Last week, FDA published its new final rule amending the “intended use” regulations for drugs and medical devices, which it hopes will “put to rest any dispute” about the agency’s interpretation of evidence relevant to establishing a medical product’s intended use under the Food, Drug and Cosmetic Act. The final rule is essentially the same as the September 2020 proposed rule except that it adds language to the proposed device regulation that clarifies its applicability to devices that are granted marketing authorization or are 510(k)-exempt, in addition to those that are approved and cleared. The final rule withdraws portions of the 2017 final rule, which was stayed indefinitely in 2018 after FDA received myriad comments from stakeholders raising complex, substantive criticisms. The new final rule will take effect September 1, 2021.
The importance of the final rule lies in the fact that a product’s intended use forms the basis for FDA’s enforcement activity in connection with off-label promotion—that is, whether firms are marketing their products in a manner that encourages a use other than that for which FDA approved it. The industry was hoping to gain some greater certainty with the amendments as to what will and will not make them vulnerable to FDA finding a new intended use. FDA opted instead for broad flexibility in light of the various fact-specific patterns of each situation.
That is, the final rule preserves the broad array of evidence FDA may consider in evaluating a firm’s objective intent with respect to a product’s intended use. While the final rule codifies the proposed rule's language that clarifies that a firm’s mere knowledge that its product is being prescribed or used by health care providers for an unapproved use cannot serve as the sole basis for finding a new intended use, the agency reiterates its position that such knowledge still may be viewed as evidence of a new intended use in FDA’s overall evaluation.
In this regard, FDA rejected comments to the proposed rule that sought to narrow the scope of relevant evidence, and vigorously defended its authority to consider “any relevant source” of information to inform its determination, citing legislative history and myriad court opinions that support its position. By way of example, in the Federal Register notice, FDA notes that courts have found the following types of evidence to be relevant to intended use (some of which are not expressly included in the regulations): labeling; promotional materials; advertising; actual use of a product by health care professionals and consumers; the identity of customers; written statements as to the circumstances of a product’s distribution; training sessions; implied claims from a product name; known effects of a product; circumstances surrounding the product sale; memoranda relating to marketing and distribution; shipping orders; and product formulation and method of intake.
Despite objections, FDA also declined to remove the proposed rule’s addition of “the design or composition of the article” as one type of evidence relevant to the evaluation of intended use, asserting that the addition is not a change to FDA’s interpretation of the regulations, but instead clarifies a “longstanding and current [FDA] policy.”
FDA also dismissed comments raising First Amendment concerns, reiterating with greater depth earlier arguments made in the preamble to the proposed rule that the intended use regulation does not impinge upon First Amendment protections, as it does not directly regulate speech. Rather, it describes evidence relevant to the evaluation of a product’s intended use. Under the regulatory scheme established by Congress, FDA continues, its mission to protect the public health through premarket review includes review of product labeling and substantiation of claims, deeming it fully consistent with the First Amendment. The agency takes the position that using speech as evidence of intended use in the context of premarket review meets the applicable test for government regulation of commercial speech, as it is adequately tailored to meet the government’s substantial interest in protecting the public health.
Finally, FDA indicates that nothing in the final rule changes the agency’s "safe harbor" policies articulated in guidance documents regarding communications that, standing alone, FDA will not consider determinative of a new intended use—for example, distribution of safety information in certain circumstances.
Overall, the final rule may come as a disappointment to those who were hoping that FDA would provide more clarity in its regulations regarding permissible activities. However, it is not surprising that FDA is rejecting “meticulous specificity,” given the complexity of the issues involved. For now, firms must continue to diligently consider on a case-by-case basis the effect that their design, marketing and distribution activities could have on their products' intended use.
