'That's false': WSJ editorial board catches FDA chief in lie about cancer drug rejection

Now the bad news: Commissioner Marty Makary has tapped Dr. Prasad’s deputy, Katherine Szarama, to replace him. Maybe the bigger problem at the FDA is Dr. Makary.Prasad, an ally of HHS Secretary Robert F. Kennedy Jr., has been under heavy fire by the board for months.White House officials gave him the boot last July, but Dr. Makary brought him back. And what a blunder that was, said the board. We’ve chronicled the innovative medicines Dr. Prasad has deep-sixed, including for the neuro-degenerative Huntington’s disease (UniQure), Hunter Syndrome (Regenxbio), Duchenne muscular dystrophy (Capricor), erythropoietic protoporphyria (Disc Medicine) and metastatic melanoma (Replimune), among others. Prasad even had a role in rejecting Moderna's newest mRNA flu vaccine.Time and again, the FDA moved the goal posts for approvals and reversed prior guidance to drug developers. Dr. Prasad demanded that they conduct nothing less than double-blind randomized controlled trials in diseases for which such trials would be unethical or next to impossible because of their rarity, said the report. All of this undermined President Trump’s longtime support for the 'right to try' new drugs for deadly or debilitating diseases.Now, the board wrote, as he leaves office while installing a loyalist in his place, Prasad is not being honest about what he did.In a CNBC interview on Monday, he defended the agency’s rejection of Replimune’s melanoma cancer drug RP1 against our criticism. 'I don’t work for Replimune. I work for the American people, and I stand by the scientists at the FDA,' he said. 'Three independent teams arrived at the same conclusions,' the board wrote. That’s false. The first review team recommended approval and was overruled by Dr. Prasad. A reviewer posted on social media that the staff had recommended approval but was later pushed out. When Replimune appealed the rejection, Dr. Prasad selected a new team to eliminate what the FDA referred to in its rejection letter as 'bias' by the first team in favor of the drug.Dr. Makary has tried to dismiss his critics as in the pocket of industry, but we speak for desperately ill patients now and in the future, concluded the board. They need advocates, not bureaucratic dishonesty.