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

Summary

By eliminating necessary safeguards for pregnant girls and women who undergo the dangerous mifepristone abortion drug regimen, 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.

Case Timeline

May 1994: At the urging of the Clinton administration, French drug manufacturer Roussel Uclaf donated the U.S. patents rights to RU-486 to the Population Council.
March 1996: The Population Council submitted an application for abortion drugs to the FDA.
September 2000: The FDA approved the Population Council’s application. Chemical abortions then became legal in the United States. The FDA’s initial approval included important safety standards.
March 2016: The FDA abandoned multiple original safety standards: it reduced the number of in-person doctor visits from three to one, expanded who could prescribe and administer abortion drugs beyond medical doctors, extended chemical abortions for babies from seven weeks’ gestation up to 10 weeks’ gestation, and eliminated the requirement for prescribers to report non-fatal complications from abortion drugs.
March 2019: ADF clients submitted a citizen petition in response to the FDA’s 2016 changes.
April 2021: The FDA announced a temporary removal of the in-person dispensing requirement while the COVID public health emergency remained.
December 2021: The FDA denied the citizen petition. On the same day, the FDA announced the permanent removal of the in-person dispensing requirement.
November 2022: ADF attorneys—representing medical associations and individual doctors who treat women harmed by abortion drugs—filed a lawsuit challenging the FDA’s reckless actions on these drugs.
April 7, 2023: A federal district court halted all the FDA’s reckless actions on abortion drugs.
April 12, 2023: The U.S. Court of Appeals for the 5th Circuit kept in place a portion of a federal district court’s order requiring the FDA to restore the critical safety standards that the agency once deemed necessary for abortion drugs while the lawsuit proceeded.
April 21, 2023: The Supreme Court paused the trial court decision that would have restored the safety standards while the lawsuit seeking to reinstate them proceeded.
August 2023: A unanimous panel for the U.S. Court of Appeals for the 5th Circuit ruled that the FDA must restore the safety standards and disallow abortion drugs from being shipped by mail.
December 2023: The Supreme Court announced it would hear the case after the Biden administration and Danco Laboratories asked it to review the 5th Circuit’s ruling.
March 2024: ADF attorney Erin Hawley argued the case before the Supreme Court.
June 2024: The Supreme Court declined to address the FDA’s reckless actions based on a legal technicality, but it broadly affirmed conscience protections for medical professionals. Three states have already intervened in the lower courts and stand ready to hold the FDA accountable.