Marty Makary's Fatal Mistakes: WSJ Calls for FDA Commissioner's Removal

The Wall Street Journal editorial board is cheering reports that President Trump plans to fire FDA Commissioner Marty Makary — and they're not pulling punches about why. The board, which initially supported Makary's 2025 appointment with hopes he'd restore credibility to a Biden-era-damaged agency, now says his tenure has been a disaster for patients denied access to life-saving therapies.

The core indictment: Makary and his deputy Vinay Prasad applied the wrong standard to the wrong diseases. Their criticism of the Biden FDA for rubber-stamping Covid vaccines for children — a population at little risk — had merit. But the board argues they then overcorrected catastrophically, demanding large randomized controlled trials for treatments targeting deadly, debilitating diseases. That's a process that takes years, during which patients deteriorate and die. Worse, the board notes it's medically unethical to give placebo to patients with fatal illnesses when early-stage trials already show promise.

The regulatory whiplash created a chilling effect on drug development. The editorial board's pointed question: why would a company spend hundreds of millions running a clinical trial if the FDA might later declare the approved protocol insufficient and demand another round? The board says this happened "repeatedly" under Makary — a damning accusation that essentially accuses him of destroying investment certainty in pharmaceutical innovation.

The personal conduct allegations are sharp. The board says Makary made "false statements in TV interviews" about rejected drugs and — more seriously — "misled a GOP Senator" who met with him about a rare disease drug rejection. His political defense, the board argues, was to deflect blame onto Big Pharma and career FDA staff, even in cases where Prasad had personally overruled staff who supported approval.

The editorial closes by calling the situation a "toxic culture" and demands not just Makary's removal but a reversal of what it describes as "arbitrary and callous rejections" of rare disease and cancer treatments. The irony the board hammers: Makary's restrictive approach mirrors the same paternalism the right criticized in Biden's vaccine policies — just applied to a different set of drugs.