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# Critics Pile on Makary’s Ouster with Melanoma Drug Denial
- URL: https://www.fdaweb.com/critics-pile-on-makarys-ouster-with-melanoma-drug-denial/
- Published: 2026-05-15T12:00:00.000Z
- Updated: 2026-09-14T13:39:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161153

FDA’s recent rejection of an experimental melanoma treatment has become a flashpoint in broader criticism of former FDA commissioner Marty Makary and the agency’s increasingly unpredictable regulatory climate under the Trump administration, according to a [report](https://kffhealthnews.org/health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/?ref=fdaweb.com) published Friday by KFF Health News. FDA last month declined to approve RP1, an experimental melanoma therapy developed by Replimune, despite clinical trial results showing tumor shrinkage or disappearance in roughly one-third of patients.

Doctors involved in the study said the decision devastated patients and researchers who viewed the treatment as potentially life-saving for advanced melanoma patients with limited options. “It was devastating news,” dermatologist **Trisha Wise-Draper** told KFF Health News.

RP1 is a genetically engineered virus designed to destroy tumor cells and stimulate immune activity alongside the immunotherapy drug Opdivo. FDA said it was not convinced the positive outcomes could be fully attributed to RP1 because the trial lacked a control arm comparing the treatment against standard therapy alone.

The agency reportedly had previously warned Replimune that its single-arm trial design could jeopardize approval. Still, the decision drew heightened scrutiny because it occurred amid internal upheaval at FDA during Makary’s tenure, which ended this week with his resignation.

Former FDA officials and industry analysts told KFF Health News that inconsistent agency decision-making under Makary created uncertainty for drug developers, investors and patients. “People have to speculate about the standards and processes by which the agency makes decisions,” former HHS official **Steven Grossman** told the outlet. “That uncertainty is bad for everybody.”

Former FDA staffer and pharmaceutical consultant **Paul Kim** criticized the broader erosion of regulatory norms under Makary, telling KFF Health News that “all the norms have been thrown out the window… Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play,” Kim said.

Kim also questioned whether the FDA could have granted accelerated approval while requiring additional confirmatory data later, arguing that the accelerated approval pathway was specifically designed to allow regulators to “take a gamble” on promising therapies for serious diseases.

The report also highlighted criticism surrounding former FDA official **Vinay Prasad**, who reportedly played an influential role in several contentious drug and vaccine decisions before resigning earlier this month.

Makary publicly defended the rejection and accused Replimune of engaging in “corporate spin” after criticism emerged following the decision, according to KFF Health News.

The controversy comes as FDA faces growing criticism from industry groups and former regulators over what they describe as conflicting signals on drug approval standards, particularly for cancer therapies, vaccines and accelerated approval programs.