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Gabrielle M. Etzel


NextImg:Trump's FDA nominee breezes through confirmation hearing - Washington Examiner

Senators from a key health panel on Thursday bombarded Dr. Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, with an onslaught of questions ranging from the safety of abortion pills to seed oils. 

Makary, a surgeon from Johns Hopkins University, received a warm welcome from both sides of the aisle in a cordial confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee. Democrats and Republicans alike asked him tough questions on many topics.

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As FDA commissioner, Makary would oversee the safety and efficacy of drugs, vaccines, foods, and medical devices, playing a central role in Trump’s “Make America Healthy Again” agenda.

Here are the most important moments from Thursday’s hearing: 

Mifepristone takes center stage

Senators on both sides of the political divide repeatedly pressed Makary on what he plans to do regarding the approval and safety protocols for the abortifacient pill mifepristone, which has become the center of politicized debates on abortion and women’s health. 

During the Biden administration, the FDA rolled back several safety regulations on mifepristone, including in-person screening requirements to determine the gestational age and location of the pregnancy before prescribing the abortion drug. 

HELP Committee chairman Sen. Bill Cassidy (R-LA), also a physician, started the hearing by asking Makary what he planned to do about these changes. Makary replied that he did not have a policy agenda for day one.

“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 and to build an expert coalition to review the ongoing data,” Makary told Cassidy within the first 15 minutes of the hearing. 

During his confirmation hearing for secretary of Health and Human Services, Robert F. Kennedy Jr. told senators on the HELP Committee that a comprehensive review of the safety information on mifepristone was one of Trump’s top priorities. 

Sen. Patty Murray (D-WA) and other Democratic senators highlighted that mifepristone, which was initially approved for pregnancy termination up to eight weeks gestation with a physician’s examination, has undergone decades of post-market safety reviews. 

Murray and others questioned whether Makary would be swayed on the issue of mifepristone safety and efficacy by the political headwinds on abortion. 

Cassidy noted at the conclusion of the hearing that, although there have been studies on the safety of mifepristone for pregnant women, there is a dearth of knowledge as to whether mifepristone is safe for infants who survive failed or reversed abortion attempts. 

Makary made both sides of the aisle aware of his commitment to following the “tried and true” independent review process the FDA has used for decades.

Food as the centerpiece of health

Makary made improving the food supply a central focus of fighting disease and improving overall health, fully endorsing Trump and Kennedy’s goals on nutrition policy.

“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. 

When asked by Sen. Tommy Tuberville (R-AL) about seed oils, a key point of the MAHA movement, Makary said that more research consolidation is necessary, but America’s unhealthy relationship with food does not boil down to one thing. 

“I don’t think it’s any one ingredient in the food supply that’s making our nation’s children sick with a 30% rate of insulin resistance and diabetes in American teenagers today, that is a massive signal in the data,” said Makary. 

Makary also laid out a plan for improving the federal school lunch program, starting with pilot programs across the country to place more healthful foods into the school system. 

Minority health research

Sen. Lisa Blunt Rochester (D-DE) ignited the fieriest exchange with Makary in the mild-mannered hearing when she asked Makary whether he would reverse Trump administration policies on race and gender regarding clinical trials.

Critics have said that the Trump administration’s efforts to dismantle diversity, equity, and inclusion efforts could have unintended consequences for minority and women’s health should they be understudied or underrepresented in biomedical research. 

When Blunt Rochester pressed Makary for a simple yes or no answer on whether or not he believed in clinical trial diversity, Makary used the example of including white people in clinical trials for sickle cell disease, a disorder that disproportionately affects black people.

“I believe in common sense, and I believe in clinical trial diversity,” said Makary. “And so I believe 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.” 

Lowering prescription drug costs

Makary said several times that he hoped to find innovative ways to make drugs and technologies more accessible for patients, including removing certain requirements to obtain a prescription before getting treatment. 

In particular, Makary referenced naloxone, the anti-opioid overdose medication, and EpiPens to treat severe allergic reactions as examples of drugs that could be sold without prescriptions. 

He also referenced deregulating blood glucose monitors so patients could track their insulin resistance before developing diabetes or pre-diabetes.

“If they can be over-the-counter, and we can feel confident about public safety with these products on the shelf at a pharmacy, it would force the companies to put a price on the shelf, and I do believe price transparency will have an effect on the entire marketplace,” Makary said.

The FDA nominee also said he would be very interested in working with Congress to reform the patent system, particularly for biosimilars, to increase competition in the drug market and lower prescription prices. 

Conflicts of interest 

Rooting out entanglements between industry and regulators has been a top priority of Kennedy’s agenda for HHS, and Makary signaled that he would be on board.

Makary heartily agreed with Sen. Rand Paul (R-KY) that FDA employees or expert advisers on FDA panels should disclose whether or not they earn royalties from pharmaceutical companies that could sway their decision-making.

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“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,” said Makary. 

Paul has several times introduced legislation that would require FDA employees and advisers to disclose the royalties they earn from pharmaceutical and biotechnology companies to improve transparency.