Tag: OPDP

OPDP

Regulatory/FDA

FDA Finalizing Study of Disclosure Effectiveness in Drug Promotion

FDA Finalizing Study of Disclosure Effectiveness in Drug Promotion

Aug. 13, 2018 – The FDA released final details about the study it plans to conduct on the effectiveness of drug company disclosures in professional and consumer prescription drug promotion in an Aug. 9 Federal Register notice. Specifically, the aim of the research is to “examine the effectiveness of clear and conspicuous disclosures in prescription […]

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Regulatory/FDA

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

July 11, 2018 – A booth display and a webpage for the investigational new drug (IND) Crenolanib besylate “suggest, in a promotional context” that the IND is safe and effective for the purposes for which it is being investigated and, therefore, misbrand it, according to an Untitled Letter issued June 28 to Arog Pharmaceuticals Inc. […]

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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

FDA Ramps Up Drug Promotion Research Focus

FDA Ramps Up Drug Promotion Research Focus

March 14, 2018 – The FDA has “prioritized a robust social and behavioral science research program” to help the agency understand “how consumers respond to prescription drug promotion,” according to FDA Commissioner Scott Gottlieb, M.D. This Office of Prescription Drug Promotion (OPDP) research “has provided key information to inform our policies related to the proper […]

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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

FDA To Study Consumer, HCP Ability to Spot Deceptive Drug Ads

FDA To Study Consumer, HCP Ability to Spot Deceptive Drug Ads

Dec. 22, 2017 — The FDA recently announced that it was planning to study whether consumers and healthcare professionals have the ability to “spot and report” deceptive prescription drug promotion practices (https://www.gpo.gov/fdsys/pkg/FR-2017-12-12/pdf/2017-26704.pdf). The FDA’s Office of Prescription Drug Promotion (OPDP), which issued the lowest number of enforcement letters ever in 2017, appears to be looking […]

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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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DTC Advertising

DTC Docket Draws Health Professional, Consumer Comments

DTC Docket Draws Health Professional, Consumer Comments

Nov. 17, 2017 — In response to an Office of Prescription Drug Promotion (OPDP) call for input on a “limited risks plus disclosure” strategy for broadcast direct-to-consumer (DTC) ads, the FDA received 39 comments from health professionals and consumers as of Nov. 16. Although several of the commenters call for a complete ban on DTC […]

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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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