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President Donald Trump’s nominee for FDA commissioner, Dr. Marty Makary, was confirmed by the Senate late Tuesday, renewing attention on what regulators may do next regarding the abortion pill mifepristone. Americans across the political spectrum are watching for signs that access could tighten under the new Republican administration in Washington, after Makary faced questions about the drug at a Senate health committee hearing.
In that testimony, Makary did not commit to specific action on mifepristone, despite prodding from both Republicans and Democrats, the Associated Press reported. The confirmation comes as mifepristone remains at the center of safety debates and legal challenges that have played out for years in Washington and in the courts.
Medical professionals, including those cited in the congressional hearing and in court filings, describe mifepristone as among the safest medications the FDA has approved. One legal brief filed with the Supreme Court by medical organizations said that when used in medication abortion, major adverse events occur in less than 0.32% of patients, citing a highly regarded study with more than 50,000 patients.
The AP also reported that abortion opponents point to FDA rule changes that broadened access. They argue that the FDA’s 2021 decision allowing online prescribing and mail-order use helped lead to more emergency complications, though doctors say that argument blends a range of patient experiences that do not all require medical emergencies.
Ushma Upadhyay, a public health scientist at the University of California, San Francisco, described how different definitions affect the debate. She said the scientists generally use a “major” adverse event definition that includes blood transfusions, major surgery, hospital admissions and death, and she was one of the authors of the 2015 study cited in the Supreme Court filing.
The dispute also reflects differences in how problems are reported on FDA labeling, including references to emergency room visits that some medical groups do not treat as major outcomes. The current FDA label lists ER visits, which ranged from 2.9% to 4.6%, as an option when patients experience prolonged heavy bleeding, severe abdominal pain, or a sustained fever, according to the Associated Press account.
Upadhyay said ER visits can reflect reasons beyond the most serious complications. Some patients may seek care to be checked out or because they have questions, she said, while others may avoid their primary care provider because of stigma. She also referenced a study she co-authored in 2018 that found slightly more than half of patients who visited the ER because of abortions received only observational care.
On effectiveness, the AP reported that mifepristone produces a completed abortion 97.4% of the time in U.S. studies cited in the FDA label. The AP said a surgical intervention is needed in 2.6% of cases, and 0.7% of the time the pregnancy continues.
The comparison to clinic-based procedures also appears in the safety debate. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists, said the risk of procedural abortion failing to end a pregnancy is “extremely, extremely low,” probably less than 0.1%, and said clinicians confirm completeness of a procedural abortion by examining tissue removed or performing an ultrasound during or after the procedure. Gupta said there are “very few complications from abortion,” whether medication or procedural, and she has performed abortion procedures for more than 20 years.
While FDA approval decisions are made case by case, supporters of mifepristone say the drug’s overall safety profile—grounded in studies and FDA reviews—compares favorably to common medications and reflects the scale of its use. The AP reported that since 2000, roughly 6 million patients have taken mifepristone, and it said a 2021 review of agency records looking for deaths likely related to the drug identified 13, or 0.00027% of patients.