Chevron Overturned: FDA at a Crossroads, But How Will Physicians Be Affected?

On June 28, 2024, the United States Supreme Court overturned the doctrine of Chevron deference, revoking the power of administrative agencies to interpret the statutes of ambiguous laws.¹ Although this major court decision made headlines in the news, many physicians still have lingering questions about how this change will have a downstream effect on the health care industry.

We spoke with pharmacist and attorney Susan C Winckler to get more information. Ms Winckler is the CEO of the Reagan-Udall Foundation, the non-profit organization created by Congress to advance the mission of the Food and Drug Administration (FDA). She has also served as President of Leavitt Partners Solutions, a national healthcare strategy firm founded by Governor Michael O Leavitt, former Secretary of the US Department of Health and Human Services. With Chevron overturned, Winckler elucidates what this ruling means for physicians.

Chevron Overturned: History and Current Interpretation

The Chevron ruling came out of the landmark 1984 case Chevron USA, Inc v Natural Resources Defense Council, Inc. In this case, the Supreme Court ruled that courts can defer to an administrative agency’s interpretation of statutes as long as those interpretations are “reasonable.”²

For the past 40 years, the Chevron deference doctrine was a foundational administrative law principle. Agencies were granted authority to interpret specific statutes, given that the courts felt the agency’s expertise made them the most suitable authority on certain laws. However, critics of the doctrine felt it gave too much power to unelected government officials, and that law interpretation should remain with the courts.²

The specific cases that brought Chevron deference into question involved the National Marine Fisheries Service of the Magnuson-Stevens Fishery Conservation and Management Act, which is a statute from 1976 that aimed to prevent overfishing.³ The National Marine Fisheries Service is an agency that required herring vessel owners to pay for contracted monitors. In 2 court cases, these owners challenged the agency’s authority to force vessel owners to bear this expense. District courts ruled in favor of the agency under Chevron, and the DC Circuit and First Circuit also affirmed these decisions.

However, the Supreme Court reviewed these cases to decide if Chevron deference should be overruled or clarified. Ultimately, the Supreme Court decided to overturn Chevron, stating that the court has the final say in interpreting the law; agencies do not.³

Although Chevron was overturned, the Supreme Court stated that past decisions based on Chevron should not be put up for review. Nonetheless, the ruling is likely to increase litigation in the lower courts in response to any agency actions.³

According to Winckler, the Chevron ruling has made the administrative branch more cautious about taking actions that are further removed from the statutes. As such, statute writing has slowed as Congress has been more cautious. Winckler says agencies across the board are focusing more on documentation and tighter reviews to tie decisions back to the statutes.

The Federal Food, Drug, and Cosmetic Act

Although other industries may feel the effects of Chevron more than the medical industry, Winckler explained that Chevron may likely affect the Food, Drug, and Cosmetic Act, given that it’s so routinely reviewed. “Congress looks at the FDA’s authorizing statute frequently – there is some greater familiarity and a must-pass package every 2 or 3 years. Congress has to respond to litigation and change statutes as needed or move into more specific statutes,” she shared.

Highly regulated prescription medications may be less vulnerable to Chevron-related changes, but Winckler feels digital tools could be affected. “The regulation of digital tools for mental health may be under more scrutiny. The FDA has a regulatory pathway for approving health interventions and deciding which ones need to come before the agency,” she explained. “If you have a digital tool developer or a physician who doesn’t think the FDA should regulate those tools, they may challenge that. They may become more available without the same safety and regulatory oversight.”

With Chevron overturned, many physicians are uncertain about how this may affect medications. Winckler anticipates that “the drug component may be more settled than other areas,” but added cannabis, ketamine, and psychedelics could run into some challenges. “It will be interesting to see how the overturning of Chevron may impact things like ketamine clinics. What could happen is that a drug developer decides to get an approved indication for ketamine that’s not already approved, which would give them patent protection and clear up the market for these other ketamine clinics,” she remarked. “That may lead to litigation from other ketamine clinics to say it’s outside the agency’s purview to regulate it.”

Other legal experts have suggested that overturning Chevron may embolden pharmaceutical companies who have criticized agency decisions in the past but didn’t go as far as to challenge them in court. In the “post-Chevron” world, litigation against the FDA’s interpretation of the Food, Drug, and Cosmetic Act may increase, especially given the high economic stakes of patent and exclusivity decisions.³

Potential Consequences for Behavioral Health

Behavioral health practices may also feel the effects of overturning Chevron, as lower courts will have more authority over the regulation of behavioral health.⁴ Those opposed to the change have expressed concern that courts don’t have the same expertise as agencies to make decisions on behavioral health regulation. They feel agencies are more well-versed in the complexities of mental health treatment. However, those in favor of overturning Chevron have argued that judges are legal experts who are the best suited to interpret laws, regardless of the subject matter.

Health care organizations have expressed concerns that overturning Chevron would disrupt publicly funded health insurance programs, including Medicare and Medicaid. As a result, this change could directly affect a large number of behavioral health providers operating under these plans.⁴

What Does the Ruling Mean for Physicians?

Winckler says the overturning of Chevron should not affect physicians or practicing psychiatrists just yet. However, the future is still somewhat uncertain. She explained, “The relative deference you typically give to the federal agency no longer applies. It’s not as if a wholesale change will happen outside the courtroom. It’s solely going to affect litigation, and it may inspire more litigation on past decisions.”

She also explained, “A lot of litigation comes from market exclusivity and patents because that’s where motivation comes from. When moving products from prescription to over-the-counter status, the FDA must determine whether there should be a longer exclusivity.”

Winckler says physicians must remain vigilant when making prescribing decisions and stay current with the laws surrounding all mental health interventions.

This article originally appeared on Psychiatry Advisor