Change FDA promo guidance: group
Two industry groups, one representing health communicators and the other medical device makers, have sharply criticized a draft FDA guidance on how to present risk information in promotional materials.
In comments submitted to the agency, the Coalition for Healthcare Communication (CHC) said it is concerned that the FDA's draft guidance on risk information in drug and medical device promotion will curtail truthful advertising by providing regulators with faulty reasoning to find a truthful advertising piece false or misleading. It said that the guidance may also discourage advertisers from presenting otherwise truthful information.
The coalition's comments said that the principles described in the guidance must be more fully described, limits to their application must be more fully established and that all must be accomplished within the limits of the Federal Food, Drug and Cosmetic Act and the First Amendment.Saying that the draft assumes new authority that reaches far beyond both the law and existing regulations, the CHC criticized it for expecting “that all advertising and promotional material contain enough information for an informed decision as to whether or not a drug should be chosen for use. This can only occur after a healthcare professional evaluates a specific product in relationship to a particular patient's needs.”