Senators Blast Cancelled Flu Shot Panel in FDA Pick Hearing

(Bloomberg) — Marty Makary, President Donald Trump’s pick to oversee US food and drug regulation, faced pointed questions in a Senate confirmation hearing over the government’s decision to cancel a key public meeting on flu shots.

Louisiana Senator Bill Cassidy, a Republican, said the Food and Drug Administration’s move threatens to undermine public confidence in government health policy, a key tenet of Health and Human Services Secretary Robert F. Kennedy Jr.’s plans for the agency. The senator had pressed Kennedy on his vaccine views in his confirmation hearing.  

“I think one of the laudable things about Secretary Kennedy’s positions is he wants more transparency in terms of how the federal government makes medical decisions as part of restoring that faith,” Cassidy said Thursday. The cancelled meeting appears to “go kind of backward on that.”

Makary pointed out that he wasn’t involved in the decision to cancel the meeting, which would have made recommendations to vaccine makers about which flu strains to target with their shots for the next season. While he wouldn’t commit to rescheduling it, he told senators that the vaccine panel would resume meeting if he’s confirmed. 

Senators on the Health, Education, Labor and Pensions Committee convened in Washington to consider Makary’s bid to lead the Food and Drug Administration. If confirmed, he would play a key role in Kennedy’s agenda for probing vaccine safety, examining dyes and additives in food, and addressing chronic diseases like obesity. 

Committee members pressed Makary on his independence and commitment to transparency. Patty Murray, a Washington Democrat, called the move to cancel the vaccine meeting “unprecedented and dangerous.”

The panel also questioned Makary on the composition of clinical trial populations after Trump issued an executive order that removed diversity, equity and inclusion language from federal websites and health data. The move sparked fears of loss of federal funding for such efforts, leading to chaos in health agencies and among researchers. 

“I believe in common sense, and I believe in clinical trial diversity,” Makary said. “I believe if you’re going to make results extrapolated to the general population, you should have results in those populations.”

For rare conditions that impact small numbers of people, like some genetic abnormalities, Makary said clinical trials should be customized to the smaller populations. Easing these conditions might speed development timelines for makers of rare disease treatments.

With a $7 billion budget, the FDA also regulates tobacco products and reviews drugs and medical devices to make sure they’re safe and effective. The agency has already undergone significant change since Trump took office. 

An undisclosed number of agency employees were terminated as part of widespread layoffs across the federal government last month. Some who conducted inspections and reviewed medical devices were reinstated, but not all.

Jim Jones, the agency’s top food regulator, resigned in protest after the layoffs slashed his staff. He was replaced by Kyle Diamantas, an attorney who formerly worked with food and beverage industry clients at the Jones Day law firm. Political appointees have been tapped to lead other divisions of HHS, but the FDA’s top ranks are still mostly made up of career staff. 

While some of Trump’s health picks such as Kennedy and Centers for Disease Control and Prevention nominee Dave Weldon have been controversial, Makary has received a relatively warm reception from industry. Scott Gottlieb, a former FDA Commissioner who’s now a member of Pfizer Inc.’s board, has said he has confidence in Makary.

A surgeon at Johns Hopkins Medicine, Makary rose to prominence for his research on health-care safety, quality and cost. He gained popularity as a contrarian willing to question public health officials’ guidance during the Covid pandemic. 

He has blasted the agency’s decisions to approve Covid booster shots for young people. Makary also called an agency decision to skip a committee meeting related to Covid vaccines “unconscionable” and demanded more monitoring for vaccine side effects. 

Until recently, Makary was chief medical officer of Sesame Inc., a telehealth platform that sells compounded copies of Novo Nordisk A/S’s weight-loss and diabetes drugs Wegovy and Ozempic. The FDA recently ended a shortage of the products, which is expected to lead to restrictions on sales of compounded versions. 

If confirmed, Makary plans to divest from a variety of positions, according to his ethics agreement. He plans to sell his stake in Global Appropriateness Measures, a company that creates health-care quality metrics aimed at cutting wasteful spending. He is also giving up board seats and advisory positions with companies including eye-care provider Harrow Inc.; privately held health insurer Sidecar Health; organ and tissue pharmaceutical company MedRegen; health-care pricing platform Turquoise Health; and employee benefits brokerage Advocate Inc. 

–With assistance from Jessica Nix.

(Updates with clinical trials comments from seventh paragraph.)

More stories like this are available on bloomberg.com