WASHINGTON — Dr. Marty Makary, President Donald Trump’s nominee to lead the Food and Drug Administration, said Thursday that he would review a Biden-era rule that allowed patients to get mifepristone without seeing a health care provider in person.
The Biden administration initially eliminated the in-person dispensing requirement in 2021, and made the change permanent in 2023. The change expanded access to the drug, as people were allowed to use telemedicine to get a prescription and the pill.
Makary appeared before the Senate Health, Education, Labor and Pensions committee for his hearing for FDA Commissioner.
“I do think it makes sense to review the totality of data and ongoing data,” Makary said, referring to how patients get mifepristone.
“I know personally of OB doctors who prefer, to insist, even though they have the option to prescribe otherwise, but they choose to insist that mifepristone be taken when necessary in their office as they observe the person taking,” Makary continued. “I think their concern is that if this drug is used in the wrong hands, it could be used for coercion.”
Since Roe v. Wade was overturned in 2022, many conservatives have set their sights on mifepristone, one of two pills used in a medication abortion. In late 2022, the Alliance for Hippocratic Medicine, an anti-abortion group, sued the FDA in an attempt to get the drug’s approval revoked, but the case was ultimately dismissed in a unanimous decision by the Supreme Court.
The FDA, however, can still make changes that affect how patients access the drug.
Sen. Josh Hawley, R-Mo., bashed the Biden administration for what he described as eliminating 20 years of in-person dispensing requirements without any “adequate” studies to back up the change and asked Makary if it makes sense that the FDA return to “the pre-political protocol.”
Democratic senators, however, pushed back on the notion that the drug’s data would need to be re-evaluated, pointing out that the FDA and independent experts have overwhelmingly deemed it safe.
Mifepristone was approved by the FDA in 2000 for medication abortion and is the most common method for ending early pregnancies in the U.S.
Some Democratic lawmakers even suggested that it’s safer than Tylenol, a claim frequently made by pro-abortion rights groups.
“If that’s your approach to something that’s been approved for decades, are you going to do the same with Tylenol?” Sen. Tammy Baldwin, D-Wis., asked. “There are a lot of side effects for daily use, including liver damage. Will you be doing that for Tylenol?”
Vaccine meetings
Prior to his nomination, Makary was a pancreatic cancer surgeon at Johns Hopkins in Baltimore. During the Covid pandemic, Makary attracted some controversy. For example, he claimed that infection was “at least” as effective as vaccination.
During his hearing, Makary was also questioned by several senators about a canceled FDA advisory committee meeting to decide which strains should be included in next season’s flu shot.
The Trump administration offered no explanation at the time for the scrapped meeting, which was set to take place next week. The cancellation has left experts concerned about the flu vaccine supply next season.
Sen. Patty Murray, D-Wash., called the cancellation “unprecedented and dangerous,” urging Makary to reschedule the meeting if he’s confirmed.
Makary said that he was “not involved in that decision” — a response he used on several occasions when asked about decisions made by the Trump administration.
While he stressed the importance of vaccine advisory committees, generally, he refused to commit to rescheduling the flu meeting in question.
Makary did say, however, that he was open to looking into the panel members of advisory committees for any potential conflicts of interest.
“We need to review the ethics policy, because people see things that appear to be a cozy relationship between the industry and the regulators that are supposed to be regulating the products,” Makary said. It’s standard practice for advisory committee members with industry ties to recuse themselves from certain meetings.
He was more equivocal in responding to a question from Sen. John Hickenlooper, D-Colo., who criticized Health Secretary Robert F. Kennedy Jr.’s endorsement of supplements such as vitamin A and cod liver oil to address a measles outbreak in West Texas.
The outbreak has led to at least 159 cases, mostly in unvaccinated children, and one death.
Hickenlooper asked if Makary would be a “more enthusiastic supporter of vaccination” than Kennedy.
“Vaccines save lives and I do believe that any child who dies of a vaccine-preventable illness is a tragedy in the modern era,” Makary said.
He defended the use of vitamin A in some cases. “The rare times in which some child dies of measles, it is often in the setting of a comorbid condition or severe malnutrition, and perhaps that is the rationale, scientifically and physiologically, as to why some supplementation in terms of nutrients may provide a benefit to children who are very sick and hospitalized,” Makary said.
If children have a vitamin A deficiency, the vitamin can be given alongside other supportive care for a patient with the measles. Most children in the United States, however, do not have a vitamin A deficiency.
Makary also vowed to address the high cost of health care in the U.S., describing it as “a backhanded tax on the poor.”
“Health care costs are spiraling out of control and burdening everyday Americans and businesses,” Makary said.
He also said he would push to examine the nation’s food supply — a shared goal of the Trump administration — claiming that the ingredients and chemicals put in foods are dangerous and the U.S. is “drugging our nation’s children at scale.”
“Half of our nation’s children are sick and no one has been doing anything meaningful on this front,” Makary said. “Food has a big part of it.”
