Notice & Comment

Overruling Chevron and FDA Decision-Making, by Nikhil Chaudhry, Dr. Reshma Ramachandran, and Dr. Joseph Ross

I. Introduction

The recent Supreme Court oral arguments in Loper Bright and Relentless demonstrate the potential dire public health consequences of overruling the Chevron doctrine. The Food and Drug Administration (FDA) relies on broad judicial deference granted by Chevron, with the primary goal of utilizing scientific and clinical expertise to protect the health and safety of the public. Through implementation of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has utilized its public health mandate to regulate and create evidence-based decisions on drugs, medical devices, and other medical products, ensuring that these products are safe and effective before and after they receive market authorization. FDA regulations set requirements and expectations for medical products at every point in their life cycle, from clinical trials and drug development to the approval of new drugs, marketing, and labeling, to post-marketing surveillance. However, these regulatory decisions can be subject to different plausible interpretations as FDA’s statutory scheme is inherently ambiguously written due to its technical nature. Importantly, FDA’s discretion to promulgate rules and interpret ambiguous statute is key to its oversight of the complex and evolving medical product landscape, a role that has been intentionally allocated by Congress. 

A glimpse of the administrative state without deference to the FDA was quickly revealed during Justice Kagan’s and Justice Jackson’s questioning in oral argument: If a new medical product is designed to promote healthy cholesterol levels, is that product a drug or a dietary supplement? What makes a clinical investigation “adequate and well controlled”? As outlined in our amicus brief, the answers to these essential questions have clear ramifications for the safety and efficacy of medical products used by the public, and the courts cannot answer these questions without sufficient scientific expertise. 

II. Complex Statutory Schemes Require Technical, Scientific Expertise 

The Federal Food, Drug, and Cosmetic Act is the prime example of a complex statute that requires delegation to the expert agency, and the Chevron opinion was explicitly written with an understanding that certain agencies fundamentally regulate based on their technical expertise. Most Article III courts lack the necessary expertise to make precedent-setting public health decisions, as judges have wisely acknowledged by utilizing Chevron in lower court cases challenging the FDA. Abandoning Chevron would be abandoning a doctrine of humility as Justice Kagan described in oral argument. 

Practicing so called “armchair epidemiology” would essentially be interpreting the technical nature of the FDCA, regulating public health without any scientific expertise. This is clearly out of reach for many courts as demonstrated in Otsuka Pharm. Co v. Price, where courts were found to be not competent to evaluate if “a company created a new ‘active moiety’ by joining a previously approved moiety to lysine through a non-ester covalent bond.” Similarly, as show in the Mylan Laby’s, Inc. v. Thompson opinion in the D.C. Circuit, there is an inherent complexity in the “evaluation of scientific data,” outlining the necessity of interpreting “statutory phrase[s]… in the context of the kind of drug at issue.” The FDA is responsible for developing scientifically sound solutions to complex public health problems, where the understanding of a given medical product and the context of the problem are constantly in flux.

Beyond these highly technical, scientific limitations in evaluating complex litigation, most courts are unable to resolve fundamental questions that make up the bread and butter of FDA decision-making. As alluded to above, the FDA is the authority that approves all “new drugs,” which requires proving that the drug demonstrates “substantial evidence of efficacy, or “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and expertise to evaluate the effectiveness of the drug involved.” Congress does not explicitly outline what qualifies as a “adequate and well-controlled” investigation, but it is clear that the intention of the narrow gap in statute was for the agency to interpret through regulatory action, not the courts. Given the breadth and ambiguous nature of the statute without express delegation to FDA’s interpretation, a world without Chevron means that any basis for a new drug approval could be challenged by ambitious litigators, forcing the courts to determine the appropriate bar for scientific evidence for approval and other regulatory decisions affecting what drugs, devices, or other medical products might be made available for the public.

Overruling Chevron would also affect specific FDA programs that are utilized to advance life-saving medical products. The FDCA allocates a special type of drug approval process known as “Fast Track” authority. This authorization mechanism is an expedited form of development and review of a drug if, as outlined in statute, (1) “it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition,” and (2) “it demonstrates the potential to address unmet medical needs for such a disease or condition.” The FDA has sole authority to determine whether an investigational new drug should qualify under these technical requirements for this “Fast Track” regulatory pathway. With this authority, the FDA has interpreted the language in this statute to execute a unique balancing act—one of finding treatments for life-threatening diseases for which there are limited or no alternative options while attempting to ensure that the inherent risk in expedited treatments is mitigated. 

Medical risk-based judgements create line-drawing problems, where the FDA must approve or deny a Fast Track application depending on its reasonable expert assessment. This creates ample opportunity for an aggrieved manufacturer to challenge the FDA’s assessment in the courts. A dreaded scenario could arise where the courts are forced to act as a drug policymaker, determining which drugs are available on the market, without any technical ability to determine if that drug is safe or effective. 

A world without Chevron could also present safety concerns in the context of medication labelling. Drug labelling is an essential practice to guide physician prescribing and patient use of medicines. Drug safety is dependent on dosage, and drug interactions can render certain drugs dangerous for individuals. These labels are situation dependent on the individual’s health circumstances and the drug’s use itself. Accordingly, the FDCA provides a guideline for manufacturers to market a correctly labeled drug, which are subject to penalties if misbranded: “unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.” The meaning of “adequate directions for use” is subject to interpretation as it is not clearly defined in the statute. The functional use of this definition for patients and prescribers requires a comprehensive and uniform labeling layout, one that is described in FDA regulations

Broadly, upsetting the balance of agency decision-making risks burdening agencies to the point where they channel all their energies into justifying their actions. Agencies would likely become slow, with deflated oversight, all while opening the floodgates for litigation. Chevron prevents unnecessary challenges from arising, and removing this test could bring in chaos, forcing an opportunity cost where new action is tied up in courts, and the ability to engage in meaningful, timely regulation for new innovations is limited. This conundrum extends beyond FDA’s regulation of new drugs—it applies to medical devices, vaccines, tobacco and food regulation, and has significance for all other regulatory agencies that have authority over medicine and public health related functions, such as the Centers for Disease Control and Prevention, the Environmental Protection Agency, and Centers for Medicare & Medicaid Services. As others have highlighted, these agencies interpret complex statutes on a daily basis and make conflicted decisions between stakeholders with varying interests, from patients to care providers to industry. 

III. Addressing Criticisms of Chevron in the Context of the FDA

Petitioners in oral argument often advanced the argument that the Chevron doctrine has prevented Congress from legislating. However, the breadth of legislation related to food and drugs since the Chevron opinion renders this argument moot. Congress passes plenty of legislation, often in collaboration with the FDA, such as the recent accelerated approval reforms in the Food and Drug Omnibus Reform Act. Additionally, Congress has overcome significant gridlock to unite in opportune moments, particularly in reauthorizing and recalibrating FDA-related legislation such as the Prescription Drug User Fee Act. These are examples where Congress has given authority to the FDA to keep up with the pace of complex scientific discovery, including around clinical trial design, which is constantly in flux in anticipation of new, innovative products.

The suggestion that agencies have become policymakers is a far better alternative than the courts transforming their independent interpretative role into policymaking. In many of the instances outlined by the petitioners, it is unclear what the test is to determine the distinction between law and policy, but it is clear that Congress has legislated with intent and often explicitly delegated authority. For example, Congress has legislated the FDCA in the context that the FDA must define statutory terms like “reasonable” in medical risk-based judgments. This definition is almost never the worst interpretation, and it is almost guaranteed that the court’s definition would be worse. In a scenario where the courts are “forced to adopt the worst interpretation,” as suggested by the result of Footnote 11 of Chevron, the alternative is one where the courts are forced into a policymaking judgment limited by the tools of statutory interpretation, one where deference becomes politicized. Courts still have policing powers as outlined in Kisor opinion, and Footnote 9 of Chevron demonstrates that the judiciary is the final authority on decisions when administrative interpretation is outside the clear intent of Congress.

Perhaps more significantly, upsetting Chevron deference risks courts producing divergent outcomes in different jurisdictions, one where it is unclear what precedent exists for the agency determination at hand. This would implicate a variety of different public health stakeholders, particularly the pharmaceutical and medical device industries. A lack of certainty could arise in meeting regulatory bars for approval, or manufacturers could have a conflicted understanding of the exact terms of enforcement on issues like drug or medical device safety. Certainty is key to industry buy-in—it is the backbone of how pharmaceutical manufacturers can plan business strategy and anticipate returns. If courts diverge in outcomes, for example on the burden of approval for a new class of gene therapies, return on investment could be unclear. Under the Chevron framework, judges have an easier time reaching common ground on complex programs that often have wide disputes. Without this framework, decisions lose uniformity value and diminish the force of executive political accountability. 

The FDA is the opposite of an insulated policymaker. In fact, stakeholder engagement is instrumental for existing and new regulations. FDA’s regulatory process involves a significant notice and comment process that robustly engages with a variety of different stakeholders. The agency also receives and responds to citizen petitions, meets with stakeholders, conducts informational workshops, and holds open meetings of its various advisory committees. This process is necessary for regulated entities to make informed decisions. Without it, the FDA and clinicians are forced to make decisions without a joint understanding of certain responsibilities for programs like postmarketing surveillance, drug safety communications, and a whole host of other issues. Overruling Chevron would fundamentally disrupt the separation of powers, and place distance between these regulated parties and regulatory processes in a way that Congress did not intend. 

logical counterargument to the absence of judicial expertise is that the lower courts are more likely to agree with the agency’s specialized interpretation. However, overruling Chevron could increase the likelihood of appeal given that each court likely has its own methods of interpretation. This can swing decisions—particularly if other doctrines are utilized such as major questions or non-delegation. Moreover, without the precedent of prior opinions that relied on Chevron in making the determination to defer to the agency, this may also lead to increased challenges to agency regulations in the courts, forcing agencies to shift their responsibilities and composition of experts focused on legal defense rather than policymaking and scientific interpretation. The increased threat of legal challenge could in turn chill efforts to develop new regulations around novel biomedical innovations, slowing their availability to patients, or worse, allowing unregulated access without a clear framework to proactively assess their safety or efficacy.

If the Supreme Court decides to fall back on the Skidmore framework of consistency and persuasiveness of the agency, FDA law experts expect this to open the litigation floodgates. Skidmore provides litigants a mechanism to attack the regulation of statute in certain circumstances such as approvals and withdrawals of medical products. Notably, the FDA implements the broad language of the FDCA by extending expansive regulatory flexibility to approve new drugs with varying quality and quantity of evidence. This medical risk-based assessment could be argued to be an inconsistent and ambiguous application of the law, allowing FDA regulatory decisions to be challenged by utilizing past approvals as precedent. For example, if a manufacturer can persuasively argue that approval of a new drug should be granted based on previously implemented regulatory flexibility of a similar, novel, in-class drug, individual approvals could face less scientific scrutiny or burden of proof as time progresses. The Skidmore framework could potentially even apply to drugs that have related indications or similar mechanisms, a distinction that is difficult to logically capture without scientific expertise.

IV. Conclusion

Overruling Chevron would drastically increase uncertainty and make public health agencies like the FDA less predictable and less effective. There is a high likelihood that decades of precedent would be undone by individual challenges to regulatory decisions, leading to great disorder—for Congress, for the agency, and for physicians and patients across the United States. The highest court should at the very least create a carve out for deference to scientific agencies, although it’s unclear how this would be operationalized. Regardless of how this court decides, with an array of complex public health and medical decisions arising in the 21st century, we need an effective government and more regulatory oversight, not less. 

Nikhil Chaudhry is a Postgraduate Associate at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency. Dr. Reshma Ramachandran is an Assistant Professor of Medicine at the Yale School of Medicine and Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency. Dr. Joseph Ross is a Professor of Medicine at the Yale School of Medicine, Professor of Public Health at the Yale School of Public Health, and Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency.

The authors would also like to thank Benjamin Seel, Will Bardwell, and Robin Thurston of Democracy Forward for their contributions in serving as Counsel of Record for the amicus brief referenced above.

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