FDA Suspends In-Person Requirement for Mifepristone Abortions Decision Puts Women at Risk

WASHINGTON — In a letter dated April 12, Acting Commissioner of the Food and Drug Administration Janet Woodcock, M.D., announced that the FDA would not enforce in-person dispensing requirements for the abortion drug mifepristone during the remainder of the pandemic.

Convincing the FDA to discard necessary safety precautions is part of the abortion industry’s long-term campaign to have women take the drug at home.

“Suspending this basic requirement places the lives of an untold number of women at risk,” said Carol Tobias, president of National Right to Life. “Telemedicine abortions and abortions by mail fit in with the plans of abortion groups to have women essentially self-abort at home. Sadly, women and their unborn babies will be the ones to suffer.”

In September 2000, the FDA approved the abortion drug mifepristone (“RU-486”) for use in the U.S. When the drug was first approved, the FDA placed restrictions on the use of the drug. The FDA felt mifepristone was one of those “medications with serious safety concerns” that required special safety regulation “to help ensure the benefits of the medication outweigh its risks.”

But, in 2016, the FDA loosened some protocols required in the prescribing of mifepristone by lifting the requirement that the drug be used no later than 7 weeks of pregnancy and expanded the time frame to allow use up to 10 weeks of pregnancy. The FDA also lowered the required dosage, expanded the types of prescribers, and reduced the number of office visits required.

Experimenting with telemedicine abortions began in Iowa in 2008. In 2016, an abortion group launched a multi-state “study” where women could have a video consult and then have the drugs shipped by overnight mail.

“Abortion groups now argue that, during the pandemic, it is ‘safer’ not to evaluate and monitor a woman taking abortion drugs than to have her come to the office. An office visit would confirm that she is not too far along for the pills to work or that she does not have an ectopic pregnancy, which these pills do not treat and can prove deadly to a woman if it goes undetected,” said Tobias.

Tobias continued, “These changes place women at greater risk because they may not be able to distinguish the signs of an incomplete abortion, a ruptured ectopic pregnancy, or a deadly infection from the ordinary pain and bleeding of completed chemical abortion. None of these changes make this process safer for the woman. What these changes do is make the process easier and cheaper for the abortion industry.”

Several state attorneys general, led by then-California AG (and now HHS Secretary) Xavier Becerra, signed a letter in March of 2020 petitioning the FDA to relax the regulations on mifepristone.