Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.
FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully 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 labeling claims, advertising matter, or oral or written statements by the manufacturer or its representatives can 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 deemed by FDA to be relevant evidence of intended use has been broadened, and in particular this extends beyond manufacturer promotional claims.
Of particular concern to the industry has been the fact that the final rule might potentially affect manufacturers’ safe-harbored communications about new uses of lawfully marketed products. When the original version of the amended definition was first published in 2017, industry commentators objected to the ‘totality’ standard which was set out in them. Although FDA, in the final rule, purports to address industry comments, the revised definition continues to raise statutory interpretation concerns and First and Fifth Amendment issues. The latter arise mainly out of the new rules’ impact on manufacturers’ safe harbored communications about off-label uses.
In the preamble accompanying the final rule, FDA responds to concerns about First Amendment protections, asserting that the Agency has issued guidance documents establishing safe harbors for certain types of industry communications about new uses. These include communications that are consistent with FDA-authorized labeling, payor communications, and industry-supported scientific and educational activities. FDA also cites draft guidances on enduring materials and responses to unsolicited requests.
According to FDA, communications undertaken in reliance on these guidance documents generally ‘would not, on their own, establish the firm’s intent that a [lawfully marketed] medical product . . . be used for an unapproved use.’ (Emphasis added.)
It would therefore appear that manufacturer communications undertaken in accordance with 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 the rule. By extension, such communications could give rise to enforcement action under the FDCA and FCA. Because of the resulting chill on manufacturers’ communications about new uses and the lack of clear, a priori standards distinguishing permissible from impermissible communications, the final rule continues to raise serious constitutional issues.