On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The stay preserves access to mifepristone as the Biden administration and Danco Laboratories, the drug’s manufacturer, appeal a lower court ruling that would greatly limit the availability of the drug.[1]
The FDA originally approved mifepristone in 2000.[2] Initially, mifepristone was approved for medical abortion during the first seven weeks of pregnancy.[3] Danco obtained FDA approval in 2016 for use of the drug through the first ten weeks of gestation.[4]
Alliance for Hippocratic Medicine v. FDA was filed by anti-abortion groups seeking to remove mifepristone from the market. On April 7, 2023, Texas federal district Judge Kacsmaryk granted a motion for preliminary injunction against Danco and the FDA, staying FDA approval of mifepristone, including the original 2000 approval, the 2016 change, and subsequent generic approval.[5] The preliminary injunction also barred mailing of mifepristone, based on the Comstock Act.[6]
On the same day as the Texas federal judge ruling, federal district Judge Rice in Washington issued a preliminary injunction preventing the FDA from altering approval of mifepristone.[7] An additional case was filed in Maryland District Court by GenBioPro, a manufacturer of generic mifepristone, arguing that even if the order in Alliance for Hippocratic Medicine v. FDA were to take effect, FDA cannot change availability of the generic mifepristone without first following the statutory and regulatory processes for withdrawing an approved drug application.[8]
Judge Kacsmaryk’s preliminary injunction was appealed to the Fifth Circuit. The Fifth Circuit reduced the scope of the district court’s preliminary injunction, overturning Judge Kacsmaryk’s stay with respect to the 2000 approval because the plaintiffs had failed to timely challenge.[9] The Fifth Circuit allowed Judge Kacsmaryk’s stay with respect to the 2016 change and generic approval.[10] This decision was further appealed to the Supreme Court.
The Supreme Court did not explain its reasoning for issuing its stay of the district court’s decision.[11] Justices Thomas and Alito dissented. In his dissent, Justice Alito asserted that Danco had failed to show that it would suffer irreparable harm from the district court’s decision and criticized the majority for failing to explain its reasoning.[12]
According to some commentators, the possibility that a single judge could undo FDA approval is “destabilizing” for pharma companies.[13] Further, the uncertainty presented by back-to-back conflicting ruling by federal judges about access to a drug, paired with the high cost of bringing a new drug to market, may result in uncertainty for the future of health care in the country.
[1] Danco Lab’ys, LLC v. All. for Hippocratic Med., 2023 U.S. LEXIS 1670, 2023 WL 3033177 (April 21, 2023).
[2] Approval Letter — Mifeprex (Mifepristone) Tablet, FDA (September 28, 2000). (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf).
[3] See id.
[4] Supplemental Approval Letter — Mifeprex (Mifepristone) Tablet, FDA (March 28, 2016) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf).
[5] All. for Hippocratic Med. v. FDA, 2023 U.S. Dist. LEXIS 61474 at *96, 2023 WL 2825871 at *32 (N.D. Tex. April 7, 2023) (no. 2:22-CV-223-Z).
[6] Id, 2023 U.S. Dist. LEXIS 61474 at *45–46 and *54, 2023 WL 2825871 at *16 and *19 (“The Comstock Act declares ‘[e]very obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance’ to be ‘nonmailable matter’ that ‘shall not be conveyed in the mails or delivered from any post office or by any letter carrier.’”).
[7] State of Washington v. FDA, No. 1:23-cv-03026 (E.D. Wash. April 7, 2023).
[8] GenBioPro, Inc. v. FDA, No. 1:23-cv-01057-SAG (D. Md. April 19, 2023).
[9] All. for Hippocratic Med. v. FDA, 2023 US. App. LEXIS 8898 at *40–41, 2023 WL 2913725 at *15, (5th Cir. April 12, 2023).
[10] Id.
[11] See Danco Lab’ys, LLC v. All. for Hippocratic Med., 2023 U.S. LEXIS 1670, 2023 WL 3033177 (April 21, 2023).
[12] See id, 2023 U.S. LEXIS 1670 at *1 and *3, 2023 WL 3033177 at *1.
[13] See Katherine Eban, “They’re Winning”: How the Mifepristone Case Could Sabotage the FDA, Vanity Fair (April 13, 2023) (https://www.vanityfair.com/news/2023/04/mifepristone-abortion-ban-fda).
