FDA Lifts Restriction on Mifepristone Access
By Jonathan Springston, Editor, Relias Media
The FDA announced Monday that it will allow mifepristone, a drug used for ending a pregnancy early, to be shipped by mail during the COVID-19 pandemic, reversing Trump- and Supreme Court-backed restrictions.
In a letter to the American College of Obstetricians and Gynecologists (ACOG), Acting FDA Commissioner Janet Woodcock indicated clinicians could prescribe mifepristone via telemedicine and that women could receive such prescriptions via mail.
“By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence, which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive,” ACOG President Eva Chalas, MD, FACOG, FACS, and ACOG CEO Maureen G. Phipps, MD, MPH, wrote in a joint statement.
The FDA approved mifepristone in 2000, but requires women to access the drug in a hospital, medical office, or clinic (not a retail pharmacy). The agency also mandates clinicians to obtain a certification before prescribing mifepristone, and for patients to sign an agreement before receiving the drug.
Considering the risks posed by COVID-19, in May 2020, ACOG and other groups challenged the in-person dispensing requirement, asking the courts to pause this mandate for the duration of the pandemic. A federal judge issued a national injunction blocking the in-person requirement, but on Jan. 12, 2021, the Supreme Court reversed that decision.
“Now, thanks to the FDA’s intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion will be able to do so safely and effectively by acquiring mifepristone though the mail, just as they would any other medication with a similarly strong safety profile,” Chalas and Phipps wrote. “We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive healthcare, and we look forward to working with policymakers to ensure this principle governs post-pandemic care.”
For much more on this and related subjects, be sure to read future issues of Contraceptive Technology Update.