FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys

The head of the Food and Drug Administration’s Center for Biologics Evaluation and Research and most recently its chief medical and science officer, Vinay Prasad, has left his role at the agency after he came under scrutiny for halting shipments of a controversial and costly gene therapy used to treat Duchenne muscular dystrophy, a severe degenerative disorder that primarily affects young boys. “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” the Health and Human Services Department spokesman, Andrew Nixon, said in a statement to STAT, which first reported the news of Mr. Prasad’s departure Tuesday night. One of the government’s top medical regulators, Dr. Prasad — previously a vocal critic of the FDA and pharmaceutical companies before he joined the agency in May — found himself in the crosshairs of MAHA believers who grew frustrated by the FDA restricting access to potentially life-saving drugs out of what they view as dangerously excessive caution. As the head of the Center for Biologics Evaluation and Research, Dr. Prasad oversaw the division that regulates vaccines, blood products, allergens, and gene therapies. Last week, the FDA asked Sarepta Therapeutics, the maker of Elevidys, a one-time treatment for Duchenne muscular dystrophy, to halt all shipments after three patients died from acute liver failure. Two of those patients were suffering from Duchenne, a progressive muscle-wasting disease that affects 15,000 children and young adults in the United States, while a third patient suffered from limb-girdle muscular dystrophy. Elevidys treats both conditions with its gene therapy. The only treatment for Duchenne muscular dystrophy, Elevidys — which is administered once, in a single dose, and costs $3.2 million — is one of the most expensive drugs currently on the market. It is not a cure, but it has shown very promising results in some patients. Following the patient deaths, the FDA placed gene therapy clinical trials for limb-girdle muscular dystrophy on clinical hold while also revoking Sarepta’s platform technology designation.“Protecting patient safety is our highest priority, and the FDA will not allow products whose harms are greater than benefits,” Dr. Prasad said in a July 18th statement. Dr. Prasad’s decision came under fire from advocacy groups and, notably, from Laura Loomer, a conservative activist and informal, but influential, advisor to President Trump. On X recently, Ms. Loomer called Dr. Prasad a “Trump-hating Bernie Bro” who was “standing in the way of kids and families who are desperate for a fighting chance at life.” Dr. Prasad had also been accused of being a “leftist saboteur” whose stringent regulatory decisions were at odds with Mr. Trump’s push for deregulation and accelerated approvals.In 2024, Dr. Prasad criticized his predecessor, Peter Marks, for approving Elevidys, accusing Dr. Marks of overriding review team decisions and overlooking its high cost and “potential toxicity.”A July 27 op-ed in the Wall Street Journal called Dr. Prasad “a one-man death panel” who “doesn’t think patients can be trusted to make their own healthcare decisions.”“The deaths look to have been a pretext for Dr. Prasad to deep-six the drug, which he had previously criticized as too costly for its benefits. Most treatments carry rare, life-threatening side effects, but doctors and patients can weigh their risks against their benefits,” the op-ed in the Wall Street Journal said.In the case of these astronomically expensive drugs, the cost will be borne by government entitlements, such as Medicaid, or by private insurers. If the FDA approves a drug, Medicaid would be obligated to cover it as would, in most cases, private insurers.On Monday, the FDA reversed the suspension, allowing Elevidys to be administered to younger patients with Duchenne who could still walk.The FDA director, Marty Makary, appointed Dr. Prasad as the Center for Biologics Evaluation and Research director and the FDA’s chief scientific officer and chief medical officer after the departures of several Biden-era FDA officials.Since taking the role in May, Dr. Prasad, who in the past has been outspoken in his criticism of giving Covid-19 vaccines to children, reportedly overrode recommendations from scientists in his own agency for two new Covid-19 vaccines made by Novavax and Moderna. Dr. Prasad questioned the ongoing risk of Covid-19, especially for young people. Prior to taking his role at the FDA, Dr. Prasad, a hematologist-oncologist, was a professor of epidemiology and biostatistics, and medicine, at the University of California, San Francisco.

FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys

FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys

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