How To Get Rid of The “Totality of the Evidence” Amendment to The Intended Use Regulation

March 7, 2017By Jeffrey K. Shapiro

A few weeks ago, we blogged about FDA’s final rule amending the “intended use” regulation.  The final rule looks very different than the proposed rule, and adopts a new “totality of the evidence” standard that does not resolve the old problems with the regulation but introduces new ones.

As discussed in the blog post, a trio of pharmaceutical industry groups have filed a request for a stay with FDA. In addition, it appears the rule is vulnerable under the Administrative Procedure Act (APA), because FDA provided an inadequate opportunity to comment on the changes that occurred between the proposed and final rules.

This blog post discusses a third approach for getting rid of the final rule. Section 801 of the Congressional Review Act (“CRA”) ([5 U.S.C. § 801(a)(1)(A)) provides:

(a)(1)(A) Before a rule can take effect, the Federal agency promulgating such rule shall submit to each House of the Congress and to the Comptroller General a report containing –

(i) a copy of the rule;

(ii) a concise general statement relating to the rule … and

(iii) the proposed effective date of the rule.

The submitted reports are maintained by the General Accounting Office (“GAO”) in a searchable database.  Our search of the database did not turn up a report.  Therefore, under the statutory language just quoted, the final rule cannot take effect; the submission of a report is a condition precedent that has not been fulfilled.  If so, the new administration may simply withdraw the rule without going through a notice and comment process as might otherwise be necessary for repeal.

One argument against enforcing the CRA in this manner (allowing a withdrawal without notice and comment) might be that the failure to submit a report is “harmless error” that should not have such drastic consequences. An obvious counter‑argument, however, would be that this requirement is intended to force agencies to inform Congress of new rules so that they may be potentially disallowed by statute.  If this requirement is not enforceable, that purpose would not be served.  Furthermore, the language is fairly clear that a report must be submitted “[b]efore a rule can take effect.”  What more could Congress have done to express the effect of non-compliance, other than to perhaps add, “and we really mean it”?

FDA cannot claim ignorance of the requirement, which originated in 1996. A search of the GAO database shows more than 1,200 reports submitted by FDA, many of them recent.  Letting FDA pick and choose without penalty which rules to submit or not would be detrimental to the enforcement of the CRA.  Since FDA chose not to comply with the CRA with respect to this specific rule, it should suffer the consequences spelled out in the plain language of the statute.

We are not aware of court cases adjudicating this issue one way or the other. So we shall have to wait and see.  The CRA has very much been in the news with Congress invoking other provisions to repeal the Obama administration’s midnight regulations.  With this level of awareness, it is probably only a matter of time before the issue ends up in court.

A final hot tip: Anyone subject to an enforcement action relying even in part on the new intended use language should raise as a defense that the rule is null and void due to non‑compliance with the CRA.  Perhaps smart government lawyers will find a way to argue to a court that the language quoted above does not mean what it appears to mean.  But, it is they who will have an uphill climb.