Groups Still Oppose ‘Intended Use’ Final Rule
Three industry trade groups are reiterating their opposition to a proposed FDA final rule defining the intended use of a drug or medical device based on the totality of the evidence rather than on a manufacturer’s promotional claim for the product, which is the current practice. In 7/18 comments, the Medical Information Working Group (MIWG) says the final rule raises two significant issues — it exceeds the scope of FDA’s authority under the Federal Food, Drug, and Cosmetic Act, and it violates the Administrative Procedures Act by adopting the “totality” language without adequate notice.
MIWG says the rule would put manufacturers in the position of having to either discontinue communication practices that FDA has acknowledged advance public health objectives or risk being held liable for enforcement actions. It also says the rule is legally problematic because it “radically departs from the well-established statutory interpretation of intended use reflected in the applicable legal authorities, including the legislative history.”
According to the Pharmaceutical Research and Manufacturers of America (PhRMA) 7/18 comment letter, FDA may establish that a manufacturer has a particular intended use for an article only when the manufacturer has made a promotional claim about that use to a third party. “The final rule adopts an expansive ‘totality of the evidence’ standard under which a particular ‘intended use’ may be established even absent any external manufacturer claim about that use,” the letter says. “Such an approach is simply not supported by the case law. We are aware of no case in which a court has found that an ‘intended use’ of a product was established absent an external claim by the manufacturer about the use.”
PhRMA also says the final rule would, in some circumstances, inappropriately restrict important speech about unapproved uses of FDA-approved medical products that could be beneficial to both healthcare professionals and the patients they serve.
Finally, AdvaMed says in a 7/18 letter that since the intended use of a medical product is a foundational concept in the application of the Federal Food, Drug, and Cosmetic Act, “it is crucial that FDA’s definition of ‘intended uses’ provide manufacturers with clear guidance and take care not to sweep broadly into permitted and protected exchange of truthful, non-misleading information. Unfortunately, FDA’s 1/9/17 final rule on the definition of intended uses … does neither.” The association calls on the agency to “abandon the final rule and adopt a clear and appropriate definition of “intended use.” Should the agency not take that step, AdvaMed says, it should, at a minimum, adopt a standard for determining “intended uses” that makes clear that (1) legitimate, protected scientific exchange, (2) truthful, non-misleading communications (including commercial speech), and (3) mere knowledge of unapproved use by third parties do not constitute evidence of an “intended use.”