“FDA’s turn away from notice-and-comment rulemaking has an obvious motive:  formal rulemaking can be quite cumbersome, and FDA would prefer where possible to avoid the time and expense involved.  But the agency’s embrace of informal rulemaking imposes significant and unwarranted regulatory burdens on affected industries.”
—Richard Samp, WLF Chief Counsel

WASHINGTON, DC—The Washington Legal Foundation late yesterday charged that the Food and Drug Administration’s (FDA) 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.  In formal comments filed at FDA’s invitation, WLF argued that curtailing use of both guidance documents and “draft” guidances is an important step in coming into compliance with the Administration’s de-regulation mandate.

Executive Orders 13771 and 13777, issued earlier this year, placed a priority on reducing unnecessary regulatory burdens on the American people, and called on each federal agency to evaluate all existing regulations and to identify those that may merit repeal or modification.  In compliance with those orders, FDA requested the public to submit comments identifying regulations whose modification would reduce regulatory burdens while still allowing FDA to achieve its public health mission.

WLF’s comments focused on FDA’s increasing reliance on guidance documents.  WLF noted that FDA has released more than 2,000 guidances and draft guidances, many covering topics that used to be covered by formal regulations adopted pursuant to the APA’s strict notice-and-comment requirements.  WLF argued that this switch to informal rulemaking imposes significant burdens on the regulated community.  Among other things, it results in an increased number of rules; regulated entities cannot afford to ignore them, yet guidances and draft guidances (because of their informal nature) are not subject to judicial review.

WLF urged FDA to 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.

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