In the coming weeks, the U.S. Supreme Court will rule on whether two fishing companies must bear the costs of third-party observers to ensure regulatory compliance on their vessels. On the surface, this issue appears to have little connection to biotechnology or medicine. However, the outcome could potentially alter the way the FDA interacts with the pharmaceutical industry due to its implications for the doctrine known as Chevron deference.
The case at hand, Chevron U.S.A Inc. v. Natural Resources Defense Council, revolved around the Clean Air Act and resulted in a ruling that regulatory agencies should be given deference when laws are ambiguous, provided the agency’s interpretation is reasonable. This principle has allowed agencies like the FDA to leverage their scientific and technical expertise in regulatory decisions, as highlighted during a panel discussion at the annual BIO conference in San Diego.
Zach Howe, Assistant District Attorney for the Southern District of California, noted that removing Chevron deference could compel courts to assume roles traditionally held by agencies. Such a shift might hinder regulatory processes that require specialized scientific knowledge.
The upcoming decision could also impact ongoing litigation concerning FDA regulations on medications, most notably, the case involving the abortion drug mifepristone. This medication, initially approved in 2000, has seen subsequent FDA actions to ease access, including permissions during the COVID-19 pandemic. If the Supreme Court decides in favor of the Alliance for Hippocratic Medicine, it could set a precedent that jeopardizes the approvals of other medications, according to Vanessa Burrows, a partner at Simpson Thacher & Bartlett.
This concern is echoed by Judy Haron from PhRMA, who indicated that a change in Chevron deference could influence not just the FDA but also other agencies like the Centers for Medicare and Medicaid Services (CMS). Legislative nuances often necessitate agency interpretations, such as those found in the Social Security Act regarding what constitutes “reasonable and necessary” services.
The wider implications of overturning Chevron deference are profound. It would alter regulatory practices established over four decades, adding significant complexity and potential litigation risks for industries that depend on clear regulatory frameworks. For further details, see the original article.