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DTC Print Ads: Package Insert Info Is Out, Drug Facts Box Is In

 
• By Brenda Sandburg

FDA’s revised draft guidance for disclosing risk information in direct-to-consumer print ads advises against the use of package insert information in the brief summary; suggests Drugs Facts box or Q&A as alternative formats.

Concluding that risk information in package inserts is too technical for consumers to understand, FDA is advising companies to stop including it in the brief summary of print ads directed to consumers. Instead, the agency recommends that companies convey appropriate risk information in a different format, such as a Drug Facts box or question and answer dialogue.

FDA issued this policy shift in its revised draft guidance, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for...

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