FDA Avoids Accountability After Supreme Court Ruling

The Food and Drug Administration (FDA) is a government agency with broad regulatory authority affecting 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 abandoning the critical safety standards it originally deemed necessary when it approved the abortion drug mifepristone in 2000.

Alliance Defending Freedom represented doctors and medical associations who stood up to challenge the FDA’s unlawful removal of commonsense safeguards for abortion drugs. And while the Supreme Court declined to address the FDA’s reckless actions for now, it did affirm that “[f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.”

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 represented all four of these organizations, as well as four individual doctors, against the FDA.

The FDA and mifepristone

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.

For 16 years the FDA maintained its commonsense safety standards for women using abortion drugs. But in 2016, the FDA began abandoning the critical protections 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 end up in the emergency room. 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 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, based on incomplete and unreliable data, the FDA eliminated the only remaining in-person visit that ensured women do not have ectopic pregnancies or other life-threatening conditions before taking abortion drugs. This allowed 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, which have endangered the health and safety of women and girls.

Supreme Court affirms conscience protections

Unfortunately, the Supreme Court’s June 2024 opinion declined to address the FDA’s reckless removal of safety standards for abortion drugs. However, three states have already intervened in lower courts and stand ready to hold the FDA accountable.

The Supreme Court also provided a notable win for the conscience rights of medical professionals. At the beginning of this case, the government argued that federal law would not protect our doctors from being forced to participate in elective chemical abortions. But at the Supreme Court, the government changed its position and said that federal conscience laws definitively protect doctors in these circumstances. This about-face helps explain why the Supreme Court parted ways with every other court to consider this case. And it resulted in the Court’s recognizing that “[f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.”

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

• 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.