ASCRS and Medical Community Advocacy Prompts FDA to Delay Flawed Intended Use Rule Indefinitely

Citing concerns from stakeholders, including ASCRS and the Alliance of Specialty Medicine, FDA Commissioner Scott Gottlieb, MD, announced this week that the agency would delay the implementation of a currently delayed final rule related to intended uses of drugs and devices indefinitely. ASCRS and the Alliance submitted comments in opposition to the final rule, which would have given the FDA the authority to include all information, even responses to unsolicited request for information about off-label uses, as evidence of an intended use. This would have been problematic because the FDA would have had the authority to take enforcement action against manufacturers for off-label promotion, even if the manufacturer did not promote such a use. We believe the regulation created a new standard that would have severely restricted the communication of scientifically valid information. In the announcement, Commissioner Gottlieb noted the FDA would continue enforcement of existing policies related labeling and off-label communication.