The FDA lifted restrictions on Monday on a commonly used abortion pill mifepristone, allowing health care providers in some US states the ability to dispense the medication without having to require in-person appointments.
Mifepristone was cleared for usage in the US in 2000, with the FDA approving a supplemental application in 2016. The drug itself is used only in cases where an individual seeks to end a pregnancy during the first 70 days of gestation.
Janet Woodcock, acting commissioner of the FDA, issued a letter on April 12 to both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine, informing the pair of groups that the US health body had concluded that offering the medication through telemedicine and mail did not raise health risks for patients.
Woodcock explained that the FDA’s Center for Drug Evaluation Research (CDER) team analyzed the risks of taking mifepristone, and found that the drug did not show any increase in safety concerns. In fact, the analysis also determined that using telemedicine options will prevent the spread of SARS-Cov-2, the deadly virus that causes COVID-19.
“CDER found that although there are limitations to the study designs, the overall findings from these studies do 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,” Woodcock explained.
Critics have repeatedly questioned the safety and efficacy of the pill, as shown in a September 2020 open letter from the US Sen. Ted Cruz (R-TX) to the former commissioner of the FDA, Stephen Hahn. At the time, Cruz expressed concern over the risks of administering the drug through telemedicine and the increase in the use of so-called “abortion pills.”
“It is an open question as to whether women receiving the abortion pill via telemedicine will ever receive blood tests, ultrasounds, or the necessary screening to determine the actual date of her pregnancy, or the potential occurrence of a deadly ectopic pregnancy,” Cruz wrote.
The FDA previously acknowledged the risks of terminating pregnancy using mifepristone in a 2018 report that cited adverse effects, such as overdose, liver failure, and death. However, since the start of the COVID-19 pandemic, more studies are being done about the expansion of mail-in drug services as a means to provide abortion services.
The latest developments came after the American Civil Liberties Union filed a lawsuit last year on behalf of the ACOG, demanding that the FDA withdraw restrictions that allegedly put patients and clinicians at needless COVID-19 risks in the pursuit of early abortion and miscarriage treatment.