Tag: Untitled Letter

Untitled Letter

Regulatory/FDA

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

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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Regulatory/FDA

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

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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Regulatory/FDA

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

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 […]

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DTC Advertising

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

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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Regulatory/FDA

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

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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Regulatory/FDA

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

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 […]

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Regulatory/FDA

OPDP Cites Risk Presentation Issues in YouTube Video, Email in New Enforcement Letters

OPDP Cites Risk Presentation Issues in YouTube Video, Email in New Enforcement Letters

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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Regulatory/FDA

Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

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 […]

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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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Off-label Promotion

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

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 […]

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