Industry May Prefer to Keep ‘Intended Use’ Rule
Attorneys Benjamin Zegarelli and Eli Greenspan (Mintz Levin) say that an FDA 1/9 final rule amending the definition of “intended use” for drugs and medical devices, which could be subject to congressional rollback, is something that industry might prefer to keep on the books. Writing in an online blog post, the two say that the final rule removes a major regulatory enforcement weapon that the agency wielded against drug and device industries 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.”
The post says that the rule’s provisions could be moot because it could be subject to elimination under the Midnight Rules Relief Act that was recently approved by the House. If passed by the Senate and signed into law by President Trump, the bill would amend the Congressional Review Act to allow Congress to group multiple regulations together and disapprove them all at once. The current Congressional Review Act requires that resolutions of disapproval be considered one at a time. The change was pushed by the House Freedom Caucus, which issued a report calling for over 200 regulations to be repealed under the Congressional Review Act, the post says.
“House Republicans are eager to roll back regulations en masse and that enthusiasm should be taken seriously,” the attorneys write. “However, the Senate 60-vote threshold remains a hurdle to passage and Senate majority leader Mitch McConnell has stayed quiet on this particular legislation…. Congress has a lot on its plate in 2017, and it’s no certainty that it will move swiftly on disapproving large groups of regulations. That said, the House has sent an early signal that it is determined to expedite the rollback process, which should begin soon after President Trump takes office.”