FOR IMMEDIATE RELEASE
Doctors for America
PO Box: 21161
2300 18th St NW Lbby
Washington, DC 20009-9996
September 25, 2025
Doctors for America’s FDA Task Force Calls for Greater Transparency on FDA Action on Leucovorin
WASHINGTON, D.C. – Doctors for America’s U.S. Food and Drug Administration (FDA) Task Force is calling for data and transparency to protect our patients in light of the FDA’s recent approval of Wellcovorin (leucovorin calcium) tablets for the treatment of autism, despite insufficient evidence of efficacy.
While physicians recognize the urgent need for safe and effective treatments for autism, regulatory decisions must be grounded in rigorous science, not anecdote.
As clinicians, we need answers. Does this therapy truly work, and if so, in which patient populations? What dose is optimal, what length of treatment is appropriate, and how should we measure patient response? Without answers to these fundamental questions, families are left with uncertainty and potentially false hope.
The Task Force calls on the FDA to uphold its promise of increasing transparency and the gold-standard of evidence-based regulation by:
- Publicly releasing the full approval package, including the review staff’s analysis and input.
- Ensuring robust post-marketing requirements and strict surveillance to evaluate safety and efficacy in real-world use.
- Convening a public Advisory Committee meeting to provide clarity and accountability on this decision.
Autism is a complex condition that demands evidence-based, clinically proven treatments. By approving a therapy without adequate data, the FDA risks undermining both its credibility and the integrity of the regulatory process. We urge the agency to take corrective action and reaffirm its commitment to rigorous scientific standards.
For press inquiries and to speak more on this issue with members of Doctors for America, please contact Alli Everton with Continuum Health Group ([email protected]).
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About Doctors for America:
Doctors for America (DFA) is a national movement of over 40,000 physicians and medical students across all 50 states and every specialty who are committed to putting patients over politics. We mobilize and train clinicians to be effective advocates, equipping them with the skills to influence policy and lead change at both state and federal levels. Our work focuses on three core areas: expanding access to affordable care, strengthening community health and prevention, and advancing health justice and equity. Unlike many organizations, DFA does not accept funding from pharmaceutical companies, insurers, or for-profit healthcare corporations—ensuring that our voice remains independent, trusted, and grounded solely in what is best for patients. By uniting the trusted voices of doctors and medical trainees, DFA drives policy change, defends evidence-based care, and works to improve the health of our patients, communities, and nation. Find out more at doctorsforamerica.org and on Twitter drsforamerica or Bluesky drsforamerica.bsky.social.