5 Quick Takeaways From Martin Makary's Senate Confirmation Hearing
Senators questioned him on various topics, including his stance on abortion pills, vaccine policies, and recent FDA staffing changes.
Yesterday, Dr. Martin Makary, President Donald Trump's nominee to lead the Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor and Pensions (HELP) Committee for his confirmation hearing. Makary, a Johns Hopkins surgeon and public policy researcher, faced questions from lawmakers on both sides of the aisle about his plans for the agency if confirmed.
Throughout the hearing, Makary emphasized his commitment to science while also advocating for "common sense" approaches to regulation. He aligned himself with the "Make America Healthy Again" agenda but was careful not to explicitly endorse some recent controversial decisions made by the administration.
Watch the full session below:
Here are our five key takeaways from his testimony:
1. He committed to science-based decision making
Makary repeatedly positioned himself as a scientist who would base decisions on data rather than politics. "I believe in the scientific process. In addition, I also believe that we can use common sense," he stated in his opening remarks. When pressed on various issues, he more than once committed to reviewing data and consulting with "professional career scientists" at the FDA before making decisions.
He also emphasized the importance of transparency to rebuild trust in the agency. "If we have the cure for pancreatic cancer, but only 40% of the public is going to come in and take it because the rest don't trust us, then that medication is only 40% effective," Makary noted. "Trust in doctors and hospitals is at a crisis right now."
2. He took an ambiguous stance on mifepristone
Several senators questioned Makary about whether he would maintain current access to mifepristone, an abortion medication that had its in-person prescribing requirements lifted during the Biden administration. Makary avoided making firm commitments either way.
"I have no preconceived plans on mifepristone policy except to take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA," Makary said. He noted that the drug's Risk Evaluation and Mitigation Strategy (REMS) "requires ongoing data collection" and suggested there could be potential drug-drug interactions that might appear in that data.
Senator Maggie Hassan (D-NH) expressed frustration with this response, stating, "I wish you were hedging a little bit less today."
3. He promised to resume vaccine advisory committee meetings
A big focus of the hearing was the recent cancellation of a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that was scheduled to evaluate influenza vaccine strain composition for the 2025-2026 flu season. This decision had raised concerns about transparency and the administration's approach to vaccines.
While Makary initially distanced himself from the decision, stating he was not involved, he ultimately committed, "The VRBPAC committee will be meeting if confirmed and I'm commissioner, yes." However, he also expressed skepticism about the committee's relationship with international organizations, particularly the World Health Organization's Global Influenza Program, suggesting the committee often just "rubber stamps" international recommendations.
Makary also assured senators that he had "no preconceived plans" to remove members from advisory committees, though he did suggest a review of ethics policies to address potential conflicts of interest.
4. He said he’d “assess” in response to FDA staffing concerns
The Trump administration recently fired thousands of probationary workers across federal agencies, including hundreds at FDA, though some terminations have since been rescinded. Several senators pressed Makary on his plans regarding these personnel changes.
Makary repeatedly stated that he was not involved in these decisions but committed to "conduct an assessment of the staffing and personnel at the agency" if confirmed. When asked directly about rehiring fired scientists, he was noncommittal, saying, "If an employee has not logged on to their VPN in two years, then I don't want to rehire that individual. But if there are people that deserve a look, of course I'm happy to look at that."
In response to concerns about understaffing causing "chaos" and "serious morale issues" at the FDA, Makary promised an "ongoing assessment to ensure that the scientists and food director have all the resources they need to do their job."
5. He supports the administration's focus on food and health
The Trump administration recently fired thousands of probationary workers across federal agencies, including hundreds at FDA, though some terminations have since been rescinded. Several senators pressed Makary on his plans regarding these personnel changes.
Makary signaled his support for the administration's focus on food and health, stating, "President Trump and Secretary Kennedy's focus on healthy foods has galvanized a grassroots movement in America. 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."
He later expanded on this, saying that if confirmed, he would instruct the FDA to look into chemicals in food that cause inflammation, even though they're currently recognized as safe. "Half of our nation's children are sick and nobody has really been doing anything meaningful on this front until we have gotten new momentum and enthusiasm from Secretary Kennedy and President Trump to finally address the root causes of these diseases," he said.
Makary also suggested that more prescription drugs could be made available over the counter, which he argued would increase transparency around pricing and potentially lower costs. He questioned why continuous glucose monitors need prescriptions when they could be used by anyone to potentially prevent pre-diabetes, asking, "Why are we holding these tools that help people to empower them with knowledge about their health until after they're sick?"
A few other quick-hit takeaways
Some additional points from the hearing:
On medical misinformation and censorship: When asked about addressing medical misinformation and disinformation, Makary stated firmly, "I do not believe in censorship of scientific opinions. I think we need a civil discourse." He added that explaining to people "with humility what we know and what we don't know" would help rebuild trust in medical institutions.
On clinical trial diversity: Responding to questions about the clinical trial diversity guidance that was recently removed from FDA's website (but later republished), Makary affirmed the importance of diverse clinical trials: "I believe that if you're going to make results extrapolated to the general population you should have results in those populations that you're making recommendations for."
On regulatory flexibility for rare diseases: Senator Lisa Murkowski questioned Makary about finding treatments for conditions like ALS. Makary emphasized that the regulatory process should be customized to the condition under consideration: "It's not possible to require two randomized controlled trials for a condition that only affects a handful of people." He advocated for a "common sense" approach to FDA's regulatory decisions for rare diseases.
On patent system reform: Makary expressed interest in working with Congress to address abuses of the patent system that have allowed companies to prevent competition from generics and biosimilars, which could help address high prescription drug prices.
On public comments in rulemaking: When asked about HHS' recent decision to waive public comment requirements in certain rulemaking situations, Makary noted there are laws governing regulations regarding public comments, but affirmed his belief in civil discourse, stating he has "been an advocate for civil discourse, coming out of an era of medical establishment censorship."
The HELP Committee has not yet scheduled a vote on Makary's nomination. If confirmed, he would join recently confirmed HHS Secretary Robert Kennedy Jr. in shaping the administration's health policy agenda for the next four years.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.
With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.