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# DoJ Not Enforcing Guidances
- URL: https://www.fdaweb.com/doj-not-enforcing-guidances/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140642

A recent Justice Department directive requires that civil litigators who bring affirmative civil enforcement (ACE) cases not convert other agency guidance documents into binding rules. Attorneys **Anne Walsh** and **Rachel Hunt** (Hyman. Phelps & McNamara) [write](http://www.fdalawblog.net/2018/01/guidance-on-guidance/?ref=fdaweb.com) in their firm’s *FDA Law Blog* that associate attorney general **Rachel Brand** said she was announcing a new policy that “helps restore” the appropriate role of guidance documents.

The action follows a Trump administration 11/2017 indication that the Administrative Procedures Act requires notice-and-comment rulemaking when purporting to create rights of obligations binding on members of the public or the agency and said that guidance may not be used as a substitute for rulemaking.

Walsh and Hunt say the Justice Department specifically identified False Claims Act cases as subject to its new policy, meaning that such cases can no longer be based on allegations that a company engaged in off-label promotion because it did not meet requirements in relevant FDA guidances. Likewise, they add, the department cannot support a theory that products are unapproved because they don’t have the documentation recommended in a specific FDA guidance, and it can’t enforce requirements on compounding facilities that have failed to perfectly follow the many guidance documents FDA has issued.

“We note that DoJ’s policy cannot stop FDA from continuing to allege violations of its guidance and taking administrative action against companies,” the attorneys conclude. “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.

The policy’s application particularly to False Claims Act cases was explained in a blog [post](https://www.druganddevicelawblog.com/2018/01/guidance-on-guidances-doj-says-its-litigators-may-not-use-noncompliance-with-fda-guidances-as-basis-for-civil-enforcement-actions.html?ref=fdaweb.com) by attorney **Stephen McConnell** (Reed Smith). “At first blush,” he says, “this new guidance will have immediate and profound effects on actions brought by the government against health care companies under the False Claims Act. Too many of those actions are premised on no actual false statement and no actual violation of a statute or regulation. Instead, these FCA cases have been permitted to go forward and exercise their *in* *terrorem* effect based on some vague violation of vague FDA guidances. Even if not vague, an FDA guidance has no real legal effect. The DoJ’s recognition of what guidances are and, more importantly, what they are not, should have the effect of cabining FCA actions in some reasonable and predictable fashion.”