Tag: Warning Letter

Warning Letter

Regulatory/FDA

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in […]

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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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Regulatory/FDA

OPDP Enforcement Letter Grand Total for 2017: Five

OPDP Enforcement Letter Grand Total for 2017: Five

Jan. 24, 2018 – In a dip from previous low-enforcement letter years, the Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters in 2017, fewer than half the number of letters issued in 2016 (11). Of the five enforcement letters sent this year, two were Untitled Letters and three were Warning […]

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Regulatory/FDA

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

Nov. 30, 2017 – False or misleading risk presentation and claims about efficacy were the primary concerns listed in the Office of Prescription Drug Promotion’s (OPDP’s) second Warning Letter of the year, demonstrating that the issues cited in previous years’ enforcement letters remain a priority for the agency. “While this is only the third enforcement […]

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Regulatory/FDA

OPDP Issues Warning Letter for Omission of Risks, Material Facts

OPDP Issues Warning Letter for Omission of Risks, Material Facts

Sept. 8, 2017 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued only two enforcement letters this year, its Aug. 24 Warning Letter to Cipher Pharmaceuticals followed a clear pattern: pursuing alleged omission of risk and omission of material facts. The letter to Cipher (ConZip Warning Letter), which licenses its ConZip® opioid […]

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