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  • Regulatory NewsRegulatory News

    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
  • Regulatory NewsRegulatory News

    FDA to study disclosure information for accelerated approval products in oncology

    The Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) wants to know how to better present disclosure information about products with accelerated approval to patients with cancer and their caregivers.   In two studies recently announced in the Federal Register , OPDP is seeking to confirm prior research on how patients interpret disclosure information for a product approved under FDA’s accelerated approval pathway on a direct-to-...
  • Feature ArticlesFeature Articles

    The FDA, prescription drug promotion, and its Bad Ad Program

    This article discusses pharmaceutical industry promotion for prescription drugs. The author provides an overview of the regulatory landscape from the US Food and Drug Administration’s (FDA) perspective followed by a discussion of the FDA’s Bad Ad Program which celebrated its ten-year anniversary in the summer of 2020. FDA's Bad Ad Program is an outreach program designed to help healthcare providers (HCPs) recognize and report potentially false or misleading prescription d...
  • Regulatory NewsRegulatory News

    Kardashian's Nurtec claims garner OPDP untitled letter

    A celebrity interview has overstepped the bounds of permissible direct-to-consumer advertising of a prescription drug, garnering an untitled letter from the US Food and Drug Administration (FDA).   The agency’s Office of Prescription Drug Promotion (OPDP) issued the letter on Monday to Biohaven Pharmaceuticals, which markets Nurtec (rimegepant) orally disintegrating tablets (ODTs) to treat migraine with or without aura.   OPDP found fault with an interview given ...
  • Regulatory NewsRegulatory News

    OPDP warns Paragard maker over promotional video

    A sponsored video that aired on NBC’s Boston affiliate in October has landed CooperSurgical a warning letter from the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) for failing to include risk information about the company’s Paragard intrauterine device (IUD).   The warning letter is the second sent by OPDP in 2021 and is the second enforcement letter sent to CooperSurgical concerning Paragard. In 2019, OPDP sent the company an unt...
  • Regulatory NewsRegulatory News

    OPDP warns AcelRx over Dsuvia promotional materials

    In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).   Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue a...
  • Feature ArticlesFeature Articles

    A deep dive into OPDP’s position on public health emergencies in the US

    This article explores the Office of Prescription Drug Promotion’s (OPDP’s) views on public health emergencies, including COVID-19, and how this affects drug promotion. The author reviews trends in past enforcement letters and concludes that promotional materials relating to current public health emergencies are heavily scrutinized by OPDP, which regulatory advertising and promotion reviewers should bear in mind.   Introduction The COVID-19 pandemic has caused innumer...
  • Feature ArticlesFeature Articles

    OPDP compliance and promotional considerations for podcasts and audio-streaming

    This article discusses the increasing interest and trend in using podcasts and audio-streaming platforms for promotional and nonpromotional activities, and how that relates to the pharmaceutical industry. The author provides a rudimentary overview of current landscape, as well as promotional considerations from a regulatory perspective to maintain compliance with the Office of Prescription Drug Promotion (OPDP) of the US Food and Drug Administration (FDA). Communication an...
  • Regulatory NewsRegulatory News

    OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot

    Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.   The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for...
  • Regulatory NewsRegulatory News

    FDA's OPDP Warns Metuchen Pharmaceuticals Over Misleading DTC Ads

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Metuchen Pharmaceuticals earlier this month for several false and misleading advertisements for its erectile dysfunction drug. In several print and online ads, including one in the American College of Cardiology’s magazine, the drug, known as Stendra (avanafil), is portrayed as being approved for a new use for which it lacks approval, and several misleading ...
  • Regulatory NewsRegulatory News

    FDA to Survey Healthcare Professionals on Prescription Drug Marketing

    The US Food and Drug Administration (FDA) on Friday announced it will go ahead with a survey of healthcare professionals (HCPs) on how they are impacted by prescription drug promotion aimed at a professional audience.   The announcement comes after the agency consulted on its plans for  the survey in March 2018 and follows two earlier surveys that looked at HCPs’ attitudes toward direct-to-consumer (DTC) advertising. The survey will also include questions about HCPs’...
  • Regulatory NewsRegulatory News

    OPDP Letters: FDA Closes Out 2017 With Record Low

    In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency. Whi...