The Downfall of Chevron

On June 28, 2024, the United States Supreme Court released its decision in Loper-Bright Enterprises et al. v. Raimondo. On first glance, it appears Loper-Bright is merely a case interpreting a fishing regulations statute, but it is much more than that. Loper-Bright is a decision that will have immense, profound changes on agency regulations and the judicial system in the near future.

The Supreme Court’s decision in Loper-Bright overturned the 40-year-old precedent of Chevron U.S.A. v. Natural Resources Defense Council. The Chevron decision created a standard of judicial deference commonly referred to as the Chevron doctrine, which required federal courts to defer to an administrative agency’s reasonable interpretation of ambiguous federal statutes and regulations. Without the Chevron doctrine, courts may review challenged regulations without considering the agency’s own expertise. In Loper-Bright, the Court found that the Chevron doctrine was inconsistent with the Administrative Procedure Act (APA). The APA specifies that courts, not agencies, will decide “all relevant questions of law” arising on review of agency actionwhich includes interpretations of constitutional and statutory provisions. The Court found that the APA requires courts to exercise their independent judgment in deciding whether an agency has acted within its authority as delegated by federal statute, and courts need not defer to an  This decision, like many recent Supreme Court decisions, will have a major impact in health law, particularly on the Food and Drug Administration (FDA) and its regulatory framework.

FDA Mission & Responsibilities

The mission of the FDA is to protect public health by “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” To effectively protect public health, the FDA enforces laws — such as the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and carries out regulatory functionsIn performing its responsibilities, the FDA is often effectively utilizing its interpretation to serve a purpose relevant to goals. The Loper-Bright decision is so impactful because of on agencies like the FDA, which relied on independent interpretation of statutes to advance agency goals.

Post-Loper-Bright Changes

Under the Chevron doctrine, in a case involving the FDA, a court could find a statute ambiguous, then rely upon the FDA’s statutory interpretation and internal decisions to resolve the ambiguity, provided the interpretation was reasonable. Courts regularly granted Chevron deference to agency statutory interpretations, giving the FDA broad discretion to regulate as it saw fit. Without the Chevron doctrine, FDA statutory interpretations will be under far greater judicial scrutiny and FDA actions will likely face legal challenges more often.

Although the Loper-Bright decision formally eliminates judicial deference to agency interpretations, some deference remains. Consistent with the APA, judicial deference will still be granted to an agency’s interpretation of fact (a scientific or technical determination). Loper-Bright takes away judicial deference for“questions of law”. The Court also notes that there may be circumstances where agency interpretations should be utilized. Courts may “seek aid from the interpretations of those responsible for implementing particular statutes… [W]hen the best reading of a statute is that it delegates discretionary authority to an agency, Without Chevron, the FDA’s technical decisions, which reflect its scientific expertise, are less likely to face scrutiny compared to controversies that do not require the agency’s substantive knowledge. After Loper-Bright, a court could still potentially determine that deference to the FDA’s interpretation of a statute is consistent with the best reading of a statute.

Specific Issues the FDA May Face

In the wake of Loper-Bright, the FDA may face heightened judicial scrutiny, increased challenges to its drug approval decisions, and longer response times before rendering approvals, giving guidance, and making rules.

Heightened judicial scrutiny may manifest as drug approval applicants to the FDA are now more likely to challenge its decisions. For example, to obtain approval for a new drug, the FDCA requires applicants to provide “substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” This FDCA provision was previously found inherently ambiguous or deemed ambiguous by courts because it lacked clear direction as to what constitutes “substantial evidence” of a drug’s effectiveness. The FDA has interpreted substantial evidence to mean that the manufacturer must provide at least two adequate and well-controlled Phase III clinical studies, each demonstrating convincing evidence of effectiveness. When challenged in Warner-Lambert Co. v. Heckler et al., the FDA’s interpretation was upheld and manufacturers were required to submit documentation showing the clinical effectiveness of their drugs. Without Chevron in place, unsuccessful applicants for FDA approval are more likely to challenge the decision because a court will make the final determination rather than deferring to the FDA. This could potentially lead to the approval of drugs that would not have passed muster before Loper-Bright and, on the flip side, the denial of drugs that would have previously been approved. Ultimately, Loper-Bright is likely to encourage unsuccessful applicants to challenge the FDA .

As their decisions will now face greater scrutiny, the FDA is likely to take more time in their decision-making and interpretation processes than before. It will need to thoroughly consider all possible interpretations of a statute prior to establishing and acting upon its own interpretations to ensure consistent outcomes if challenged in court. Overall, the potentially slower FDA response time could disturb the stability upon which industries like medical products and medical drugs relied. 

What’s Next?

Although the FDA is now afforded significantly less deference than it previously had under the Chevron doctrine, it is not at a complete loss after the Loper-Bright decision. A decision by the United States District Court for the District of Columbia shows that courts might still give weight to agency interpretations under certain circumstances. In Novartis Pharmaceuticals Corporation v. Becerra et al., the court approved of the FDA’s decision and refused to substitute its own opinion because the FDA “provided a reasoned scientific basis for its conclusion.” The court in Novartis agreed with the FDA’s opinion, given the ample evidence and research that existed behind the agency’s determinations. This decision could indicate that courts will not treat the Loper-Bright decision as a complete overthrow of agency decisions but instead consider agency decisions with respect to the expertise and diligence they are founded upon. Agency interpretations could still be considered to some degree if they are well supported and persuasive. The Loper-Bright decision does not mean that courts will automatically rule against the agency and their decisions.

There is a possibility that Congress could take action statutorily the Chevron standard of judicial deference, but it is highly unlikely. The regulatory landscape will continue to change as decisions regarding the FDA are rendered, and the implications for health policy and the law are revealed.