In October 2018, the United States Food and Drug Administration (FDA) released a draft guidance on how to present efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertising, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry.”
The FDA believes that when firms develop DTC promotional materials, they should consider how to best convey information about a drug’s efficacy and risks so the intended audience understands it, including consideration of whether to provide efficacy and risk information by using words, numbers, or visual aids, or a combination of these elements.
In recent years, FDA has observed an increase in quantitative presentations of efficacy and risk information in DTC promotional materials submitted to the Agency. Recent research on the communication of treatment information suggests that consumers can recall and comprehend efficacy and risk information when it is provided quantitatively versus qualitatively.
This new draft guidance raises concerns that consumers differ in their interpretations of what qualitative descriptors mean and they may not understand relative frequency information presented in DTC ads, such as a 33% reduction in symptoms. Therefore, FDA believes that perhaps a change in conveying efficacy and safety information to consumers quantitatively instead of qualitatively may increase their comprehension.
“Quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks,” the draft guidance says. “Quantitative efficacy or risk information may offer more precision than qualitative information, which consumers can use to form more accurate perceptions about the drug.”
The recommendations in the guidance apply to DTC promotional materials regardless of the medium in which they are presented (i.e., print, electronic, audiovisual, broadcast).
To that end, the FDA recommends the following:
- Use Absolute Probability Presentations. Information should be conveyed 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 the advertisement, including frequencies using the same denominator (preferably a multiple of 10), and when possible, using whole numbers;
- Use Appropriate Visual Aids. Since visual aids help consumer comprehension, they should be used but 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; and
- Include Comparator Numbers. Both the treatment and the control groups should be represented to improve consumer perceptions about a drug’s efficacy and risk.
The guidance comes on the heels of a Nature study that said consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed.
While this guidance isn’t really “new” per se, prior guidances relating to DTC have acknowledged the role of the healthcare provider in prescribing and caring for patients. This guidance leaves out any references to healthcare providers and the role they can play.
The comment period for this draft guidance ends on December 17, 2018.