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

Tina Papagiannopoulos*

Why It Made the List

This lawsuit garnered widespread attention last year because of its potential impact on access to medication abortion and, more broadly, on foundational principles underpinning the approval and regulation of drugs in the United States.

The case involves a legal challenge to the U.S. Food and Drug Administration’s (FDA’s) approval and subsequent regulatory changes for mifepristone, a drug that has been available in the United States as part of an approved medication abortion regimen for over twenty years. In an unprecedented decision in April 2023, federal district court Judge Matthew Kacsmaryk granted a motion for preliminary injunction filed by anti-abortion activists, who asked the court to suspend virtually all of the FDA’s decisions and actions regarding the drug’s approval.[1] This decision had sweeping implications on access to medication 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 government appealed the case 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 have negated subsequent changes to the FDA’s approval regarding the drug’s conditions of use and administration.[2] The Fifth Circuit’s ruling would have allowed access to this regimen only through in-person administration and only to women whose pregnancy had not progressed beyond seven weeks of gestational age.

As the government explained in its appeal to the Supreme Court, this was the first time any court has ever “restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”[3] The pharmaceutical and biotechnology industries, which had been following this case with much anticipation, submitted amicus briefs cautioning the Court that upending the drug approval process in the manner suggested by the lower courts would create regulatory uncertainty, resulting in detrimental impacts on research and investment in innovative therapies.

A detailed discussion of the lawsuit up to this point was included in last year’s compilation of Top Food and Drug Cases, but the chapter ended on a cliffhanger due to the timing of that publication, which was shortly before the Supreme Court rendered its decision. This chapter picks up where last year’s left off by summarizing the Supreme Court’s opinion[4] and discussing the potential aftermath of the decision in light of other key developments, including the Supreme Court’s subsequent opinion in Loper Bright.[5]

Summary and Discussion

Mifepristone has been FDA-approved since 2000 as part of a two-drug regimen along with misoprostol for medication abortion. The use of the drug was first approved through seven weeks gestation, and FDA had originally imposed other conditions on its use, including that the drug be distributed under a controlled system, that it be provided in-person and under the supervision of a qualified physician, that doctors and patients follow a strict regimen requiring the patient to appear for three in-person visits with the doctor, that it be dispensed with a Medication Guide, and that prescribing doctors report incidents of serious adverse events to the sponsor.

FDA made several changes affecting the use of the drug over time, including modifications to the drug’s labeling and to the interventions required under the drug’s Risk Evaluation and Mitigation Strategy (REMS). In 2016, for example, FDA extended the approved use from seven to ten weeks gestation, removed in-person requirements for follow-up provider visits, and allowed non-physician healthcare providers to prescribe the medication. In 2019, FDA approved a generic version of mifepristone. In 2021, FDA removed the in-person dispensing requirements, and in 2023, the agency permitted certified pharmacies to dispense the medication. Even under the more “relaxed” conditions, the drug is still subject to a REMS and, accordingly, has more restrictions on its use than do most other drugs that have been approved by the FDA.

The plaintiffs, consisting of four pro-life medical associations and four obstetricians, challenged each of the agency’s actions through 2021 under the Administrative Procedure Act (APA) and sought equitable relief. By the time the case had reached the Supreme Court, only the claims regarding the FDA’s 2016 amendments to the drug approval conditions and its decision to exercise enforcement discretion over the in-person dispensing requirements in 2021 had survived.

The questions presented by the government on appeal were:

1. Whether the respondents had standing to challenge FDA’s 2016 and 2021 actions. The government contended that the respondents lacked standing under Article III of the U.S. Constitution because they failed to demonstrate a cognizable injury or establish that their alleged injuries were directly attributable to the FDA’s actions in 2016 and 2021.
2. Whether FDA’s 2016 and 2021 actions were arbitrary and capricious under the APA. The government defended each of the FDA’s actions, asserting that the agency acted within its legal authority when it modified the conditions of use and REMS requirements for the drug.
3. Whether the district court properly granted preliminary injunctive relief. The district court had ordered a “stay” of the 2000 approval and all subsequent challenged actions related to the approval pending a decision on the merits. The Fifth Circuit upheld the stay with respect to FDA’s 2016 and 2021 actions—which would have required a return to the conditions of use that were in place for mifepristone in 2011 pending a decision on the merits—but the Supreme Court stayed the entire district court decision pending appeal. The appellants argued that, even if the plaintiffs had standing and the FDA’s actions were deemed arbitrary and capricious, the district court’s remedy (as upheld by the Fifth Circuit) was inappropriate, as the balance of equities and the public interest did not justify preliminary injunction relief. In other words, respondents’ asserted injuries from the availability of mifepristone under the current conditions (as opposed to the pre-2016 conditions) could not justify requiring the FDA and the sponsor to change the labeling and bring the drug into compliance with the prior conditions of use while restricting access for many women who are seeking to lawfully terminate their pregnancies.

The Court unanimously ruled in favor of the government on the threshold issue of standing, allowing it to sidestep a decision regarding the merits of the case that would have required an inquiry into potentially divisive questions about abortion and FDA authority. Justice Brett Kavanaugh delivered the opinion of the Court, while Justice Clarence Thomas wrote a concurring opinion critiquing associational standing.

It is a fundamental legal principle that, to establish standing, “a plaintiff must demonstrate (1) that she has suffered or likely will suffer an injury in fact, (2) that the injury likely was caused or will be caused by the defendant, and (3) that the injury likely would be redressed by the requested judicial relief.”[6] The respondents presented several standing theories but ultimately failed to demonstrate that FDA’s actions caused or likely would cause them a concrete injury. As the Court explained at the outset of the opinion, FDA did not require the respondents to perform or refrain from performing any action. None of the respondents prescribed or used mifepristone, but rather they wanted FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. The Court held that a plaintiff’s desire to make a drug less available for others does not establish standing to sue under Article III of the Constitution. Each of the respondents’ attempts to establish injury in fact and causation were discussed and rejected in turn.

First, they contended that FDA’s relaxed regulation of mifepristone could cause downstream conscience injuries to the individual doctors. The Court rejected this argument because it found that federal conscience laws fully protect doctors from being required to perform abortions or provide treatment against their consciences, breaking any causal link between FDA’s actions and potential conscience injuries.

The respondents next asserted that FDA’s relaxed regulation of mifepristone could cause a variety of downstream economic injuries to the doctors. They essentially argued that they could have to divert resources and time from their other patients to treat patients with mifepristone complications, that they were subject to an increasing risk of liability suits from treating those patients, and that they faced potentially increasing insurance costs. The Court found that these alleged economic harms were far too speculative and lacked evidentiary support. The Court also flatly rejected the novel concept of “doctor standing” that would allow healthcare providers to challenge general safety regulations and refused to create such a doctrine “out of whole cloth.”[7]

The medical associations further claimed that they had organizational standing because the FDA’s actions hindered their services and missions by requiring them to expend significant costs to oppose the FDA at the expense of other priorities. The Court disagreed, finding that organizations cannot “spend their way into standing” by expending resources to oppose government actions. Just like an individual, an organization may not establish standing simply based on the “intensity of the litigant’s interest” or because of strong opposition to the government’s conduct, “no matter how longstanding the interest and no matter how qualified the organization.”[8] This is because the standing doctrine “protects the ‘autonomy’ of those who are most directly affected so that they can decide whether and how to challenge defendants’ action.”[9] It also preserves judicial resources and allows federal courts to decide some contested legal questions later—after the political branches have had the opportunity to resolve them.[10]

After the Supreme Court’s ruling, the case returned to the Texas district court on remand. The medical groups and physicians have dismissed their claims, but the case is not yet over because three states (Missouri, Idaho, and Kansas) had filed separate intervenor complaints in the litigation while the Supreme Court proceedings were pending. The government moved to dismiss the complaints from these Intervenor States, arguing that the lawsuit was not jurisdictionally proper because the Texas district court never had jurisdiction over the original plaintiffs’ claims and that the states could not establish venue in Texas. The Intervenor States, in turn, argued that the Texas court had jurisdiction and that venue was proper at the time that their complaints were filed.

Judge Kacsmaryk granted the Intervenor States leave to file a joint amended complaint, and they did so in January 2025.[11] The Intervenor States argue they have standing because they bear increased healthcare costs from treating mifepristone complications, their ability to regulate healthcare within their borders is undermined by the FDA’s actions, and they have sovereign interests in enforcing their own abortion restrictions.[12] The government has moved to dismiss the Amended Complaint, but Judge Kacsmaryk has not yet ruled on whether the states can proceed with the case.

Impact

The Supreme Court’s decision had the potential to cut off access to medication abortion, even in states where abortion remains legal, and upend the entire framework of FDA drug regulation. The affront to FDA’s authority and scientific expertise elevated questions about administrative law and agency deference that once appeared to have been long settled. The pharmaceutical industry reacted with alarm, warning that allowing courts to second-guess the agency’s scientific decisions—as the lower courts were eager to do here—would have a deleterious effect on the drug approval process, create regulatory uncertainty, and ultimately reduce investment in new medicines.

To the extent FDA’s actions regarding mifepristone were referenced in the opinion, the Court appeared to be deferential to or, at a minimum, sympathetic towards the agency’s position and demonstrated an understanding about the FDA regulatory system and drug approval process that the lower courts did not appear to possess. For one thing, the Court recognized that the restrictions FDA imposed on mifepristone were extra requirements that are not required for all drugs, including the adverse event reporting obligations on prescribers. The Court also recognized that in the FDA drug-approval context, “virtually all drugs come with complications, risks, and side effects,” which may include an increased risk of heart attack, cancer, birth defects, or stroke.[13] This at least dulls the plaintiffs’ arguments that FDA’s actions were arbitrary and capricious when it revised certain REMS conditions despite the potential for side effects associated with the drug.

By dispensing with the matter on standing grounds, however, the Supreme Court avoided directly addressing the level of deference that should be afforded to FDA’s medical product approval and regulatory decisions. The topic of deference did not even come up. Notably, the Alliance for Hippocratic Medicine (AHM) opinion was delivered less than a month before the Court’s landmark decision in Loper Bright,[14] which overruled Chevron,[15] the Court’s seminal administrative law case on agency deference. The Chevron doctrine directed courts to defer to an executive agency’s interpretation of an ambiguous statute that it administers so long as the agency’s interpretation was reasonable. Loper Bright held that a court should not defer to an agency’s interpretation of an ambiguous statute but instead should do its “ordinary job of interpreting statutes” and find the “best” reading of the statute by applying the traditional tools of statutory interpretation.[16] Courts are to respect the views of the Executive Branch, which may have the power to persuade the court, but not abdicate their duty to exercise their own legal judgment.[17] According to the Court, previous cases finding that specific agency actions were held lawful under the thirty-year-old Chevron doctrine are still subject to stare decisis despite the Court’s change in interpretive methodology.[18]

Although the lower courts in AHM did not base their decisions on Chevron, FDA’s actions with respect to mifepristone would not necessarily be subject to review under the Loper Bright standard of deference. As discussed above, Loper Bright is applicable to an agency’s interpretation of an ambiguous statute. The statute is not ambiguous here. The FDCA clearly authorizes the agency to disapprove or withdraw any drug application when there is a lack of substantial evidence that the applicant’s drug will have the effect it is purported to have under the conditions of use prescribed, recommended, or suggested in the labeling.[19] The statute also unambiguously authorizes the agency to determine whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks and whether to approve a proposal for a REMS or modification to an existing REMS.[20] These determinations require FDA to perform a risk-benefit analysis and take appropriate action based upon a careful and expert review of available scientific evidence.

As the expert agency tasked with making these determinations, FDA’s actions are reviewable under the APA’s arbitrary and capricious standard, which requires a court to find that:

(1) the agency has relied on factors which Congress has not intended it to consider; (2) the agency entirely failed to consider an important aspect of the problem; (3) the agency’s explanation runs counter to the evidence before the agency; or (4) the explanation is so implausible that it could not be ascribed to a difference in view or the product of agency expertise. . . . Agency action is also arbitrary and capricious if the agency offered insufficient reasons for treating similar situations differently.[21]

The appropriate scope of review, therefore, is narrow and limited to a consideration of whether the agency examined the relevant data and “articulated a satisfactory explanation for the decision” that provides a “rational connection between the facts found and the choice made.”[22] Courts are to afford a “high level of deference to the agency’s scientific analysis of the evidence before it, and must avoid unduly second-guessing those scientific judgments.”[23] Under this standard of review, the court “may not substitute its own judgment for that of the agency.”[24] But that is exactly what the district court did in AHM.

Because the Supreme Court decided the AHM case on standing grounds, the Court left open the potential for others to sue, and indeed the saga is not over. The plaintiffs asserted that if they did not have standing, it was possible that no one else would have standing to challenge FDA’s 2016 and 2021 actions. The Court did not find this convincing, and its decision has not stopped others from trying to restrict access to this drug through litigation. Not only have three states interfered in this lawsuit, but several states have also filed separate lawsuits in their respective jurisdictions challenging the FDA’s mifepristone decisions, attempting to establish standing under various theories. In the meantime, Washington and several other states with Democratic attorneys general have filed suit against the FDA seeking to lift restrictions on access to mifepristone.[25]

The fundamentals of standing, according to the Court, are “well-known and firmly rooted in American constitutional law.”[26] Given that standing is an elemental legal principle, it is astounding that this case proceeded as far as it did on such nebulous standing grounds. The Supreme Court opinion nevertheless provided additional guidance to lower courts regarding the standing doctrine that will potentially limit the opportunity for groups to challenge agency actions based solely on ideological grounds going forward.

First, the ruling reaffirmed and strengthened the Court’s approach to standing when plaintiffs challenge the regulation of third parties and warned against courts becoming a “vehicle for the vindication of the value interests of concerned bystanders.”[27] This type of discourse is better suited for a “legislative assembly, a town square, or a faculty lounge” and is the province of the Legislative and Executive branches of the government.[28] If the Court were to allow a doctor to challenge an FDA decision to approve a new drug on the theory that the use of the drug by others may cause more patient visits to the doctor, “virtually every citizen would have standing to challenge virtually every government action that they do not like.”[29] The Court simply refused to allow the federal judiciary to go down this “uncharted path.”[30]

The Court likewise significantly limited the scope of organizational standing. Like individuals, organizations need to demonstrate injury in fact, and they cannot establish standing simply because of the intensity of their opposition to the government’s conduct. According to the opinion, they also cannot manufacture standing by virtue of the resources they expend to challenge and advocate against the government’s actions.[31]

It is worth noting that the government has maintained its position that the Intervenor States do not have standing in the AHM suit, even after the change in administration.[32] If a litigant challenging the FDA on mifepristone or any other drug approval decision gets past standing, however, the Court may need to address the appropriate standard of deference to apply to the agency’s review. Scientific decisions performed by an expert agency pursuant to a statutory delegation of authority have historically been reviewed under the APA’s arbitrary and capricious standard and afforded a higher degree of deference than what is afforded to an agency’s interpretation of an ambiguous statute, as discussed above. Although Loper Bright pertained to the latter category, it is possible that the Court’s decision in that case foreshadowed an erosion of other principles of agency deference.

The extent to which the Trump Administration will defend FDA’s decisions with respect to mifepristone will be something to watch if this issue comes before the Court on the merits. In the meantime, the Trump Administration could pursue various administrative paths to restrict mifepristone access. President Trump has already issued an Executive Order restricting the use of federal funding to “promote elective abortion.”[33] The administration also could, for example, direct the FDA to strengthen the REMS program for mifepristone, potentially reverting to pre-2016 requirements or creating additional barriers to prescription and distribution; or it could prioritize enforcement against telehealth providers or mail-order pharmacies that distribute mifepristone across state lines. Any such administrative actions would likely face immediate legal challenges from abortion rights advocates, potentially leading to another round of litigation centered on different legal questions than those addressed in AHM.

 

* Tina Papagiannopoulos is Counsel at Manatt, Phelps & Phillips, LLP, where she counsels clients on a range of regulatory, policy and compliance matters involving the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), in addition to assisting with various litigation and transactional matters involving life sciences companies. With a focus on therapeutics, she advises on product development and regulatory approval, marketing exclusivities, advertising and promotion, post-approval obligations, and responses to investigation and enforcement actions. Tina also offers guidance to FDA-regulated clients to help them navigate issues that have the potential to materially impact their businesses, including formal agency meetings and processes involving public comment and petitioning.

[1]   All. for Hippocratic Med. v. U.S. Food & Drug Admin., 668 F. Supp.3d 507 (N.D. Tex. 2023).

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

[3]   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.

[4]   U.S. Food & Drug Admin. v. All. for Hippocratic Med., 602 U.S. 367 (2024).

[5]   Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).

[6]   All. for Hippocratic Med., 602 U.S. at 380.

[7]   Id. at 391.

[8]   Id. at 394.

[9]   Id. at 379–80.

[10] Id. at 380.

[11]  Amended Complaint, State of Missouri v. U.S. Food & Drug Admin., No. 2:22-CV-00223-Z (N.D. Tex., Jan. 6, 2025), ECF No. 217.

[12]  The Amended Complaint also challenges FDA’s approval of the generic version of mifepristone in 2019 on additional grounds. The generic sponsor, GenBioPro, Inc., has intervened in the case to defend against those allegations.

[13] Id. at 392.

[14] Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).

[15] Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

[16] Loper Bright, 603 U.S. at 400–03.

[17] Id. at 402.

[18] Id. at 412.

[19] 21 U.S.C.§§ 355(d) and (e).

[20] 21 U.S.C. § 355-1.

[21] Teva Pharms. USA, Inc. v. U.S. Food & Drug Admin., 514 F. Supp.3d 66, 106 (2020) (internal citations omitted).

[22] Id.

[23] Id.; See also FCC v. Prometheus Radio Project, 592 U.S. 414, 423 (2021) (explaining that judicial review under the APA’s arbitrary and capricious standard is deferential and that “a court may not substitute its own policy judgment for that of the agency”); U.S. Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 579 (2021) (Roberts, C.J., concurring in the grant of application for stay) (“[C]ourts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”) (internal citations omitted).

[24] Teva Pharms., 514 F. Supp.3d at106.

[25] State of Washington v. U.S. Food & Drug Admin., Case No. 1:23-cv-03026 (E.D. Wash.).

[26] U.S. Food & Drug Admin. v. All. for Hippocratic Med., 602 U.S. 367, 380 (2024).

[27] Id. at 382.

[28] Id.

[29] Id. at 392.

[30] Id.

[31] Id. at 394.

[32]  Defendants’ Reply Memorandum in Support of Motion to Dismiss, State of Missouri v. U.S. Food & Drug Admin., No. 2:22-CV-00223-Z (N.D. Tex., May 5, 2025), ECF No. 247.

[33] Enforcing the Hyde Amendment, Exec. Order No. 14182, 90 Fed. Reg. 8751 (Jan. 24. 2025).