What’s at Stake in the U.S. Supreme Court in FDA v. Alliance for Hippocratic Medicine?

By: Carrie Flaxman, JD and Skye Perryman, JD 

By now, you’ve likely heard about the lawsuit challenging the Food and Drug Administration's (FDA) approval of mifepristone that was filed soon after the U.S. Supreme Court overturned Roe. After a whirlwind period last April when the U.S. Supreme Court took action to block an order from Texas federal Judge Matthew Kacsmaryk that would have stayed the drug’s approval, the case is now back at the nation’s highest court. Oral arguments are scheduled for March 26 at 10 am and can be heard through the Supreme Court’s website.  

During oral arguments, the Court will hear from a Department of Justice attorney representing the FDA; an attorney for Danco Laboratories, LLC, the manufacturer of the brand medication Mifeprex; and an attorney from the extremist law firm Alliance Defending Freedom (ADF) representing the plaintiff group, Alliance for Hippocratic Medicine. ADF, a Southern Poverty Law Center-designated hate group, was behind the Mississippi abortion ban upheld in Dobbs. The Alliance for Hippocratic Medicine, meanwhile, was incorporated in Amarillo, Texas, mere months before the case was filed by representatives of the anti-abortion American Association of Pro-Life OB/GYNs and the Christian Medical and Dental Society.   

The Court will primarily consider two issues.  

First, the Court will consider whether the plaintiffs, who are physicians opposed to abortion who do not provide abortions themselves, have “standing” (i.e., legal injury that allows them to sue). They claim they have standing because patients who have taken mifepristone might come to them experiencing complications, requiring the plaintiffs to provide care. This claim is based on junk science. Abortion opponents falsely claim that mifepristone is unsafe; indeed, the publisher of two of the studies relied on by Judge Kacsmaryk recently retracted them because of “undeclared conflicts of interest and after expert reviewers found that the studies demonstrate a lack of scientific rigor.”  

Second, the Court will consider whether the FDA was wrong to alter mifepristone’s approved conditions of use in 2016 and to eliminate the requirement that the drug be dispensed in person in 2021. (Although Judge Kacsmaryk would have suspended the approval of mifepristone altogether, the Fifth Circuit Court of Appeals disagreed with him, and the Supreme Court did not take up that part of the plaintiffs’ original claims.) 

The stakes are high. As the Department of Justice has stated, if the Supreme Court rules for the plaintiffs, “it would upend the regulatory regime for mifepristone, with disruptive consequences for FDA, mifepristone’s sponsors, and women who need access to the drug.” Among other consequences, patients would no longer be able to obtain mifepristone through the mail or at certified pharmacies, and providers would be forced to observe restrictions that FDA concluded were unnecessary after exercising its scientific judgment. Indeed, this case marks the first time that any court has taken action to “[restrict] access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”  

The threats this case pose to abortion as well as to the drug approval system as a whole are highlighted by the unprecedented showing of amicus (“friend of the court”) briefs for the FDA. SMFM joined ACOG, AMA and other national medical organizations on a brief that highlighted the safety of mifepristone and the importance of access. Other briefs were filed by: GenBioPro (the manufacturer of generic mifepristone); hundreds of pharmaceutical companies and executives and pharmaceutical-industry associations and investors sounding the alarm about the impact on the stability of the drug industry; the Pharmaceutical Research and Manufacturers of America (PhRMA); 263 Members of Congress; provider and patient advocacy groups; former military officials explaining to the Court how critical access to medication abortion is for military readiness; and many others.  

A decision could come in the case at any time after oral argument, but it is expected by late June.  

Carrie Flaxman, JD, is a Senior Legal Advisor and Skye Perryman, JD, is President and CEO at Democracy Forward. Democracy Forward is a national legal organization that advances democracy and social progress through litigation, policy and public education, and regulatory engagement. 

For more information about this case, SMFM’s advocacy efforts to expand access to mifepristone, and clinical resources related to medication abortion, visit SMFM.org/mife.