FOR IMMEDIATE RELEASE
Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC 20009-9997
Doctors for America
Continuum Health Group
Leading Health Experts Urge Revisions to FDA Reform Bill
WASHINGTON, D.C—May 20, 2022. Today Doctors for America’s Food and Drug Administration (FDA) Task Force, and leading experts in the field of regulatory policy along with organizations representing consumers, patients, and clinicians sent a letter to the leadership of the Senate Health, Education, Labor and Pensions (HELP) Committee with recommendations on increasing transparency and protecting patient safety at the FDA.
In response to the Senate HELP Committee’s FDA User Fee discussion draft, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA) released earlier this week, clinicians, researchers, and advocates joined forces to support changes to the accelerated approval pathway and ask for measures to ensure clinical trial diversity.
Over 35 leading experts, medical professionals and advocacy organizations sent a letter requesting three key changes to the accelerated approval pathway. In order to protect patients from potential harm the group recommends:
- Advisory committees must be convened to review all accelerated approval drug candidates and upon approval, manufacturers must complete post-approval studies that confirm the drug’s predicted clinical benefit.
- Accelerated approval drugs that fail to show clinical benefit after five years must be automatically withdrawn from the market.
- Required postapproval studies to confirm clinical benefit must be underway upon accelerated approval and sponsors must submit routine reports of their progress.
The group also outlined two clear improvements to increase clinical trial diversity and ensure therapies are designed and effective for every patient that needs them:
- Make diversity action plans publicly available for independent evaluation.
- Include enforcement measures to ensure representation in clinical trials.
A copy of the letter and suggested amendments to the FDASLA draft can be found here.
For press inquiries for members of the FDA Task Force and Doctors for America please contact Claire Onyechi with Continuum Health Group ([email protected]).