Two combined cases—Loper Bright Enterprises, Inc. v. Gina Raimondo and Relentless, Inc v. Department of Commerce—could have wide sweeping implications for the federal government’s ability to deliver for the American people and for our democracy as a whole.

These cases, also referred to as Loper Bright/Relentless, concern the relationship between federal agencies, Congress, and the courts and address a concept known as Chevron deference. Chevron deference, which is a concept that originated in a 1984 case Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, is a legal doctrine that stands for the proposition that when Congress passes a law that is ambiguous or unclear judges should defer to the expertise of federal agencies so long as the agency interpretation is reasonable.

In the nearly 40 years since Chevron, administrative agencies have been empowered to conduct countless services and programs serving the American people. Loper Bright/Relentless threatens administrative agencies’ ability to continue delivering for the people. In Loper Bright, some commercial fishing companies asked the court to overrule Chevron deference in response to a rule the National Marine Fisheries Service issued. The petitioners in Relentless challenged the same federal fishing rule, and similarly requested the overturning of Chevron deference. The Supreme Court then combined the two cases to become Loper Bright/Relentless.

If petitioners successfully convince the court to overturn Chevron, all administrative agencies and the thousands of programs and services they run could be at risk. Briefs filed in these matters highlight wide-sweeping implications that could disrupt our health care sector, environmental sector, national security sector, and small business sector, among others, if the Court sides with petitioners in Loper Bright/Relentless.

Physicians and experts in pharmaceutical and regulatory policy explain to the U.S. Supreme Court that the FDA’s regulation of drugs and medical devices is highly technical, relies on scientific expertise, and requires complex policy judgments; all decisions to which judges should continue to defer, not substitute their own non-expert assessments.

The logic behind Chevron deference is that “[j]udges are not experts in the field,” as the Chevron court put it. Many of the decisions the FDA makes interpreting the Federal Food, Drug, and Cosmetic Act require expert analysis to reach scientifically-sound results. For instance, the FDA is responsible for: approving new drugs and medical devices, evaluating whether new drugs seeking FDA approval meet various safety standards, overseeing the labeling of drugs to ensure health care professionals understand their usage and patients can too, and more. 

Each of the FDA’s responsibilities have large ramifications on the country’s public health. The Court should avoid the potential for destabilizing a regulatory regime that the FDA has capably used for nearly a century to foster scientific and medical innovation, while also ensuring that dangerous or ineffective drugs and medical devices do not routinely threaten public health, as they once did.

On January 17, 2024, the Supreme Court heard oral arguments in these cases, during which justices referenced concerns raised in this brief.

Specifically, Justice Kagan began her questions for the day by asking whether courts should determine if a product designed to promote healthy cholesterol levels “is a dietary product or a drug”—which is an example we provided in the brief. 

Justice Jackson referenced the FDA specifically several times, noting that it is FDA regulation that ensures how drugs are approved by “adequate and well-controlled investigation”—a point also made in our brief.