Food and Drug Administration Safety and Innovation Act (FDASIA)

Food and Drug Administration Safety and Innovation Act (FDASIA)

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.
"Support for FDA user fees is a testament to the important role FDA plays in America’s healthcare continuum. FDA’s medical product decisions sit at the intersection of public health, innovation, and commerce and touch the lives of nearly every American every day," said FDA Commissioner Margaret A. Hamburg, M.D.
This is the fifth reauthorization of the Prescription Drug User Fee Act or PDUFA, first enacted in 1992, and the third reauthorization of the Medical Device User Fee Act, or MDUFA, first enacted in 2002. Both programs have provided steady and reliable funding to maintain and support a staff of trained reviewers who must determine whether a proposed new product is safe and effective for patients and do so within a certain time period. The new user fee programs for generic drugs and biosimilar biologics build on the successes of these two established user fee programs.

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Fact Sheets

• New User Fees for Generic Drugs Will Enhance Americans’ Access to Less Expensive Drugs and Generate Major Cost Savings¹
• Medical Device User Fee Amendments of 2012²
• Pediatric Provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)³
• Increased Patient Participation in Medical Product Regulation⁴