By Editorial Board, May 8, 2026 | From: The Wall Street Journal

Press reports say President Trump is planning to sack Food and Drug Administration Commissioner Marty Makary. That would be great news for patients who have been denied access to life-saving therapies on his watch.

We wrote approvingly in 2025 about Dr. Makary’s appointment in hopes that he’d restore credibility to an agency damaged by the Biden team’s Covid blunders. He talked about improving regulatory flexibility and increasing transparency. But once in office he and the deputies he hired, especially Vinay Prasad, did the opposite.

Drs. Makary and Prasad criticized the Biden FDA with good reason for rushing approval of Covid vaccines for children. Covid presented little risk for children. Green-lighting the shots based on results from antibody studies with little safety follow-up fueled a broader public skepticism about vaccines.

Yet Drs. Makary and Prasad didn’t seem to understand that the risk-benefit assessment for approving drugs for deadly diseases must be different. They demanded nothing short of large randomized controlled trials to prove the efficacy of medicines for debilitating diseases. This could take years, during which time patients would progress and some would die.

They also ignored that it’s unethical to give patients with fatal diseases a placebo when a treatment has shown promise in early-stage trials. Their actions ran counter to President Trump’s first-term support for a “right to try.” By moving goalposts and reversing prior agency guidance, they created enormous uncertainty that chilled drug development.

Why spend hundreds of millions of dollars running a clinical trial if the FDA may later decide that the protocol it had approved was no longer good enough to warrant approval and another trial was needed? That’s what has happened repeatedly under Dr. Makary.

Nor did he do his homework. At least that’s the charitable explanation for his false statements in TV interviews about drugs the agency rejected. Our sources say he also misled a GOP Senator who met with him about a rare disease drug rejection.

When agency rejections drew criticism, his political dodge was to lambaste Big Pharma—ignoring patients and doctors begging for approval. He also blamed rejections on career staff, even when Dr. Prasad overruled those who supported approval.

The FDA needs a leader who will take responsibility for the agency’s decisions and bring in others who support innovation and Mr. Trump’s right-to-try drugs mission. Instead, Dr. Makary looked on as Dr. Prasad drove out scientists who didn’t share his mission of restricting access to drugs whose benefits he didn’t think justified their costs. This is the same paternalism that destroyed the credibility of the Biden Administration’s vaccine policies.

Removing Dr. Makary is a necessary step to remedy a toxic culture that has taken hold at the FDA. Whomever Mr. Trump taps to take over will have his work cut out repairing the damage. One place to start is reversing the agency’s arbitrary and callous rejections of rare disease and cancer treatments. There’s no time to waste for patients today and tomorrow.