FDA to expand availability of abortion pills

A rule change from the Food and Drug Administration (FDA) will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription in states where abortion is legal.

 

The move happened without much fanfare, but it was a step that abortion advocates had been clamoring for. The agency first announced it was seeking to change the prescribing safety protocols last year.

  • Mifepristone is regulated under a Risk Evaluation and Mitigation Strategy (REMS), a safety program the agency required for certain drugs to ensure that their benefits outweigh their risks.
  • The medication is used with another drug, misoprostol, to terminate pregnancies, and the FDA has said the drugs are safe and effective for use in the first 10 weeks of pregnancy.

The FDA started the reevaluation process by temporarily lifting a requirement that mifepristone be dispensed in person at a clinic or hospital because of the COVID-19 pandemic. The Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.

  • But those changes were never finalized under the regulatory process, until now.
  • Now, pharmacies that are certified in the FDA’s REMS program can now dispense mifepristone directly to patients in stores and by mail. But it’s unclear how many pharmacies will choose to do so.

Medication abortion is becoming increasingly common. In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S., according to the Guttmacher Institute, a pro-abortion research group.

 

Attorney General Merrick Garland in June indicated the Justice Department will take action against states that ban abortion pills, though it’s unclear if the federal government has that power.