FDA Nominee Marty Makary to Face Grilling Over Cutbacks and Policy Shifts

Dr. Marty Makary may face sharp questions from senators about whether he will defend the Food and Drug Administration against staff cutbacks and industry pressure on Thursday, although he is still expected to sail through his confirmation hearing to become the agency’s commissioner.

Dr. Makary built his reputation as a contrarian in the medical field, gaining widespread notice by speaking out about medical errors. Those close to him have remarked on his willingness to agree with Robert F. Kennedy Jr., the nation’s health secretary, on a variety of issues.

As a pancreatic cancer surgeon and health policy researcher at Johns Hopkins University, Dr. Makary has been viewed by some as a study in contrasts. He has written several books criticizing what he considers flaws in medical orthodoxy that result in recommendations backed by scant evidence.

Yet he also drew attention from the Trump team as a Fox News personality with more controversial views, like his relatively early predictions that Covid would fade as a concern and that widespread immunity would take hold long before it did.

Dr. Reshma Ramachandran, an assistant professor at the Yale School of Medicine, said that it was not clear which is the “true Marty Makary.”

She said that was an important question, given some of Mr. Kennedy’s pronouncements. The health secretary has suggested that the F.D.A. should lift constraints on risky products like raw milk, which can be rife with bacteria, and had embraced hydroxychloroquine, a drug briefly used as a Covid therapy before its risks were deemed to exceed any benefit.

“I’m hoping, and kind of desperately hoping,” she said, “that just a top-line overall priority for him is to maintain the integrity and independence of the agency.”

Mr. Kennedy has already begun to signal shifts in vaccine policy, an area Dr. Makary would also oversee at the F.D.A. Mr. Kennedy has expressed an interest in examining the safety of vaccines that have been on the market for decades and that protect millions of American children and adults against debilitating diseases.

The agency has vast regulatory authority over products including prescription and over-the-counter drugs, medical devices, tobacco and about 80 percent of the food supply.

The F.D.A. has a staff of about 18,000 and a budget of about $7.2 billion. Among its many oversight roles, the agency regulates artificial intelligence software used to scan medical images, an area where the agency has been dismissed as too permissive in its approvals.

If confirmed, Dr. Makary would first encounter tensions among staff members, who have been whipsawed by the Trump administration’s aggressive cost-cutting measures in recent weeks.

The staff endured an initial round of about 700 layoffs, decimating some product-review teams that ensure the safety of medical devices such as surgical robots and systems that deliver insulin to people with diabetes. Those firings were followed by some job reinstatements.

On Tuesday, panic swept through some quarters of the agency when the Trump administration put about two million square feet of the agency’s Maryland office space up for possible sale before backing off. Concern also spread when the lease to a key drug-safety lab in St. Louis was posted as savings on the “Wall of Receipts” advertised by Elon Musk’s so-called Department of Government Efficiency. (The agency said on Wednesday that the lab would remain open.)

Further staff cuts are expected.

“What are the F.D.A. resources going to look like in an environment where it seems like the current approach is slashing and burning, without any kind of thoughtful deliberation?” asked Dr. Aaron S. Kesselheim, a Harvard professor of medicine who has studied the F.D.A.

In documents filed with the Office of Government Ethics, Dr. Makary pledged to step away from millions of dollars in financial interests. Those steps include resigning from his role as co-owner of Global Appropriateness Measures, a company that scans health data for signs of inappropriate medical care with clients including health plans and physician groups. He also said he resigned from positions at Sesame, a telehealth company that provides weight-loss medications, and from MedRegen, a pharmaceutical company, and others.

There are many other issues that Dr. Makary would face, including a new review that Mr. Kennedy pledged to undertake on the safety of abortion pills. Tobacco companies could emerge emboldened after the Biden administration failed to advance cigarette restrictions, and after having heavily contributed to President Trump’s campaign. The president’s decision to impose tariffs could affect the supply of essential medicines from overseas.

He will also be expected to advance Mr. Kennedy’s goal of ending what he has described as corruption in public health agencies, closing the revolving door between the F.D.A. and the industries it regulates. Dr. Makary will be expected to work with the Make America Healthy Again coalition, which is banking on the administration to identify and remove unhealthy food additives.

Those priorities are already appearing to clash, though: The new acting chief of the F.D.A. food division, Kyle Diamantas, comes directly from a law firm where he was defending the maker of infant formula, a regulated product, against claims that it harmed premature babies.