Guidance May Not be Used as a Substitute for Rule making

On November 2017, Trump Administration issued a memo stating that “the Administrative Procedure Act requires notice-and-comment rulemaking when purporting to create rights or obligations binding on members of the public or the agency.”  In the memo the Department of Justice stated that “The Department will no longer engage in this practice. Effective immediately, Department components may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch (including state, local, and tribal governments).”

As part of FDA’s administrative authority, it issues many guidances to help the industry it regulates. FDA however, clearly states that “guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.” Unfortunately, FDA appears to consider its guidances more than suggestions or recommendations and cites companies for noncompliance to these recommendations.

Although this is an interesting development, this DOJ policy is not binding on the FDA.  Therefore, it remains to be seen if FDA will change it’s own policies in light of the DOJ decision.


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