By:Hannah Zuckerman
Published on: May 4, 2023
In 2000, the U.S. Food and Drug Administration (“FDA”) approved the drug mifepristone (mifeprex).[1] Patients use mifepristone in conjunction with misoprostol to induce an abortion, which can be safer than a surgical abortion.[2]Access to mifepristone made abortion more accessible across the nation and made medication abortion the most common abortion method.[3] These drugs have also become the standard for treating miscarriages.[4]
On November 18, 2022, an anti-abortion coalition filed a lawsuit against the FDA in the Northern District of Texas that jeopardizes the FDA’s approval of mifepristone.[5] The complaint seeks an injunction of mifepristone’s approval on the grounds that the FDA exceeded its authority when it approved the drug and eased related Risk Evaluation and Mitigation Strategies (“REMS”).[6] If the plaintiffs prevail, the court will have interfered with the FDA’s authority in an unprecedented way, severely limiting access to essential health care for millions of individuals and stifling drug innovation generally.[7]
- The FDA’s Approval of Mifepristone Under Subpart H of the FDCA Was a Permissible Use of Agency Discretion
The complaint alleges that the FDA inappropriately approved mifepristone under Subpart H, a regulation of the Food, Drug, and Cosmetic Act (“FDCA”), because pregnancy is not an “illness.”[8] However, the FDA historically uses “illness” interchangeably with “disease” and “condition” when assessing whether a drug may seek approval via Subpart H.[9] Thus, the FDA’s approval of drugs to treat “conditions” under Subpart H is a permissible interpretation of its own regulations.[10] Nevertheless, the plaintiffs misrepresent pregnancy in the United States and the therapeutic benefits and safety of mifepristone. The complaint alleges that pregnancy rarely leads to complications that threaten the life of the mother or child.[11] However, data clearly shows that the U.S. disproportionately has the highest maternal mortality rate amongst developed nations.[12]
In 2007, Congress deemed drugs with elements to ensure safe use as having approved REMS, which included mifepristone.[13] The plaintiffs also do not dispute that mifepristone can be approved under the REMS framework.[14]Thus, the plaintiffs’ contentions that mifepristone was inappropriately approved under Subpart H are no longer relevant given that mifepristone shifted to the REMS framework because the drug included elements to ensure safe use.
- The FDA’s expansion of Mifepristone REMS was permissible under the FDCA
The plaintiffs also allege that the FDA deviated from its authority by expanding multiple mifepristone REMS.[15]Elements of contention include modifications to the original maximum gestational age limit, dosage and administration recommendations, in-clinic requirements, and provider licensing requirements.[16] However, the FDA may modify REMS after analyzing safety and efficacy data and determining that the REMS are not necessary to ensure that the drug’s benefits outweigh its risks.[17] The FDA repeatedly approved mifepristone REMS modifications following data supporting that the restrictions are not necessary to ensure that the drug’s benefits outweigh the risks.[18]
- The Approval of Mifepristone Does Not Violate the Comstock Act
The lawsuit also alleges that the FDA’s approval of mifepristone and the distribution of the drug via mail violates the Comstock Act.[19] The Comstock Act prohibits the mailing or conveyance of contraceptives and abortion items wherein the sender intends them to be used unlawfully.[20] The FDA asserts that the plaintiffs’ Comstock claim is untimely, not exhausted, and lacks merit. The Comstock Act does not impact the FDA’s safety and efficacy analysis, and the agency is not required to consider the Act when deciding whether to approve a drug.[21] Further, Congress’s failure to amend the Comstock Act accordingly shows an implicit endorsement of the interpretation.[22]
- The Plaintiffs Lack Standing
The plaintiffs lack standing to bring this claim because they do not have a cognizable, imminent, and irreparable injury that warrants injunctive relief.[23] Rather, the plaintiffs’ injury is merely speculative.[24] Comparatively, issuing a preliminary injunction would significantly harm millions of individuals by denying them access to a safe and effective drug that has been on the market for over two decades.[25] The FDA argues that the plaintiffs lack standing because the statute of limitations expired on many claims and the plaintiffs did not exhaust administrative remedies expressly articulated in the FDCA and the Administrative Procedure Act.[26] Further, the agency is owed deference regarding scientific analysis, and studies involving mifepristone showed that the benefits of the drug outweigh the risks.[27]
Congress enacted provisions in the FDCA that provide procedures regarding the approval and withdrawal of drugs from the U.S. market.[28] Included in these provisions are administrative and procedural safeguards for drug sponsors, such as withdrawal notice and opportunity for a hearing.[29] By enacting these provisions, Congress intended that the FDA maintain authority over the approval and withdrawal of drugs from the U.S. market.[30] Given that the majority of the plaintiffs’ claims are procedural in nature, the plaintiffs should be bound by administrative exhaustion requirements.[31] If the court orders an injunction, it would be the first time a court violates Congress’s intent by mandating that the FDA withdraw a drug from the U.S. market.[32]
Any day now, a single court in Texas could be responsible for removing an essential drug from the U.S. market. As discussed, such a ruling would be unprecedented in American jurisprudence and completely undermine the entire U.S. drug approval process, opening the door for other regulated products to be unjustly pulled from the U.S. market. If the Texas court orders an injunction, the appellate and supreme courts must rule to preserve the integrity of the courts and the U.S. drug approval process.
[1] See Defendants’ Opposition To Plaintiffs’ Motion For A Preliminary Injunction at 4, Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Admin., 2:22-CV-00223-Z, 1, 3 (2022) [hereinafter Defendants’ Opposition] (explaining the history of mifepristone).
[2] See id. at 4, 38.
[3] See Rachel K. Jones, et al, Medication Abortion Now Accounts for More Than Half of All US Abortions, Guttmacher Institute (February 2022), https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions .
[4] See Jessica Beaman, MD MPH, et al., Medication to Manage Abortion and Miscarriage, 35 J. Gen. Internal Med. 2398, 2398 (May 14, 2020).
[5] Complaint, Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Admin., 2:22-CV-00223-Z (2022) [hereinafter Complaint].
[6] Id. at 110.
[7] See Brief of Food and Drug Law Scholars as Amici Curiae in Support of Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction at 14, 19, Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Admin., 2:22-CV-00223-Z, (2022) [hereinafter Amici Brief for Defendants] (highlighting the negative impact on patient access and the health care industry industry that would result from withdrawing mifepristone from the U.S. market).
[8] Complaint at ¶ 50.
[9] See id. at ¶ 186(describing the language of subpart H); see also Amici Brief for Defendants at 6 (describing how illness, disease and condition became used interchangeably); see also 57 Fed. Reg. 58,942 (Dec. 11, 1992) (noting in the preamble for Subpart H that the FDA intended to apply the regulation to “conditions or diseases that can be serious. . .”).
[10] See 57 Fed. Reg. 58,942, (Dec. 11, 1992) (indicating that Subpart H applies to conditions and diseases); see also Chevron, U.S.A., Inc., v. Nat’l Resources Def. Council, Inc., 476 U.S. 837, 844 (1984) (holding that the court cannot overrule an agency’s reasonable interpretation of their governing statute).
[11] Complaint at ¶ 51.
[12] See Roosa Tikkanen, et al., Maternal Mortality and Maternity Care in the United States Compared to 10 Developed Countries, The Commonwealth Fund, (Nov. 18, 2020), see also Press Release, Racial and Ethnic Disparities Continue in Pregnancy-Related Deaths, CDC, https://www.cdc.gov/media/releases/2019/p0905-racial-ethnic-disparities-pregnancy-deaths.html (last reviewed Sept. 6, 2019) (finding that Black, American Indian, and Alaska Native women are two to three times more likely to die from pregnancy compared to white women).
[13] See Amici Brief for Defendants at 6 (explaining that Congress enacted the FDAAA which shifted drugs under Subpart H to the REMS regulatory framework).
[14] Defendants’ Opposition at 26.
[15] Complaint at ¶ 197.
[16] Id.
[17] 21 U.S.C.A. § 355-1 (g).
[18] See Defendants’ Opposition at 4-7, 23 (noting that the FDA analyzed safety and efficacy data prior to approving a supplemental New Drug Application for Mifeprex in 2016 that altered the drug’s indication, lableing, and REMS for mifepristone. During the Covid-19 pandemic, the FDA exercised discretion by not enforcing the in-person dispensing requirement; the agency approved a supplemental application modifying this REMS requirement January 2023).
[19] Complaint at ¶ 15-17.
[20] Defendants’ Opposition at 29; 18 USCA § 1461.
[21] Defendants’ Opposition at 28-29.
[22] See id. at 29 (noting Congress did not amend the Comstock Act after federal courts ruled the Act did not prohibit mailing contraceptives or abortion products).
[23] See id. at 1, 31-32.
[24] Id. at 1, 8-16.
[25] See id. at 38-39 (noting the detrimental impacts that would result from removing mifepristone from the market).
[26] Id. at 16-17; Amici Brief for Defendants at 14.
[27] See Defendants’ Opposition at 21-24, 33-38 (defending the agency’s authority to review scientific data).
[28] 21 USCA §§ 301–392; Amici Brief for Defendants at 16.
[29] Amici Brief for Defendants at 15-18.
[30] Id. at 16.
[31] Defendants’ Opposition at 8; Amici Brief for Defendants at 18.
[32] Amici Brief for of Defendants at 19.