FDA Approves REMS Modification for Certified Retail Pharmacies to Dispense Abortion Pills
- January 06, 2023
The Food and Drug Administration (FDA) moved to expand access to abortion pills with a regulatory change that allows retail pharmacies to sell the drug mifepristone directly to patients.
The agency approved January 3 a modification to mifepristone risk evaluation and mitigation strategy (REMS), which is shared by the brand-name and generic manufacturers of the drug, Denco Laboratories, LLC and GenBioPro, respectively.
With the REMS modification, retail pharmacies may now apply for certification from the drug’s manufactures to dispense mifepristone directly to patients who have a prescription from a certified prescriber.
Under the original REMS, only a physician could dispense mifepristone to patients. In 2021, during the COVID-19 pandemic, the Biden administration temporarily lifted the in-person requirement to allow mifepristone to be prescribed via telemedicine and delivered by mail. The updated REMS makes that change permanent.
The FDA approved Mifeprex, the brand-name version of mifepristone, in 2000 for medical termination of pregnancy. Mifepristone, taken in combination with a second drug misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period).
“At a time when people across the country are struggling to obtain abortion care services this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco said in a statement.
While the new certification process for retail pharmacies is expected to expand access to mifepristone generally, the change would not apply in the states that have near-total bans on abortions since the Supreme Court overruled Roe v. Wade last summer. Legal challenges to the FDA’s modification of the REMS for mifepristone also are likely.