Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration

More than 20 years ago, the FDA approved the use of a two-drug regimen for abortion. Both drugs, known as mifepristone and misoprostol, can cause serious complications for women and girls who take them.

The FDA ignored these risks and failed to properly research the potential harms of the drugs before they approved them. Since then, the FDA has removed safeguards that were put in place to protect women and girls seeking these dangerous drugs.

Alliance Defending Freedom’s clients have been challenging the FDA’s approval of these drugs since the beginning, but the FDA has not heeded the concerns. It sat on one petition filed by our clients for 14 years before ultimately denying it. Since the FDA continues to recklessly push dangerous abortion drugs without properly researching and explaining the complications they cause, ADF has filed this lawsuit on behalf of four doctors and four medical associations.

Yes. If the drug manufacturer’s own information is to be believed, between 100,000 (2%) and 350,000 (7%) of mifepristone users have had unsuccessful chemical abortions and required surgical intervention. The FDA’s currently approved label for mifepristone also states that between 2.9-4.6% of women will end up in an emergency room.

Women have faced severe bleeding, life-threatening infections, and the inability to give birth to children in the future as a result of these drugs. Women who face these complications can require emergency medical treatment, surgeries, blood transfusions, or hysterectomies to treat them.

The FDA first approved chemical abortion drugs in 2000. Former President Bill Clinton and his administration began pressuring French pharmaceutical company Roussel Uclaf to bring mifepristone, the first drug in the two-drug regimen, to the United States between 1993 and 1994. The company “donated” the U.S. patent for the drug to The Population Council, an organization that was founded to address “world overpopulation.”

The Population Council filed a new drug application with the FDA in 1996, and the FDA gave it priority review. It initially approved the drug, asked for more information, and by 2000, it approved the two-drug abortion regimen of mifepristone and misoprostol for use in the United States with minimal restrictions. Since that time, the FDA has removed the few safeguards that were in place initially.

Initially, the FDA required women and girls to attend three in-person doctor’s visits before they could be prescribed chemical abortion drugs. But in 2016, the FDA reduced the number of required in-person visits to one.

In 2021, the FDA claimed it was temporarily removing the in-person requirement due to COVID-19, meaning women and girls could be prescribed chemical abortion drugs via telemedicine and receive them in the mail. It soon made this change permanent, allowing these dangerous drugs to be distributed through the mail without even requiring a single in-person doctor’s visit.

No. While proponents of chemical abortion drugs claim they are safe for women and girls, this is false. No abortions are safe, and each one is meant to take an innocent life. But chemical abortion drugs are even more likely than surgical abortions to cause complications for the mother. Research has shown that women and girls who have chemical abortions experience a complication rate that is four times higher than those who have surgical abortions.