By illegally approving chemical abortion drugs, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.
Frequently Asked Questions
What is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration about?
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.
Do mifepristone and misoprostol cause side effects?
Yes. One in five women who take chemical abortion drugs experience complications, and they can be serious. 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.
When did the FDA approve abortion pills for use in the United States?
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.
Does the FDA allow abortion pills to be sent by mail?
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.
Is it safe to take abortion pills?
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.