How Trump FDA is breaking his promise to America patients

nypost.com · Feb 24, 2026 · Collected from GDELT

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A worrisome new ideological shift at the Food and Drug Administration threatens to undermine President Trump's worthy goals -- from within. REUTERS Months into his second term, President Donald Trump’s top health officials were clear. They promised to focus on “cures” and “meaningful treatments.” They wanted revolutionary medicine to be developed in the United States. They didn’t want the treatments of tomorrow to come from China. But a concerning new ideological shift at the Food and Drug Administration threatens to undermine these worthy goals — from within. Patients are frustrated, and are waiting longer for groundbreaking treatments. Biotechnology companies are confused. The spirit of the “right to try” philosophy of Trump’s first term has hit a wall of inflexibility in his second. A “rare” disease is one that affects fewer than 200,000 people in the United States — but chances are you know someone living with one. An estimated 30 million Americans have one or more rare disorders, 95% of which have no FDA-approved treatment. I run the non-profit Alliance for Regenerative Medicine. We represent biotech companies, research institutions and patients pursuing cutting-edge medical treatments called cell and gene therapies, or CGTs. This is Rare Disease Week, an international observance meant to celebrate the patients we serve and the incredible science we can now use to attack diseases at their source — often with a single dose. Over the past decade, the FDA approved a few dozen CGTs that have saved or transformed the lives of thousands of people living with rare diseases who otherwise faced death or serious disability. At least 900 ongoing clinical trials in the United States are testing more of these powerful medicines: Each one represents tremendous hope for millions of other patients and their families — not only for those suffering with rare diseases, but also common ones like heart disease, Parkinson’s disease and diabetes. Turning this revolutionary science into FDA-approved medicine takes years and hundreds of millions of dollars. China is racing to eclipse the US as the global leader in this transformative corner of biotechnology. Let’s go back to Trump’s vision: Last year, in an unprecedented display of support, his top health officials announced they wanted America to remain the global biotech leader. Senior administration leaders convened executives, scientists and patient groups to chart a positive vision to accelerate the development of these important medicines. But over the past four months, the FDA has surprisingly rejected several promising CGT medicines. Of course, setbacks do happen in drug development. It’s the FDA’s new and unusual behavior that’s damaging — both for patients and for Trump’s bold vision. In some of these rejections, the FDA changed the requirements for approval seemingly at the last minute, reversing commitments it had made just months before to bring these medicines forward. The parallels with the agency’s initial rejection of Moderna’s flu vaccine this month are stark. The FDA told Moderna it was OK with its clinical trial design. But then it initially refused to even consider the company’s application, saying that design was inappropriate. Fortunately for Moderna, and for those who want to protect themselves from the flu next winter, the agency reversed course and will now review Moderna’s evidence. But the thousands of patients, many of them children, waiting for CGTs from biotech firms like Atara Biotherapeutics, uniQure, Ultragenyx and REGENXBIO don’t yet have a clear path forward. They don’t have seven months until the next flu season — because for these patients with rare diseases, time is functionality. For them, time is life . . . or death. We urgently need a common-sense course-correction at FDA that puts patients first. First, the agency should honor the commitments it originally made to companies and patients about what evidence would be acceptable for approval. Second, it could further verify the strong signals that these medicines work by gathering additional data from patients after approving the therapies. Finally, it could assemble a group of outside experts, known as an FDA Advisory Committee, to transparently review these medicines and listen to testimony from patients. These practical steps put patients first, and rigid ideology a distant second. The FDA commonly used these approaches in approving dozens of CGTs over the last decade, including during the first Trump administration. The president needs an FDA that abides by its commitments and implements his vision for the future of medicine. We can help thousands of rare disease patients right now — and millions more in the future — with an FDA that follows his call. Tim Hunt is CEO of the Alliance for Regenerative Medicine and the father of a young man with a rare disorder.