On September 24, 2015, FDA published a proposed rule that, if finalized, would amend the agency’s regulations defining “intended use” for drugs and devices.  Given the central role that  “intended use” plays in FDA’s regulatory system, we regard this as an important development.

Background

The concept of “intended use” has long served as a fundamental tenet of FDA’s regulatory system.  The intended use of a product determines whether it meets the definition of a drug, device, or other regulated product under the Federal Food, Drug, and Cosmetic Act (FDCA) and thus may be regulated by FDA.  Intended use also gives rise to the concept of off-label use or promotion.  For example, most medical devices are approved or cleared for a particular intended use described in that product’s labeling.  If evidence demonstrates that the manufacturer’s actual intended use is different than the approved or cleared use, this can result in the product becoming misbranded, triggering civil or criminal penalties.  Therefore, one of the most critical questions in FDA law is how intended use is defined.  What evidence should be considered when defining the intended use for a drug or device?

Both the drug and device regulations broadly define intended use.  The current regulation for devices, 21 C.F.R. § 801.4, states:

The words intended uses or words of similar import … refer to the objective intent of the persons legally responsible for the labeling of 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 the circumstances that 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 devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a 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 device which accords with such other uses to which the article is to be put.

This regulation (as with the counterpart drug regulation, 21 C.F.R. § 201.128) has long posed interpretive challenges.  For example, the regulation defines intended use according to the “objective intent” of the manufacturer as expressed in promotional activity of the manufacturer, but then suggests that other evidence, such as how the product is actually used by physicians/consumers, can also determine intended use.  With very limited exceptions (in cases with unusual facts), courts have determined “intended use” by reference to the claims used by manufacturer to promote its products.  For example, as stated by the Fourth Circuit, “no court has ever found that a product is ‘intended for use’ … within the meaning of the FDCA absent manufacturer claims as to that product’s use.”  Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155, 163 (4th Cir. 1998), aff’d, 529 U.S. 120 (2000), but see U.S. v. Travia, 180 F. Supp. 2d 115 (2001).

FDA’s Proposed Rule

FDA’s proposed regulation arises out of its regulation of tobacco products.  The proposed rule primarily addresses the circumstances when a tobacco product would be considered to have an intended use that triggers regulation as a drug or device.  The preamble, however, more broadly addresses the concept of intended use.  FDA continues to assert that intended use can be determined broadly, stating that “[i]n the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products.”  However, FDA “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.”

The primary change to both the drug and device intended use regulation would be to strike the last sentence of the regulation (“But if a manufacturer knows ….”).  According to FDA:

[T]he Agency does not 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.  Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA’s interpretation and application of these regulations. These changes would not reflect a change in FDA’s approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.

If finalized, these changes would clarify aspects of FDA’s approach to assessing the intended use of a drug or device.  But given the importance of this concept and the lack of clarity on how intended use is determined, drug and device companies should review FDA’s proposal and consider submitting comments to the docket on ways in which FDA could further clarify its policies.  The agency will accept comments until November 24, 2015.