5 Key Insights from FDA Nominee Marty Makary’s Confirmation Hearing

Dr. Marty Makary, the candidate to lead the Food and Drug Administration (FDA), testified before the Senate Health, Education, Labor, and Pensions Committee (HELP) during a mostly amicable confirmation hearing on March 6.

The surgeon and researcher from Johns Hopkins University faced numerous inquiries from legislators across party lines on various subjects, including the safety of abortion pills, seed oils, flu vaccines, and the necessity for greater information transparency.

The FDA operates under the Department of Health and Human Services, led by Robert F. Kennedy Jr.

Similar to Kennedy, Makary has consistently critiqued COVID-19 mandates, advocated for the elimination of harmful chemicals and toxins from the American food supply, and called for increased transparency in healthcare.

Trump emphasized the need for Makary to “course-correct and refocus the Agency,” as well as to investigate “harmful chemicals contaminating our Nation’s food supply and drugs being administered to our Nation’s youth, so that we may finally confront the Chronic Disease Epidemic.”

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

Should he be confirmed, Makary plans to investigate vaccine safety, examine additives and dyes in food, and tackle chronic diseases, among other initiatives.

These topics were among those addressed at the March 6 confirmation hearing. Here are five key insights from the discussion:

Flu Vaccine Meeting

On February 27, the FDA canceled its annual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBAC), typically held to discuss and select flu strains for the upcoming fall season. Makary was questioned about this decision by both Democratic and Republican lawmakers. He committed to reviewing the decision if confirmed.

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

The FDA’s internal scientists will determine the strains for flu shots and communicate with manufacturers to ensure that updated vaccines are prepared for the fall, as outlined by the Trump administration.

HELP Chairman Bill Cassidy (R-La.) first raised the issue of the meeting’s cancellation during Kennedy’s confirmation hearing last month; Cassidy expressed difficulty in supporting Kennedy due to the nominee’s remarks regarding vaccines.

“What is lost is the transparency,” Cassidy remarked, indicating that the lack of public discourse on vaccines undermines Kennedy’s “radical transparency” pledge.

Makary consistently emphasized that he was not involved in the decision to cancel the VRBAC meeting. He added that the committee has often only “rubber-stamped” recommendations sanctioned by the World Health Organization’s Global Influenza Program.

Several committee members pressed Makary to assure them that a VRBAC meeting would be held if he is confirmed. The nominee declined to make such a promise, asserting that the FDA does not require VRBAC input to decide on the flu vaccine formulation.

Senator Patty Murray (D-Wash.) characterized the decision to cancel the meeting as “unprecedented and dangerous.”

Senator Tammy Baldwin (D-Wis.) expressed concern that the cancellation may be “a ploy to install vaccine skeptics.”

“I have no preconceived plans to reorganize that committee or any committee,” Makary responded. “Secretary Kennedy is committed to making America healthy again.”

Food and Nutrition

In his opening comments, Makary expressed his intent to support the administration’s Make America Healthy Again initiative, focusing on chronic disease and childhood health issues.

He emphasized the importance of nutrition in this agenda.

“Childhood obesity is not simply a matter of willpower, and early onset Alzheimer’s is not solely due to genetics. We need to, and we will, address food as it relates to our health,” Makary asserted in his opening statement.

Senator Tommy Tuberville (R-Ala.) inquired about the FDA’s list of food additives that receive minimal regulation as they are categorized as “generally recognized as safe.”

Makary stated that chemicals in food affect gut microbiomes and induce inflammation in the digestive tract.

“Research now indicates concerns with some of these ingredients. We must examine these components, and you have my promise to do so if I am confirmed as FDA commissioner,” he indicated.

Tuberville also questioned Makary regarding seed oils. Kennedy has often advocated that food would be healthier when cooked with beef tallow instead of seed oils.

Makary acknowledged the need for further research and noted that chronic illness cannot be attributed to a single ingredient.

“Seed oils exemplify an area where consolidation of the scientific research would be beneficial, and I don’t think it’s just one ingredient in the food supply causing illness in our children,” Makary pointed out.

He expressed the desire to initiate a pilot program aimed at enhancing the nutritional quality of school lunches. The U.S. Department of Agriculture oversees the school lunch program, and Kennedy along with Secretary of Agriculture Brooke Rollins are expected to collaborate on various food-related matters.

Transparency

Throughout his confirmation hearings and after taking office, Kennedy has often emphasized the need to establish an era of “radical transparency” within the Department of Health and Human Services, a perspective that aligns with Makary’s previous comments.

In 2021, Makary advocated for a comprehensive revamp of the culture and leadership at the FDA, claiming it was “broken” and “mired in politics and red tape.”

During the March 6 hearing, Makary asserted his commitment to fulfilling Kennedy’s vision of “radical transparency.”

“If confirmed, I aim to ensure the FDA maintains the gold standard of reliable science, transparency, and common sense to restore public trust and reclaim America’s health,” Makary expressed.

His 2012 book, “Unaccountable,” called for greater transparency by outlining issues within U.S. healthcare. This work later inspired a Fox drama series titled “The Resident.”

Corruption

Kennedy is vocal about eradicating what he deems “corporate corruption of government health agencies,” and Makary reaffirmed support for this aim during his testimony on March 6.

Makary concurred with Sen. Rand Paul (R-Ky.) that FDA personnel and panel experts should disclose any royalties received from pharmaceutical companies.

“I desire to see American companies succeed. I want life sciences companies to prosper, but we must maintain an impartial scientific review process devoid of any conflicts,” Makary articulated.

He addressed numerous questions regarding the recent layoffs within the FDA. Some employees who conducted inspections and assessed medical devices have since been reinstated.

Makary promised to conduct an evaluation, if confirmed, “to ensure that scientists and food inspectors possess all necessary resources to perform their duties effectively.”

Mifepristone

Makary faced numerous inquiries regarding his plans for the approval and safety protocols concerning the chemical abortion drug mifepristone, which has surfaced as a contentious topic.

The FDA relaxed safety regulations on mifepristone during the Biden administration, including eliminating in-person screening requirements to ascertain gestational age and pregnancy location before prescribing the drug.

Cassidy pointed out that while studies on the safety of mifepristone for pregnant women exist, there is limited understanding regarding its effects on infants surviving failed or reversed abortion attempts.

Makary promised to adhere to the “tried and true” independent review process the FDA has utilized for decades.

The FDA continuously compiles reports on side effects and complications associated with mifepristone, and Makary stated he would not “prejudge the data without examining it first.”

Senator Maggie Hassan (D-N.H.) urged Makary to commit to maintaining the drug’s availability under its current framework, which allows health professionals to prescribe it online.

“The concern is whether you are going to unilaterally overrule the existing data for political reasons,” Hassan remarked. “We need assurance that when you say you’re an independent scientist, that you genuinely mean it.”