Despite a near unanimous vote recommending otherwise from its own independent Advisory Committee, the U.S. Food and Drug Administration (FDA) approved the Alzheimer’s disease drug, aducanumab. This decision was the culmination of a continued assault on the agency and its regulatory standards meant to protect patients and ensure them access to safe and effective drugs, devices, and other medical products. In 2022, new challenges to these evidentiary standards are already emerging in the form of legislation such as the must-pass Prescription Drug User Fee Act as well as the proposed Cures 2.0 package. Both these bills seek to codify further regulatory flexibility to approve treatments and other products not just more quickly, but also with further uncertainty of their benefit for our patients.
This year, Doctors for America has received grant funding from Arnold Ventures to re-establish the FDA Task Force to educate, mobilize, and empower a multispecialty group of DFA members and clinicians to provide unbiased expertise in evaluating and responding to the FDA regulatory process in a way that maximizes meaningful clinical outcomes for our patients.
To support and strengthen an FDA that puts patients first, the FDA Task Force is currently recruiting new members. No prior expertise in FDA policy is needed, but is always welcome. Over the next year, the DFA FDA Task Force will:
- Educate our members on the regulatory process and the evidentiary base for drug and device approvals
- Develop longitudinal curriculum for DFA members and other clinician organizations including medical professional societies on the history and origins of the agency, strengths and weaknesses of current regulatory approval processes, and case studies of the impact of recent and prior approvals on clinical practice
- Advocate in support of patient-centered regulatory reform, including public testimony, op-eds, educational meetings with policymakers, and more
- Support DFA members in applying to and joining FDA advisory committees
- Work with a coalition of national patient and consumer advocacy organizations as well as experts concerned with maintaining integrity of the FDA and keeping drugs and devices safe and affordable