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Focus on Regulation

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.  Slipped within this proposed rule, however, is another, more far-reaching proposal to revise the intended use regulations for drugs and devices more generally.

Specifically, FDA proposes to truncate the final sentence of the current drug and device intended use regulations, 21 CFR 201.128 and 801.4, which state that a manufacturer’s knowledge may be a basis for determining intended use:

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.

Under FDA’s proposal, the revised intended use regulations for prescription drugs and medical devices, would omit this final sentence and be limited to:

The words intended uses or words of similar import [ ] refer to the objective intent of the persons legally responsible for the labeling of drugs/devices.  The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown [ ] by circumstances [in which] the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug/device, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

FDA characterizes this trimming of its intended use regulations as a reflection of its current policy, rather than a change in policy.  As the agency explained: “FDA is taking the opportunity to propose corresponding changes to existing regulations at [21 CFR 201.128 and 801.4], and to conform them to how the Agency currently applies these regulations to drugs and devices generally.”  Id.(emphasis added); see also id. at 57757 (“As FDA has previously stated, [ ] 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).

Moreover, FDA reiterated that remaining language in the intended use regulations would still allow ample opportunity for FDA to look far and wide for evidence of intended use:

FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold [ ].  In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade product regulation by avoiding making express claims about their products.

Id.(emphasis added).

Given FDA’s position that these proposed revisions merely reflect “business as usual,” they may have limited practical impact on FDA’s regulatory approach in this area; however, this proposed rule represents a valuable opportunity for drug and device companies to seek further clarification from the agency about its interpretation of the intended use regulations.  Comments may be submitted within 60 days from the date of publication (by Tuesday, November 24).