Introduced in the Senate as S. 3187 by Tom Harkin (D-IA) on May 15, 2012; Signed into law by President Barack Obama on July 9, 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.^[1]