Ten years ago, Congress created the FDA’s user fee programs for generic and biosimilar medicines when it enacted Generic Drug User Fee Amendments (GDUFA) and The Biosimilar User Fee Act (BsUFA) as part of the FDA Safety and Innovation Act of 2012.
For generic drugs, the number of applications submitted to the FDA had increased substantially since enactment of the Hatch-Waxman Act and FDA’s review of abbreviated new drug applications (ANDA) was often slow and unpredictable. For biosimilar medicines, FDA’s approval pathway for these new treatments had been created as part of the Biologics Price Competition and Innovation Act (BPCIA) in 2010.
With passage of the first GDUFA and BsUFA in 2012, Congress helped ensure FDA would have sufficient resources to carry out its mission.
Over 10 years of the Generic and Biosimilar programs at FDA, the generic and biosimilar industry has provided more than $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients – including $469 billion from new generics and more than $12 billion from biosimilars – and a dramatic increase in patient access to life-saving treatments.
Resources and Fact Sheets:
- AAM Letter of Support for Food and Drug Amendments of 2022 Act
- AAM Statement on FDA User Fee Reauthorization
- AAM Testimony Before Subcommittee on Health of the House Committee on Energy and Commerce
- GDUFA Reauthorization: A Primer
- BsUFA Reauthorization: A Primer
- The Generic Drug User Fee Amendments (GDUFA III)
- The Biosimilar User Fee Act (BsUFA III)