Chevron Ruling Could Chill FDA’s Public Health Efforts, Stem AI, LDT Regulation

Chevron Ruling Could Chill FDA’s Public Health Efforts, Stem AI, LDT Regulation

June 28, 2024, Inside Health Policy

Jerry Masoudi’s commentary was included in an Inside Health Policy article considering how the U.S. Supreme Court’s decision to overturn the Chevron doctrine could force the Food and Drug Administration (FDA) to spend more time considering the political and legal environment surrounding regulatory efforts.

Jerry told Inside Health Policy it was reassuring that the Supreme Court chose to say past court decisions are not vulnerable to being overturned simply because they were decided under Chevron. He said the new paradigm might limit the uncertainty when FDA policies change dramatically between presidential administrations, and likely won’t impact most individual product approvals. Jerry added that the decision will increase uncertainty if courts make conflicting rulings on a regulation in different districts and could lead to an increase in forum-shopping in which plaintiffs file suit in a specific jurisdiction in search of the ruling they want.

“It may result in FDA relying more heavily on guidance, because when it puts in place regulation, that’s when it’s likely to be challenged in court,” he said. “The guidances, as they say, are voluntary. They’re recommendations. It may result in more FDA guidance, as opposed to regulation, which also create uncertainty.”