FDA dispenses with in-person requirement for abortion pill access during the pandemic
Women seeking the abortion pill mifepristone during the pandemic will be able to order it through the mail and will no longer have to go into a clinic in person, acting FDA commissioner Janet Woodcock wrote Monday in response to a series of concerns from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.
Mifepristone is a drug that can end a pregnancy that is less than 10 weeks along, and has created a whirlwind of political and legal questions related to this in-person requirement.
In announcing the change, Woodcock said that based on a review of the medical literature, there does not appear to be “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.” She also noted that the requirements of the drug’s risk evaluation and mitigation strategy still need to be met.
This means that many patients in need of termination of early pregnancy will be able to access safe, effective mifepristone by mail, rather than having to risk avoidable COVID exposure to themselves and their clinicians. 2/
— ACOG Action (@ACOGAction) April 13, 2021
Mifepristone has been ensnared in legal challenges related to this in-person requirement for accessing the drug since the pandemic began.
The Supreme Court in October did not allow the former Trump administration to restrict access to mifepristone via this in-person requirement but said lower courts should continue hearing ongoing arguments.
But Justice Sonia Sotomayor, joined by Justice Elena Kagan, explained how FDA and HHS waived in-person requirements for several other drugs during the pandemic, including controlled substances like opioids, but still required women to go into health care clinics to obtain mifepristone.
“Because the FDA’s policy imposes an unnecessary, unjustifiable, irrational, and undue burden on women seeking an abortion during the current pandemic, and because the Government has not demonstrated irreparable harm from the injunction, I dissent,” Sotomayor wrote.