Tag: OPDP research

OPDP research

DTC Advertising

OPDP Will Study Accelerated Approval Product Disclosures to Gauge Consumer Understanding

OPDP Will Study Accelerated Approval Product Disclosures to Gauge Consumer Understanding

June 21, 2021 – Amid increased scrutiny of its accelerated approval pathway – partly prompted by the recently rescinded approval for two oncology product indications and the controversial approval of Biogen’s aducanamab for Alzheimer’s disease – the FDA’s Office of Prescription Drug Promotion (OPDP) has announced plans to study how well consumers understand the limitations […]

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DTC Advertising

OPDP to Study DTC Multiple Indication Ads, Completes Three Studies in 2020

OPDP to Study DTC Multiple Indication Ads, Completes Three Studies in 2020

May 24, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) is preparing to study whether consumers are challenged when multiple indications for the same drug are promoted in a single television ad. “It is our hypothesis that participants will be more likely to correctly recall and understand the first indication when it is […]

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Regulatory/FDA

Impact of Celebrity, Influencer Drug Product Endorsements to Be Studied by OPDP

Impact of Celebrity, Influencer Drug Product Endorsements to Be Studied by OPDP

Feb. 3, 2020 – How much effect the status of drug product endorsers – be they celebrities, physicians, patients or social media influencers – has on consumers is the subject of a new study proposed by the FDA’s Office of Prescription Drug Promotion (OPDP) in the Jan. 28 Federal Register. “We are interested in the […]

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Regulatory/FDA

OPDP To Explore Promotional Implications of Drug Names

OPDP To Explore Promotional Implications of Drug Names

Jan. 27, 2020 – What’s in a name? The FDA’s Office of Prescription Drug Promotion (OPDP) announced a new study last week to answer whether the proprietary name of a prescription drug has an influence on how that drug is perceived and whether drug names that suggest or overstate efficacy misbrand those drugs or affect […]

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DTC Advertising

OPDP Study of Oncology DTC TV Ads Needs Tweaking, Commenters Say

OPDP Study of Oncology DTC TV Ads Needs Tweaking, Commenters Say

Dec. 9, 2019 – The Office of Prescription Drug Promotion’s (OPDP’s) proposed study of  the increasingly-common direct-to-consumer (DTC) television advertising for oncology drugs seeks to examine how consumers parse the information they are receiving, but commenters on the proposal argue that some of the study’s parameters should be changed before moving forward. The proposed OPDP […]

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DTC Advertising

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

Sept. 16, 2019 – Five research studies conducted by the FDA’s Office of Prescription Drug Promotion (OPDP) – four of which examine aspects of direct-to-consumer (DTC) advertising – are complete and awaiting peer review and publication, according to OPDP’s Website. “Taken together, the OPDP studies now nearing release will make an important contribution to the […]

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Regulatory/FDA

FDA Ramps Up Drug Promotion Research Focus

FDA Ramps Up Drug Promotion Research Focus

March 14, 2018 – The FDA has “prioritized a robust social and behavioral science research program” to help the agency understand “how consumers respond to prescription drug promotion,” according to FDA Commissioner Scott Gottlieb, M.D. This Office of Prescription Drug Promotion (OPDP) research “has provided key information to inform our policies related to the proper […]

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