CME And Disclosure Of Unapproved Uses: FDA

Under the final US Food and Drug Administration Continuing MedicalEducation guidance, the FDA will consider whether there is meaningful disclosure to an audience, at the time of a program, as to whether any unapproved uses of products will be discussed.

The Final Guidance on Industry-Supported Scientific and Educational Activities, published in the Federal Register, allows general disclosure statements on off-label uses for drugs, rather than requiring companies to cite each unapproved use discussed during a CME presentation. The more specific disclosure had been required under previous FDA policy statements, according to Health News Daily.

The final guidance also contains certain revisions, mostly intended to focus better on core FDA concerns that the provider should develop the subject program uninfluenced by the supporting company, and ensuring disclosure of relationships between and among the supporting company, provider, presenters and products discussed that may be relevant to an assessment of the information presented. While the number of changes may be significant, they do not change the fundamental intent to distinguish industry-supported scientific and educational activities that are free from supporting company influence from those that are not, says the FDA. The final document retains a 1994 addition of a "safe harbor" for presentations conducted by accredited CME providers.