The Food and Drug Administration (FDA) is a government agency whose work often goes unnoticed. Yet it has broad authority to affect our day-to-day lives—not only the food we eat, but also the medicines and drugs we take.
Part of the FDA’s mission is to be “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”
Unfortunately, the FDA has not been fulfilling this mission when it comes to its decisions about high-risk abortion drugs. In 2016, the agency began dismantling the critical safety standards it originally deemed necessary when it approved the abortion drug mifepristone in 2000.
But now, thousands of doctors are standing up to the FDA, and Alliance Defending Freedom is representing them to challenge the agency’s unlawful removal of critical safety standards for pregnant women and girls.
What is the Alliance for Hippocratic Medicine?
The Alliance for Hippocratic Medicine is a nonprofit membership organization representing nearly 30,000 health-care professionals. According to its mission statement, “The Alliance for Hippocratic Medicine (AHM) upholds and promotes the fundamental principles of Hippocratic medicine. These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing healthcare with the highest standards of excellence based on medical science.”
The Alliance for Hippocratic Medicine’s member organizations include major medical groups such as the American College of Pediatricians, the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical & Dental Associations.
Alliance Defending Freedom is representing all four of these organizations, as well as four individual doctors, against the FDA.
The FDA and mifepristone
This lawsuit is the culmination of decades-long efforts by ADF’s clients to hold the FDA accountable for its reckless actions. The FDA has spent the last decade removing what few protections were initially in place for abortion drugs.
Mifepristone was originally developed and tested by French pharmaceutical company Roussel Uclaf S.A. under the name RU-486. By 1990, the drug had become widely available in France.
Under pressure from President Bill Clinton’s administration, Roussel “donated” the U.S. patent for RU-486 to the Population Council, an organization founded by John D. Rockefeller III to address supposed world overpopulation. The Population Council conducted clinical trials in the U.S., then filed a new drug application with the FDA in March 1996.
In 2000, the FDA approved abortion drugs for use in the United States.
After the initial approval, the FDA began chipping away at the critical safety standards it had put in place for these drugs, putting women and girls in harm’s way.
In fact, chemical abortions are 50 percent more likely than surgical abortions to result in an emergency room visit within 30 days. According to the FDA’s own data, roughly one in 25 women who take abortion drugs will require emergency services. And the number of chemical abortion-related emergency room visits increased by over five hundred percent between 2002 and 2015. Women can face severe bleeding and life-threatening infections—requiring emergency medical treatment, surgeries, blood transfusions, and hysterectomies—as well as the inability to have future successful pregnancies.
As emergency room doctors, ADF’s clients have seen with their own eyes the disastrous consequences of the FDA’s recklessness.
The FDA removes critical safety standards
In 2016, the FDA dangerously reduced the number of in-person doctor visits from three to one, expanded who could prescribe and administer abortion drugs beyond licensed doctors, expanded the availability of abortion drugs from seven weeks of pregnancy to 10 weeks, and eliminated the requirement for prescribers to report all serious non-fatal complications from the drugs.
In April 2021, during the COVID-19 pandemic, the FDA eliminated the last meaningful safety standard. Based on incomplete and unreliable data, the agency removed the requirement that an abortion provider physically meet with the woman before giving her the abortion drugs, thus allowing for chemical abortions by mail and telemedicine. In December 2021, the FDA made this change permanent.
That’s why ADF attorneys filed a lawsuit challenging the FDA’s reckless actions on abortion drugs, which have endangered the health and safety of women and girls.
What’s at stake?
Women need to be able to trust medical professionals. The FDA betrayed women and girls when it removed its own safety standards that prioritized their health and well-being. After evading responsibility for years, it is time for the FDA to do what it is legally required to do: protect women and girls.
- 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 proceeds.
- 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 proceeds.
- 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. The Court will hear oral arguments on the removal of safety standards, but not the initial approval of the drug, in March 2024.