The Future of FDA Policy: Reflections From the Summer of 'Chevron'
Sheppard Mullin attorneys discuss 'Loper Bright Enterprises v. Raimondo' and include the considerations stemming from the decision, both generally and with respect to FDA practice, specifically. They write: "Now, after having spent the summer pouring over cases, articles, and thought leadership on the matter, we're not sure the win is so sweeping—especially in the U.S. Food & Drug Administration arena."
September 12, 2024 at 10:00 AM
8 minute read
Civil ProcedureBefore June 28, unless you were a lawyer or federal agency employee, the term "Chevron" probably meant little more to you than a gas station. But on June 28, when the Supreme Court overturned the long-standing "Chevron Doctrine"—which previously directed lower courts to defer to a federal agency's reasonable interpretation of a silent or ambiguous statute—regulated industry notched what was hailed a sweeping win and "Chevron" became part of our daily vernacular.
Now, after having spent the summer pouring over cases, articles, and thought leadership on the matter, we're not sure the win is so sweeping—especially in the U.S. Food & Drug Administration ("FDA" or the "Agency") arena.
FDA Policy: Business As Usual?
Loper Bright Enterprises v. Raimondo may not be the "sword" that we had initially assumed it would be against FDA policy. First, although the court formally eliminated the framework requiring binding agency deference, it did not eliminate the concept of agency deference altogether. Second, a significant portion of FDA policy is established through informal guidance, which was never subject to Chevron deference in the first place.
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