New FDA “Intended Use” Labeling Rule Causes Industry Convulsions

The FDA issued a final rule regarding intended use labeling on January 9, 2017 that sent device and drug makers into convulsions.

The final rule requires manufacturers to “provide…adequate labeling”…if the “totality of the evidence” establishes that a manufacturer objectively intends that a device [or drug] introduced into interstate commerce by the manufacturer is to be used for “conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements.”

When the FDA proposed to revise this rule in 2015, the agency removed the famous “knowledge” sentence which said that if a manufacturer “knows, or has knowledge of facts” that would give him notice, that a drug or device is to be used for uses other than the ones for which he offers it, then he must provide adequate labeling.

In the agency’s own citation from a case settled with pharma company Allergan, FDA said it would no longer “regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”

Jeffrey Shapiro writes on Hymen, Phelps & McNamara, PC’s fdalawblog that, “Shockingly, [the final rule] does not delete the ‘knowledge’ sentence as expected. On the contrary, it ‘amends’ the sentence to create an entirely new sentence that FDA had not mentioned in original proposal. Now the sentence incorporates a brand new ‘totality of the evidence’ standard.

“It appears that FDA has now written itself a blank check to find whatever intent it wishes to find, using an unconstrained calculus as to what the ‘totality of the evidence’ shows. Worse, the manufacturer’s knowledge can be part of this evidentiary mix, thus negating the long overdue proposal to eliminate ‘knowledge’ as an element of intended use.”

Industry Petition

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) immediately petitioned the FDA following this “unexpected decision” to revise the definitions of “intended use” for drugs and medical devices.

The industry groups call for this final rule to be stayed indefinitely and reconsidered because FDA failed to give fair notice or a meaningful opportunity to comment on this major shift.

If you want to sign the petition, click here.

The new rule is due to go into effect on March 21, 2017.