BY: JENNIFER SHUTT
WASHINGTON — President Donald Trump’s nominee to lead the Food and Drug Administration refused to commit to keeping access to medication abortion as it is now, or changing prescribing guidelines, in response to questions from both Democrats and Republicans during his confirmation hearing Thursday.
Martin Makary testified that if confirmed as FDA commissioner, which appeared likely, he will review data on mifepristone and follow the research where it leads him.
“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.
Medication abortion is a two-drug regimen consisting of mifepristone and misoprostol that accounts for about 63% of all pregnancy terminations within the United States, according to research from the Guttmacher Institute.
The FDA originally approved mifepristone in 2000 and changed its prescribing guidelines in 2016 and 2021.
It is currently approved for use up to 10 weeks gestation and can be prescribed via telehealth and shipped to patients.
Trump announced in November that he would nominate Makary, a surgeon at Johns Hopkins Hospital in Maryland, to run the FDA.
Makary’s biography says he “has published over 250 peer-reviewed scientific articles and has served on several editorial boards.”
“Dr. Makary served in leadership at the World Health Organization Patient Safety Program and has been elected to the National Academy of Medicine,” according to his biography. “Clinically, Dr. Makary is the chief of Islet Transplant Surgery at Johns Hopkins. He is the recipient of the Nobility in Science Award from the National Pancreas Foundation and has been a visiting professor at over 25 medical schools.”
Prescription changes?
Republican members of the Health, Education, Labor and Pensions, or HELP, Committee asked Makary questions that appeared to recommend he revert prescribing guidelines to what was in place before changes were made during the last decade.
Democrats seemed to suggest he should keep use as it is now during the nearly two-hour hearing.
Chairman Bill Cassidy, R-La., asked if Makary would reinstate the in-person dispensing requirement that used to exist and require doctors to report all adverse events or medical complications to the FDA.
Missouri Republican Sen. Josh Hawley — whose wife, Erin Morrow Hawley, argued a case over access to mifepristone before the U.S. Supreme Court — asked Makary if he would require a return to the “pre-political protocol that requires in-person dispensing for chemical abortion drugs.”
Makary replied that he thinks “it makes sense to review the totality of data and ongoing data.”
“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 it,” Makary said. “And I think their concern there is that if this drug is in the wrong hands, it could be used for coercion.”
New Hampshire Democratic Sen. Maggie Hassan also asked Makary about his views on mifepristone and whether he would keep the current prescribing guidelines in place.
She said Democrats’ questions about access to the pharmaceuticals that are involved in medication abortion weren’t about him taking an analytical look at the data.
“The concern is whether you are going to unilaterally overrule the data that currently exists for political purposes and for political reasons, and that’s what we’re looking for your reassurance on,” Hassan said.
“You have told us you are an independent scientist. I believe that. You have a very distinguished career as a physician,” Hassan added. “But we need to know that when you say you’re an independent scientist, that’s really what you mean. And then with the politics get heated around abortion, that you won’t abandon that independence.”
Makary repeated his earlier comments that he had “no preconceived plans to make changes to the mifepristone policy” and that he planned to review the data, if confirmed.
FDA firings
Senators from both political parties asked Makary about the Trump administration firing probationary employees at the FDA and whether he would try to reinstate some of those former federal workers.
Maine Republican Sen. Susan Collins told Makary that she expects any assessments about staffing at FDA are undertaken by him and not an “outside force.”
“In February, we learned that hundreds of probationary employees at FDA were dismissed. And this really concerns me, because we need a flow of young, new scientists and researchers, especially since we’re seeing retirements and resignations,” Collins said. “And ironically, more than half of the FDA employees are funded under various industry user fee agreements. So there is revenue coming into the FDA to pay for these employees.”
Makary testified he hasn’t been involved in any of the decisions on FDA staffing made so far during the Trump administration.
“But, if confirmed, you have my commitment that I will do an assessment,” he said.
In response to a question from Maryland Democratic Sen. Angela Alsobrooks later in the hearing, Makary said he welcomed “input on efficiencies at the agency.”
“At the same time, I want to make sure that the scientists and food inspectors and staff central to the core mission of the agency have all the resources they need to do their job well,” Makary said.
Food safety
The food side of FDA didn’t come up often during Makary’s confirmation hearing Thursday, though he did talk about where he thinks the federal agency should focus those efforts during an exchange with Alabama Republican Sen. Tommy Tuberville.
Makary committed to have the FDA look at preservatives and other additives in food, saying the country has to “reassess what we’re doing, because we’re not on a good path right now.”
The federal government, he said, should also ensure children’s school lunches are healthier.
“One thing I would like to work on is a school lunch program for some school districts on a pilot basis to transition to healthier foods,” Makary testified. “A lot of school districts want to, but they don’t know how, and they may not have the funds. I’ve been discussing this with Jay Bhattacharya and others in the administration, and I hope that’s something we can do.”
Bhattacharya is Trump’s nominee to lead the National Institutes of Health. He had his confirmation hearing on Wednesday and is awaiting a confirmation vote.
Alaska Republican Sen. Lisa Murkowski asked about the FDA’s food inspections and pressed Makary not to cut federal funding for state and local governments, which she said “conduct about 60% of food processing facility inspections, 90% of produce safety inspections, 100% of retail food inspections.”
“This impacts us in the state of Alaska, when it comes to our seafood industry and in other areas,” Murkowski said. “So I’m looking for a commitment from you that under the Trump administration, the FDA is going to maintain funding for these contracts with state and local governments. They’ve proven that it’s more cost-effective, more efficient, and it also is what Congress has asked for.”
Makary said he would be “happy” to look at it.