Experts: Chevron deference ruling could impact recent FDA regulations

Legal experts say a recent US Supreme Court (SCOTUS) ruling that struck down Chevron deference could be used to challenge the Food and Drug Administration’s (FDA) authority on issues such as its recent decision to regulate laboratory-developed tests (LDTs). However, they noted that the courts will likely continue to defer to the agency on most decisions involving its expertise.

On 28 June, SCOTUS overturned the decades-old precedent of Chevron deference in the combined case Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo. The doctrine gave federal agencies significant leeway to interpret laws that Congress has not explicitly articulated.

Eva Temkin, a partner at Arnold & Porter, told Focus that despite concerns that FDA will lose all deference authority in interpretive decision-making and scientific fact-finding, that is unlikely as a practical matter.

“I think courts will still look to FDA scientific decision-making and that will still be a place where FDA enjoys considerable discretion,” she said. “But I do think the agency is going to have to take a really hard look at the way that it goes about making decisions on questions of statutory interpretation, and I recognize that it can be very difficult to disaggregate questions of statutory interpretation from questions of science and the FDA regulated landscape.”

John Elwood, also a partner at Arnold & Porter, agreed with Temkin, and told Focus that the emphasis in the discourse over the case has been on what agencies such as FDA have lost, and noted that there hasn’t been enough discussion about what authority remains in the hands of the agency.

“This is a big opinion, but it is only involving whether you can confer deference from ambiguity, but there's still a lot left to agency decision-making,” he said. “There are still areas where agencies are going to get deference... Areas where agencies have expertise and it's clear that Congress has set up a mechanism that counts on agency expertise like drug approvals.”

From the industry perspective, Temkin said that while manufacturers may want to challenge some FDA decisions, they also want consistency. She noted that sponsors make decisions such as how they will conduct trials and gather information long before they submit their premarket application and likely don’t want to shake up the current regulatory regime because that would introduce a lot of uncertainty.

Temkin thinks stakeholders may oppose FDA’s regulatory authority on more recent and less entrenched issues, such as LDT oversight and the definition of software as a medical device (SaMD), which will be easier to challenge using SCOTUS’ most recent decision. She also noted that the issue may also be applied in areas such as orphan drug exclusivity, where the courts have already disagreed with the FDA, but the agency has not yet applied the court’s interpretation.

Temkin said that over the past decade, she’s seen FDA request more specificity when Congress writes legislation that affects the agency so there is no ambiguity about its authority, such as its support for the Verifying Accurate, Leading-edge IVCT Development (VALID) Act and provisions in 2022 Food and Drug Omnibus Reform Act (FDORA). Considering the recent SCOTUS decision, she predicts that will continue to be the case.

Experts: Chevron deference ruling could impact recent FDA regulations

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