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  • 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...
  • Regulatory NewsRegulatory News

    OPDP Issues Third Warning of 2017

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate). FDA said both Zolpimist’s webpage , supported by Amherst Pharmaceuticals, and exh...
  • Feature ArticlesFeature Articles

    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
  • Regulatory NewsRegulatory News

    FDA Warns Drugmaker Over Opioid Marketing Materials

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride). The warning letter, only the second sent from OPDP in 2017, comes as the US grapples with an ongoing opioid epidemic that has brought increased scrutiny on opioid makers and their marketing practices. According to ...
  • Regulatory NewsRegulatory News

    OPDP Study Raises Questions About the Balance of Information in Mobile Ads

    A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs. As with other mediums for drug advertising, including print, television, web and social media, the study finds that mobile ads tend to present the benefits of drugs more prominently than their risks. "This echoes prior research across a broad range o...
  • Regulatory NewsRegulatory News

    FDA Cracks Down on TV Ad for Prescription Weight Loss Drug

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television advertisement that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl). OPDP found the ad , which opens with groups of women simulating a brain, contained efficacy claims for Contrave, but failed to include important risk information....
  • Regulatory NewsRegulatory News

    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
  • Regulatory NewsRegulatory News

    FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine). The letter, the fifth of which was issued this year by OPDP (the last one was issued in September), focuses on the video’s use of the general terms “e...
  • Regulatory NewsRegulatory News

    Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

    In just its third untitled letter of the year (and the first in almost five months), the US Food and Drug Administration (FDA) on Tuesday called out Jazz Pharmaceuticals subsidiary Celator Pharmaceuticals for promoting an investigational drug in a panel at the American Society of Clinical Oncology’s (ASCO) annual meeting in June. The company promoted the investigational drug, which was previously granted a breakthrough therapy designation by FDA, with claims that it is...
  • Regulatory NewsRegulatory News

    OPDP Untitled Letter Takes Issue With Shionogi's Copay Assistance Voucher

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has found that Shionogi’s “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion to help treat head lice is false or misleading because it omits important risk information. The omission of such risk information means that the voucher misbrands Ulesfia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative, ...