Insights

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken effect, the Food & Drug Administration ("FDA" or "Agency") announced it was delaying the rule's effective date until March 19, 2018, to obtain public comments on issues raised in an industry petition and on any other issues raised with respect to the rulemaking.

In a 2015 proposed rule, the Agency proposed changing the existing "intended use" regulations for drugs and medical devices to clarify that FDA would not regard a firm as intending an unapproved new use for an approved or cleared drug or device based solely on that firm's knowledge that its product was being prescribed or used by doctors for such use. However, in the final rule published January 9, 2017, FDA did not to delete the language but, rather, added new language creating a new and different standard for the rule providing: "And if the totality of the evidence establishes that a manufacturer objectively intends that a drug [or device] … is to be used for conditions, purposes, or uses other than the ones for which he offers it is approved (if any), he is required … to provide for such drug [or device] adequate labeling that accords with such other intended uses."

FDA stated that adding the "totality of the evidence" standard did not change its goals under the proposed rule, and it clarified that the new language embodies its longstanding position that "intended use" can be based on "any relevant source of evidence," including a variety of direct and circumstantial evidence. (Notably, FDA's original proposed removal was "to better reflect FDA's interpretation and application of [the intended use] regulations" and "would not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices.")

Notwithstanding FDA's reasoning, industry members petitioned FDA to reconsider the rule, to revert to the language proposed in 2015, and to stay the final rule indefinitely. The petitioners claim FDA's final rule violated the fair notice requirements of the Administrative Procedure Act, and that the "totality of the evidence" standard is a new and unjustified standard that would introduce significant constitutional concerns and negatively affect the public health by chilling valuable scientific speech.

Consequently, FDA has delayed the effective date of the amended regulations and is requesting comments specially related to: (i) how FDA should consider situations where companies and individuals distribute medical products and/or seek to import medical products without explicit promotional claims; (ii) the potential public health consequences and relevant policy considerations that should be considered in evaluating any approaches to intended use; (iii) how First Amendment considerations apply to the use of non-speech evidence in determining intended use, such as the circumstances surrounding the distribution of a product or the context in which it is sold; and (iv) whether stakeholders believe there is a distinction between considering "any relevant source of evidence" and "the totality of evidence," and whether there are any suggestions about what wording provides the most clarity to regulated entities.

FDA also encouraged submitting comments regarding off-label communications of approved/cleared medical products (see next story) to also submit their comments to the present docket if pertinent to the specific issues raised.

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