Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications

FDA News Release

• For Immediate Release: January 18, 2017

We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, 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The first draft guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,” explains the FDA’s current thinking and recommendations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. 

The second draft guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” explains the FDA’s current thinking about firms’ medical product communications that include data and information that are not contained in their products’ FDA-required labeling, but that concern the approved or cleared uses of their products.

We have opened a public comment period for each draft guidance, and look forward to receiving input from a broad range of stakeholders.

We also look forward to stakeholder input on another, distinct topic – communications about unapproved uses of approved or cleared medical products. The FDA held a Part 15 hearing in November 2016 to hear from a broad range of stakeholders regarding this topic.  We have now reopened the comment period for the docket opened in connection with that public hearing for an additional 90 days (until April 19, 2017) to allow interested parties an opportunity to review the two draft guidances before submitting comments to any of the relevant dockets.

We have also added a document to the docket for the public hearing titled “Memorandum:  Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which provides additional background on the issues the FDA is considering as part of our comprehensive review of our rules and policies relating to firm communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations. We are requesting input on the Memorandum as it relates to the questions set forth in the initial notice of public hearing.