Tag: OPDP

OPDP

Regulatory/FDA

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

July 26, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) cited Amgen for making misleading claims that the delivery of its product Neulasta® through the Onpro® on-body injector is more effective than delivery through the pre-filled syringe (PFS) or is more effective than FDA-licensed biosimilars, which are only available through PFS. OPDP takes […]

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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June 21, 2021 – Amid increased scrutiny of its accelerated approval pathway – partly prompted by the recently rescinded approval for two oncology product indications and the controversial approval of Biogen’s aducanamab for Alzheimer’s disease – the FDA’s Office of Prescription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

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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