Will Trump Administration Scrap ‘Intended Use’ New Rule?
FDA has delayed the effective date of a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use.” The delay, according to an FDA notice, allows the Trump Administration to review and decide whether the rule should stay on the books.
“Ultimately, the proposed (and now final) rule’s revision of the drug/device intended use regulations does little to change long-standing FDA policy,” according to a Hogan Lovells client alert. “Still, given the significant role played by the concept of intended use in driving FDA’s jurisdiction over medical products, the codification of this interpretation is a notable development. Overall, the amended language of the final rule, if not ultimately rescinded by Congress under the Midnight Rules Relief Act3, can be counted as a ‘win’ for industry, as it explicitly eliminates the possibility (however remote) of FDA enforcement action based solely on a manufacturer’s knowledge of an off-label use of its product.”
Attorneys Benjamin Zegarelli and Eli Greenspan (Mintz Levin) also agree that the clarification is a positive development for industry. Writing in an online blog post, the two say that the final rule removes a major regulatory enforcement weapon that the agency has wielded against drug and device companies since 1976. The approved version clarifies that FDA will determine intended use based on the “totality of evidence,” but not on knowledge that the product is being prescribed or used for an unapproved (off-label) use.
The attorneys say that the language of the “knowledge” provision of the intended use regulations gives FDA freedom to punish any manufacturer for even knowing about off-label uses. “In contrast to situations in which a manufacturer affirmatively promotes a regulated product for an off-label use,” they write, “FDA has only rarely invoked the ‘knowledge’ provision as the basis of an enforcement action. The revisions … provide much needed clarification of FDA’s intended use doctrine and will give drug and device manufacturers some protection against discretionary enforcement actions based on off-label uses.”