FDA Drafts 2 Guidances on Medical Product Communications
The FDA has announced 2 new draft guidances for medical product communications, such as off-label information and communicating cost-effective data
The FDA has announced 2 new draft guidances for medical product communications, such as off-label information and communicating cost-effective data. Although the FDA determines what appears on the labels of products, some companies have pushed to communicate information that isn’t on the label.
The first draft guidance, titled “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,”pertains to the FDA’s recommendations on companies’ communication of health care economic information, specifically in the case of approved drugs under section 502(a) of the FD&C Act. It also provides answers to frequently asked questions, and offers recommendations on communications regarding investigational drugs and products that have yet to be approved.
The second draft guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” provides recommendations for FDA medical product communications involving products that have been approved for certain use, but do not have certain information included on their FDA label.
The FDA stated that companies should disclose reasoning for why additional, off-label data is relevant to the product so that it remains consistent with FDA-required labeling.
Statement from FDA Commissioner Robert Califf, MD announcing new draft guidances on medical product communications [news release]. FDA’s website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537371.htm. Accessed Jan. 18, 2017.