What the Overturning of Chevron Could Mean for the FDA and Industry: A Roundup of Initial Analyses
Legal experts and industry analysts weigh in on how the end of Chevron could reshape FDA regulations and the life sciences.
As you might have heard, the Supreme Court overturned the Chevron Doctrine.
Chevron has been a principle in U.S. administrative law since 1984 that guides courts in reviewing federal agencies' interpretations of statutes. It involves a two-step analysis: first, determining if Congress has clearly spoken on the issue, and if not, deferring to the agency's interpretation if it's reasonable. This doctrine gives agencies significant latitude in interpreting ambiguous statutes based on their presumed expertise and political accountability.
If you need a great introduction or refresher on Chevron, we suggest this primer published by the Congressional Research Service last year.
Today’s cases may well give life sciences companies free rein to combat FDA regulations in cases where Congress was less-than-clear about what it intended or wanted.
Below is a brief roundup of initial analyses and perspectives on how the end of Chevron may impact the FDA and the industries it regulates. We’ll update this list as time goes on and more analysis emerges.
(Politico) Chevron ruling could clog the drug pipeline: POLITICO's take on the Supreme Court's Chevron ruling is that it could significantly slow down the FDA's drug and medical device approval processes. By overturning the Chevron deference, the ruling opens the door to increased legal challenges and longer decision-making times for the FDA. This could disrupt the stability medical product manufacturers rely on and impact other health policies, such as Medicare drug negotiations, private insurance coverage, EMTALA, and NIH clinical trial rules.
(Arnold & Porter) Chevron Overturned: What Does It Mean for Life Sciences Companies: Arnold & Porter focuses on the implications for the life sciences industry, suggesting that agencies like the FDA may need to adjust their rulemaking practices in light of the decision. They discuss the potential for challenges to longstanding regulations, noting that while the Court stated prior cases relying on Chevron are not automatically invalidated, there may be opportunities to seek reconsideration under certain circumstances. The analysis highlights the Court's recognition that some statutes expressly grant agencies discretionary authority, which courts must respect. Arnold & Porter also notes the potential for increased litigation and suggests that regulated industries may have new opportunities to engage with agencies to modernize or clarify authorities or to encourage Congress to clarify ambiguous statutes.