The Food and Drug Administration (FDA) this week denied two citizen petitions from groups related to accessing mifepristone, a drug used in medication abortion.
The petitions came from a conservative group seeking to restrict the use of the drug, and also from a medical group seeking to expand its use for a new indication.
In denying both, the agency appears to be holding its ground on abortion pills, which have rapidly become the newest flashpoint in the fight over abortion.
FDA first approved mifepristone for medication abortion in 2000. The drug is used in combination with a second pill, misoprostol, during the first 10 weeks of pregnancy.
In one petition, the anti-abortion group Students for Life asked FDA to revert prescribing rules back to 2011, to require mifepristone to be administered in-person only, and then only after three office visits.
FDA loosened the rules as a result of the COVID-19 pandemic to allow a telehealth prescription, and for the drugs to be sent through the mail. The group argued that telehealth should only be an option for women “in absolute need under extreme circumstances.”
Students for Life also asked FDA to restrict the use of mifepristone to the first seven weeks of pregnancy, rather than the currently allowed 10 weeks.
Patricia Cavazzoni, head of the FDA’s Center for Drug Evaluation and Research, wrote in her denial that the actions requested were essentially the same ones the agency had already denied in 2019, when other anti-abortion groups submitted citizen petitions.
“Your Petition does not provide any new data or evidence beyond what was provided” in support of the other petitions, Cavazzoni wrote. At that time, she said FDA “carefully considered the information submitted” and issued a detailed response.
But FDA separately also denied a petition from the American College of Obstetricians and Gynecologists, which asked for a new indication to make it clear the drug can be safely used to help reduce complications from a miscarriage.
Only the drug’s manufacturer can submit an application asking for such a change in the labeling, Cavazzoni wrote. The applicant must also show that the drug is safe and effective for a new indication.
The combination of mifepristone and misoprostol has been shown to significantly improve the management of early pregnancy loss and result in fewer complications.
But the combination is not explicitly indicated for miscarriage management, and patients in states that have restricted access to abortion have reported being denied the medications to treat their miscarriages, as pharmacists said they feared prosecution for dispensing the drugs.
