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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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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Jan. 31. 2022 – Presenting drug benefit information without also including risk information in a social media post on Instagram misbrands Eli Lilly’s Trulicity® according to a recent enforcement letter to the company from the FDA’s Office of Prescription Drug Promotion (OPDP). In the Jan. 19 Untitled Letter, OPDP states that it reviewed the post […]
Read more 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 […]
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Aug. 30, 2021 – In an Aug. 9 Untitled Letter, FDA’s Office of Prescription Drug Promotion (OPDP) cited Eton Pharmaceuticals Inc. for presenting benefit information in sponsored links for Alkindi® Sprinkle (hydrocortisone) oral granules without including any risk information about the product, which “is used in a vulnerable pediatric population” and may cause serious adverse […]
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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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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 […]
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 […]
Read more May 26, 2020 – Since 2015, the FDA’s Office of Prescription Drug Promotion (OPDP) has issued a yearly high of 11 enforcement letters (2016) and a low of five enforcement letters (2017), and so far in 2020, OPDP has issued just one enforcement letter. The three Warning Letters and seven Untitled Letters issued by 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 […]
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