The U.S. Food and Drug Administration (FDA) announced that the agency would implement coronavirus guidance documents without first holding comment periods to solicit public feedback. The agency stated that it would not be feasible or appropriate to review public comments before implementing coronavirus guidance documents.
Guidance documents, which advise interested parties about how agencies implement regulations, are exempt from the procedural requirements of the Administrative Procedure Act (APA), including public comment periods. However, the FDA encourages members of the public to provide feedback on its draft guidance documents. The agency’s internal Good Guidance Practices regulation requires the FDA to hold comment periods prior to implementing guidance documents that put forth new statutory or regulatory interpretations, make significant changes to policy interpretations, feature complex scientific subject matter, or involve controversial issues.
The FDA stated that it would continue to hold public comment periods on the coronavirus guidance documents and retroactively revise guidance as needed based on public feedback. The agency has issued coronavirus-related guidance documents in recent weeks, including guidance on the production of alcohol-based hand sanitizer to help boost supply, guidance on conducting clinical trials for medical products during the coronavirus outbreak, and guidance on diagnostic coronavirus tests for clinical laboratories and commercial manufacturers.