The Biden administration will temporarily lift a medication abortion restriction that requires abortion pills to be dispensed in person, reversing a Trump-era policy and handing abortion-rights groups one of their first major victories of the new administration.
In a two-page letter letter to the American College of Obstetrics and Gynecologists, a professional medical organization, acting FDA Commissioner Janet Woodcock announced Monday evening that her agency would "exercise enforcement discretion" surrounding the FDA's requirement that abortion patients using mifepristone to terminate a pregnancy obtain the pills in-person from a medical provider. The decision will allow providers in some states to prescribe via telemedicine and send the pills in the mail.
Citing four medical publications, Woodcock wrote, "these studies do not appear to show increases in serious safety concerns… occurring with medical abortion as a result of modifyiing the in-person dispensing requirement during the COVID-19 pandemic."
Monday evening's decision reverses a Trump administration policy supported by the Supreme Court earlier this year. Last year, ACOG, which represents about 90% of obstetricians and gynocologists in the field, requested that the FDA lift its long-standing requirement that mifepristone (also sold as Mifeprex), the first pill of two used to induce a medication abortion, be dispensed by a doctor in-person. The medical group argued that not only was the in-person requirement medically unnecessary, but in the context of the COVID-19 pandemic placed patients and medical staff at risk of exposure to the virus.
When the FDA rejected the request, ACOG and a coalition of medical organizations sued, and in July a federal court agreed, temporarily suspending the FDA's in-person rule. In August an appellate court unanimously declined the Trump administration's request to reverse the lower court's decision. Two weeks later, the Trump administration went to the Supreme Court, asking for it to block the lower courts' orders.
In that request, attorneys for the FDA wrote that the drug used in medication abortion "carries serious risks, including bleeding requiring surgical intervention... and that in-person dispensing mitigates those risks."
In January, the justices allowed the Trump administration to reinstate the in-person requirement, reversing the lower courts' decisions. The Supreme Court's decision was its first major action on abortion since Justice Amy Coney Barrett was confirmed last fall.
However, Monday's announcement renders the Court's January decision moot, given the rule change comes from the FDA itself and not a lower court.
On Monday evening, ACOG chief executive officer Maureen G. Phipps said in a statement she "applauds" the FDA's decision.
"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," Phipps said.
Monday's decision, however, only lifts the in-person requirement for the duration of the pandemic. How the administration will handle the restriction moving forward remains unclear.
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