Washington, D.C., May 12, 2026 — Alliance for mRNA Medicines Executive Director Clay Alspach released the following statement after it was reported that Dr. Marty Makary is expected to resign as commissioner of the U.S. Food and Drug Administration (FDA):
“The FDA’s historic role as a trusted, science-driven regulator is critical to sustaining American leadership in biomedical innovation and delivering new treatments and cures to patients. The promise of RNA technology to help fight cancer, rare diseases, infectious diseases, and other serious conditions depends on an FDA that evaluates all research — including mRNA research — on its scientific merits. At this time of extraordinary medical progress, we need a regulatory environment grounded in predictability, transparency, and rigorous evidence-based review.
“We look forward to working with the FDA’s future leadership team and hope they will reaffirm the agency’s longstanding commitment to scientific integrity and timely decision-making across all therapeutic platforms. We also urge continued work to develop new regulatory frameworks that can accelerate the development and review of personalized therapies and other next-generation medicines. Ensuring the FDA remains a strong institution will be critical to delivering RNA-based medicines and other lifesaving breakthroughs to patients who urgently need them.”
Alliance for mRNA Medicines (AMM)
The Alliance for mRNA Medicines (AMM) is dedicated to advancing and advocating for an RNA platform approach to medicine, including protein replacements, gene editing and cell engineering strategies, immunotherapies and vaccines to treat cancer, rare disease, autoimmunity and other chronic and infectious illnesses for the benefit of patients, public health, and society.
We advance this mission by shaping policy, accelerating regulatory science, expanding access, and enabling manufacturing — while convening the scientists, innovators, and industry leaders who are turning RNA’s promise into reality. Our goal is simple: ensure that transformative RNA medicines reach every patient who needs them. Learn more at https://mrnamedicines.org
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