Marty Makary (FDA chief) smears begin

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Food and Drug Administration Commissioner Marty Makary was supposed to be one of President Donald Trump’s more conventional, qualified personnel picks, with sterling academic credentials and bipartisan support.

But just over a year into his tenure, those inside the agency that regulates roughly one-fifth of consumer spending in the US describe a culture rocked by staff clashes, leadership turmoil, industry backlash and an embattled, paranoid leader. Outside, drug companies say they’ve been blindsided by setbacks.

Some people familiar with the dynamics called the situation unsustainable. While no immediate ouster is planned, people familiar with the matter who requested anonymity to discuss personnel matters say one more high-profile misstep could put his job at risk.

Makary, 55, and his allies defend his record, pointing to his successful moves to reduce synthetic food dyes, crack down on misleading television ads and streamline drug approvals. He’s a regular guest on television and often appears over Trump’s shoulder in the Oval Office, serving as the immaculately coiffed face of ambitious announcements.

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Makary’s transition from being an academic, surgeon and television commentator to managing an agency of more than 16,000 employees has been a rocky one.

He’s regularly clashed with other officials in the administration, and tightened his inner circle in what people familiar with his management describe as a paranoid effort to control the flow of information. He also avoids putting things in writing, the people said.

Makary disputed the characterization in an interview, touting “the most transparent administration in history” and saying he eats lunch in the agency cafeteria and openly talks about the agency’s ideas.

“Commissioner Marty Makary continues to be an invaluable asset for the Trump administration because he continues to deliver on President Trump’s agenda of modernizing the FDA’s drug approval process, restoring Gold Standard Science in agency decision-making, and implementing the President’s MAHA agenda,” White House spokesman Kush Desai said in a statement.

But Makary acknowledged staff morale was low after thousands of layoffs and retirements spurred by the Department of Government Efficiency. While he maintains that staffing levels have stabilized, a string of hiring blunders attracted negative attention.

Prasad, whom Makary chose to lead the agency’s vaccine and gene therapy regulation, was a polarizing, outspoken academic and podcaster. Though officials described him as bright, he took a confrontational approach to working with biotech companies, repeatedly issuing dramatic rebukes that were walked back days later.

Prasad sparked a firestorm of controversy when he halted shipments of a Sarepta Therapeutics Inc. gene therapy after safety issues became public and refused to review an application for a Moderna Inc. flu vaccine after one of the largest industry-sponsored trials in recent years. Prasad also got into a dispute with a company producing a gene therapy for Huntington's disease after it claimed the FDA was requiring it to perform fake brain surgery to evaluate whether the treatment works.

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Klomp helped broker a meeting between Makary and Scott Gottlieb, his predecessor during Trump’s first administration, according to people familiar with the matter. Makary acknowledged he had spoken with former commissioners to get advice on how to be most effective in his role. Gottlieb declined to comment.

Makary also expanded outreach to biotech executives and investors and Capitol Hill offices, people with knowledge of the meetings say.

And HHS has looked to alleviate some bottlenecks, implementing an organizational overhaul elevating some of Makary’s high-performing hires who worked on policy and food issues. New processes have been put in place to ensure more visibility and collaboration in decision making, including at the FDA, people familiar with the matter said.

The agency also has installed what people speaking on the condition of anonymity called new systematic rigor in the department’s hiring practices. The FDA has multiple high-level vacancies. Makary said he’s searching for “straight as an arrow” scientists in recruiting. He selected career official Mallika Mundkur as acting chief medical and scientific officer after Prasad’s departure.

“The FDA is trying to get better,” Weinberg said. “There are a bunch of people who are listening and asking questions and taking feedback and they are meeting with the biotech industry. I’m very happy about that. That wasn’t always the case.”

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