FDA ends restrictions on mailing abortion pills during pandemic
The Food and Drug Administration (FDA) on Monday ended restrictions on mailing abortion pills during the pandemic, after the Trump administration moved to keep the decades-old requirement for in-person pickup of the drug amid the public health emergency surrounding the coronavirus pandemic.
Acting FDA Commissioner Janet Woodcock sent a letter to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine, informing the groups that the FDA determined that providing the pills remotely through telemedicine and mail did not escalate the risks.
The letter cited analysis from the FDA’s Center for Drug Evaluation and Research, which noted that permission to get the drug mifepristone without appearing in-person will prevent spread of COVID-19.
Mifepristone is used to end early pregnancies and treat pregnancy loss during the first 10 weeks of pregnancy.
The FDA's decision only applies to getting mifepristone during the public health emergency and does not address what will be done after the pandemic.
The decision comes after the American Civil Liberties Union (ACLU) filed a lawsuit last year on behalf of the ACOG against the Trump administration for its decision to enforce the in-person pickup mandate for mifepristone, while suspending the same requirements for other drugs during the pandemic.
Lower courts decided that the FDA could not enforce in-person dispensing requirements for the abortion pill while the legal case continued, allowing clinics to continue distribution through mail. The Supreme Court eventually determined the administration could enforce the in-person mandate for mifepristone.
The ACOG released a statement on Monday celebrating the FDA decision after calling for the in-person mandate to be abolished for years “given that there is no safety reason for the restrictions.”
The in-person dispensing mandate has been in place since the FDA approved the abortion pill in 2000. Before the pandemic, the organization and other health groups had called for the removal of the in-person requirement, saying it hampers access to abortion and is not needed because the drug is safe.
“Requiring the medicine to be dispensed in person, then taken elsewhere at the patients’ discretion, is arbitrary and does nothing to bolster the safety of an already-safe medicine,” ACOG President Eva Chalas and CEO Maureen Phipps said in a release.
“When the COVID-19 pandemic began, ACOG recognized that the in-person dispensing requirement for mifepristone was not just burdensome, it was also dangerous,” they added.
ACLU senior legislative counsel Georgeanne Usova called on the FDA to “comprehensively evaluate” the policies after the pandemic to ensure they aren’t presenting “medically unnecessary, harmful obstacles.”
“We cannot stop here: the restrictions on medication abortion are outdated and have obstructed patients’ access for far too long,” Usova said.
Usage of abortion pills in the U.S. has grown since its FDA approval in 2000, with the pills being used in 39 percent of abortions in 2017, according to the Guttmacher Institute.
A group of House Democrats, including Oversight Committee Chair Carolyn Maloney (D-N.Y.) and Rep. Ayanna Pressley (D-Mass.), called on Biden's FDA in February to drop the in-person restriction on mifepristone.
Maloney and Pressley said they were pleased with the decision in a joint statement, saying the mandate has "for too long .. created barriers for people seeking medication abortion care."
"But this is just a first step," Maloney and Pressley said.
"It is imperative the federal government make every effort to protect and expand access to safe, legal abortion in the United States—including by permanently eliminating outdated, ideological restrictions on medication abortion care," they added.