FDA: new guidance on product communications, even off-label

The FDA released two draft guidance documents on how drug and device makers should communicate information about their products. In one of the documents, the US Agency set out guidelines on how to promote products for off-label use. Even if this off-label information, still unevaluated by the FDA, is consistent with some of the Agency’s requirements, it is still not considered evidence of a new intended use, the agency stressed. Including information which can appear already assessed and endorsed by the FDA would mean misleading advertising for the product, which could be highly detrimental to firms if information is proved to be false. Meanwhile, the second draft guidance deals with the communication between companies and payers, including communications about drugs and devices that are not yet approved. The FDA allows organizations dealing with drug coverage to ask for financial information different from the data submitted to the agency for indication approval. Such information, however, must relate to FDA-approved indications, be based on scientific evidence, and specify any differences between the FDA-approved labeling and the merely economic information. Meanwhile, information on investigational products should clearly indicate their investigational status and specify that their safety and efficacy have yet to be proven.