Marty Makary Grilled on Abortion Medication, Vaccines at Senate Confirmation Hearing

Marty Makary, M.D., M.P.H., nominated to be FDA commissioner, at his Senate confirmation hearing today.

Marty Makary, M.D., M.P.H., said nothing today during his confirmation hearing to be FDA commissioner that would upset his chance of being confirmed.

Makary, a surgeon at Johns Hopkins who has written several popular books about healthcare, was questioned most closely about mifepristone, one of a pair of drugs used to induce abortions early in pregnancy, and the cancellation of an FDA advisory committee about flu vaccines.

In response to other questions, Makary mentioned making naloxone (sold as Narcan), an emergency drug for rapidly reversing opioid overdoses, and Epipen (epinephrine autoinjections), an emergency treatment for anaphylaxis, available over the counter to reduce healthcare costs and make their price more transparent. Makary said he would love to work with Congress on legislation that would change patent law that has enabled “patet thickening [sic]” that makes it more difficult for biosimilars and some generic drugs to come to market. He also spoke about making continuous glucose monitors over the counter.

“Why are we requiring continuous glucose monitors to have a doctor’s prescription when it’s good for people to use these monitors and learn about what they’re eating? We don’t just want to limit continuous glucose monitoring to people with diabetes,” he said at the hearing of the Senate Committee on Health, Education, Labor and Pensions.

FDA critic

In his jauntily written books, Makary has skewered hospitals, medical journal editors, researchers and government health officials. In his 2024 book, “Blind Spots: When Medicine Gets It Wrong and What It Means for Our Health,” Makary directs some of his scathing remarks at the agency he is likely to lead. He writes that the FDA blocked fecal transplants for years “but patient groups won out and sent a blunt message to government bureaucrats: Stop regulating shit.” He noted that the FDA approved Xolair (omalizumab) 19 years after it was approved in Europe. In a chapter on HIV being transmitted through blood donations, Makary writes scornfully about the FDA waiting seven years before requiring blood banks to test donated blood. He also portrays the FDA and its then-commissioner, David Kessler, as overreacting to reports of disease caused by silicone breast implants and faults him for overseeing the approval of Oxycontin (oxycodone hydrochloride). The senators didn’t ask him about the litany of FDA criticism in his book, and Makary touched only briefly on his overall views of the agency. He spoke about “customizing the regulatory process” to diseases and the number of people affected, and he invoked “common sense” — which has become a Trump administration catchphrase — when talking about changes at the agency. “I think we can use some common sense to ask some big questions we’ve never asked before at the FDA. Why does it take 10 years for a drug to be approved? Why does a college student who suffers from chronic abdominal pain for years and we have no idea what is going on, they go to Italy for a summer and they’re suddenly cured of their abdominal pain? Why does a peanut allergy medication that’s been safe — with data for decades — get approved in Europe before the United States when nearly 10% of our population has a good allergy?”

Makary was mild mannered in his testimony, showing little if any of the slashing attitude he assumes in his book as critic of the “medical establishment” and groupthink. He exchanged pleasantries about sports teams with the senators and thanked them for meeting with him prior to the hearing.

Both Republican and Democratic senators asked Makary about staffing cuts at the FDA implemented by Elon Musk’s Department of Government Efficiency (DOGE). Makary largely deflected, saying several times he had not been involved in the DOGE cuts and said he would do an “assessment” of staffing and personnel at the agency. But in answering questions from Sen. John Hickenlooper, Democrat from Colorado, Makary noted the number of FDA employees has doubled since 2007.

Pressed on mifepristone

The senators, especially the Democrats, pressed Makary hardest on the topic of mifepristone. Approved by the FDA in 2000, mifepristone, which works by progesterone, has tortuous regulatory and legal history, including a 2024 Supreme Court case. In January 2023, the Biden administration relaxed the rule that had required the pill to be administered in person in a clinic, medical office or hospital. Antiabortion groups say the liberalization undercuts state laws restricting or banning abortions. Makary told the senators he would convene professional career scientists to look at the “totality of data” about mifepristone, would follow risk evaluation and mitigation — commonly referred to by the acronym REMS — rules that have been applied to the drug, and would “follow the independent scientific review process at the FDA, which is a tried-and-true process. On at least two occasions, though, Makary mentioned the possibility of drug-to-drug interactions with mifepristone. In answering questions from Sen. Josh Hawley, a Republican from Missouri, Makary said he knew obstetricians who insist on in-person dispensing because they are concerned that if the drug was in the wrong hands, it would be used coercively.

“The concern is whether you are going to unilaterally overrule the data, that currently exists, for political purposes and political reasons, and that’s what we’re looking for,” said Sen. Maggie Hassan, a New Hampshire Democrat.

The senators, including the chair, Sen. Bill Cassidy, a Louisiana Republican, also asked Makary repeatedly about the cancellation of the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. The meeting, which had been scheduled for Marc 13, was canceled last week. The committee was slated to consider which flu strains the next flu season’s vaccine should be based on. Makary said he would reevaluate the topics that deserve a convening of the committee. Later in the hearing, he assured Sen. Susan Collins, a Maine Republican, that the committee would meet, but he did not elaborate about when.

HHS Secretary Robert F. Kennedy Jr. has promoted antivaccine views and, since being confirmed as secretary, has been criticized for his handling of a measles outbreak in Texas that has resulted in two deaths. Makary sounded a positive note about vaccines: “Vaccines save lives, and I do believe that any child who dies of a vaccine-preventable illness is a tragedy.”