On September 25, 2015, the FDA issued a proposed rule ostensibly designed to merely clarify the circumstances in which a tobacco product “intended” for human consumption will be deemed subject to regulation as a drug, device, or a combination product. On its face, the proposed rule only affects tobacco products. However, if one reads the preamble and the proposed regulations carefully, they will see that the FDA is also quietly proposing the amendment of the drug and device “intended use” definitions at 21 C.F.R. §§201.128 (drugs) and 801.4 (devices) to: (1) eliminate the need for a manufacturer or distributor to label a drug or device for an off-label, or unapproved, use solely because it has knowledge that the product is being prescribed or used by a physician(s) for that off-label use; and (2) to ameliorate industry fears that the FDA may deem the off-label use by a physician(s) to be an unapproved use, potentially resulting in FDA action against the manufacturer or distributor.
The original “intended use” definitions for drugs and devices were issued in on February 13, 1976 (41 FR 6911). They state that to establish a product’s intended use, and thereby determine the FDA’s regulatory authority and appropriate labeling, the FDA is not limited by the manufacturer or distributor’s subjective claims of intent, but can also consider objective evidence, such as direct and circumstantial evidence. This objective intent may be shown by labeling claims, advertising matter, or oral and written statements by the manufacturer or distributors or their representatives. It may also be shown by circumstances in which the product is, with the knowledge of the manufacturer, distributor, or their representatives, offered and used for a purpose for which it is neither labeled or advertised. This objective intent definition will not be altered if the proposed rule is finalized.
The proposed rule, however, removes the following language from both 21 C.F.R. §§201.128 and 801.4, which has been present since 1976:
“But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug 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 which accords with such other uses to which the article is to be put.”
While the FDA has never enforced this so-called ‘knowledge’ provision, this long-overdue removal of the language should eliminate any lingering doubt in the minds of industry that providing FDA-approved on-label product use information to physicians that may be prescribing the product off-label will not subject the manufacturer or distributor to criminal or civil liability, or accusations that their labeling is inadequate. As the FDA explicitly states on page 57757 of the proposed rule: “The Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use [emphasis added].”
Firms, however, are not totally off the hook. They should take note of the fact that the FDA deliberately used the word “solely.” Therefore, if something more than mere knowledge of off-label use by the physician is present, the FDA may still take action.