Guidance on Guidance: Enforcement to be Curtailed

We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding:

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

or

FDA’s 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.

This language provided little solace to FDA-regulated companies who have seen regulatory consequences result from a failure to comply with FDA’s guidance, for example in Warning Letters citing to guidance documents to support findings of noncompliance.

Until now. Last November, the Trump Administration reaffirmed 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,” and made clear its view that guidance “may not be used as a substitute for rulemaking.” The Department of Justice announced that it will discontinue its own practice of binding private parties without rulemaking, and imposed on itself the requirement that its guidance documents clearly state, among other things, “that compliance with those standards is voluntary and that noncompliance will not, in itself, result in any enforcement action.”

Last week, DOJ Associate Attorney General Rachel Brand announced that it will apply DOJ’s position about its own guidance documents to prohibit DOJ from using its civil enforcement authority to convert other agency guidance documents into binding rules. DOJ issued a memorandum directed at all DOJ civil litigators who bring affirmative civil enforcement (ACE) cases, defined as “civil lawsuits on behalf of the United States to recover government money lost to fraud or other misconduct or to impose penalties for violations of Federal health, safety, civil rights or environmental laws.” Of note, DOJ made clear that this policy is “new,” and that it “helps restore” the appropriate role of guidance documents. DOJ now limits the use of guidance documents to certain circumstances – e.g., to prove the requisite mens rea – and “effective immediately,” prevents civil litigators from using “noncompliance with guidance documents as a basis for proving violations of applicable law.” This policy applies to pending and future civil enforcement actions.

DOJ specifically identifies False Claims Act cases as subject to this new policy. For FDA-regulated companies, the impact could be huge. DOJ can no longer base False Claims Act cases on allegations that a company engaged in off-label promotion because it did not meet the requirements set forth in FDA’s Good Reprint Practice Guidance or the draft guidance governing Responses to Unsolicited Requests for Information.   It cannot support a theory that products are unapproved because they do not have the documentation recommended in FDA’s guidance on Deciding When to Submit a New 510(k) for a Change to an Existing Device or establishing Preamendment Status. And it cannot enforce requirements on compounding facilities that have failed to perfectly follow the countless guidance documents FDA has issued in lieu of notice-and-comment rulemaking.

We note that DOJ’s policy cannot stop FDA from continuing to allege violations of its guidance and taking administrative action against companies. Perhaps that will change soon. Nevertheless, the impact of the DOJ policy necessarily will extend to FDA enforcement decisions given DOJ involvement in any ACE cases brought to enforce FDA laws.