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FDA Reverses Course on Abortion Drugs by Mail

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The Food and Drug Administration (FDA) will once again allow abortion-inducing drugs to be prescribed remotely and sent via mail. Typically, a patient seeking a medical abortion—that’s the type induced via prescription drugs mifepristone and misoprostol—must be prescribed and receive the drugs at a physician’s office, hospital, or medical clinic, per FDA rules. But the COVID-19 pandemic has spurred a lot of legal back-and-forth over this.

Last summer, a federal court temporarily suspended the in-person prescription requirement. The in-person prescription requirement during pandemic times presents a “substantial obstacle” (of the sort barred by Roe v. Wade) to women seeking abortions, U.S. District Judge Theodore Chuang ruled in July 2020, issuing a preliminary injunction blocking enforcement of the FDA’s in-person rules until at least 30 days after an end to the public health emergency was declared.

The Trump administration challenged this ruling, and the Supreme Court asked in October that the court reconsider, given that “relevant circumstances” may have changed. Then, in January, the Supreme Court granted the Trump administration’s request to ignore the district court’s ruling while a federal appeals court was hearing the matter. That meant that being prescribed abortion drugs once again required an in-person visit.

Now, the FDA says the requirement is again suspended.

In an April 12 letter to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), Acting FDA Commissioner Janet Woodcock wrote that a review of the literature does “not appear to show increases in serious safety concerns (such as hemorrhage, ectopic pregnancy, or surgical interventions) occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.”

As a result, the agency would “exercise enforcement discretion” with regard to in-person dispensing requirements and “the dispensing of mifepristone through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber,” Woodcock wrote.

While the suspension is only temporary, it will hopefully pave the way for a more permanent relaxing of the FDA’s in-person prescription and dispensation rule. Like with so many other areas of coronavirus-related regulation relaxing, the lack of adverse outcomes associated with this pandemic prescribing experiment should call into question the need for such regulations even in ordinary times.

“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,” said ACOG CEO Maureen G. Phipps in a statement.

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