The Brief Summary
The Brief Summary is a monthly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates related to OPDP. Subscribe to The Brief Summary here and join the "Prescription Drug Promotion" listserv.
On June 27, 2023, the FDA issued a final guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” This guidance finalizes the draft guidance issued in October 2018. The guidance provides recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products, prescription animal drugs, and in DTC promotional labeling for nonprescription animal drugs (collectively, “promotional communications”). The recommendations are informed by current research findings related to communicating health information and cover the following topics:
- Providing quantitative efficacy or risk information from the control group, when applicable;
- Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies;
- Formatting quantitative efficacy or risk information; and
- Using visual aids to illustrate quantitative efficacy or risk information.
The guidance outlines recommendations for how manufacturers, distributors, and packers (collectively, “firms”) that include quantitative efficacy or risk information in DTC promotional communications for their drugs can make the language and presentation more consumer-friendly.
Core Launch Updates
On November 20, 2020, OPDP hosted a webinar to provide an overview of the upcoming changes to the OPDP Core Launch Review process. The webinar will provide information to:
- Identify promotional materials that qualify for Core Launch Review within the OPDP Advisory Process
- Understand the changes to the Core Launch Review process and incorporate those changes into existing promotional material development strategies
- Utilize the various resources provided by OPDP to support the Core Launch Review process
The recorded webinar is available at the link below.