PhRMA releases new DTC advertising guidelines
December 16, 2008
Five months after updating its Code on Interactions with Healthcare Professionals, the Pharmaceutical Research and Manufacturers of America (PhRMA) released updated guidelines for direct-to-consumer (DTC) advertising.
PhRMA’s Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines, which originally went into effect in January 2006, provide guidance to pharmaceutical research and biotechnology companies on ways to ensure DTC communications provide accurate, accessible, and useful information to patients and consumers.
New principles state:
- DTC product advertisements should identify when actors are being used to portray healthcare professionals
- DTC television or print advertisements featuring a celebrity endorser should accurately reflect the opinions, findings, beliefs, or experience of the endorser
- The legal requirement that DTC print advertisements should include FDA’s MedWatch number for reporting of potential adverse events and DTC television advertisements should include the company’s toll-free number or refer patients to a print advertisement that contains the MedWatch number
Existing revised or expanded principles recommend companies:
- Consider individually setting specific periods of time for education before launching a branded DTC campaign
- Placing DTC television or print advertisements containing content that may be inappropriate for children in programs or publications “reasonably expected to draw an audience of approximately 90 percent adults (18 years or older).”
- Present risks and safety information, including the substance of relevant boxed warnings, “with reasonably comparable prominence to the benefit information, in a clear, conspicuous, and neutral manner, and without distraction from the content.”
- Seek and consider feedback from healthcare professionals and consumers when creating new DTC advertising
In addition, the guidelines state companies should not use DTC ads to promote products for off-label uses.