Tag: omission of risk

omission of risk

Regulatory/FDA

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program. In a Sept. 22 Warning Letter […]

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Regulatory/FDA

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

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 […]

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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

OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking

OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking

July 22, 2019 – Social science research conducted at the FDA’s Office of Prescription Drug Promotion (OPDP) is designed to investigate issues relevant to healthcare professional and consumer use of medical product information, to consider the audience’s perception and comprehension of that information, and to assess the accuracy and effectiveness of promotional messaging, according to […]

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Regulatory/FDA

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form […]

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Regulatory/FDA

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

Feb. 23, 2018 – Companies, especially those that make opioid products, should make sure that promotional material displayed at conference exhibit booths clearly communicate their products’ risks and limitations of use, and that they heed advisory comments from the Office of Prescription Drug Promotion (OPDP), which issued an Untitled Letter to Collegium Pharmaceutical Inc. on Feb. […]

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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 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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