FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communication

Overview


James Cohen, Jiayan Chen, and Michael Ryan wrote this bylined article describing new FDA rules governing how manufacturers disseminate new risk information relating to approved uses of a prescription drug. “In light of the variability in evidence and the potential for new risk information to generate confusion among providers, … the FDA found that guidance was necessary to help ensure the appropriate distribution of such information,” the authors wrote, adding that it brings “some welcome clarity” despite its limitations.