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Replies to post #21996 on Charlotte's Web Holdings Inc (CWBHF)
In overruling Chevron on Friday, the Supreme Court ushered in a new framework, dubbed Loper Bright. Courts are now required to “exercise their independent judgement in deciding whether an agency has acted within its statutory authority” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This new framework could have significant consequences for the FDA and its regulatory authority, according to an analysis by global law firm Sidley.
The firm contends that Loper Bright could potentially open the regulator’s drug approvals to legal challenges. Companies need to provide “substantial evidence” that their drug candidates are safe and effective before securing approval, but courts in the past have found this ambiguous and have allowed the FDA to ask for additional requirements, such as data showing that the candidate’s effects are clinically meaningful, according to Sidley.
Under Loper Bright, more companies could try and challenge this approach, Sidley warned.
The overturning of Chevron could also pose some jurisdictional questions for the FDA, which is typically given the leeway to decide what constitutes a dietary supplement or a device product. These kinds of determinations affect how products are regulated, produced, or imported—and companies can now mount stronger challenges to this function by the FDA.
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