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 […]
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Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity Pharmaceuticals Inc. in a healthcare professional email for XATMEP® (methotrexate) oral solution indicate that Azurity “appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and […]
Read more 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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Dec. 20, 2019 – As 2019 comes to an end, the FDA’s Office of Prescription Drug Promotion issued its third Warning Letter of the year to Alkermes Inc. for a medication-assisted treatment drug print ad for Vivitrol® and followed that up with an unprecedented press release about the enforcement action on Dec. 11. OPDP also […]
Read more Dec. 2, 2019 – In its sixth Untitled Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) cited Nascent Biotech Inc. for promoting an investigational new drug (IND) as a safe and effective treatment for brain cancer on its website. This is the second enforcement letter in 2019 to address issues related to […]
Read more 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. 5, 2019 – In two new Untitled Letters, the FDA’s Office of Prescription Drug Promotion (OPDP) makes clear that omitting risk information, misrepresenting product efficacy and using visuals that distract from risk messaging in direct-to-consumer (DTC) broadcast ads may draw the agency’s enforcement attention. In a July 25 Untitled Letter to CooperSurgical Inc., OPDP […]
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 […]
Read more Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]
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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