E&C FDA User Fee Reauthorization Package Addresses the Accelerated Approval Pathway, Clinical Trial Diversity, and Generic Market Entry

Yesterday, the House Energy and Commerce (E&C) Committee released the legislative text for the reauthorization of the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA) (press release, section-by-section).

In addition to the reauthorization of the user fee programs, the Food and Drug Amendments of 2022, includes the several provisions to support patient access to drugs and devices and spur innovation. Highlights include:

  • Strengthening the Accelerated Approval Pathway by requiring postapproval studies by underway at the time of approval and streamlining the process for withdrawal;
  • Increase clinical trial diversity by requiring sponsors to submit action plans to the FDA early in the development process and issuing guidance on decentralized trials;
  • Increase generic drug market entry through increased transparency and changes to the labeling process; and
  • Authorizing the Emerging Technology Program to support the adoption and improve the development of innovative approaches to drug design and manufacturing.

Notably, the legislation did not include a range of other health care priorities others have been pushing for in recent months (e.g., Medicare telehealth expansion and Medicare coverage reforms for innovative medical devices).

A markup of the legislation is expected next week and legislators hope to have the legislation passed by July. However, the Senate version has not yet been released and will likely differ from the House version, which may delay the process. The ultimate deadline for passage is the end of September, which is when the user fee programs are set to expire.

Our full summary available to WHG clients is available here.

Erin Slifer joined Wynne Health Group in May 2019, following a year-long internship with the firm’s policy team while pursuing