It’s All in the Numbers: FDA Issues New Draft Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

What is “truthful and non-misleading” in prescription drug promotion is often in the eye of the beholder. And, when it comes to enforcement, FDA is usually the arbiter. Over the years, FDA has taken on a number of initiatives and invested significant resources to better understand consumer comprehension of direct-to-consumer (DTC) prescription drug promotion.  One of its oldest drug advertising guidances still in effect, dating back to 1999, relates to consumer-directed broadcast advertisements and significant attention has been given to consumer comprehension of DTC promotion in several draft guidances, including one on Risk Presentation and another on Brief Summary Requirements.

In its new draft guidance, FDA asserts that conveying efficacy and safety information to consumers quantitatively, as opposed to qualitatively, may increase consumer comprehension. The draft guidance, entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements” (hereinafter, “Draft Guidance”), raises concerns that consumers differ in their interpretations of qualitative descriptors such as “rare, common, most,” and that consumers may not understand relative frequency information presented (e.g., 33% reduction in symptoms). To help improve consumer comprehension, FDA recommends the following with regard to the content and format of quantitative efficacy and safety information:

• Use Absolute Probability Presentations – firms should convey information in terms of absolute frequencies (e.g., 57 out of 100) or percentages (57%); if relative frequency information is provided (e.g., 50% reduction of risk), absolute probability measures should also be provided (e.g., 50% reduction of risk – 1% had a stroke compared to 2% in the control group).
• Choose a Consistent Format – presentations should be consistent throughout a piece, frequencies should use the same denominator (preferably a multiple of 10), and when possible, whole numbers should be used.
• Use Appropriate Visual Aids – visual aids help consumer comprehension and should be carefully and clearly labeled and defined, should include information proportionate to the quantity described (bar graphs representing appropriate proportions), and should include both the numerator and denominator of ratios or frequencies.
• Include Comparator Numbers – both the treatment and the control groups should be represented to improve consumer perceptions about a drug’s efficacy and risk.

While the information in the Draft Guidance is not really “new,” what is new (to this blogger, at least) is the lack of reference to health care providers. Although the Draft Guidance specifically addresses DTC promotion of prescription human drugs and biologics, prior guidances relating to DTC promotion have acknowledged the role of the health care provider with regard to prescribing and care of patients. In its draft guidance on Brief Summary Requirements, FDA states that “the consumer brief summary should include the indication for the use being promoted, any clinically significant drug interactions, and information regarding topics or issues consumers should discuss with their health care providers.” FDA, Draft Guidance, Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs, 8 (Revision 2) (Aug. 2015). In its Draft Guidance on Presenting Risk Information, FDA states that presenting risk information in consumer promotion is important as it “helps consumers know whether drugs or devices may be appropriate for them as well as what they should tell their healthcare professionals about before taking or using or while taking or using a product.” FDA, Draft Guidance, Presenting Risk Information in Prescription Drug and Medical Device Promotion, 2 (May 2009). And FDA’s final guidance on Consumer Directed Broadcast Advertisements acknowledges that the broadcast advertisement must not be false or misleading which, in the case of a prescription drug, would include “communicating that the advertised product is available only by prescription and that only a prescribing healthcare professional can decide whether the product is appropriate for a patient.” FDA, Guidance, Consumer-Directed Broadcast Advertisements, 2 (Aug. 1999). The absence of any mention of the health care provider’s role in facilitating consumer comprehension of a prescription drug’s efficacy/safety, or appropriateness, is surprising.