Office of Prescription Drug Promotion (OPDP) News
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.
2023 News
On December 26, 2023, FDA issued a final guidance entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers.” The final guidance was issued in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule” (CCN Final Rule, issued November 21, 2023, 88 FR 80958). This guidance is a Small Entity Compliance Guide (SECG) presented in a question-and-answer format that explains key provisions of the CCN Final Rule. The effective date of the final rule is May 20, 2024, and the compliance date is November 20, 2024.
On November 20, 2023, the U.S. Food and Drug Administration issued a final rule to amend its prescription drug advertising regulations, entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule). The rulemaking implements a requirement of the Food, Drug, and Cosmetic Act (the FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85), that in human prescription drug ads presented directly to consumers in television or radio format stating the name of the drug and its conditions of use, the statement relating to major side effects and contraindications (“major statement”) must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, FDA is establishing standards to help ensure that the major statement in these advertisements is presented in the manner required. The effective date of the final rule is May 20, 2024 and the compliance date is November 20, 2024.
On October 23, 2023, FDA issued a revised draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This draft guidance supersedes the revised draft guidance issued in 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”
This revised draft guidance, when finalized, will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products. Specifically, this guidance relates to firms’ sharing of the following types of communications with HCPs:
- Published scientific or medical journal articles (reprints)
- Published clinical reference resources, as follows:
- Clinical practice guidelines (CPGs)
- Scientific or medical reference texts (reference texts)
- Materials from independent clinical practice resources
- Firm-generated presentations of scientific information from an accompanying published reprint
For the purposes of this guidance, these specific types of communications from firms to HCPs of scientific information on unapproved uses of certain approved/cleared medical products in combination with the disclosures recommended in this guidance are referred to as SIUU communications. Other communications by firms are not specifically addressed by this draft guidance, and the Agency does not intend to convey any views on such communications in issuing this draft guidance.
If a firm shares an SIUU communication with HCPs in a manner that is consistent with the recommendations in this guidance, FDA does not intend to use such communication standing alone as evidence of a new intended use.
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
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