FDA Quietly Proposes Change to Intended Use Rule

Device makers will want to be aware of one sentence omitted from a proposed rule about tobacco products.

Marie Thibault

Unsurprisingly, MD+DI focuses mainly on medical devices and diagnostics. So it was a surprise to learn that FDA’s wording choices in a product rule for tobacco products could have an impact on medical device makers.

But Susan Lee, senior associate at Hogan Lovells, and Jennifer Agraz Henderson, counsel at Hogan Lovells, point out in a recent blog post that when FDA chose to remove one sentence from a proposed tobacco product rule they formally removed one burden for device and drug companies. Lee and Henderson explain that FDA took this sentence out of its intended use rule:

But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug/device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.

In a conversation with MD+DI, Henderson elaborated on what this actually means for device makers. FDA's long-standing intended use rule informs the regulator's jurisdiction and enforcement ability. This specific sentence, called the "knowledge provision," has caused manufacturers to worry that even though they don't promote use of their device or drug for an off-label purpose, if they have knowledge of off-label use, FDA could bring enforcement against them. 

In practice, Henderson says, FDA has not historically enforced this sentence. "The implications of removing this is almost like removing an unnecessary appendage . . . it's never been literally enforced or used by the agency . . . so it's removal is probably not going to impact the industry from a regulatory perspective all that much," she says.

It's not completely clear why FDA is proposing this change now, after years of leaving the wording intact, and in this manner. "They're very clear in this proposed rule that essentially, it's business as usual . . . this is how they've always operated and they don't use this provision."

Still, Henderson adds, FDA has made the change as part of a proposed rule, leaving it open for comment. This gives device and drug manufacturers the change to give the regulator their take on the proposal or to perhaps ask for clarifying or additional language. 

"I would hope that through the notice and comment rule-making process that you would get industry comments and perhaps some proposals for additional clarifying wording . . . I think that's probably the best possible outcome here," Henderson says. 

Even with this change, device makers shouldn't expect to be scot-free when it comes to intended use going forward. Henderson says, "I think even with removal of this language . . . the language in what remains of the intended use regulations still gives [FDA] quite a bit of leeway in terms of what they are looking at to establish intended use and the various circumstantial evidence . . . I don't think it's going to limit them."

The proposed rule's comment period closes November 24th.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET]