Notice & Comment

Politicizing Deference to the FDA Considering the Alliance for Hippocratic Medicine Cases, by Anne Zimmerman

I. Introduction

The Food and Drug Administration (FDA) approved mifepristone for terminating pregnancy in 2000. On April 7, 2023, a Texas court issued a preliminary injunction suspending FDA approval in Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Administration, et al. On April 12, the Fifth Circuit Court of Appeals partially overruled, allowing the drug approval to persist, yet partially granted the motion for a stay pending appeal on the FDA decision to make mifepristone available by mail. On April 14, 2023, the Supreme Court ordered an administrative stay on the Texas District Court ruling. (The status of mifepristone will remain as it was prior to the order until Wednesday April 19.)  Deference to administrative agencies is grounded in the Administrative Procedure Act and steeped in public policy and legal theory and practice. Agencies have subject-matter expertise, and they are well positioned to interpret statutes as well as regulations they enact. The FDA has a public health mandate. Deference to agencies generally presumes Congress would want agencies that promulgate regulations to oversee disputes about their application. Judicial oversight is also a fundamental part of the system of checks and balances. Many argue that the FDA could have published an interpretation preventing the current controversy, although it is likely the same plaintiffs would challenge any interpretation or policy guidance. This article examines deference considering the Alliance for Hippocratic Medicine opinion and the FDA’s broad mandate. The Fifth Circuit was silent on deference to the FDA and the Supreme Court has not relied on Chevron deference in recent cases when it could have, leaving the public unsure of the doctrine, and its application to the FDA. Kisor v. Willkie, a recent Supreme Court case applying Auer v. Robbins,is a helpful guide.

II. Regulating Mifepristone 

Mifepristone was approved for pregnancy termination and is proven safer than surgical abortions. In the 1990s, prior to FDA approval, there were studies noting its potential to improve abortion safety, and to treat endometriosis and advanced breast cancer, among other conditions. In 2000 the FDA approved mifepristone. In 2007, the FDA adopted the framework of Risk Evaluation and Mitigation Strategies (REMS) at the request of Congress under the FDA Modernization Act of 1997. In 2008 a Government Accountability Audit acknowledged the approved status of mifepristone. In 2011, mifepristone was transitioned to the REMS program. In 2016, the FDA altered some of the safety measures. In 2019 generic mifepristone was approved. Prior to the COVID-19 pandemic, the FDA continued to require it to be dispensed in person by certified practitioners and specialized consent paperwork, while drugs of comparable safety did not have similar restrictions. In 2021, the FDA suspended the in-person dispensing requirement. And in 2023 the FDA lifted the in-person requirement by modifying the REMS. The Fifth Circuit providesa table of the FDA approval and status history of mifepristone.

The FDA approval process and the intensive government oversight throughout mifepristone’s approved history are a testament to its safety and efficacy. There were many steps and changes, each with medical and public health rather than political justification. The FDA’s mission is to protect and promote public health. The FDA is responsible for ensuring safety and efficacy of drugs, and it is tasked with speeding innovation so promote effective, safer, and affordable drugs. Drug approvals are one of the most common agency responsibilities. 

The Fifth Circuit order suggests that mifepristone’s safety is an open issue. Using an analogy to car safety research, the order proclaims that the FDA’s observations and studies of mifepristone with the safeguards in place is not an indication of mifepristone without them. The safety data concern medical events, like adverse reactions. Researching the drug’s safety with safeguards and later removing them is a common practice, like moving prescription drugs to over the counter after data on how the drug and its availability affect people. That is fundamentally unlike researching how cars without seatbelts would perform by analyzing accident data from cars with seatbelts. In the case of seatbelts, the safeguard itself would significantly impact the outcome. Drug interactions, side effects, and efficacy are unaffected by procedural safeguards, making the data appropriate and in keeping with common practices.

Many called for federal preemption through an interpretive guidance to ensure its availability and compel states to provide access to it. An interpretation could have nipped any allegations of ambiguity in the bud. Yet there is no reason to believe that the plaintiff (now appellees) would not pursue any avenue to challenge any declarations or interpretive guidances by the FDA.

The Alliance for Hippocratic Medicine case vacating FDA approval of mifepristone must be contextualized in the broader, new limitations on abortion rights since Dobbs v. Jackson Women’s Health. Without Roe v. Wade and the undue burden test of Planned Parenthood v. Casey, the states have more ability to limit or protect abortion. Prior to Dobbs, states tried to limit abortion access subject to the undue burden test and then under the pretext of public safety during the pandemic, declaring abortion non-essential and severely limiting access to it against advice of the American Gynecological & Obstetrical Society. Courts reacted to state claims and the circuits split on pandemic abortion access. The Alliance for Hippocratic Medicine case indicates a deviation from the spirit of the Dobbs case as it uses federal courts and the federal legal apparatus to make a medicine used in over 50 percent of abortions illegal in all states. The purported justification for Dobbs was leaving abortion regulation up to states. Despite such context, this article addresses deference to agency interpretations.

III. Deference: Agency Authority and Expertise

The Administrative Procedure Act allows federal courts to hear challenges to regulations or actions by federal agencies. In Chevron v. Natural Resources Defense Council, Inc., the Supreme Court held that when agencies interpret a law that is ambiguous, courts must give the agency deference if the interpretation is reasonable. Auer v. Robbinswhich the Supreme Court relies on over Chevron in Kisor v. Willkie in 2019, confirms deference to agencies interpretating their own regulations. The two cases define the type and scope of deference to agencies in resolving disputes concerning laws and regulations. Deference to agencies prohibits courts from imposing their own interpretationsChevron deference extends to agencies unless the agency action was arbitrary and capricious, an abuse of discretion, inconsistent with a law, or Congress has unequivocally spoken on the issueAuer deference allows agencies to resolve disputes about ambiguous regulations. The rationale for deference is that the agency has subject-matter expertise. Deference includes the presumption that Congress intended the agency to interpret its regulations. Yet deference is not appropriate “when a court concludes that an interpretation does not reflect an agency’s authoritative, expertise-based, ‘fair[, or] considered judgment.’”

In Kisor, the Supreme Court limited the scope of Auer deference, which applies to genuinely ambiguous regulations and held that the reason for the presumption matters and that countervailing reasons may negate deference to the agency. In Kisor, the ambiguity was about the phrase “relevant official service department records” and the agency was the U.S. Department of Veterans Affairs (“VA”). The VA’s mission is to care for those who have served in the military. The case was about detailed wording, arguably ancillary to its mission. It was not its bread and butter. In the Alliance for Hippocratic Medicine case, drug approvals are the essence of the FDA. They are its raison d’etre and crucial to its existence. A case unraveling an approval that has been in place for 23 years is unlike the fact pattern that led to the limitations on deference in Kisor. If Kisor is an indication that the Supreme Court is wavering on Chevronand Auer deference, it is not an indication that the Court would abandon the authority vested in the FDA to serve its central purpose. (In his concurrence Chief Justice Roberts also clarifies that the case does not limit Chevrondeference.)

The reasons for deference remain strong. The agency that makes the rule is likely to know what it meant when a rule is ambiguous. And the agency understands the policy concerns. Agencies investigate and collect facts unlike courts. Agencies have accountability to the executive branch and to the President. Auer deference favors consistency as courts would vary on ambiguous regulations. Auer does not lead to giving the agency deference if the agency decision is unfair. The Kisor Court noted that an agency could issue an interpretation before cases and avoid the issue, although plaintiffs could still challenge such a move by the FDA.

The Alliance for Hippocratic Medicine v. FDA District Court Opinion

The Alliance for Hippocratic Medicine judge indicated that the original approval of mifepristone was improper under Subpart H. He indicates a procedural error. The opinion says there is a lack of ambiguity so deference to the FDA is not appropriate. The opinion suggests that pregnancy is not an illness and that mifepristone does not offer therapeutic benefit treat a disease, and therefore, that its original approval and its subsequent updates, categorizations, and transitions, each themselves demonstrative of additional approval, are invalid. Yet the FDA regularly included conditions and “Subpart H is available for drugs intended to treat serious or life-threatening conditions, whether or not they were understood colloquially to be ‘illnesses.’” While the subsequent approvals of mifepristone under REMS removed it from Subpart H, the FDA preamble to Subpart H says, “conditions or diseases that can be serious for certain populations or in some or all of their phases.” Congress also applied the REMS framework to diseases or conditions. Professionals include pregnancy as one such condition. Chevron footnote 9 restricts deference and requires courts to use other tools of statutory construction before deferring to the administrative interpretation and the Alliance for Hippocratic Medicine opinion cites Kisor for the proposition that a court must “exhaust” tools of construction. In American Hospital Association v. Becerra, the Supreme Court sided against an agency statutory interpretation based on what the Court considered “traditional tools of statutory interpretation.” 

In Alliance for Hippocratic Medicine, the attempt to use other statutory construction tools should fail. It is difficult to argue plain language when the FDA has plainly used the language differently all along and included the word “conditions”. 

IV. The Fifth Circuit (Alliance for Hippocratic Medicine, et al., Plaintiff-Appellees, v. Food and Drug Administration, et al., Defendant Appellant, v. Danco Labs, Intervenor Appellant)

The Fifth Circuit per curiam order weighs in on deference by way of absence. The order refers to the Administrative Procedure Act and its arbitrary-and-capricious standard without any reference to Chevron or Auer.  The Fifth Circuit order says the agency action must be reasonable and reasonably explained and there must be a connection between the facts and the choice the agency makes. While true, ignoring cases that require (or reject) deference to agencies is a red flag. The word deference does not appear in the Fifth Circuit order. The order does not limit judicial review of agency action generally and could be interpreted as expanding judicial review while shrinking the scope of deference.

V. The Supreme Court

The administrative stay does not indicate the court’s leanings, but Chevron deference is becoming Chevronindifference. There is a sense in the literature based on the recent cases that Chevron and Auer are limited, possibly to such a degree that an expanded territory of tools of construction could surpass deference. The Chief Justice’s nod to Chevron in Kisor leaves the door open despite Justice Kavanaugh’s failure to mention Chevron in American Hospital Association.

VI. Politicizing Deference to the FDA 

It is apparent that Congress wanted the FDA to be the decision maker on drug approvals, to promulgate rules promoting safety and public health, and to oversee. Justice Kagan frowned upon medical advice from the bench during the pandemic in favor of deference to experts when she referred to “armchair epidemiology.” Justice Kagan was the architect of the Kisor opinion, but her dissent in South Bay Pentecostal is a strong indication that she believes experts should make scientific decisions. To unravel a drug approval under the backdrop of Dobbs by declaring a regulation unambiguous and then proceeding to interpret it in a manner contrary to the FDA’s common interpretation is weaponizing semantics. 

The worst result may be deferring to agency decisions when the judges or justices politically agree with them and using judicial review to privilege interpretations from outside the agency when they do not. Providing judicial review when the agency is seen as a political foe and the action is not politically palatable to one political party is an unacceptable result. Deference to agencies should be strongest when the issue is central to the agency’s purpose and the action is reasonable, as one could reasonably infer from Kisor. Drug approval is an agency action deserving deference as it is arguably the primary purpose of the FDA. Under Chevron and Auer, agency interpretations must be reasonable, cannot be arbitrary and capricious, and must be limited to ambiguity. Courts do not and should not defer to agencies recklessly. Trust in the experts and the trustworthiness of the motives must be earned. While judicial review is often warranted, the judiciary cannot supplant medical experts at all, let alone for political purposes.

If one were to view the opinion of the district judge in Alliance for Hippocratic Medicine (or the Fifth Circuit) and the FDA as two countervailing positions, they are not symmetrical, not two sides of the same coin. The FDA action of making a drug available does not impose an ideology on anyone as, to some degree, everyone is arguably free to choose not to terminate a pregnancy. That decision can be life threatening. The Alliance for Hippocratic Medicineopinion uses procedural nonsense to limit access to reproductive health care. Anti-abortion ideology is markedly present in both the District Court opinion and the Fifth Circuit, although the Fifth Circuit zeroes in on safety as well as the rights of doctors to conscientiously object to providing abortion care. The harms noted include the doctors’ exposure to bleeding patients, moral anguish on behalf of patients, and moral anguish in following a medical abortion with surgical follow-up that violates their personal beliefs. Exposure to bleeding patients is a part of medical practice. While doctors are admirable in both trying to prevent harm to patients and in being true to their own deeply held beliefs, they could also prevent their harm by pursuing other livelihoods that do not expose them to patients in need of medical care. Even within medicine, routes like dermatology or many other subspecialties would avoid reproductive health care altogether. The described harms are unavoidable only in places with severe shortages in emergency care. Doctors who have specifically become OB-GYNS may feel the obligations and moral distress, but perhaps another calling would be more suitable. The District Court opinion places a huge imposition on the public and would endanger those in need of care while the FDA side asks nothing of the public.

VII. Example: Comparison to Opioid Approval

Judicial oversight is valuable and key to our three-pronged system of government. Each branch has a role with potential to protect democracy by providing checks and balances. Agencies, including the FDA, are accountable and properly subject to judicial review, which prevents them from acting in arbitrary and capricious ways and from being unreasonable. When Oxycontin led to addiction and widespread death, the judiciary did not revoke FDA approval, nor did federal courts order restrictions on dosage for chronic or moderate pain. Yet regulatory failures were widely noted. The cases and controversies that arose were generally brought by states, groups, and individuals, who sued Purdue Pharmaceuticals and its subsidiaries, manufacturers, distributors, and drug stores. State legislatures made laws limiting distribution, and implementing prescribing safeguards, but states did not act to make Oxycontin illegal altogether or interfere with the FDA approval. The approval of dangerous opioids and their continued FDA-approved use during an opioid epidemic despite known FDA failures did not trigger a court to vacate the drug’s approval. The opioid case is a stronger case for finding a drug approval arbitrary and capricious, even fraudulent.

The opioid example has in common with mifepristone that states did regulate access. Under Dobbs, states can regulate access to abortion with discretion much broader than that under Casey, and many have done so strictly, and in violation of the spirit of the U.S. Constitution, individual liberty, equality for women, and respect for medical autonomy. (Constitutional challenges should arise and those in need of medical care have sued states that have endangered their health and wellness.) While there is not a comparable relevant issue of a fundamental right to control one’s own body, in the opioid example, the states exercised their authority. States had the ability to restrict use, require safeguards in prescribing, and even implement criminal laws regarding possession. The states had many tools to try to limit the impact of OxyContin’s FDA approval. 

Allowing approval to stand in the wake of the opioid epidemic and challenging it in the mifepristone case is suspect. The U.S. expects 100,000 opioid deaths this year. It is difficult to find a non-political explanation for the privileged treatment of a deadly drug and the singularly unusual judicial treatment of a drug used for 23 years. 

Drug approvals should remain in the domain of scientists and experts, who deserve deference under the current laws and standards. There is room and justification for judicial oversight in many cases. The plaintiffs and courts cannot reasonably explain why this drug and why now. The political, ideological motive is clear in the text.

VIII. Conclusion

The mifepristone controversy speaks to a societal issue and the abortion debate rather than just efficacy and safety. Other medicines and devices have complex social concerns too. For example, approval of a medicine for the death penalty concerns social as well as medical issues; the opioid epidemic has huge social costs. And other agencies are even less deserving of deference – the failure of the Bureau of Alcohol, Tobacco, Firearms and Explosives to properly protect the public from guns is astounding, and seemingly arbitrary and capricious. Societal issues should be debated in public discourse. Supreme Court case law will always be subject to being overruled. History demonstrates that rulings can shock society. With an increasingly politicized judiciary, it is more pressing to use legislation. At present, states can do so in the reproductive rights arena. Fair representation requires remedying gerrymandering and ensuring an ethical judiciary that has not pre-decided cases based on ideology or politics. If we are to move forward as a country dedicated to liberty and individual rights, then it is crucial to depoliticize medical decisions. Challenging FDA-approved drugs must not be permitted as a method of exerting social control. The FDA role in public health is not political and its approvals need not reflect any sentiment about the ethics of abortion at all. Chevron and Auerdeference speak to trust in agency expertise. Deference to the FDA is not absolute, and it should not be, but court opinions and orders that challenge it must avoid “armchair” medicine and epidemiology as well as politics and ideology. 

Anne Zimmerman, JD, MS, CIPP-US (Certified Information Privacy Professional), CEET (Certified Ethical Emerging Technologist), Founder, Modern Bioethics; Chair, New York City Bar Association Bioethical Issues Committee; Editor-in-Chief, Voices in Bioethics (Columbia University journal and podcast); Consultant, MyBioethics (ed-tech app); Co-Founder, Co-Chair, Bioethics Forum of the Collaborative for Palliative Care.

Her recent book, Medicine, Power, and the Law: Exploring a Pipeline to Injustice explores the relationships between medicine, science, and technology and the criminal and civil justice systems. Her prior experience includes corporate governance, criminal justice reform, and nutrition counseling with a focus on policy surrounding access to a healthy food supply. She is active in fundraising for Cycle for Survival and an avid supporter of research for rare cancer. For a full list of her publications, please visit this link.

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