What You Need to Know About the Alliance for Hippocratic Medicine v. FDA Supreme Court Case

Background on The Case

• Months after Roe v. Wade was overturned in 2022, a newly formed group called the Alliance for Hippocratic Medicine sued the FDA for its approval of mifepristone, a drug that is used in nearly two thirds of all abortions nationally  
• On March 26, 2024, the same Supreme Court justices who undid the abortion protections afforded by Roe heard arguments about tightening access to medication abortion  
• Many people are watching this case to see whether the Court will block the FDA’s independence in determining the conditions required to assure drug safety, in addition to the impact on abortion access  

Arguments of the Case

• The Alliance for Hippocratic Medicine argues two points: 

• • Originally, they argued that the FDA should not have approved mifepristone in 2000 during the initial trial in the Fifth Circuit 
  • Now, they’re arguing that the FDA should not have made access to mifepristone easier in 2016 and 2021  
• The FDA and drugmaker Danco argue that the challengers aren’t harmed by the prescribing rules and that the FDA followed correct procedure and scientific evidence in its decision making  
• The Supreme Court denied the plaintiff’s appeal that requested the Court to review the FDA’s original approval of mifepristone from 2000 from the initial case and instead is considering two things:  
  • Whether the plaintiffs have standing to bring the case forward 
  • Whether the FDA’s 2016 and 2021 actions to revise the Risk Evaluation and Mitigation Strategies (REMS) and other conditions are arbitrary and capricious  

What’s at Stake

• Access to Medication Abortion

  • At least 63% of all abortions in 2023 were medication abortions, which require one dose of mifepristone (blocks progesterone) and one dose of misoprostol (causes cramping and empties uterus)
  • The Fifth Circuit ruled that the FDA should roll back its prescribing rules to the 2011 regulations – this would lead to a dramatic decrease in the number of people who are able to access the medication
    • This would lead to a shutdown of telemedicine access and undo retail pharmacies’ new ability to dispense it
    • It would be made it available up to seven weeks of pregnancy, instead of the current 10 weeks
      • Roughly half of medication abortions happen after seven weeks since the earliest someone might find out they are pregnant is at four weeks
    • Many abortion providers are prepared to switch to a misoprostol-only regimen, however it requires more doses and may come with more side effects

• Miscarriage Care & Other Health Issues

  • When someone has a miscarriage, doctors often prescribe the mifepristone + misoprostol regimen
  • In addition to abortion and miscarriage management, mifepristone is also used for treatment of Cushing’s syndrome, uterine fibroids, and endometriosis

• Interference of State Sovereignty

  • The ruling to limit access to mifepristone would extend to states that have attempted to protect access to medication abortion
    • 22 Democratic governors filed an amicus brief arguing that the use of federal courts to override the FDA’s judgment would set an “enormously disruptive” precedent and have a negative impact on state governments

• Destabilization of the Drug Industry

  • Drugmakers are worried about what this case could mean for the FDA’s regulatory process for other medications, not just mifepristone
    • Hundreds of drug company executives signed a letter last year in support of FDA’s authority to regulate medications without judicial interference
    • Many believe that this case sets precedent that allows groups or individuals to push back against the FDA approval process because they “don’t like the way the FDA handled it”

• A Path to a National Abortion Ban

  • • There is a built-in possibility in this case that the Comstock Act is going be reinstated as an abortion ban
      • • The Comstock Act is a 19^th century law that prohibited the mailing of “indecent” or “immoral” items. Rules in this act could include not only abortion pills, but birth control and any equipment that is used for any type of abortion
    • The plaintiffs of this case use Comstock as one of their arguments, and if the Court agrees with their understanding of the now-defunct law, the risk of a total abortion ban is high

Today’s Arguments

• The arguments today were by:
  • Solicitor General Elizabeth B. Prelogar, on behalf of the Biden administration
  • Jessica L. Ellsworth, on behalf of Danco (the drug manufacturer behind the brand name version of mifepristone, Mifeprex)
  • Erin Hawley, wife of Sen. Josh Hawley (R-Mo) and senior counsel at the Alliance Defending Freedom, representing the Christian legal group challenging access to mifepristone
• The oral arguments and questions focused more on the topic of standing, rather than the FDA’s decisions to lift restrictions regarding access to mifepristone
  • Standing refers to whether or not the group challenging the law actually faces harm from it and thus can sue
• Restricting access to mifepristone could open the floodgates to other negative effects, such as severely disrupting the federal system for developing and approving drugs
  • This would harm the FDA and pharmaceutical industry, as well as women across the nation

What’s Next?

• The Supreme Court Justices will issue a decision on the case, typically by the end of June, though it may come earlier or later
• The National Women’s Health Network will continue to closely monitor the Alliance for Hippocratic Medicine v. FDA case and will continue to track and release updates on this case