Regulatory Silence at the FDA

Regulatory Silence at the FDA

By Jordan Paradise. Full Text Here.

Action speaks louder than words, but silence often speaks loudest. Where statutory language specifically directs a federal administrative agency to act, the agency must adhere to the conditions and timeframe provided by Congress. Yet the statute may instead give general authority to an agency, use vague or capacious terms, and leave ample discretion to the agency to determine how best to interpret the statutory language and accomplish regulatory tasks. Facing difficult policy choices and an absence of direct statutory mandate, agencies may determine that not acting is the most rational option for any number of reasons. Decisions not to act may be less likely to trigger citizen petitions, industry criticism, pushback from Congress, or protracted litigation. However, decisions not to act nonetheless have an impact.

This Article explores a realm in which the U.S. Food and Drug Administration (FDA) has consistently decided not to act when in fact the statutory framework provides implicit authority and discretion to the agency to act: the intersection of product approval and patent law. Two recent examples illustrate this phenomenon. The first involves patent protection and access to innovator product risk evaluation and mitigation strategies; the second involves the patent procedures for biosimilar biologic approval. In both examples, the FDA has neglected to introduce meaningful guidance or direction that would address ambiguity inherent in the statute. Despite a Supreme Court decision in June 2017 regarding aspects of the biosimilar patent procedures, industry uncertainty and bad behavior remain. The significant and unfortunate results of agency decisions not to act may be felt across a variety of fronts, some easily quantifiable (such as litigation costs), and others less so (such as higher costs to consumers, approval delays, abandoned products, and patient safety).

Drawing from administrative law literature and case law, this Article argues that the FDA has a duty derived from its public health mission to act assertively in such cases where inaction creates a state of industry uncertainty and imposes negative impacts on access and innovation. Incremental agency activities during the second half of 2017 have addressed general problems with competition and the current FDA Commissioner is scrutinizing ongoing industry behaviors. However, acting by expressly interpreting ambiguous provisions in the statute, where appropriate, would directly address the problems at hand.