The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceuticals and medical devices – 21 CFR §201.128 (drugs) and 21 CFR §801.4 ( devices). The final rule will take effect on September 1, 2021.
The new rule could end a multi-year process of knowledge-based labeling guidelines in old regulations. The proposed changes to clarify the “intended use” regulations began in 2015, which we discussed previously.
The intended use doctrine states that manufacturers must develop products that are reasonably safe for the intended use. FDA regulations define intended use as “the objective intention of those legally responsible for the labeling of [the pharmaceutical product or medical device]. “
Under the old “intended use” rules for drugs and devices, the FDA said manufacturers must “include adequate labeling” for unapproved uses for which the manufacturer may know the product is being used.
In particular, there were concerns that a manufacturer’s knowledge of an unapproved use of their product would trigger requirements for re-labeling, which in turn could make its distribution of a product illegal without a supplement.
Originally, the FDA proposed to remove the knowledge-based labeling directive. However, in a final rule amended in 2017 that never came into effect and that the public has not commented on (83 FR 2193-2217), the FDA instead proposed a rule requiring manufacturers to include adequate labeling for unapproved uses “if the totality of the evidence establishes that the manufacturer has the objective intention [their drug or device] be used for unapproved use. Shortly after the proposal, organizations filed petitions raising concerns (i) that public comment was not allowed on the amendment and (ii) with the proposed standard of proof. The organizations have requested a suspension of the effective date of the rule. As a result, the FDA maintained the 2017 rule.
Under the final rule, two important changes will be made to the regulations:
- First, the FDA will remove the part of the regulation that says manufacturers must “include adequate labeling” for unapproved uses of which it is simply aware, as was originally proposed in 2015. Manufacturers will not need to provide labeling for unapproved uses unless the manufacturer is considered to intend the product to be used for unapproved uses.
- Second, the FDA clarifies that “intended use” is determined by examining “any relevant source” of evidence, including direct and circumstantial evidence surrounding the manufacture and sale of a product, rather than the “ full evidence ”proposed in 2017.
The final rule “also amends the codified language of the Regulation on the intended use of medical devices in order to clarify its applicability to devices approved, authorized, having obtained a marketing authorization or exempted from pre-market notification. “.
In commenting on the benefits of these changes, the FDA said the final rule should “resolve questions of whether manufacturers should think about developing an action plan or a strategy related to a new potential use of their medical products that are approved, licensed, market authorization, or pre-market notification exemption simply because a manufacturer has knowledge of unapproved uses of these products by third. The FDA also said it did not expect the new rules to impose significant additional costs on manufacturers.
The final rule reflects the FDA’s emphasis on clarifying the meaning of “intended use.” While other developments may arise, the new rule is a relief for manufacturers of pharmaceuticals and medical devices.
Faegre Drinker’s Life Sciences Industry Group is monitoring the implementation of the final rule and will provide any necessary updates.