FDA issues new draft guidances on medical product communications

The US Food and Drug Administration today announced the issue of new draft guidance on medical product communications, with FDA Commissioner Robert Califf saying that the agency is aware of a high level of interest about its views on such matters.

The FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.

The first draft guidance, “ Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,” explains the FDA’s current thinking and recommendations on firms’ communication of health care economic information (HCEI) about approved drugs under section 502(a) of the FD&C Act, which was recently amended by the 21st Century Cures Act. It also answers common questions and provides the FDA’s recommendations regarding firms’ communications to payors about investigational drugs and devices that are not yet approved or cleared for any use.