Last week, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee marked up and passed the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. While the Doctors for America FDA Task Force was grateful to see the committee adopt several constructive amendments toward strengthening the FDA, including an amendment that would add transparency to the accelerated approval pathway, additional measures are still needed to ensure the therapies and medical products that we prescribe our patients are safe and clinically effective. Specifically, the FDA Task Force is asking Congress to include the following in the final version of this legislation:
1. Automatic expiration of drugs approved under accelerated approval that fail to show benefit in post-approval studies after five years.
2. Mandated post-approval studies for all drugs approved under accelerated approval.
3. Require FDA to convene advisory committee meetings for all accelerated approval drugs.
4. Clarify that Real-World Evidence should only augment post-approval studies, not fully support.
Additionally, the FDA Task Force is deeply concerned that FDASLA continues to lack any provisions to address the lack of diversity in clinical trials. The inclusivity of racially and ethnically diverse patients in clinical trials is paramount for drugs to be proven safe, effective and included as standard of care in clinical guidelines. The FDA Task Force strongly urges leaders in the Senate HELP Committee and the House Energy and Commerce Committee to work together to ensure that the language aimed at increasing diversity in clinical trials included in the House-passed Food and Drug Amendments of 2022 is incorporated in the final version of this must-pass legislation.
As this legislation moves forward, the Doctors for America FDA Task Force will continue advocating on behalf of patients by speaking to legislators about why these reforms are critical to ensuring patients have timely access to therapies with proven clinical benefit and that therapeutic approvals are free from any undue conflict of interest and rely on the highest evidentiary standards.