KEY TAKEAWAYS FROM FDA’S DRAFT GUIDANCE ON COMMUNICATIONS CONSISTENT WITH LABELING AND MEMORANDUM ON OFF-LABEL COMMUNICATIONS

In January of 2017, the FDA released a 63 page memorandum on First Amendment considerations related to off-label communications, as well as a draft guidance entitled “Medical Product Communications that are Consistent with the FDA-Required Labeling”. This guidance comes on the heels of a lively two day meeting the FDA held in November to address stakeholder concerns and challenges on communications regarding off-label use of drugs and medical devices. While the draft guidance provides some clarity around permissible on-label communications, uncertainty remains for off-label communications and the turn of the new administration may delay FDA providing any further certainty.

• Key takeaways and best practices for ensuring on-label marketing claims “consistent” with product labeling
• Understanding FDA’s First Amendment
• Insights from 6 enforcement letters FDA issued in December 2016
• Audience polling on marketing and communication examples based on FDA’s current recommendations

Speaker:
Julie Tibbets
Partner
Alston & Bird LLP