Makary said in an interview at the Semafor World Economy Summit that he has “no plans to take action” to restrict mifepristone, the pill used in nearly two-thirds of abortions in the United States.
“There is an ongoing set of data that is coming into the FDA on mifepristone,” Makary said Thursday. “So if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”
Hawley, who so far has pressed all of President Donald Trump’s health-related cabinet picks on their stance on abortion, said on X that Makary’s statements on mifepristone were “exceptionally disappointing to say the least.”
“Not a good beginning at the FDA,” Hawley added.
Much of Makary’s confirmation hearing revolved around mifepristone, considering its central role in debates over federal and state abortion policy. Republicans and Democrats on the Senate health committee grilled the former Johns Hopkins surgeon about his plans for the medication.
Health committee chairman Bill Cassidy (R-LA) made mifepristone his first question for Makary, to which the then-hopeful FDA Commissioner responded that he had “no preconceived plans on mifepristone policy except to take a solid, hard look at the data.”
Ongoing controversy
This is not the first time Hawley, a key Republican on the health committee, has had a dust-up with Makary over abortion.
Hawley threatened to break with Republican ranks in the first step of Makary’s confirmation process after it came to light that a former Biden administration Justice Department attorney, Hillary Perkins, was selected as FDA chief counsel.
Perkins, in her role as a career DOJ attorney, defended the Biden administration’s decisions to roll back safety precautions for mifepristone. Hawley’s wife, Erin Morrow Hawley, represented the doctors suing the FDA in her capacity as leading counsel for the religious advocacy group Alliance Defending Freedom. The suit was ultimately dismissed by the Supreme Court on technical grounds.
Josh Hawley said before the key confirmation vote last month that choosing Perkins “calls into question [Makary’s] judgement” and threatened to vote against him during the health committee’s preliminary vote, which would have tanked Makary’s nomination.
Although Perkins insisted that she supports Trump and is personal against abortion, she was forced to resign, securing the path for Makary’s confirmation.
Safety data on mifepristone
Abortion-rights advocates argue that there is adequate proof that mifepristone is safe, based on the data available since the pill first received FDA approval in September of 2000.
Originally, the medication was approved for up to seven weeks of pregnancy, and patients were required to see a physician to confirm the age of the pregnancy and rule out dangerous conditions that would make the drug ineffective, such as ectopic pregnancy.
The FDA began to relax these restrictions in 2016, increasing the gestational age limit to 10 weeks of pregnancy and removing requirements for physicians to report adverse complications, other than death.
Opponents of mifepristone say that there is not sufficient evidence, though, regarding the post-2021 policy of allowing the pill to be prescribed without in-person screenings. They note that only data collected since 2016, without non-fatal complication reports, was used by FDA scientists to justify that decision, which opened the door for telehealth physicians to sell pills to patients online.
The FDA’s warning label on mifepristone says that between 2.9% and 4.6%, or approximately 1 in 25 patients, will require an emergency room visit to treat potentially life-threatening complications, including sepsis and hemorrhaging.
With approximately 643,000 mifepristone abortions in 2023, that’s roughly 20,000 to 30,000 women suffering complications following medication abortion.
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A recent study from the United Kingdom found that nearly half of women undergoing a medication abortion experienced more pain than they were told to expect by their healthcare providers. Four in 10 women ranked their pain as “severe,” between an 8 and a 10 on a standard pain scale.
Another recent University of Pennsylvania study found that medication abortions put patients at five times the risk of experiencing severe pain compared to surgical abortions. They are also more than nine times as likely to develop severe bleeding complications.
