The Post-Chevron Regulatory Landscape: Implications for the FDA and Healthcare Industry

Chevron Deference Overturned:
The U.S. Supreme Court overruled the Chevron doctrine in Loper Bright Enterprises v. Raimondo, Case No. 22-451, 603 U.S. _(2024), ending nearly 40 years of judicial deference to federal agencies' interpretations of ambiguous statutes.

Impact on FDA:
The elimination of Chevron deference is expected to expose FDA decisions and interpretations to greater judicial scrutiny, potentially leading to an increase in legal challenges against FDA regulations and decisions.

Healthcare Industry Implications:
The ruling will significantly impact the healthcare industry, affecting agencies like the U.S. Department of Health and Human Services (HHS), FDA, and the Centers for Medicare and Medicaid Services (CMS). This could lead to a patchwork of health regulations due to contradictory rulings in different jurisdictions.

Legal and Regulatory Challenges:
The decision in Loper and Corner Post will create a sea change in administrative law, with wide-ranging implications for regulated industries. This includes an anticipated increase in litigation to test the new limits of agency deference and potentially revisit existing precedent.

Scientific Determinations:
While the ruling may have less impact on FDA's scientific determinations, such as drug reviews, decisions based on interpretations of regulation or statute, like marketing exclusivity, could face heightened scrutiny.