Last week the Supreme Court heard oral arguments in FDA v. Alliance for Hippocratic Medicine. This case arose out of a challenge to the FDA’s authorization of mifepristone, one of the two drugs currently approved for use in medication abortions. The Supreme Court considered two issues: first, whether the respondents had Article III standing to challenge the FDA’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use, and second, whether the “FDA’s 2016 and 2021 actions were arbitrary and capricious.”[1] In 2016, the FDA loosened restrictions around the authorization and use of mifepristone, including eliminating the requirement for prescribers to report all nonfatal serious adverse events, extending the period in which it can be used from 7 weeks to 10 weeks, eliminating the requirement that administration of mifepristone occurs in-clinic, removing the requirement for an in-person follow-up exam, and allowing healthcare providers other than physicians to dispense chemical abortion drugs.[2] In 2021, the FDA removed the requirement that mifepristone be prescribed and dispensed in person.[3]
Almost the entirety of the hour-and-a-half oral argument focused on the whether the respondents had standing, highlighting many Justices’ concerns over the issue. The respondents, Alliance for Hippocratic Medicine (“the Alliance”), describe themselves as “four national medical associations and four doctors experienced in caring for pregnant and post-abortive patients … seek[ing] to protect women and girls from the documented dangers of chemical abortion drugs.”[4] The Alliance’s theory of injury seems to be too attenuated for many of the Justices liking, resting on a “long chain of remote contingencies.”[5] Specifically, their theory of injury is that although these doctors are not required to prescribe mifepristone, they might someday have to treat a woman who was prescribed mifepristone by someone else and ended up in an emergency room with complications that would require a doctor with a conscience objection to abortion to participate in the procedure.[6] Jessica Ellsworth, arguing on behalf of Danco, the manufacture of mifepristone, offered a practical consideration for why standing is not appropriate for the Alliance: If mifepristone really were a dangerous drug, the FDA, and especially Danco Labs, would have certainly been sued in product liability litigation.[7] Notwithstanding the fact that complications arising from mifepristone use are very rare (2.9 – 4.6% of women who take the drug seek treatment in an ER),[8] the existence of federal protections for conscious objections diminishes respondents’ assertion of an imminent injury.[9] The Alliance failed to identify a single doctor that had actually had actually exercised their conscious objection right and was forced to treat a woman suffering complications from mifepristone anyway.[10] Justice Kagan pressed Erin Hawley, the attorney who argued on behalf of the Alliance, on this issue and asked her to give an example of a plaintiff that actually could meet traditional standing requirements.[11] Hawley pointed to a declaration by a doctor who said that she had been required to perform a procedure known as a dilation and curettage (D&C), which removes tissue from the uterus, “which she was required to perform due to a life-threatening emergency.”[12] But in response to further questions, Hawley conceded that the doctor had not actually objected to performing the procedure.[13]
Justice Gorsuch seemed particularly cornered about size of the remedy, since finding for the Alliance would lead to a nationwide injunction that barred anyone from prescribing mifepristone.[14] Justice Jackson explained this quite well during the argument, highlighting the “significant mismatch . . . between the claimed injury and the remedy that’s being sought.”[15]: She noted that the challengers argue that they suffer a “conscience injury, that they are being forced to participate in a medical procedure that they object to.”[16] The “obvious common-sense remedy,” Jackson continued, “would be to provide them with an exemption,” but they already have that and are instead “seeking an order preventing anyone from having access to these drugs at all. And I guess I’m just trying to understand how they could possibly be entitled to that.”[17]
The conservative majority appeared highly skeptical of the Alliance’s standing theory despite expressing open hostility to both the administrative state and abortion access.[18] The difference in outcome may lie in the unique position the FDA holds in American life. A number of amicus briefs warned that reversing the FDA’s authorization of the drug on the grounds of safety and efficacy would discourage investment in drug research and development and ultimately cost American lives.[19] Ruling in the Alliance’s favor threatens to stifle pharmaceutical innovation by disrupting industry’s expectations in the settled regulatory framework and, fortunately, the Supreme Court seems hesitant to do so on the grounds of an untenable claim to standing.
[1] Brief of Petitioner-Appellant at i, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024)
[2] Id. at 5-7.
[3] All. for Hippocratic Med. v. U.S. Food & Drug Admin., 668 F. Supp. 3d 507, 522 (N.D. Tex. 2023).
[4] Complaint at 8, All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-CV-223-Z, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023).
[5] Transcript of Oral Argument at 5, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024).
[6] Id. at 60.
[7] Id. at 54.
[8] Brief of American College of Obstetricians and Gynecologists, supporting Petitioner at X, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024).
[9] Transcript of Oral Argument at 34, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024).
[10] Id. at 75.
[11] Transcript of Oral Argument at 75.
[12] Id. at 77.
[13] Id.
[14] Id. at 70.
[15] Id. at 42.
[16] Id.
[17] Id. at 42-43 (emphasis added).
[18] See Dobbs v. Jackson Women’s Health Organization, 19-1392, 597 US _ (2022) (holding that the U.S. Constitution does not protect a right to abortion); See generally John Kruzel, How is the ‘war on the administrative state’ faring at the Supreme Court, Reuters (Jan. 19, 2024), https://www.reuters.com/legal/how-is-war-administrative-state-faring-supreme-court-2024-01-19/; Ilya Shapiro, The Supreme Court Takes on The Administrative State, Manhattan Institute (Feb. 15, 2024), https://manhattan.institute/article/the-supreme-court-takes-on-the-administrative-state.
[19] See Brief of Pharmaceutical Companies, Supporting Petitioner, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024); Brief of Pharmaceutical Research and Manufacturers of America, Supporting Petitioner, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024); Brief of Pharmaceutical Companies, Executives, Supporting Petitioner, U.S. Food & Drug Admin. v. All. For Hippocratic Med., Nos. 23-235, 23-236 (2024).
Comments