Informal Guidance and the FDA

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Informal Guidance and the FDA

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Title: Informal Guidance and the FDA
Author: Lewis, Kevin Michael
Citation: Kevin Michael Lewis, Informal Guidance and the FDA (August 2011).
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Abstract: This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of policymaking, as opposed to more formalized procedures like notice-and-comment rulemaking or case-specific adjudication. Using major developments in administrative law and modifications to the FDA's regulatory regime as milestones, I trace how and why the FDA's use of informal guidance to fulfill its statutory mandate has changed over the past century. Along the way, I identify important doctrinal questions that persist today, namely (1) whether informal advisory opinions bind the FDA and (2) the degree of judicial deference guidance documents should receive under the Supreme Court's decisions in Chevron and Mead. I attempt to resolve these doctrinal ambiguities. I then undertake a normative analysis of the FDA's increasing reliance on informal guidance, and conclude that, on the whole, this development has benefited the FDA's major stakeholders: regulated entities, the general public, and the agency itself. I close with modest proposals for reform and suggestions for further research. The article features an appendix with several tables illustrating the FDA's output of informal guidance documents by year, to facilitate further study.
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