FDA will not scale back abortion pill availability, says commissioner
Food and Drug Administration (FDA) Commissioner Marty Makary said on Thursday the agency has “no plans” to restrict access to the abortion pill mifepristone.
Until 2023, the FDA’s in-person dispensing rule meant that pharmacies could not sell mifepristone. Women who wanted a chemical abortion could only obtain the pill in clinics, hospitals, and medical offices. When the FDA removed the requirement, the agency was met with legal challenges that were ultimately struck down last year by the US Supreme Court, which sided with the FDA.
Rather than scale back the pill’s availability to pre-2023 levels, however, Commissioner Makary assured attendees at the Semafor World Economy Summit last week that the agency has "no plans to take action.”
“There is an ongoing set of data that is coming into the FDA on mifepristone,” he qualified. “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.”
Sen. Josh Hawley (R-MO) reacted to Makary’s remarks on X, which he said were “exceptionally disappointing to say the least. Not a good beginning at the FDA.”
Mifepristone safety
On Monday, the Ethics and Public Policy Center (EPPC) published the largest-ever study on mifepristone. Using an insurance claims database, researchers analyzed 865,727 mifepristone abortions between 2017 and 2023. They found that within 45 days of taking the pill, 10.93% of women experienced serious adverse events such as sepsis, infection, cardiac issues, anaphylaxis, or hemorrhage. EPPC notes that this rate is at least 22 times higher than the 0.5% rate displayed on the drug label.
“The abortion pill is not medicine. It's a lethal drug that kills babies & endangers mothers,” human rights group Live Action wrote on X in response to the study. “[The] FDA has abandoned its duty to protect women & children, fast-tracking mifepristone through lies & stripping away even basic safety measures. Mifepristone shouldn't merely be regulated — it must be pulled from the market & banned outright.”
The Family Research Council issued a similar call: “The data is comprehensive. We urge the @US_FDA to protect women and unborn children — investigate mifepristone and repeal the drug's approval.”
The FDA’s prescribing label for mifepristone warns that between 2.9% and 4.6% of women who take the pill require ER visits.
Last year, a team of researchers from the Charlotte Lozier Institute teamed up with physicians from the American Association of Pro-Life Obstetricians and Gynecologists to conduct a study on mifepristone by analyzing ER visits. The researchers selected four cohorts of women: women with no pregnancies, women who gave birth, women who had surgical abortions, and women who had chemical abortions by taking mifepristone. Using data from 2004 to 2015, they looked for any increase in ER visits by these women within 30 days of their outcomes. The group with no pregnancies was analyzed according to all their visits across the 11-year period. They discovered that ER visits among women who gave birth increased by 9.2%, among women with no pregnancies by 42.8%, among women who had surgical abortions by 280.4%, and among women who took mifepristone by 2,649.7%. There was a similar scale for ER visits coded as “severe” or “critical.”
Nonetheless, Planned Parenthood describes mifepristone as “very safe” and CNN says it’s even safer than low-risk drugs like penicillin.
Who makes mifepristone?
When the FDA approved mifepristone in 2000, it took great care to conceal certain information. All documents related to the approval have been redacted so that government employee names and the location of the manufacturer, Danco Laboratories, remain hidden.
To this day, the location of Danco Laboratories is not known to the public. The company uses a P.O. box as its address, is not listed on any public exchanges, and refuses to disclose the identities of its executives. According to the LA Times, Danco says this is because it fears violence from pro-life groups, though there have been no reports of attacks on Pfizer, which manufactures misoprostol. Misoprostol is a pill used together with mifepristone as part of the chemical abortion regimen.
