FDA waives in-person requirement for access to abortion pills during pandemic – Endpoints News

Women seeking mifepristone, an abortion pill during the pandemic, will be able to order it by mail and no longer have to visit a clinic in person, FDA Acting Commissioner Janet Woodcock wrote Monday in response to a series of concerns from the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine.

Mifepristone is a drug that can terminate a pregnancy of less than 10 weeks and has created a whirlwind of political and legal issues 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 “an increase in serious safety issues (such as haemorrhage, ectopic pregnancy or surgical procedures) occurring with medical abortion as a result of the change in the in-person dispensing requirement during the COVID-19 pandemic She also noted that the requirements for the medication risk assessment and mitigation strategy still need to be satisfied.

This means that many patients in need of early pregnancy termination will be able to access safe and effective mifepristone by mail, rather than having to risk avoidable exposure to COVID for themselves and their clinicians. 2/

— ACOG Action (@ACOGAction) April 13, 2021

Mifepristone has been embroiled in legal challenges related to this in-person requirement to access the drug since the start of the pandemic.

In October, the Supreme Court did not allow the former Trump administration to restrict access to mifepristone through this in-person requirement, but said lower courts should continue to hear ongoing arguments.

But Judge Sonia Sotomayor, joined by Judge Elena Kagan, explained how The 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 to health care clinics to obtain mifepristone.

“Because FDA policy places an unnecessary, unjustifiable, irrational, and undue burden on women seeking abortions during the current pandemic, and because the government has failed to demonstrate the irreparable harm of the injunction, I am in disagree,” Sotomayor wrote.