Jan. 17, 2022 – A common theme among the enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) is the manner in which a drug’s promotional materials present product benefits while omitting product risk information. In its final Untitled Letter of 2021 to Eli Lilly, OPDP repeated this message, but the company’s […]
Read more March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially […]
Read more 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 […]
Read more 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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