DTC Print Ads: Package Insert Info Is Out, Drug Facts Box Is In
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s revised draft guidance for disclosing risk information in direct-to-consumer print ads advises against the use of package insert information in the brief summary; suggests Drugs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FDA issued this policy shift in its revised draft guidance, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.” The new document revises a draft guidance FDA issued in 2004.
FDA regulations require Rx drug ads to include a brief summary of side effects, warnings, precautions and contraindications from the labeling. To fulfill this requirement, consumer-directed print ads frequently include the complete risk-related sections of the package insert. Promotional labeling pieces must include adequate directions for use and to do so they generally include the full PI.
“FDA believes these approaches are not optimal for consumer-directed prescription drug print advertisements and promotional labeling pieces because many consumers lack the technical background to understand some of the information as described in the PI,” the draft guidance states.
“To provide better and more actionable information for consumers, FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers.”
Labeling Highlights Section May Be Model
FDA suggests that the risk information selected for inclusion in the consumer brief summary can be in line with the risk information included in the Highlights section of drug labeling. It says the information should include: boxed warnings; all contraindications; and certain information regarding warnings and precautions. It also recommends that the brief summary include the most frequently occurring adverse reactions.
The draft guidance says various formats may be used to convey the information and it cites two that have been tested in research: a Drug Facts box and a Q&A format. A Drug Facts box has been included on every over-the-counter medicine since FDA issued a final rule on labeling requirements for OTC drugs in 1999.
The agency says that in a 2011 study testing various brief summary formats, the Drug Facts box resulted in better recall of the risk information when compared to the traditional format that was written in consumer-friendly language, and consumers reported that they felt more confident in their ability to use the information.
As for the Q&A format, the study found that consumers had more positive attitudes to it compared to the traditional brief summary but found no difference in recall or confidence between the Q&A and traditional formats.
Guidance v. Regulation
FDA had suggested an alternative to the package insert when it issued its initial draft guidance. That document said a DTC print ad would be in compliance with the brief summary requirement if it included the risk information that would appear in the Highlights section of FDA-approved labeling for the product (Also see "Alternatives To Brief Summary Outlined In Draft Guidance" - Pink Sheet, 4 Feb, 2004.).
In response to that document, the Pharmaceutical Research and Manufacturers of America said FDA should implement changes to the brief summary requirements through regulations. It noted that regulations require ad sponsors to disclose all risk information while the guidance suggested this would confuse consumers, thus creating a “regulatory Catch-22” (Also see "FDA "Brief Summary" Changes Should Be Written In Regs - PhRMA" - Pink Sheet, 12 May, 2004.).
PhRMA said it is reviewing FDA’s revised draft guidance and could not yet comment on it.
FDA announced the availability of the revised draft guidance in a Federal Register notice slated for publication on Feb. 9. Comments are due 90 days after publication.
The agency estimates that approximately 400 firms disseminate 24,000 consumer-directed print promotional labeling pieces annually.
FDA requests comments on the draft guidance’s recommendations regarding the content and format of the consumer brief summary; the relevant research that has been conducted or alternative formats developed since it received comments on the 2004 draft guidance; and the recommendation to no longer use the full PI to provide adequate directions for use.