Tag: OPDP

OPDP

Regulatory/FDA

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]

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Regulatory/FDA

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]

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Regulatory/FDA

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

Sept. 21, 2020 – A radio ad that promotes the benefits of a product but omits all of the contraindications associated with its use creates “a misleading impression about the drug’s safety,” according to an FDA Office of Prescription Drug Promotion (OPDP) Warning Letter issued recently to Sprout Pharmaceuticals Inc. for ADDYI®, a female libido […]

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DTC Advertising

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

Sept. 7, 2020 – A direct-to-consumer (DTC) television ad featuring an animated syringe yielded Xeris Pharmaceuticals Inc. an enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) for alleged violations related to the product’s risk profile that “create a misleading impression about its safety and effectiveness.” In an Aug. 14 Untitled Letter, OPDP […]

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DTC Advertising

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Aug. 3, 2020 – The background music in direct-to-consumer (DTC) ads “is a distraction from the presentation of risks … and bombards the viewer with excess stimuli making it difficult for them to retain the information,” according to an Aug. 3 Citizen Petition sent to the Food and Drug Administration (FDA) by Knowledge Ecology International […]

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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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Regulatory/FDA

OPDP to Study How Source, Graphics and Time Affect Physician Perceptions of Info

OPDP to Study How Source, Graphics and Time Affect Physician Perceptions of Info

Aug. 26, 2019 – How healthcare professionals are influenced by different factors in prescription drug journal abstracts or sales aids – context, rigor of the underlying clinical study and time – is going to be examined by the FDA’s Office of Prescription Drug Promotion (OPDP). In a recent Federal Register notice, the agency stated that […]

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Regulatory/FDA

OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking

OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking

July 22, 2019 – Social science research conducted at the FDA’s Office of Prescription Drug Promotion (OPDP) is designed to investigate issues relevant to healthcare professional and consumer use of medical product information, to consider the audience’s perception and comprehension of that information, and to assess the accuracy and effectiveness of promotional messaging, according to […]

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Regulatory/FDA

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

Oct. 4, 2018 – According to Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock, the FDA’s Office of Prescription Drug Promotion’s (OPDP’s) decreased number of enforcement actions is largely due to the agency’s concerns regarding First Amendment issues that have been raised in recent court rulings. Speaking at a Sept. 21 discussion […]

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Regulatory/FDA

FDA Studying Extent of Risk Information in DTC Print Ads

FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, […]

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