In re: FDA Use of Guidance Documents
- Case Date: 12/7/2017
- Project Name: Health Care Project
On December 7, 2017, WLF filed formal comments with the Food and Drug Administration (FDA), charging that FDA’s heavy reliance on “guidance” documents as its principal regulatory tool undercuts the notice-and-comment-rulemaking requirements of the Administrative Procedure Act (APA) and imposes excessive burdens on the regulated community. WLF urged FDA to curtail its use of both guidance documents and “draft” guidances, arguing that doing so is an important step in coming into compliance with the Administration’s de-regulation mandate (as set forth in Executive Orders 13771 and 13777). WLF requested that FDA adopt several procedural reforms, including rules providing that: (1) a “draft” guidance not placed into final form within two years of issuance shall be automatically abrogated; and (2) no guidance will be issued in draft or final form until after FDA has determined that use of formal APA notice-and-comment procedures is not feasible.
|Awaiting FDA response.|
More Information and Downloads:
12/7/2017: Download the Comments
Food Safety News: Do FDA ‘guidance’ documents skirt the regulatory process?