Every five years, Congress is required to reauthorize the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Amendments (BsUFA). These industry agreements not only ensure critical funding for Food and Drug Administration (FDA), but they also provide an opportunity to advance FDA policies that modernize and improve regulatory review processes and enhance patient access to affordable medicines. GDUFA and BsUFA, originally authorized in 2012 and 2017, respectively, are initially negotiated by FDA and representatives of the generic and biosimilar industries to address various regulatory challenges and subsequently sent to Congress for approval and signed into law.
As Congress begins consideration of the third GDUFA reauthorization and second BsUFA reauthorization ahead of the September 2022 deadline, it is critical that lawmakers use this opportunity to address complex generic approval timelines and remove barriers to generic drug approvals. Specifically, Viatris supports the following legislation:
- H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022
- H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022
- Introduced by Representative Ann Kuster (D-NH), this bill would increase transparency in the generic drug approval process. Known as Q1/Q2 assessments, this part of FDA’s review of a generic drug application ensures the generic formulation is quantitatively and qualitatively the same as its reference listed drug. By reverting to FDA’s prior policy of disclosing critical information about any deficiencies identified during the assessment to generic drug manufacturers, this legislation would facilitate more timely approval of complex generic drugs. Click here to learn more about the significance of Q1/Q2 and the critical need for greater transparency. Read the legislative text here.
As the Congress continues the process of reauthorizing the FDA User Fee programs, Viatris urges policymakers to include these important provisions in the GDUFA package.