Risk and Effectiveness Information in Promotional Labeling and Marketing Claims-

A draft guidance published by FDA in 2009 describes factors the FDA considers when evaluating advertisement and promotional labeling for prescription drugs, advertisement for restricted medical devices and promotional labeling for all medical devices. So why take look at the draft guidance now? A review of the Drug Marketing and Warning Letters Office of Prescription Drug Promotion (OPDP) provides a reminder that history repeats itself.  Both the draft guidance and OPDP provide numerous examples to aid sponsors in developing promotional labels and advertisements.  Prescription and medical device promotion is complex and there are many factors (not listed here) detailed in the draft guidance that should be considered when developing promotional materials to avoid misbranding.

Both FDA and the FTC review the “net impression” in Direct to Consumer advertising seen by consumers and health care providers. Net impression is defined as an assessment of the “piece as a whole.” The advertising should convey accurate and non-misleading impression of benefit and risk?  In comparison, the FTC uses the interpretation of net impression to determine whether the promotional piece is likely to mislead a consumer. 

Under FD& C Act promotional materials must comply with the following or the drug or device is considered misbranded:

·         Cannot be false or misleading in any particular

·         Must reveal material facts about the product being promoted, including facts about the consequences that can result from use of the product as suggested in the promotional piece

·         Should present information about effectiveness and information about risk in a balanced manner

If you see yourself needing assistance in preparing and reviewing promotional labeling and advertising, Kinexum experts can assist you with the complexities.