5 Takeaways From FDA Nominee Marty Makary’s Hearing

Dr. Marty Makary, the nominee to lead the Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor, and Pensions Committee (HELP) at a mostly cordial confirmation hearing on March 6.

The Johns Hopkins University surgeon and researcher fielded a plethora of questions from lawmakers on both sides of the aisle about topics ranging from the safety of abortion pills and seed oils to flu vaccines and information transparency.

The FDA is part of the Department of Health and Human Services, which is led by Robert F. Kennedy Jr.

Like Kennedy, Makary over the years has criticized COVID-19 mandates, advocated removing chemicals and toxins from the U.S. food supply, and proposed greater transparency in medicine.

In a Nov. 22 Truth Social post announcing Makary’s nomination, President Donald Trump said that the agency has lost the trust of Americans and “lost sight of its primary goal as a regulator.”

Makary is needed to “course-correct and refocus the Agency,” Trump wrote, as well as to evaluate “harmful chemicals poisoning our Nation’s food supply and drugs and biologics being given to our Nation’s youth, so that we can finally address the Chronic Disease Epidemic.”

Minutes after Kennedy was sworn in as secretary of the Department of Health and Human Services on Feb. 13, Trump established a Make America Healthy Again Commission to review the safety of antidepressants, vaccines, stimulants, and weight-loss drugs—all products regulated by the FDA.

If confirmed, Makary would explore vaccine safety, research additives and dyes in food, and address chronic diseases, among other initiatives.

“You have my commitment to review what the committees are doing, and how they are being used,” Makary said.

The FDA’s internal scientists will determine strains for the shots and send them to manufacturers to make sure that updated vaccines are ready for the fall, according to the Trump administration.

HELP Chairman Bill Cassidy (R-La.) first inquired about the meeting’s cancellation at Kennedy’s confirmation hearing last month; Cassidy said he was “struggling” to support Kennedy because of the nominee’s comments about vaccines.

“What is lost is the transparency,” Cassidy said, adding that cutting public discussion on vaccines detracts from Kennedy’s “radical transparency” pledge.

Makary repeatedly noted that he was not part of the decision to cancel the VRBAC meeting. He added that the committee has often just “rubber stamped” recommendations approved by the World Health Organization’s Global Influenza Program.

Several HELP committee members asked Makary to commit to holding a VRBAC meeting if he is confirmed. The nominee declined, saying the FDA does not need VRBAC input to choose a flu vaccine makeup.

Sen. Patty Murray (D-Wash.) called the decision to scrap the meeting “unprecedented and dangerous.”

Sen. Tammy Baldwin (D-Wis.) said she was concerned that the meeting’s cancellation could be “a ploy to install vaccine skeptics.”

“I have no preconceived plans to rearrange that committee or any committee,” Makary responded. “Secretary Kennedy wants to make America healthy again.”

Nutrition, he noted, is an important component of that agenda.

“Childhood obesity is not a willpower problem, and the rise of early onset Alzheimer’s is not a genetic cause. We should be, and we will be, addressing food as it impacts our health,” Makary said in his opening statement.

Sen. Tommy Tuberville (R-Ala.) asked Makary about the FDA’s list of food additives that get little regulation because they are classified “generally recognized as safe.”

Chemicals in food impact the gut microbiome and create inflammation in the gastrointestinal tract, Makary said.

“There’s a body of research now that suggests concern with some of these ingredients. We have to look at those ingredients, and you have my commitment to do so if confirmed as FDA commissioner,” he said.

Tuberville also asked Makary about seed oils. Kennedy has frequently said that foods would be healthier if prepared with beef tallow instead of seed oils.

Makary noted that more research is needed and that chronic illness cannot be attributed to one item.

“Seed oils are a good example of where we could benefit from a consolidation of the scientific research, and I don’t think it’s any one ingredient in the food supply that’s making our nation’s children sick,” Makary said.

He added that he’d like to develop a pilot program to make school lunches healthier. The U.S. Department of Agriculture manages the school lunch program, and Kennedy and Secretary of Agriculture Brooke Rollins are expected to work together on several food-related issues.

In 2021, Makary called for an overhaul of the culture and leadership at the FDA, which he said was “broken” and “mired in politics and red tape.”

Makary said on March 6 that he will carry out Kennedy’s mission of “radical transparency.”

“If confirmed, I hope to ensure the FDA holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and make America healthy again,” Makary said.

Makary agreed with the view of Sen. Rand Paul (R-Ky.) that FDA staff members and FDA panel expert advisers should disclose if they receive royalties from pharmaceutical companies.

“I want American companies to thrive. I want life sciences companies to thrive, but we need to call balls and strikes and keep that independent scientific review process free of any conflicts,” Makary said.

He fielded multiple questions about recent layoffs of FDA staff members. Some of the employees who conducted inspections and reviewed medical devices were reinstated.

Makary said that he would conduct an assessment, if confirmed, “to ensure that the scientists and food inspectors have all the resources they need to do their job.”

The FDA rolled back safety regulations on mifepristone during the Biden administration. This included in-person screening requirements to estimate the gestational age and location of the pregnancy before prescribing the abortion drug.

Cassidy said studies on the safety of mifepristone for pregnant women have been conducted but that there is limited knowledge as to mifepristone’s effect on infants who survive failed or reversed abortion attempts.

Makary said that he would follow the “tried and true” independent review process used by the FDA for decades.

The FDA continually collects reports of side effects and complications regarding mifepristone, and Makary said he wouldn’t “prejudge the data without seeing it.”

Sen. Maggie Hassan (D-N.H.) told Makary that she wants him to commit to keeping the drug available under its current framework, which permits health professionals to prescribe it online.

“The concern is whether you are going to unilaterally overrule the data that currently exists for political purposes,” Hassan said. “We need to know when you say that you’re an independent scientist, that’s what you really mean.”