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November 12, 2024
Quarterly Opinion
Joshua M. Sharfstein
Michelle L. Bedoya
Oct 24, 2024
Jul 22, 2024
Apr 1, 2024
Back to The Milbank Quarterly Opinion
In a series of decisions, the US Supreme Court has severely constrained the authority of federal agencies to regulate in the interest of public health. This shift raises crucial questions about how agencies can continue to protect health amid new legal limitations.
Part of this shift stems from the “major questions doctrine,” under which the Court, in the 2022 case West Virginia v. Environmental Protection Agency (EPA), held that the EPA lacks broad authority under the Clean Air Act to regulate greenhouse gas emissions without clear congressional authorization for actions with vast economic and political significance. This decision restricted the EPA’s ability to regulate emissions to mitigate the health impacts of the climate crisis. The doctrine that the decision established undermined the ability of federal agencies to tackle other new and significant challenges.
Another major change is the termination of the so-called Chevron deference,1 the legal standard that had instructed judges to defer to reasonable agency interpretations of relevant laws. In Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, the Court instead instructed judges to use their independent judgment in deciding whether an agency has acted within the law. Without this deference, courts are now more likely to disregard agency actions that require some interpretation of the law to implement.
The potential impact of the Court’s new direction is vast. The major questions doctrine has been described as a “wrecking ball for agency policymaking.”2 The end of Chevron deference has been called a threat to “thousands of existing regulations that are essential3” because it undermines “the foundation for effective governance and protecting public health.” Specifically, in recent weeks, commentators have expressed concerns about the fate of environmental protections, clinical testing,4 consumer protections,5 and health care programs, including the Health Insurance Marketplaces created by the Affordable Care Act.2
At the same time, the actual impact of the Court’s decisions on health policy remains uncertain. A new legal structure does not emerge overnight; it is built brick by brick as judges interpret the Supreme Court’s decisions and set up new precedents. This process provides opportunities to make the case that public health agencies need space and authority to protect Americans from illness, injury, and death.
Even at the Supreme Court, the doctrines are still in flux. Justice Elena Kagan, in a dissenting opinion, argued that the major questions doctrine permitted the Court to substitute its judgment for that of Congress on matters of delegation and policymaking. But Justice Amy Coney Barrett called the doctrine nothing more than a restatement of the Court’s longstanding approach to statutory interpretation, which involves determining the boundaries of agency authority based on the “text in context” of the statute. She said that courts should still allow agencies to regulate even without a specific Congressional authorization, as long as the regulation is consistent with the agency’s usual type of actions and adheres to principles of reasonableness and a common-sense interpretation of statutory text.
With respect to Chevron deference, Justice Kagan, once again in dissent, argued that the Court was simply taking for itself decision-making authority that Congress had assigned to agencies. Chief Justice John Roberts responded that while courts should no longer “defer” to agencies, they may still “respect” the informed judgement of agency interpretations based on their persuasiveness under the standard established in the Skidmore v. Swift & Company case. Roberts noted that the degree of that respect would depend on the thoroughness, reasoning, and consistency of an agency’s view—and “all those factors which give it power to persuade, if lacking power to control.”
Courts may differ in how they interpret and apply Chief Justice Roberts’ endorsement of Skidmore. Some judges might view “respect”’ as merely a cursory acknowledgment of an agency’s approach, without giving serious weight to the agency’s position. Others, however, might interpret “respect” as a considerable form of deference, where the court not only considers but also relies on the agency’s expertise and the persuasive strength of its judgment.
In the face of the Court’s current jurisprudence that imposes new challenges on agencies aiming to protect public health, a key question is how to maximize the room for effective science-based policymaking. We offer here several suggestions for agencies, outside organizations, and public health law faculty.
Agencies. In anticipation of an increase in legal challenges to agency actions, agencies can take extra care to explain their decisions. This should involve carefully documenting the statutory authority for their actions, the expertise being applied, and the rationale behind their decisions within the regulatory process. This includes developing a well-supported record, with which agencies can justify their decisions with compelling scientific evidence. While these steps may not entirely prevent judicial interference, they can be advantageous under the Skidmore standard and offer a persuasive basis that courts and others can reference during appeals. Beyond these immediate strategies, agencies can work with Congress to clarify, expand, and modernize their statutory authority, leveraging their technical expertise to assist in drafting legislation that reinforces their regulatory roles.6
Outside organizations. Medical and public health organizations outside government should engage early and often in court cases that threaten to undermine the authority of agencies to protect health. By developing and submitting expertise-driven amicus briefs (akin to Brandeis briefs7) these groups can present courts with in-depth, evidence-based perspectives on the potential impacts of specific cases. Expert organizations, along with advocacy groups, academic societies, and professional organizations, can draw on their specialized knowledge to highlight the complex realities that agencies face and must manage, thus supporting the need for deference to expert regulatory bodies.
Such an approach was successful in the recent case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, a lawsuit by anti-abortion groups and doctors to overturn the FDA’s approval of mifepristone. While the case did not involve Loper Bright or the major questions doctrine, public health and medical groups, along with the pharmaceutical industry, united in strong opposition to a federal district court ruling that invalidated the FDA’s approval of the medication. These groups underscored the profound implications of the ruling for reproductive health and the integrity of the FDA’s scientific decision-making process. In an amicus brief to the appellate court, leading companies and trade organizations warned that allowing the decision to stand could “empower any plaintiff to grind drug approvals to a halt,” potentially disrupting patient access to critical medicines and threatening pharmaceutical innovation. The Supreme Court, on appeal, preserved the FDA’s authority concerning mifepristone – for now, at least. The case was narrowly decided on grounds of whether the plaintiffs had standing to bring a case; additional challenges, involving the agency’s statute or other laws, are likely to come.
Health law faculty. Health law faculty are experts who stand at the intersection of legal doctrine and medical and public health practice. Now is the time for them to develop new legal frameworks to balance judicial oversight with agency expertise. The current wave of cases undermining agency authority has deep roots in conservative legal circles that have long advocated for a more limited role of the administrative state. By adopting a similar strategic approach and advancing legal theories that emphasize the necessity of agency judgment in safeguarding public health, faculty can help to reshape the emerging doctrines.
The shifting legal landscape has yet to arrive at a final destination. The future of public health protection is being shaped right now in courtrooms across the country. For those concerned about the direction of judiciary for health, now is not the time to assume the worst or give up hope—it’s time to act.
The authors acknowledge Lawrence O. Gostin, JD for helpful comments on an earlier draft of this manuscript.
Joshua M. Sharfstein is associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health. He served as secretary of the Maryland Department of Health and Mental Hygiene from 2011 to 2014, as principal deputy commissioner of the US Food and Drug Administration from 2009 to 2011, and as the commissioner of health in Baltimore, Maryland, from December 2005 to March 2009. From July 2001 to December 2005, Sharfstein served on the minority staff of the Committee on Government Reform of the US House of Representatives, working for Congressman Henry A. Waxman. He serves on the Board on Population Health and Public Health Practice of the Institute of Medicine and the editorial board of JAMA. He is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined residency program in pediatrics at Boston Medical Center and Boston Children’s Hospital, and a 2001 graduate of the fellowship program in general pediatrics at the Boston University School of Medicine.
Michelle L. Bedoya, JD, LLM, is a PhD student in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Prior to starting her PhD, she earned her LLM with a concentration in health law and policy from the George Washington University Law School in Washington, DC. She is also an attorney at a national firm specializing in civil litigation, regulatory law, compliance, and health care law.
Before joining her current firm, Bedoya worked at the nation’s largest minority- and women-owned law firm, a full-service business law firm serving public and private companies, professionals, entrepreneurs, and individuals. She has also served as a compliance analyst and attorney for a Fortune 500 national health care enterprise, and as a defense attorney focusing on health litigation, administrative law, and the representation of health professionals and licensed health facilities.
Bedoya’s research focuses on mental health policy, with a particular emphasis on laws and policies that address the broader ecological factors influencing mental health. Her work also explores the intersections between law and public health, evaluating the impact of these relationships on overall health outcomes.
