Tag: OPDP

OPDP

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

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

Oct. 4, 2018 – According to Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock, the FDA’s Office of Prescription Drug Promotion’s (OPDP’s) decreased number of enforcement actions is largely due to the agency’s concerns regarding First Amendment issues that have been raised in recent court rulings. Speaking at a Sept. 21 discussion […]

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Regulatory/FDA

FDA Studying Extent of Risk Information in DTC Print Ads

FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, […]

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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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