On October 16, 2018, the Food & Drug Administration (FDA) released a new draft guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. This guidance provides recommendations to marketers of prescription drugs, biologics, and veterinary medicines about how to present benefit and risk information to consumers in promotional materials. The recommendations are not binding, and do not create any new obligations for marketers. This guidance does, though, give useful direction for ways to improve patient understanding of promotional claims. The FDA will accept comments and suggestions on the draft guidance for 60 days.
In this POV from Intouch’s external regulatory expert Dale Cooke, we provide an overview of the guidance and offer recommendations for ensuring consumers and healthcare professionals understand promotional communications. Three steps marketers of prescription products can take are discussed:
- Review existing practices and policies for presenting quantitative information in DTC promotion.
- Update practices and policies (as needed) to reflect FDA’s recommendations.
- Evaluate existing and in-development promotional materials against the guidance recommendations.