The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
Marty Makary, President Donald Trump’s pick for FDA Commissioner, is set to face the Senate on Thursday amid the industry’s growing anxiety about the recent upheavals and uncertainty at the agency.
Like most of Trump’s health picks, Makary is not without controversy. While he serves as the chief of islet transplant surgery at Johns Hopkins, he has also publicly spoken out against the Department of Health and Human Services, particularly its decision to deploy a coronavirus booster vaccine with, according to him, insufficient human data.
The FDA—alongside other top health authorities—has recently seen high-level disruptions. Last week, the agency announced that a meeting of its Vaccine and Related Biological Products Advisory Committee had been canceled without explanation. The panel of external experts was scheduled to convene on March 13 to decide which vaccine strains to include for the upcoming flu season.
A meeting of the Centers for Disease Control and Prevention’s vaccines advisors was also postponed days earlier.
Rare Disease Day, an event the FDA was organizing with the National Institutes of Health (NIH), was likewise postponed. The two-day event was originally scheduled for Feb. 27 and 28, during which time the two agencies were supposed to present their latest research on rare diseases, as well as foster discussions between experts and stakeholders.
Compounding the industry’s worries is the recent exodus of high-ranking officials at the FDA, as well as the recent rush of layoffs at the agency. In January, Patrizia Cavazzoni, who previously led the FDA’s Center for Drug Evaluation and Research (CDER), stepped down from her post after seven years at the Center. A few weeks earlier, Namandjé Bumpus, principal deputy commissioner, likewise resigned after two years.
The Trump administration has also so far fired some 1,000 FDA employees—though the agency last month said it plans to ask around 300 to return.
In a note to investors on Wednesday, analysts at Jefferies agreed that these disruptions at the FDA could pose “some increased risk” not just for vaccine development, but also for “more aggressive accelerated filings and/or around rare disease areas.” The high levels of employee turnover could also imperil other agency activities, in turn posing greater risk to biopharma companies, they wrote.
Still, Jefferies urged a more level-headed view of the situation, noting that in recent meetings, many companies—including Gilead and Denali—have told the FDA that “things have been on track,” with “no notable changes or delays.” On the contrary, “in some cases the new CDER leadership is even more on board for accelerated filings and more pro-rare disease … than prior CDER oversight.”
Makary’s hearing on Thursday will provide more color on matters at the FDA. “We believe he is neutral of the FDA and don’t expect material shift in major directions,” the Jefferies analysts wrote, noting that Makary will however have to ensure that the agency’s resources “do not fall off” and impact approvals.
The hearing for Makary on Thursday comes after Trump NIH pick Jay Bhattacharya was grilled by senators on Wednesday, who also questioned him regarding his history of criticizing COVID-19-related lockdowns and mandatory vaccination policies, as per CNN.
