On March 26, 2024, the Supreme Court heard oral arguments for U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine which involves Food and Drug Administration (“FDA”) regulations of mifepristone, a drug that induces abortion.[1] The case raises questions about the future of abortion access throughout the U.S. and, more broadly, the ability of courts to review and limit the FDA’s expert decision-making and regulating.[2] During the oral arguments, two Justices were focused on a long-dormant law that could be used to ban abortion nationally with no action from congress: The Comstock Act.[3]
The Comstock Act is an anti-obscenity law originally passed in 1873.[4] Section 2 of the original Act, now codified as 18 U.S.C. § 1461, provides that “[e]very article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use . . . shall not be conveyed in the mails or delivered from any post office or by any letter carrier.”[5] Despite the broad impact implied by the plain text of this section, the law has historically been construed narrowly.[6] By the mid-1900s, the judiciary, legislature, and U.S. Postal Service reached a consensus interpretation: Section 1461, and the Comstock Act as a whole, does not “prohibit[] a sender from conveying [prohibited] items where the sender does not intend that they be used unlawfully.”[7] The Biden Administration, in a 2022 memorandum from the Office of Legal Counsel, detailed this history and underscored that the Administration does not consider the Act to limit the lawful distribution of medication abortion, even in areas that restrict abortion access.[8]
The plaintiffs in Alliance for Hippocratic Medicine argue that the FDA’s 2021 decision not to enforce mifepristone in-person dispensing requirements violated the Comstock Act by “authoriz[ing] the widespread mailing and shipping of abortion drugs.”[9] The District Court for the Northern District of Texas found this position persuasive, determining, in part, that the 2021 decision violated the plain text of the Comstock Act.[10] While the merits of the Comstock Argument are not formally in front of the Supreme Court and the Fifth Circuit did not rule on the Comstock Act arguments, Justice Alito’s and Justice Thomas’ inquiries during oral arguments indicate that some members of the Supreme Court may issue opinions that reach the merits of these arguments.[11] The FDA fielded Justice Alito’s implication that the agency should have considered Comstock in its 2021 decision by maintaining that it is not authorized to account for other laws when modifying such regulations.[12] Justice Thomas asked mifepristone manufacturer Danco Laboratories, before the court as an intervenor-appellant on behalf of the FDA,[13] to respond to an argument that it faces a “Comstock problem” in shipping its product.[14] Danco underscored that the issue was not presented below and noted that the Act “has not been enforced for nearly a hundred years.”[15] Plaintiffs, however, countered that the “plain text” of the Comstock Act is “pretty clear.”[16]
Even if Alliance for Hippocratic Medicine is dismissed for lack of standing, the Comstock Act could spell danger for abortion access in every state.[17] As the law is presently enacted, a presidential administration amenable to a different interpretation of the Act could enact a nationwide abortion ban.[18] Likewise, a purely textualist interpretation of section 2 from the Supreme Court could have the same effect.[19] Therefore, the best safeguard against a national ban would be for Congress to remove “abortion” from the Comstock Act.[20] Such congressional action would not only resolve questions about the liabilities and responsibilities of the federal agencies regarding the mailing of all abortifacients, but it would also preclude any imposition of liability on private citizens and physicians.[21]
Access to safe abortions—and abortion medication—is access to healthcare.[22] Thus, repealing the abortion provisions of the Comstock Act is a crucial measure in furthering public health and safety.[23] Such legislative action would further be representative of the American public’s opinion, as 61 percent of Americans believe that abortion should be legal in all or most cases.[24]
[1] Transcript of Oral Argument at 1, U.S. Food & Drug Admin. v. All. for Hippocratic Med., Nos. 23-235, 23-236 (U.S. argued Mar. 26, 2024); All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210, 222 (5th Cir. 2023).
[2] This essay focuses narrowly on the Comstock Act in the context of this case. It is crucial to note, however, that a decision invalidating the FDA’s actions could stand to destabilize the regulatory state and the availability of beneficial medications. See Wendy Parmet, Abortion Case Could Harm Womens’ Health and Upset Pharma Markets, Bʟᴏᴏᴍʙᴇʀɢ L. (Mar. 26, 2024, 4:30 AM), https://news.bloomberglaw.com/us-law-week/abortion-case-could-harm-womens-health-and-upset-pharma-markets (discussing the Supreme Court’s recent reticence to afford administrative agencies deference as an “effort to dismantle the regulatory state” and noting that by disregarding the FDA’s scientific conclusions, “the Fifth Circuit opened the door to a judge withdrawing any drug based on their own non-expert opinion that some non-existent study might be helpful”).
[3] Madlin Mekelburg, Abortion Pill Fight Isn’t Over. Foes Look to 1873 Obscenity Law, Bloomberg L. (Mar. 26, 2024, 4:24 PM), https://www.bloomberg.com/news/articles/2024-03-26/abortion-pill-fight-isn-t-over-foes-look-to-1873-obscenity-law. See generally Parmet, supra note 2; Bᴇᴄᴄᴀ Dᴀᴍᴀɴᴛᴇ & Kɪᴇʀʀᴀ B. Jᴏɴᴇs, Cᴛʀ. ғᴏʀ Aᴍ. Pʀᴏɢʀᴇss, A Yᴇᴀʀ Aғᴛᴇʀ ᴛʜᴇ Sᴜᴘʀᴇᴍᴇ Cᴏᴜʀᴛ Oᴠᴇʀᴛᴜʀɴᴇᴅ Rᴏᴇ ᴠ. Wᴀᴅᴇ, Tʀᴇɴᴅs ɪɴ Sᴛᴀᴛᴇ Aʙᴏʀᴛɪᴏɴ Lᴀᴡs Hᴀᴠᴇ Eᴍᴇʀɢᴇᴅ (2023), https://www.americanprogress.org/article/a-year-after-the-supreme-court-overturned-roe-v-wade-trends-in-state-abortion-laws-have-emerged/#:~:text=After%20Dobbs%20was%20decided%2C%20states,public%E2%80%94on%20what%20law%20controls (detailing a concerted effort to restrict abortion in many states).
[4] Mekelburg, supra note 3; Celine Castronuovo, Anti-Abortion Groups Defend Century-Old Mailing Law in Pill Case, Bloomberg L. (Mar. 18, 2024, 5:05 AM), https://news.bloomberglaw.com/health-law-and-business/anti-abortion-groups-defend-century-old-mailing-law-in-pill-case.
[5] 18 U.S.C. § 1461 (setting forth penalties and imprisonment for transgressors); Memorandum from Christopher H. Schroeder, Assistant Attorney General, Office of Legal Counsel, to General Counsel, U.S. Postal Service 3 n.6 (Dec. 23, 2022).
[6] Memorandum from Christopher H. Schroeder, supra note 5, at 5; Dan Diamond, Alito and Thomas Kept Bringing Up Comstock. That Scared Abortion Rights Supporters, Wash. Post (Mar. 26, 2024, 6:40 PM), https://www.washingtonpost.com/health/2024/03/26/comstock-act-supreme-court-abortion-pill (“[The Comstock Act has] always been narrowly interpreted.”) (internal quotes omitted); Brief of Petitioner-Appellant at 31, U.S. Food & Drug Admin. v. All. for Hippocratic Med., Nos. 23-235, 23-236 (U.S. filed Mar. 15, 2024) (“The [year after enactment], Congress clarified that the importation restriction, like the federal-territory restriction, was limited to drugs for “causing unlawful abortion.”).
[7] Memorandum from Christopher H. Schroeder, supra note 5, at 5 (“On several occasions, Congress reenacted and amended the Comstock Act against the backdrop of the judicial precedent in a manner that ratified the federal courts’ narrowing construction.”). Notably, many of these interpretations involved the Act’s prohibitions on contraceptives, provisions that were later repealed by Congress. Castronuovo, supra note 5.
[8] Memorandum from Christopher H. Schroeder, supra note 5, at 20-21 (“[I]n light of the many lawful uses of mifepristone and misoprostol, the fact that these drugs are being mailed to a jurisdiction that significantly restricts abortion is not a sufficient basis for concluding that the mailing violates section 1461.”). Note, misoprostol is used for medication abortion. Id. at 1.
[9] Brief of Respondent-Appellee at 77-78, U.S. Food & Drug Admin. v. All. for Hippocratic Med., Nos. 23-235, 23-236 (U.S. filed Feb. 22, 2024).
[10] All. for Hippocratic Med. v. U.S. Food & Drug Admin., 668 F. Supp. 3d 507, 539-543 (N.D. Tx. 2023), vacated in part, aff’d in part, 78 F.4th 210 (5th Cir. 2023), cert. granted, 144 S. Ct. 537 (2023) (issuing a preliminary injunction removing mifepristone from the market). The district court also found that the Plaintiffs had third-party standing, as they were “within the zone of interests of the Comstock Act.” Id. at 530. The district court’s preliminary injunction was later stayed by the Supreme Court, pending review. Danco Lab’ys., L.L.C. v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023).
[11] All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210 (5th Cir. 2023); Transcript of Oral Argument, supra note 1, at 26-28, 47-49, 90-91; Castronuovo, supra note 4; Diamond, supra note 6 (“The Supreme Court may be about to hand [anti-abortion activists] a legal roadmap [to resurrecting the Comstock Act].”); Mekelburg, supra note 3 (“[A]bortion opponents could revive the argument in a future case, particularly if Alito and Thomas signal they are receptive.”). Justice Alito, addressing the Solicitor General, stated: “Shouldn’t the FDA have at least considered the application of 18 U.S.C. 1461?” Transcript of Oral Argument, supra note 1, at 26. Justice Thomas, addressing counsel for Danco Laboratories, L.L.C., asked, “[H]ow do you respond to an argument that mailing your product and advertising it would violate the Comstock Act?” Id. at 48.
[12] Id. at 26-28 (noting that the FDA does not consider the 2021 provision to affirmatively approve mailing). In its brief, the FDA also argued that the Comstock Act only bars items “intended for unlawful use.” Brief of Petitioner-Appellant, supra note 6, at 31.
[13] All. for Hippocratic Med., 78 F.4th at 222.
[14] Transcript of Oral Argument, supra note 1, at 47-48.
[15] Id. at 48-49.
[16] Id. at 90.
[17] Castronuovo, supra note 4.
[18] Id.; Diamond, supra note 6.
[19] See generally Nisha Shetty, Dueling Abortion Pill Rulings Ripe for Supreme Court Fight, Bʟᴏᴏᴍʙᴇʀɢ L. (May 11, 2023, 11:51 AM), https://www.bloomberglaw.com/bloomberglawnews/health-law-and-business/XE452HKC000000?bna_news_filter=health-law-and-business#jcite.
[20] Id.; Castronuovo, supra note 4. Congress similarly repealed the Act’s ban of contraception in the 1970s. Shetty, supra note 19; Memorandum from Christopher H. Schroeder, supra note 5, at 16.
[21] See generally Memorandum from Christopher H. Schroeder, supra note 5, at 6, 15-16.
[22] Amy Roeder, The Negative Health Implications of Restricting Abortion Access, Hᴀʀᴠ. T.H. Cʜᴀɴ Sᴄʜ. ᴏғ Pᴜʙ. Hᴇᴀʟᴛʜ (Dec. 13, 2021), https://www.hsph.harvard.edu/news/features/abortion-restrictions-health-implications (citing the significant health risks of pregnancy and high death rates that result from unsafe abortions); Annalies Winny, Alissa Zhu, & Lindsay Smith Rogers, Public Health in the Field: The Public Health Case for Abortion Rights, Johns Hopkins Bloomberg Sch. of Pub. Health, https://publichealth.jhu.edu/2021/public-health-in-the-field-the-public-health-case-for-abortion-rights (explaining that women who seek and cannot obtain abortions experience higher levels of domestic abuse and more serious health issues; noting that restrictive abortion laws result in higher rates of abortion-related maternal deaths); Parmet, supra note 2 (noting that mifepristone is also used by doctors “off-label” for the treatment of uterine fibroids, endometriosis, and miscarriage).
[23] Castronuovo, supra note 4; Parmet, supra note 2; Winny, Zhu, & Rogers, supra note 22.
[24] Pᴇᴡ Rsᴄʜ. Cᴛʀ., Pᴜʙʟɪᴄ Oᴘɪɴɪᴏɴ ᴏɴ Aʙᴏʀᴛɪᴏɴ (2022).