Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration

Bryant Godfrey & Tina Papagiannopoulos*

I. Why This Case Made the List

Mifepristone has been available in the United States as part of an approved medication abortion regimen for over twenty years. In an unprecedent decision, a Texas district court granted a motion for summary judgment filed by anti-abortion activists, who asked the court to suspend virtually all of the U.S. Food and Drug Administration’s (FDA’s) decisions and actions with respect to the drug’s approval. The Texas court’s order caught nationwide attention because of its sweeping implications on access to abortion across the country—including in states and under circumstances where abortion is legal—and because of the ruling’s broader implications on FDA’s authority as an expert agency that has been entrusted by Congress to make drug approval decisions based on scientific grounds.

The case was appealed to the Fifth Circuit, which overturned the Texas court’s ruling with respect to the drug’s original approval but affirmed the portions of the district court’s decision that would negate subsequent changes to the FDA’s approval regarding the drug’s conditions of use and administration. If these changes take effect, access to this regimen will be available only through in-person administration, and only to women whose pregnancy has not progressed beyond seven weeks of gestational age.

The Fifth Circuit’s decision is now pending before the Supreme Court. According to the government, “[T]his case marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s use.”[1] The pharmaceutical and biotechnology industries have been following this case with anticipation and have cautioned the Court that upending the drug approval process in the manner suggested by the lower courts would have devastating ripple effects on research and investment in innovative therapies.

Oral arguments were held on March 26, 2024, and a decision is expected by the end of June.

II. Summary of the Case

The regulatory status of mifepristone hangs in the balance pending a Supreme Court appeal of decisions made by a federal court in Texas and the Fifth Circuit Court of Appeals in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.[2] Mifepristone is the first part of a two-drug regimen, which has been legally prescribed by physicians for use with misoprostol since 2000 for the medical termination of early pregnancy.

The case was brought in November 2022 by four anti-abortion medical organizations, the Alliance for Hippocratic Medicine (AHM), American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), American College of Pediatricians (ACOP), and Christian Medical & Dental Associations (CMDA) on behalf of themselves, their members, and their patients, and four individual doctors on behalf of themselves and their patients. Plaintiffs filed a motion for a preliminary injunction in the U.S. District Court for the Northern District of Texas, naming the U.S. Food and Drug Administration (FDA), the FDA Commissioner and other top officials, the U.S. Department of Health and Human Services (HHS), and the HHS Secretary as defendants. The motion asked the court to overturn virtually all of FDA’s reviews and actions with respect to mifepristone since 2000—which would render the product an unapproved drug—and essentially disregard the federal drug approval regime that has long relied on FDA’s scientific expertise in making approval decisions. Allegations in the complaint challenge the procedural integrity of FDA’s review process as well as the underlying safety and effectiveness data relied upon by FDA to approve mifepristone in 2000 and subsequent changes to the labeling and conditions of use.

The defendants’ opposition to the motion for preliminary injunction refuted the allegations of procedural inadequacies, explained FDA’s authority to review and approve drugs as mandated by Congress, and detailed the extensive twenty-three-year history of safety and effectiveness data supporting all of FDA’s actions regarding the use of mifepristone.

Numerous amicus curiae briefs have been filed in support of both sides. For example, amicus briefs were filed in the district court by twenty-two states and several organizations in support of the plaintiffs’ motion.[3] Amicus briefs in support of FDA, filed by twenty-one states and the District of Columbia, American College of Obstetricians and Gynecologists, the American Medical Association, and other medical professionals, and nineteen FDA law scholars, highlighted the extensive safety profile of mifepristone and the thoroughness of FDA’s review, and warned of the potential unraveling of a rigorous regulatory framework for the approval of all drugs.[4] Amicus briefs were also filed in the appellate courts by a variety of interested persons and organizations, including pharmaceutical industry groups, patient advocacy groups, reproductive rights groups, religious coalitions, and members of Congress.

A. Factual Background/Regulatory History of Mifepristone

A review of the regulatory history of mifepristone and some of the associated political tug-of-war is necessary to fully understand this case.

FDA first approved a new drug application (NDA) for mifepristone, branded as Mifeprex, for use with misoprostol (a previously approved drug) in September 2000 for medical termination of intrauterine pregnancy through seven weeks gestation. This approval followed a tumultuous and politically fraught journey to the U.S. market and involved a lengthy four years of FDA deliberations from the time of submission to approval, notwithstanding strong support from the American Medical Association (AMA), a battery of completed clinical studies, and a decade of postmarketing experience in France, Sweden, and the United Kingdom.[5]

Mifeprex was approved pursuant to FDA’s regulations in 21 C.F.R. 314 Subpart H.[6] As part of its approval, FDA required confirmatory post-market studies as well as certain conditions of use: that the drug be provided in-person and under the supervision of a qualified physician, distributed under a controlled system, and dispensed with a patient Medication Guide (MedGuide). The supervising physician was required to attest to being able to accurately assess the duration of a pregnancy, diagnose an ectopic pregnancy, and provide surgical intervention in cases of incomplete abortion or severe bleeding or assure that patients have access to appropriate follow up care if needed to manage complications. The supervising physician was also required to notify the sponsor in the event of an ongoing pregnancy that was not terminated subsequent to the conclusion of the treatment procedure and to report any hospitalization, transfusion, or other serious events to the sponsor.

In August 2002, plaintiff AAPLOG, along with the Christian Medical Association and Concerned Women for America, submitted a citizen petition requesting that FDA revoke the approval of Mifeprex and impose an immediate stay on the drug’s approval pending final action on the petition.[7] The petitioners raised safety arguments about the abortion regimen, argued that the approval violated the legal requirements of FDA’s accelerated approval regulations in Subpart H, and questioned the scientific quality of the trials used to support the product’s NDA.

Congress subsequently enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA).[8] In response to safety concerns surrounding Vioxx and other prescription drugs, FDAAA added Risk Evaluation and Mitigation Strategies (REMS) authorities to the Federal Food, Drug, and Cosmetic Act (FDCA), which expanded upon and integrated FDA’s existing tools (such as labeling and communication plans, restricted dispensing, and patient registries) to manage safety issues with select drugs and ensure that the benefits of such drugs outweighed the risks of serious complications. Drugs that were approved prior to 2007 were automatically deemed by FDAAA to be subject to an approved REMS if they were subject to “elements to assure safe use” (ETASU) under Subpart H regulations.[9]

FDAAA required sponsors of such “deemed” drugs to submit a proposed REMS to FDA. Danco Laboratories, LLC, the sponsor of the Mifeprex NDA, submitted a supplemental new drug application (sNDA) with a proposed REMS, and FDA approved the sNDA in June of 2011.[10] The 2011 REMS required a MedGuide, ETASU, a controlled distribution system, and a timetable for submission of assessments of the REMS.[11] The ETASU required that prescribers of Mifeprex be specially certified and that they sign a Prescriber’s Agreement Form agreeing that they meet the specified qualifications (which were the same as those required in the initial approval); that they will follow the guidelines in the agreement; and that they will report any ongoing pregnancy not terminated subsequent to the conclusion of the treatment procedure as well as any hospitalization, transfusion, or other serious event to Danco. In addition, the drug could only be dispensed in certain health care settings by or under the supervision of a certified physician and only to patients who signed a Patient Agreement Form. These agreements required that the patient return to the provider’s office or clinic two days later to receive misoprostol and return for a follow-up visit fourteen days later.

On March 29, 2016, FDA approved a subsequent sNDA filed by Danco to modify Mifeprex’s indication, labeling, and REMS.[12] Specifically, FDA approved a labeling change that extended the indication from seven weeks to ten weeks gestation based on safety and effectiveness data from multiple studies that were submitted to FDA in the supplement. FDA also assessed the mifepristone REMS program to “determine whether each element remains necessary to ensure that the drug’s benefits outweigh the risks.”[13] The revised REMS reduced the number of required in-person clinic visits required to one. Mifepristone was still required to be dispensed in person by or under the supervision of a certified prescriber in certain healthcare settings. However, the patient was permitted to take the misoprostol tablets at home and the Patient Agreement recommended, but did not require, that the patient follow up with the healthcare provider a week or two after taking mifepristone.[14] FDA determined, after reviewing several published studies, that at-home administration of misoprostol was safe because of “exceedingly low rates of serious adverse events” and that there was no significant difference in outcomes based on whether patients underwent self-assessment of health or had follow-up appointments via phone call or in-person.[15] FDA allowed other healthcare providers, not only physicians, who meet the REMS certification requirements to prescribe mifepristone, finding no serious health concerns associated with such prescribing. Although prescribing providers were required to report deaths to Danco, the revised REMS no longer required that prescribers report other serious adverse events to Danco. FDA also dispensed with the requirement that the MedGuide specifically be part of the REMS “to minimize the burden on the healthcare delivery system of complying with the REMS.”[16]

On the same day, FDA denied the 2002 citizen petition requesting to revoke the original Mifeprex NDA.[17] The agency defended its original approval of the drug under Subpart H, pointed out that the application was deemed to have in effect a REMS in 2007 and has had an approved REMS since 2011, and responded to the petitioners’ arguments with respect to the safety of the drug and the quality of the clinical trials the agency relied upon when it approved the application. FDA also advised the petitioners that its concurrent decision to approve an sNDA with updated dosing and labeling does not reflect a decision that there were any safety or effectiveness concerns with the previous regimen.

In March 2019, plaintiffs AAPLOG and ACOP filed a citizen petition with FDA requesting that the agency “restore and strengthen elements of the Mifeprex regimen and prescriber requirements approved in 2000,” retain the Mifeprex REMS, and continue limiting the dispensing of Mifeprex so that it could only be dispensed to patients in clinics, medical offices, and hospitals by or under the supervision of a physically present certified physician who has ruled out ectopic pregnancy. The citizen petition argued that the drug should be limited to seven weeks of gestation and that certified prescribers should be required to report “deaths, hospitalizations, blood transfusions, emergency room visits, failures requiring surgical completion, ongoing pregnancy, or other major complications directly to FDA.”[18]

FDA approved an abbreviated new drug application (ANDA) submitted by GenBioPro, Inc. for a generic version of mifepristone on April 11, 2019 and approved a “shared system” REMS that was required for all mifepristone products approved for medical abortion.[19] The ETASU under the shared system REMS were substantially the same as those under the 2016 REMS for Mifeprex.[20]

The agency announced in March 2020 that FDA would exercise enforcement discretion during the COVID-19 public health emergency by refraining from enforcing laboratory testing (e.g., liver enzyme testing) or imaging study requirements (e.g., magnetic resonance imaging) in applicable REMS programs.[21] On April 20, 2020, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) sent a letter to FDA requesting that the agency expand this policy to REMS requirements for mifepristone and certain other prescription drugs requiring in-person administration because these requirements serve as a barrier to accessing the treatment and “cause unnecessary delays in obtaining time-sensitive healthcare, without supporting improvements to patient safety or outcomes.”[22] Numerous other organizations similarly urged FDA to suspend the in-person administration requirement of the mifepristone REMS on the same public health grounds.[23]

In May 2020, ACOG and other parties, supported by amici curiae briefs from national health organizations and twenty-three state attorneys general, successfully filed suit in U.S. district court to enjoin the Trump Administration from enforcing the in-person requirements.[24] The district court concluded that these requirements placed a “substantial obstacle” to women securing abortions during the pandemic, allowing for mail delivery of mifepristone nationwide.[25] The Trump Administration appealed and fought the injunction throughout 2020, and in January 2021, the Supreme Court granted an emergency stay of the injunction.[26]

The change in Administration, the ACOG lawsuit, and a pending 2017 lawsuit filed by the American Civil Liberties Union (ACLU), persuaded FDA Acting Commissioner Janet Woodcock and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni to undertake a comprehensive review of the mifepristone REMS.[27] FDA wrote to the ACOG and SMFM in April 2021 in response to their April 2020 letter explaining that the agency had conducted a literature and adverse event review and decided to exercise enforcement discretion during the public health emergency towards the mifepristone in-person dispensing and patient requirements, as well as the dispensing of mifepristone by mail under a certified provider’s supervision following a telehealth consultation by a certified provider.[28]

In December 2021, FDA completed its comprehensive review of the mifepristone REMS program and decided to make its COVID-related changes permanent.[29] The agency directed the drug’s sponsors to submit proposals to revise the shared system REMS to permit the drug to be dispensed by certified licensed health care providers and pharmacies (including retail pharmacies) and require that pharmacies that dispense the drug be certified accordingly. The sponsors subsequently prepared a proposed REMS modification and submitted it to their respective applications.

FDA also responded to the plaintiffs’ 2019 citizen petition in December 2021 by denying their request to restore and strengthen the regimen and prescriber requirements and granting in part and denying in part the request to retain the mifepristone REMS.[30] Specifically, FDA found that certain elements of the REMS program (such as the healthcare provider certification) continued to be necessary to ensure safe use but that the REMS must be modified to remove the requirement that mifepristone be dispensed in person only in certain healthcare settings.

FDA approved the drug sponsors’ application supplements on January 3, 2023, permanently removing the in-person dispensing requirements from the shared system REMS.[31] The REMS requires pharmacies that intend to become certified to dispense mifepristone to complete a Pharmacy Agreement Form. By signing this form, the pharmacy agrees to establish processes and procedures to ensure compliance with various requirements, including verifying that the prescriber is certified, ensuring that the patient receives the drug within an appropriate time period, tracking and verifying the receipt of each shipment of the drug, and fulfilling various reporting and recordkeeping requirements.[32]

B. Lower Court Decisions

In the pending lawsuit, the plaintiffs asked the district court in their complaint and motion for preliminary injunction, among other things, to overturn:

(1) FDA’s 2000 approval of Mifeprex;
(2) FDA’s 2016 changes to the Mifeprex REMS and drug labeling;
(3) FDA’s 2016 denial of the first citizen petition;
(3) FDA’s 2019 approval of the generic version of mifepristone;
(4) FDA’s subsequent changes to the Mifepristone REMS Program, including the 2021 enforcement discretion decision; and
(5) FDA’s 2021 response to the plaintiffs’ second citizen petition concerning the in-person dispensing requirement for mifepristone.[33]

The plaintiffs also asked the court to enter declarative relief including a declaration that the FDCA prohibits FDA from approving any marketing application “that fails to limit distribution of chemical abortion drugs” under a federal law enacted in 1873 referred to as the Comstock Act, which prohibits sending any articles designed, adapted, or intended for producing abortion through the U.S. mail.[34] As explained below, such declarative relief is not consistent with an opinion taken by the U.S. Justice Department’s Office of Legal Counsel in December 2022, which concluded that the Comstock Act does not prohibit the mailing of mifepristone or misoprostol where the sender lacks the intent that the recipient will use them unlawfully.[35]

Shortly after the Supreme Court overturned Roe v. Wade in June of 2022, the United States Postal Service (USPS) asked the Department of Justice (DOJ) for guidance on how to approach the mailing of medication abortion. Specifically, USPS asked DOJ to opine on whether the mailing of mifepristone and misoprostol violates the Comstock Act, which provides that “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” is a “nonmailable matter” that USPS may not lawfully deliver.[36]

The DOJ opinion notes that the “consensus interpretation” over the last century, among courts, Congress, and USPS has been that the Comstock Act does not prohibit a sender from conveying such items where the sender does not intend for the items to be used unlawfully. In practice, this means the Comstock Act would not encompass the mailing of such items where the individual does not have knowledge that the items will be used unlawfully. Notwithstanding the significant variation in abortion laws across states, the relevant drugs can be used lawfully to some degree in all fifty states. According to the memo, “the fact that the drugs are being mailed to a jurisdiction that significantly restricts abortion is not a sufficient basis for concluding that mailing” violates the statute.

The defendants’ opposition to the plaintiffs’ motion for preliminary injunction argues, among other things, that 1) plaintiffs have no legal standing or interest allowing them to challenge FDA’s approvals and related actions; 2) most, if not all, of plaintiffs’ claims are barred by the statute of limitations; 3) the only possibly actionable challenge is to FDA’s 2019 denial of plaintiffs’ citizen petition, in which they only asked FDA to revert the 2016 REMS restrictions for mifepristone to the original restrictions established in 2000; and 4) plaintiffs have suffered no harm, much less any imminent or irreparable harm, to justify a preliminary injunction.[37] As the holder of the approved NDA for Mifeprex, Danco was permitted to intervene in the case and filed its own opposition to the plaintiffs’ demands, citing two-plus decades of safety and effectiveness data and information and multiple FDA evaluations.[38]

The government also argues that FDA’s approval decisions are made pursuant to the FDCA and the Public Health Service Act (PHSA). Although the Comstock Act and other laws (such as state wholesale distribution laws and state licensing laws concerning the practice of medicine) may affect how a medical product is used or distributed, FDA is not required to account for these laws and does not have the authority to deny a drug application based on the implication of these laws. Even if FDA were required to consider the Comstock Act, the government argues, FDA’s decisions related to in-person dispensing were not inconsistent with the Comstock Act because the Comstock Act does not prohibit the mailing or other conveyance of abortion-inducing drugs under all circumstances.[39]

A hearing on the motion for preliminary injunction was held on Wednesday, March 15, 2023, in the District Court for the Northern District of Texas, Amarillo Division, before Judge Matthew J. Kacsmaryk. Judge Kacsmaryk issued a preliminary injunction order on April 7, 2023 that purported to stay every decision FDA has made regarding mifepristone since its approval in 2000, including modifications to the drug’s conditions for use in 2016, the approval of the generic version in 2019, and the 2021 suspension of the requirement for in-person dispensing under the drug’s REMS. The Texas court rejected several substantial procedural arguments that were raised by the government (including standing, statute of limitations, and ripeness) to find that plaintiffs had a substantial likelihood of success on the merits that FDA’s approval of the drug was arbitrary and capricious.

On April 12, 2023, a panel of the United States Court of Appeals for the Fifth Circuit granted in part an emergency request by the government and Danco to stay the Texas Order pending a decision on the merits.[40] The Fifth Circuit’s emergency stay order preserved FDA’s 2000 approval of the drug based on the statute of limitations, but it declined to reject the Texas Order’s rulings with respect to changes FDA made to the drug’s approval beginning in 2016. The Fifth Circuit’s ruling would therefore have preserved some levels of access to Mifeprex (the brand drug) but with the same restrictions and conditions of use that were in place in 2011 and would have restricted access to the generic mifepristone.

In response to a motion for an emergency stay of relief filed by the government and Danco, the Supreme Court ruled on April 21, 2023 that the entire Texas Order be stayed pending the appeal in the Fifth Circuit and a potential petition for the Appellate Decision to be reviewed by the Supreme Court.[41] This order ensured that brand and generic mifepristone would remain available under the current conditions of use at least through the Fifth Circuit’s decision.

The government’s appeal to the Fifth Circuit contended that the Texas court inappropriately substituted its own judgment for the expert opinion of FDA, mischaracterized the level of clinical trial evidence necessary to support a drug’s conditions of use, and erred in its evaluation of the science. According to the appellants, the court ignored the vast record of safety and efficacy that the agency considered during its comprehensive administrative reviews of the data as well as the decades-long history of safe use, and instead relied upon studies that were not part of the administrative record and that were scientifically unsound.

The Fifth Circuit affirmed in part and vacated in part, vacating the district court’s holdings that FDA’s original approval of mifepristone in 2000 and approval of a generic in 2019 were unlawful. The court found that the claim with respect to the 2000 approval was likely barred by the statute of limitations and that the plaintiffs did not establish organizational injury based on the approval of the generic version of the drug. However, the court found that FDA’s 2016 amendments to the drug approval conditions and decision to exercise enforcement discretion in 2021 were arbitrary and capricious under the Administrative Procedure Act (APA).[42]

The government appealed the Fifth Circuit’s decision to the Supreme Court.

C. Issues Before the Supreme Court

Below are the issues that were presented to the Supreme Court.

(1) Whether the Alliance (and other respondents) have standing to challenge FDA’s 2016 and 2021 actions.
(2) Whether FDA’s 2016 and 2021 actions were arbitrary and capricious under the APA.
(3) Whether the district court properly granted preliminary injunctive relief.

The appellants argued that the respondents lacked standing under Article III of the U.S. Constitution because they were unable to establish a cognizable injury or that their asserted injuries were fairly traceable to FDA’s 2016 and 2021 actions.[43] The government also defended each of FDA’s actions, arguing that the agency acted lawfully when it changed the conditions of use and REMS requirements for the drug. According to appellants, even if the plaintiffs had standing and FDA’s actions were arbitrary and capricious, the district court’s remedy was improper because the balance of equities and the public interest did not support preliminary injunction relief.

Article III Standing

Whether the respondents have Article III standing is a paramount issue. Respondents alleged that they and their members are harmed by FDA’s actions regarding mifepristone because women experiencing complications from taking mifepristone can “overwhelm the medical system” and place “enormous pressure and stress” on doctors to treat these emergencies; these doctors may be forced into situations in which they feel complicit in facilitating an abortion against their moral beliefs; and doctors who are forced to treat these women are unable to practice “evidence-based medicine” due to their inability to obtain informed consent given the “inaccurate and false safety profile” of this regimen that FDA allegedly created.[44] Respondents also alleged that their efforts to treat women who experience complications from mifepristone due to FDA’s actions have diverted them away from other priorities.[45]

The government vehemently contests that the respondents have standing because these assertions of harm rely upon a series of speculative contingencies that include the actions of independent actors. At the heart of the argument is whether the respondents have a cognizable injury. The Fifth Circuit held that the respondents made a sufficient showing of associational standing because a certain percentage of women who take mifepristone will experience adverse events or require surgical abortions, that some percentage of these women will seek emergency care, and that some of the organizations’ members are likely to treat patients who experience such adverse effects.[46] The circuit court found that there was a substantial risk of injury to the respondents’ members and that the injury was cognizable because providing this treatment may violate the conscience of these physicians, divert time and resources away from their other patients, and expose them to greater liability and insurance costs.[47]

According to the appellants, the respondents failed to establish whether any of their members have conscientiously objected to performing such procedures and, if so, why they chose to proceed rather than invoking applicable conscience protections. The government further points out that “stress and pressure” are part of the job for doctors who have chosen to provide emergency care in hospital settings, and the respondents “have not cited any authority suggesting that simply being presented with a person in need of emergency care qualifies as an Article III injury to a doctor whose chosen profession is treating patients in an emergent setting.”[48] The appellants further contend that the respondents’ standing argument is based on a “statistical probability that some of their unidentified members might be called upon to treat women” who were prescribed the drug and experienced “exceedingly rare” adverse events.[49] Moreover, the government argues that the Fifth Circuit erred in holding that the respondents’ alleged injuries are fairly traceable to FDA’s actions in 2016 and 2021, which made incremental changes addressing the drug’s conditions of use.[50] Such an attenuated statistical approach to standing, the government argues, has been emphatically rejected by the Supreme Court.[51]

Administrative Procedure Act

The appeal also challenged the Fifth Circuit’s holdings that FDA acted arbitrarily and capriciously in violation of the APA when it approved the changes to the conditions of use and the revised REMS in 2016 and when it removed the in-person dispensing requirement in 2021. The Fifth Circuit found that FDA’s failure to consider the cumulative effect of increasing the maximum gestational age in the conditions of use from seven weeks to ten weeks, expanding the types of healthcare providers who could prescribe mifepristone, removing the in-person requirements for the misoprostol administration and subsequent follow-up appointment, removing the prescribers’ obligation to report non-fatal adverse events, and other changes to the approval and REMS conditions in 2016 were likely arbitrary and capricious.[52]

The Fifth Circuit also found shortcomings in FDA’s explanations for its decision in 2021 to remove the in-person dispensing requirement and therefore determined that the respondents were likely to succeed in showing that this action also violated the APA.[53] The court found FDA’s rationale deficient in part because FDA examined adverse event data collected during a period of time when prescribers were no longer required to report non-fatal adverse events, eliminating “perhaps the best source of data” on the drug’s safety profile.[54] FDA’s rationale was also deficient, according to the court, in part because FDA also relied on studies that were “merely not inconsistent” with its conclusion rather than studies that affirmatively supported its position.[55]

The appellants defended FDA’s decisions by pointing to the agency’s “exhaustive review” of “experience and data gained in the last 20 years from millions of women in the U.S. and abroad” and discussing various studies that supported the agency’s decisions.[56] With respect to FDA’s actions in 2016, the government argues that the APA only requires an agency to review the record and reasonably consider the relevant issues and provide a reasonable explanation for its decisions. The agency was not required under this standard to commission or conduct scientific studies that examined the cumulative effect of its changes but rather would be justified in relying on the data that it had used to determine that the changes that it had concluded were safe individually to predict that the changes would be safe collectively.[57] Despite this point, the appellants contend that FDA had in fact considered “at least three studies that closely mirrored challenged aspects of the 2016 conditions” and that the agency had adequately explained its reasoning.[58]

The appellants likewise defended FDA’s decision in 2021 when it removed the in-person dispensing requirement by discussing FDA’s analysis of reported clinical studies and review of adverse event data. The government pointed out that manufacturers of all drugs are required to report adverse events, which FDA routinely monitors, and that FDA’s changes in 2016 did not remove the reporting requirements governing mifepristone’s sponsors. According to the government, the arbitrary and capricious standard under the APA is deferential and “does not give litigants or the courts a license to unduly second-guess the agency’s scientific judgements,” and the APA did not “compel FDA to maintain heightened reporting requirements it had determined were unnecessary to account for changes in risk that FDA had determined would not occur.”[59]

Balance of Harms and Public Interest

Lastly, the appellants contend that even if the plaintiffs have standing and were likely to succeed on the merits of their claim that FDA’s actions were arbitrary and capricious, the lower courts erred in their deliberation of the balance of equities and public interest factors necessary to support preliminary injunction relief. According to the government, the portions of the district court order that were affirmed by the Fifth Circuit “would impose grave harms on the government, mifepristone’s sponsors, women seeking legal medication abortions, and the public” and that “respondents’ asserted injuries cannot remotely justify the disruptive alteration of the status quo that the district court’s preliminary relief would entail.”[60]

III. Implications for Access to Mifepristone

The plaintiffs almost succeeded in blocking FDA’s approval of mifepristone entirely and depriving women across the country of a treatment that FDA has determined to be safe and effective for terminating early pregnancy when used in accordance with the drug’s approved conditions of use. For many patients, medication abortion is a safer method than surgical abortion, which can carry heightened risks for some patients, such as those who are allergic to anesthesia. Access to surgical abortion is also limited for many patients, even in states where abortion is legal, due to practicalities and costs associated with undergoing surgery.

Although the Fifth Circuit did not affirm the district court’s decision in its entirety, reverting to the conditions of approval and REMS that were applicable to mifepristone in 2016 would deny access to this treatment for women whose pregnancy has progressed beyond seven weeks of gestational age while simultaneously forcing women to overcome additional hurdles to obtain the regimen in a timely manner.

Republican states favor the in-person dispensing requirements because allowing patients to access a prescriber through telehealth services and receive the regimen through the mail threatens their ability to enforce their respective state’s abortion bans. Democratic states, on the other hand, argue that continued access to mifepristone is especially important in meeting the increased demand for clinics caused by an influx of out-of-state patients seeking abortion care. They contend that imposing restrictions on access to mifepristone would reduce the availability of care to both in-state and out-of-state patients and will potentially drive more patients toward procedural abortion. These states also stress the importance of telehealth services in expanding care to rural and underserved areas.[61]

Attorneys general from Missouri, Idaho, and Kansas filed a motion to intervene as plaintiffs in the case in hopes of scoring an end run around the respondents’ potential standing issues and obtain a ruling on the merits because the states could “assert many harms the private plaintiffs cannot.”[62] In particular, the states can allege that state-run insurance programs and hospitals have incurred direct monetary harm resulting from the adverse effects of mifepristone and that the states have incurred harm to their sovereign interests in creating and enforcing their laws. The motion cautions that “a holding that the private plaintiffs lack standing would nearly guarantee this case comes before this Court again on an emergency application or certiorari petition within months.”[63] These states succeeded in their efforts to intervene in the district court case, but the Supreme Court denied their motion.

IV. Implications on FDA’s Authority

This lawsuit has garnered widespread attention because the Supreme Court’s pending decision will have ramifications that extend well beyond access to medication abortion. The government has stressed the uniqueness of this case, noting that FDA has identified no other example “where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market—much less an example that includes a two-decade delay.”[64]

Congress has delegated the responsibility to evaluate the safety and efficacy of drugs and other medical products to FDA, an agency with the requisite scientific expertise to determine whether a sponsor’s NDA contains substantial evidence demonstrating that the drug is safe and effective for its intended use, based on adequate and well-controlled investigations.[65] FDA’s NDA approval process is rigorous and involves a careful analysis by scientists across many disciplines to determine whether the drug’s benefits outweigh its risks.

Instead of affording deference to FDA’s decisions with respect to mifepristone, the district court substituted its own judgment for that of the FDA. The court relied upon select studies that would hardly meet FDA’s standards for valid scientific evidence while disregarding the extensive amount of evidence from studies and data that FDA considered as part of the administrative record. Moreover, the court excoriated FDA for not imposing the same conditions in the product labeling and in the REMS program that were present in the clinical trials that supported the agency’s decisions. This criticism is entirely misguided. Most clinical trials are conducted under more restrictive conditions than those that are ultimately imposed in a product’s approved labeling, and the statute does not require FDA to limit a drug’s approved conditions of use to the exact conditions outlined in the supporting clinical trial protocols.

The lower courts’ decisions have alarmed the pharmaceutical and biotechnology industries, which depend upon FDA’s regulatory process for the scientific evaluation and approval of their products. Shortly after the district court’s opinion was issued, dozens of biotech and pharmaceutical company leaders signed an open letter criticizing Judge Kacsmaryk’s ruling as a brazen act of judicial interference, expressing their concerns that the decision undermines FDA’s authority over drug approvals and sets a dangerous precedent. The letter states:

As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.

Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.[66]

Several organizations have filed amicus briefs stressing this point. For example, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed an amicus brief with the Supreme Court warning that the Fifth Circuit’s ruling upends the settled FDA regulatory regime and paved a new path to contest initial and supplemental drug approvals, which “threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed opportunities.”[67] A group of pharmaceutical companies, executives, and investors filed a separate amicus brief explaining the importance of respecting FDA’s scientific judgment and regulatory flexibility in fostering the development of innovative therapies and pointing out the flaws in the lower courts’ criticisms of FDA’s decisions with respect to mifepristone.[68] In particular, the brief lambasts the lower courts for expecting FDA to limit a drug’s approved labeling to the precise conditions of use that were studied in clinical trials and to only approve labeling and REMS changes upon review of studies that evaluated the consequences of proposed changes as a whole. The group argues that the decisions create an impossible and impractical drug approval standard that, if allowed to take effect, “will result in a seismic shift in the clinical development and drug approval process” that would chill drug development and investment.[69]

The implications of this case on administrative law extend beyond agency deference. It is astonishing, for example, that the lower courts accepted the standing arguments that were made by the plaintiffs. If standing is permitted on such speculative and attenuated grounds, FDA could be exposed to lawsuits from a host of litigants who disagree with FDA’s choices on moral or other bases. This poses a threat not just to FDA but also to regulated industry, healthcare providers, and patients who rely on FDA to make scientifically sound decisions that are in the interest of the public health. This would also set a dangerous precedent that could be used to award standing to a broad range of parties that seek to challenge an action by other administrative agencies. The Supreme Court’s decision also could set an unfeasible precedent with respect to an agency’s obligation to consider the implications of its actions on laws that are not within the four corners of its governing statutes.

* Bryant Godfrey is a Partner at Foley Hoag LLP, where he advises FDA-regulated companies throughout the product lifecycle, including development, approval, labeling, advertising/promotion, post-marketing obligations, enforcement investigations, and regulatory strategy and compliance. Mr. Godfrey previously held several Senior Counsel positions with FDA where he advised on a range of issues relating to medical products and tobacco products. Tina Papagiannopoulos is a Counsel at Foley Hoag LLP, where she provides policy advice and counsels FDA-regulated clients on applicable regulatory and compliance requirements under the Federal Food, Drug, and Cosmetic Act; Public Health Service Act; and Federal Trade Commission Act.

[1]   Brief for the Federal Petitioners at 12, U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235 (S. Ct. Jan. 23, 2024), ECF No. 29.

[2]   All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 22-cv-223 (Apr. 7, 2023), 2023 WL 2825871; All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210 (5th Cir. 2023).

[3]   Amicus Curiae Brief of Miss. et al. in Supp. of Pls.’ Mot. For Prelim. Inj., All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z (N.D. Tex. Feb. 10, 2023), ECF 55-1.

[4]   Brief for the States of N.Y. et al. as Amici Curiae in Supp. of Defs. & in Opp’n to Pls.’ Mot. For Prelim. Inj., All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z (N.D. Tex. Feb. 10, 2023), ECF 59-1; Brief of Amici Curiae Medical & Pub. Health Soc’ys in Opp’n to Pls.’ Mot. for Prelim. Inj., All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z (N.D. Tex. Feb. 10, 2023), ECF 99-1; Unopposed Mot. of Food & Drug Law Scholars for Leave to File Amicus Curiae Brief in Supp. of Defs., All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z (N.D. Tex. Feb. 10, 2023), ECF 70.

[5]   Associated Press, AMA Endorses Testing, Use of French Abortion Pill, Wash. Post, June 28, 1990; Derek Hawkins, For Abortion Pill Mifepristone, Political Battle is Nothing New, Wash. Post, Mar. 22, 2024; U.S. Gov’t Accountability Off., GAO-08-751, Rep. to Cong. Requesters, Food & Drug Admin.—Approval and Oversight of the Drug Mifeprex (Aug. 2008),‌gao-08-751.pdf.

[6]   U.S. Food & Drug Admin., Approval Letter (Mifeprex), NDA 20-687, (Sept. 28, 2000),

[7]   Citizen Pet. from Am. Ass’n of Pro-Life Obstetricians & Gynecologists, Docket No. FDA-2002-P-0364 (Aug. 20, 2002).

[8]   U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA), Pub. L. No. 100-85, 121 Stat. 823 (2007).

[9]   Pub. L. No. 110-85, § 909(b)(1); see also 73 Fed. Reg. 16,313 (Mar. 27, 2008).

[10]  U.S. Food & Drug Admin., Supp. Approval (Mifeprex), NDA 020687/S-014 (June 8, 2011),

[11]  U.S. Food & Drug Admin., Risk Evaluation & Mitigation Strategy (REMS) (Mifeprex), NDA 20-687 (2011),

[12]  U.S. Food & Drug Admin., Supp. Approval (Mifeprex), NDA 020687/S-020 (Mar. 29, 2016), [hereinafter 2016 Approval Letter].

[13]  Id.

[14]  Id.

[15]  U.S. Food & Drug Admin., Summary Review for Regulatory Action (Mifeprex), NDA 020687/S-020 (Mar. 29, 2016),‌020SumR.pdf.

[16]  2016 Approval Letter, supra note 12.

[17]  Citizen Pet. Denial Resp. from U.S. Food & Drug Admin. to the Am. Ass’n of Pro-Life Obstetricians & Gynecologists et al., Docket FDA-2002-P-0364 (Mar. 29, 2016),

[18]  Citizen Pet. From Am. Ass’n of Pro-Life Obstetricians & Gynecologists & Am. Coll. of Pediatricians, Docket FDA-2019-P-1534 (Mar. 29, 2019),

[19]  U.S. Food & Drug Admin., ANDA Approval (mifepristone), ANDA 091178 (Apr. 11, 2019),

[20]  U.S. Food & Drug Admin., Initial Shared Systems REMS Approval (Apr. 2019),

[21]  U.S. Food & Drug Admin, Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals, Docket No. FDA-2020-D-1106 (Mar. 2020),

[22]  Letter from the Am. Coll. of Obstetricians & Gynecologists & Soc’y for Maternal-Fetal Med. to the U.S. Food & Drug Admin. (Apr. 20, 2020),

[23]  Letter from Organizations and Health Care Providers to Food & Drug Admin. (Apr. 28, 2020),

[24]  Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., 472 F. Supp. 3d 183 (D. Md. 2020).

[25]  Id. at 216.

[26]  U.S. Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578 (Jan. 2021).

[27]  J. Mot. to Stay Pending Agency Review, Chelius v. Becerra, 2023 U.S. Dist. LEXIS 137629 (2023), No. 1:17-00493 JAO-RT (D. Haw. May 7, 2021), ECF 148.

[28]  Letter from U.S. Food & Drug Admin. to Am. Coll. of Obstetricians & Gynecologists & Soc’y For Maternal-Fetal Med. (Apr. 12, 2021),

[29]  Letter from U.S. Food & Drug Admin. to The Society of Family Planning (Dec. 16, 2021),

[30]  Response Letter from U.S. Food & Drug Admin. to Citizen Pet. Submitted by Am. Coll. of Obstetricians & Gynecologists & Soc’y for Maternal-Fetal Med., Docket No. FDA-2019-P-1534-0016 (Dec. 16, 2021),

[31]  U.S. Food & Drug Admin., Supp. Approval (Mifeprex), NDA 02000687/S-025 (Jan. 03, 2023), [herein-after Mifeprex NDA Supp. Approval]; U.S. Food & Drug Admin., Prior Approval Supp. Approval (mifepristone), ANDA 091178/S-004 (Jan. 03, 2023),‌docs/appletter/2023/091178Orig1s004ltr.pdf; U.S. Food & Drug Admin., Summary Review (Mifeprex), NDA 020687/S-025 (Jan. 3, 2023),‌NDA/2023/020687ORIG1S025.PDF; U.S. Food & Drug Admin., Approved Risk Evaluation and Mitigation Strategies (REMS) (Mar. 23, 2023),‌index.cfm?

[32]  Mifeprex NDA Supp. Approval, supra note 31; U.S. Food & Drug Admin., ANDA 091178, GenBioPro Pharmacy Agreement Form (Mifepristone Tablets, 200mg) https://www.accessdata.‌

[33]  Pls.’ Brief in Supp. of their Mot. for Prelim. Inj., U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022), ECF 7, U.S. LEXIS 1504 (2023).

[34]  Compl. at 111, All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022), ECF 1.

[35]  U.S. Dep’t of Justice, Mem. Op. for the Gen. Counsel U.S. Postal Service, Slip Op., Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions (Dec. 23, 2022),

[36]  Comstock Act, 18 U.S.C. 1461.

[37]  Defs.’ Opp’n to Pls.’ Mot. for Prelim. Inj., All. for Hippocratic Med. v. U.S. Food & Drug Admin., 2:22-cv-00223-Z (N.D. Tex. Jan. 13, 2023), ECF 28.

[38]  Intervenor Danco Lab’ys, LLC’s Mem. of Points & Auths. in Opp’n to Pls.’ Mot. for a Prelim. Inj., All. for Hippocratic Med. v. U.S. Food & Drug Admin., 2:22-cv-00223-Z (N.D. Tex. Jan. 10, 2023), ECF 50.

[39]  Defs.’ Opp’n to Pls.’ Mot. for Prelim. Inj., supra note 37, at 28–30.

[40]  All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 23-10362 (5th Cir. Apr. 12, 2023)

[41]  Order on Application for Stay, Danco Lab’ys., L.L.C. v. All. for Hippocratic Med., No. 22A901, 598 U.S. __ (Apr. 21, 2023).

[42]  All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210 (5th Cir. 2023).

[43]  Brief for the Federal Petitioners, supra note 1.

[44]  Pls.’ Brief in Supp. Of their Mot. for Prelim. Inj., supra note 33, at 8–9.

[45]  Id. at 7.

[46]  All. for Hippocratic Med., 78 F.4th at 232–33.

[47]  Id. at 235–36.

[48] Brief for the Federal Petitioners, supra note 1, at 26.

[49]  Id. at 12.

[50]  Id. at 28–29.

[51]  Id. at 18.

[52]  All. for Hippocratic Med., 78 F.4th at 246.

[53]  Id. at 250–51.

[54]  Id. at 249–51.

[55]  Id. at 250–52.

[56]  Brief for the Federal Petitioners, supra note 1, at 35.

[57]  Id. at 36–37.

[58]  Id. at 38–39.

[59]  Id. at 42–44.

[60]  Id. at 42–46.

[61]  Brief for States of N.Y. et al. as Amici Curiae in Support of Petitioners, U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235 (S. Ct. Oct. 12, 2023).

[62]  Notice of Intervention Below, and Mot. of Mo., Idaho & Kan. to Intervene at 2, U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235 (S. Ct. Jan. 22, 2024).

[63]  Id. at 11.

[64]  Defs. Opp’n to Pls.’ Mot. for Prelim. Inj., supra note 37, at 31.

[65]  21 U.S.C. § 355(d); 21 C.F.R. §§ 314.50, 314.105(c).

[66]  Open Letter from Various Pharm. Execs. in Supp. of FDA’s Auth. to Regulate Meds. (last viewed Apr. 20, 2024).

[67]  Brief for the Pharm. Rsch. & Manufacturers of Am. as Amicus Curiae in Supp. of Pet’rs at 3–4, U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235 (S. Ct. Oct. 12, 2023).

[68]  Brief of Pharm. Cos., Execs. & Investors as Amici Curiae in Supp. of Applicants, U.S. Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235 (S. Ct. Oct. 12, 2023).

[69]  Id. at 17–18.