The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product.  FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).

In the Final Rule, FDA had amended the intended use regulations for drugs and devices at 21 C.F.R 201.128 (drugs) and 21 C.F.R. 801.4 (devices).  In announcing the delayed implementation, FDA attempted to clear up what it viewed as a misunderstanding about the Final Rule.  FDA emphasized that one of the revisions was meant to clarify that mere knowledge that the product was being prescribed or used by healthcare providers for an unapproved new use would not be sufficient on its own for FDA to find an unapproved new intended use for an approved or cleared drug or device.  In addition, the Final Rule was “intended to embody FDA’s longstanding position . . . that intended use can be based on ‘any relevant source of evidence,’ including a variety of direct and circumstantial evidence.”  The Final Rule used the phrase “the totality of the evidence” to accomplish this goal.

The industry petition had set forth constitutional and public health concerns, and also included claims:

  • that the Final Rule was promulgated in violation of the Administrative Procedure Act;
  • that the “totality of the evidence” language in the Final Rule is a new and unsupported legal standard; and
  • that the revisions to the intended use regulations are contrary to the “settled interpretation” of intended use.

The Final Rule, originally scheduled to be effective February 8, 2017, had already been delayed once, to March 21, 2017, as a result of a memorandum from the Assistant to the President and Chief of Staff, entitled Regulatory Freeze Pending Review that was issued in January.  FDA is accepting comments through May 19, 2017.