United States: FDA Issues Final Rule On "Intended Use"

On August 2, 2021, the Food and Drug Administration (FDA) issued its final rule modifying its regulations on the intended use of medical devices, prescription drugs and biologics. The FDA's regulation of pharmaceuticals and medical devices hinges on finding "intended use" and this final rule, following a 2015 proposed rule and repealing its 2017 rule, governs how the FDA determines a disseminated product's intended use.

Most importantly, the final rule repeals the 2017 rule's "knowing clause," which seemed to imply that a party may be accountable for off-label use if the party "should have known" the product was likely to be used off-label. As of April 2021, the provision required that if a marketing authorization holder is aware of or has knowledge of information that might alert it to the fact that a device they introduce into interstate commerce will be used for other purposes, the marketing authorization holder is then required to provide sufficient labeling. The rule mandated that a marketing authorization holder acquire cleared or approved labeling for such uses. The FDA unexpectedly approved this proposed rule in 2017 without removing the knowing clause, which created an uproar in the industry.

The FDA has now removed the knowing clause and has provided important guardrails for individuals who are legally responsible for the labeling of products. Under the final rule, the FDA will evaluate the intent of such individuals based on language used in promotional materials, the design or content of such material or the events surrounding its release. In addition, evidence from labeling claims, commercial material, word of mouth or remarks made in writing by such persons or their representatives can be used to demonstrate objective intent. However, a company would not be considered to be planning an unauthorized use of the new device, drug or biologic that had been accepted, certified, received selling permission or excluded from premarket notice only because it was administered or used by healthcare practitioners in a different manner.

What This Means for Manufacturers

Overall, there are three major takeaways from this revised regulation:

First, eliminating the knowledge requirement greatly improves statutory clarification, bringing the regulation closer to the legal framework.

Second, this rulemaking also includes a new significant caveat that prevents the FDA from implying off-label promotion simply because an otherwise legally marketed product is being used off-label. The FDA proposed removing the concept "solely" to emphasize that a producer's awareness of off-label usage should not be considered by the FDA when determining intentional usage.

Finally, the FDA now has the authority to examine "design and composition" when evaluating anticipated use. To the degree that the FDA conjectures an unauthorized new intended use from a device's design and content as it has been authorized or certified, this will run counter to Section 513(i)(1)(E) of the Food, Drug and Cosmetic Act.