June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC. OPDP reviewed a “Doctor […]
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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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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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Oct. 7, 2019 – Promotional materials are false or misleading not only if they make efficacy claims that are unsupported, but also if they fail to bring to light the risks associated with use of the product, the FDA’s Office of Prescription Drug Promotion said in two enforcement letters issued in September to address claims […]
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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 […]
Read more 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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