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Abstract

Administrative Agencies often rely on guidance documents to carry out their statutory mandate. Over the past few decades, the Food and Drug Administration (FDA) has been criticized for using soft law guidance documents to exercise powers beyond those authorized by Congress. Since attacks on the use of guidance documents persist and agencies need soft law to respond quickly and flexibly to rapid technological growth, it is essential to develop a solution that preserves this crucial regulatory mechanism and prevents its abuse. The most likely alternative to soft law guidance is formal regulation, which must be developed through the notice-and-comment process. The delays introduced by these formal processes, however, leave innovators uncertain about how to comply in the interim, which slows innovation. Alternatively, agencies may turn toward even less formal mechanisms, which are less expensive. However, these informal mechanisms also present problems, namely vagueness, contradictory rulings, and regulatory accumulation. This Note focuses on how courts can curb the abuse of guidance documents and avoid the pitfalls associated with these two alternatives.

This Note identifies the ends of FDA regulation, the various mechanisms the FDA uses to achieve these ends, and the Agency’s and regulated entities’ attitudes toward guidance documents. Courts may either treat notice-and-comment rulemaking as necessary to finality and refuse merits review or classify such documents as final and conduct a merits review. This Note endorses the latter solution because it helps courts preserve agency discretion, principally limits discretion, and incentivizes uniformity and predictability. This solution is limited to documents that are practically binding on the agency.

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