In 2004, the FDA promulgated requirements for drug print advertisements.  FDA, 69 Fed. Reg. 6307 (May 10, 2004).  Those regulations required “the entire risk-related sections of the FDA-approved professional labeling.”  The FDA is now significantly changing its course because of  “recent social science research” indicating that non-material information should be omitted from drug advertisements in print in order to be more effective for consumers.  FDA, 80 Fed. Reg. 6998-99 (Feb. 9, 2015).  Instead of listing all risks, the FDA is recommending that any print advertisement display:

  • The most serious and the most common risks associated with the product, while omitting less important information.
  • The indication for the use being promoted.
  • The information regarding patient directives (such as “discuss with your health care provider any pre-existing conditions” or “tell your health care provider if you are taking any medications”).
  • A statement that more comprehensive information can be obtained from various sources, including the manufacturer.

In addition to focusing on the most important risks, the FDA wants the information “presented in a way most likely to be understood by consumers.”  However, the draft recommendation does not provide much guidance to manufacturers on how to do that.  The burden will be on manufacturers to sort out what risks can be omitted and how to write in plain language “most likely to be understood by consumers.” 80 Fed. Reg. 6999.
These requirements would be permissive, and drug manufacturers could include more information if they desire. The FDA is currently seeking comments on the proposal.
The FDA’s revised draft guidance document, Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, details the proposed changes.