FOR IMMEDIATE RELEASE
June 7, 2022
Doctors for America’s FDA Task Force Calls on Senate Improve PDUFA Reauthorization
Washington, D.C.: In anticipation the the US Senate the Health, Education, Labor and Pensions (HELP) Committee’s June 8th, markup of S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Doctors for America’s FDA Task Force submitted a letter to committee leadership with suggested improvements to the bill. The FDA Task Force is speaking out to ensure that the therapeutics physicians prescribe to their patients are clinically proven to be safe and effective based on the highest evidentiary standards.
The FDA Task force is asking Congress to include the following in the final version of FDASLA:
- Automatic expiration of drugs approved under accelerated approval that fail to show benefit in post-approval studies after five years.
- Mandated post-approval studies for all drugs approved under accelerated approval.
- Require FDA to convene advisory committee meetings for all accelerated approval drugs.
- Clarify that Real-World Evidence should only augment post-approval studies, not fully support.
- Include measures to ensure clinical trial diversity and allow for these measures to be enforceable (to hold sponsors accountable) should sponsors not ensure adequate representation in their studies.
You can read the full letter outlining why these provisions are imperative to keep patients safe here.
For press inquiries for members of the FDA Task Force Doctors for America please contact Claire Onyechi ([email protected]).