Chevron Challenges: Supreme Court Decisions Could Reshape FDA Authority

May 20, 2024

This term, the U.S. Supreme Court heard arguments on and will decide two cases that could have major impacts on federal agencies’ authority to interpret federal statutes—and to enforce federal statutes according to their interpretations. The cases, Loper Bright Enterprises v. Raimondo and Relentless Inc. v. U.S. Department of Commerce, involve challenges to the Court’s decision in Chevron v. Natural Resources Defense Council made 40 years ago, which established what has since become known as the Chevron doctrine.

The Chevron Doctrine and Its Erosion in Recent Years

The Chevron doctrine holds that when a federal statute is ambiguous, a federal agency charged with enforcing the statute can interpret the statute independently—and the courts must generally respect the agency’s interpretation unless it is unreasonable. Over the past 40 years, federal agencies across the executive branch have relied on the Chevron doctrine to act without seeking additional direction from Congress, and without fear of judicial second-guessing. At least 17,000 cases cite or rely on Chevron.

In recent years, however, the Supreme Court has begun to limit federal agencies’ authority under the Chevron doctrine. In 2021, the Court invalidated an eviction moratorium that the U.S. Centers for Disease Control and Prevention (CDC) issued during the COVID-19 pandemic, ruling that the CDC had exceeded its authority under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. In 2022, the Court invalidated the U.S. Environmental Protection Agency’s (EPA) efforts to force power plants to use cleaner alternatives to coal, which the EPA had implemented under the Clean Air Act. In 2023, the Court rejected the U.S. Department of Education’s federal student loan forgiveness program based on a lack of sufficient statutory authority.

Implications for FDA-Regulated Industries

The potential elimination or further limitation of the Chevron doctrine could have significant implications for FDA-regulated industries, which relies on Chevron to interpret and enforce complex statutes governing product approval, marketing, and post-market surveillance. A shift in the Court’s stance could lead to increased judicial scrutiny of FDA decisions, creating uncertainty and potential delays in regulatory approvals.

For example, the FDA’s authority to issue guidance documents and make interpretive decisions about statutory and regulatory requirements could be constrained, leading to a more rigid and less flexible regulatory environment. This could impact the approval process for new drugs and devices, changes to labeling, and post-market requirements. Companies might face more litigation as courts take a more active role in interpreting statutes rather than deferring to FDA’s expertise.

Will the Supreme Court Eliminate the Chevron Doctrine in 2024?

Given the Supreme Court’s recent willingness to overturn longstanding precedents, such as Roe v. Wade, there is a possibility that the Court may eliminate or significantly restrict the Chevron doctrine in 2024. The Court’s decision to hear Loper Bright Enterprises v. Raimondo and Relentless Inc. v. U.S. Department of Commerce suggests that it considers the legitimacy of the Chevron doctrine to be an open question. Regardless of what the Court decides, its opinion may have significant implications for the FDA and companies that are subject to their regulatory authority.

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