FDA Rejects Petitions Related to Abortion Pill Mifepristone

A woman looks at an abortion pill—RU-486, or mifepristone—displayed on a smartphone in Arlington, Va., on May 8, 2020. Olivier Douliery/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) recently denied two petitions—one from pro-life group Students for Life, and one from the American College of Obstetricians and Gynecologists (ACOG)—regarding an abortion pill, marking the latest move in efforts to determine regulation over chemical abortion.

Chemical abortion, also referred to by other terms such as “abortion by medication,” is the most popular method of abortion in the United States, comprising more than half of total U.S. abortions.

The abortion pill of concern in the petitions, mifepristone, is the first of a two-drug regimen designed to kill an unborn child in pregnancies up to 10 weeks after conception.

Specifically, mifepristone acts to deprive the unborn child of nutrients needed to stay alive and stops the pregnancy from progressing, while a second drug, misoprostol, induces labor to expel the unborn child.

Pro-life group Students for Life petitioned the FDA to restore the restrictions the agency imposed in 2011 on mifepristone, which at the time did not permit the drug to be prescribed over the phone, to be issued by mail, or to be picked up at a local pharmacy.

Those restrictions would mean the drug could “only be administered by or under the supervision of a physically present physician,” and the patient would need to visit the doctor’s office at least three times to be prescribed the two drugs. It would also mean the drug could only be administered for up to seven weeks of pregnancy, rather than the 10 weeks that it is currently allowed to be prescribed for.

Students for Life also requested that mifepristone should be contraindicated for women who do not have convenient access to emergency medical care.

But the FDA rejected the group’s petition. In a brief letter, Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said that Students for Life’s petition “does not provide any new data or evidence” beyond what had been provided in a 2019 petition that a separate pro-life group had submitted to the FDA, which the agency deemed similar to the latest petition. As such, the FDA referred Students for Life to its December 2021 response to the 2019 petition.

‘Reckless and Negligent’

Kristi Hamrick, the policy director of Students for Life, said the FDA’s denial was “reckless and negligent,” reported Politico.

The FDA also denied a petition from the ACOG, which asked for the FDA to ask the holder of the approved new drug application (NDA) of mifepristone to apply to have mifepristone have “miscarriage management” added as an indication to the labeling of the drug.

The ACOG had also requested the FDA to make adjustments to the drug’s restrictions—the risk evaluation and mitigation strategy (REMS) for mifepristone—to make it easier to use the drug to manage miscarriage.

Cavazzoni pointed out there were multiple steps involved in making the change to the labeling of mifepristone and that only the holder of the NDA could submit a supplemental application and provide data to establish the drug is safe and effective for that use before any updates to labeling are added.

The FDA official also pointed out that adjustments made to the drug’s restrictions would only be made if “miscarriage management” was approved to be added to the drug’s labeling.

ACOG Federal Affairs Director Rachel Tetlow said the group was disappointed by the FDA decision, reported Politico.

The FDA’s move comes on the same day that it finalized a rule change to have both physical and online pharmacies be able to dispense mifepristone to patients. It means any pharmacy, not just a handful, can become certified via a short form to fill the prescriptions for mifepristone.

Meanwhile, the Department of Justice on Tuesday said in a legal opinion that the U.S. Postal Service could continue to deliver abortion pills across the United States even after the Supreme Court has overturned Roe v. Wade in June 2022.