Tag: efficacy claims

efficacy claims

DTC Advertising

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Bausch Health Companies Inc. takes issue not only with omission of risk information in a direct-to-consumer (DTC) video and a webpage of a healthcare professional website, but also with a lack of balance […]

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Regulatory/FDA

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

June 19, 2019 – The FDA’s Office of Prescription Drug Promotion (OPDP) has cited VIVUS Inc. for making false or misleading claims about the efficacy of and risks associated with Qsymia capsules, which are intended to be an adjunct treatment for obesity with a reduced-calorie diet and increased exercise, but allegedly were promoted as being […]

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Regulatory/FDA

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018

Aug. 30, 2018 – In its fourth enforcement letter of 2018, the FDA’s Office of Prescription Drug Promotion (OPDP) cited ASCEND Therapeutics US LLC for allegedly false claims in a sell sheet for EstroGel® 0.06%, stating that the sell sheet “is concerning because it falsely suggests that EstroGel contains the lowest effective dose of estrogen […]

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Regulatory/FDA

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

Nov. 30, 2017 – False or misleading risk presentation and claims about efficacy were the primary concerns listed in the Office of Prescription Drug Promotion’s (OPDP’s) second Warning Letter of the year, demonstrating that the issues cited in previous years’ enforcement letters remain a priority for the agency. “While this is only the third enforcement […]

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