What do the extensive FDA “Intended Use” regulations mean for secure communications regarding new uses? | Knowledge
Ahead of their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones examine some of the effects of the Final Rule.
The FDA’s final rule to change its regulations on the intended use of medical products is now in effect as of September 1. that are considered relevant in determining whether a legally marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.
The principle that claims on labeling, advertising or oral or written statements by the manufacturer or its representatives may create a new intended use is retained from earlier versions of the regulations. However, under the Final Rule, the scope of the type of evidence considered by the FDA to be relevant evidence of intended use has been widened, and in particular this extends beyond the manufacturer’s promotional claims.
Industry is particularly concerned that the final rule could potentially affect secure communications from manufacturers regarding new uses of legally marketed products. When the original version of the amended definition was first published in 2017, industry commentators objected to the standard of “totality” stated therein. Although the FDA, in the final rule, claims to respond to industry comments, the revised definition continues to raise issues of statutory interpretation and issues related to the First and Fifth Amendments. The latter mainly result from the impact of the new rules on secure communications from manufacturers concerning uses outside marketing authorization.
In the preamble accompanying the final rule, the FDA addresses concerns about First Amendment protections, saying the agency has issued guidance documents establishing safe zones for certain types of industry communications on new uses. . These include communications that comply with FDA-approved labeling, communications with payers, and scientific and educational activities supported by industry. The FDA also cites draft guidelines on sustainable materials and responses to unsolicited requests.
According to the FDA, communications undertaken on the basis of these guidance documents in general “would not, by them selves, establish the company’s intention that a [lawfully marketed] medical product. . . be used for unapproved use. ‘ (I underline.)
It would therefore appear that manufacturer communications undertaken pursuant to a Safe Harbor Guidance Document are not categorically excluded from the definition of intended use, and could be used as evidence of “objective intent” under of the rule. By extension, such communications could give rise to enforcement actions under the FDCA and the FCA. Due to the resulting cooling in manufacturers’ communications on new uses and the lack of clarity, a priori As standards distinguish between authorized and prohibited communications, the final rule continues to raise serious constitutional issues.