FDA DISPUTE CONSIDERATIONS FOLLOWING NEGATIVE AGENCY ACTION
When confronted with a negative agency action from the US Food and Drug Administration (FDA) or any regulatory agency, a company or sponsor must consider its options for responding to or challenging the decision in an administrative, or, when possible, legal and judicial forum. This article takes an informal look at those options in general without advocating for one position or the other. Rather, it is meant to help frame the issues for consideration.
Comprehensive legal strategy
As an initial matter, it is important to first take an assessment of the situation and form a comprehensive legal strategy for reaching the end goal that has been blocked by the negative agency decision. In most cases, the FDA will initially present a decision made by a review division or perhaps a centre decision on a citizen petition (a kind of formal request by anyone to ask the agency to do or not do something).
Since the FDA wants its decisions to be based on substantial scientific principles, it typically attempts to focus on the scientific issues presented rather than regulatory interpretations. In some cases, the FDA’s interpretations of statutory provisions and its corresponding enacted regulations or guidance may be based on how it believes or hopes the statute should be interpreted versus a developed policy based on the legislative history, which may not be well documented as a reference.
Oct-Dec 2022 issue
McDermott Will & Emery LLP