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.

The Brief Summary - Editions

2023 News

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 This guidance finalizes the draft guidance issued in October 2018.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.

2022 News

OPDP’s Social Science Research Program: Aiming to Understand How Health Care Providers and Patients Interpret Prescription Drug Information

2021 News

FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit

FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia

OPDP Reflects on 2020, Looks Forward to 2021 as It Helps Ensure Prescription Drug Promotion Is Truthful, Balanced and Accurate | FDA

2020 News

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.

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