• Regulatory NewsRegulatory News

    FDA to Further Study Deceptive Drug Advertising

    The US Food and Drug Administration (FDA) says it plans to study how well consumers and healthcare professionals are able to identify deceptive or misleading information in drug advertisements. While FDA says there have been a number of studies in the past looking into the occurrence and influence of deceptive advertising, there hasn't been research into how well consumers and healthcare professionals are able to identify deceptive drug promotion. "The ability to identi...
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    FDA Warns Two Pharma Companies Over Misleading Ads

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements. One of the warnings was sent to Salt Lake City-based Spiraso due to “false or misleading claims and/or representations about the risks associated with Tuxarin ER” on the company’s website. Tuxarin is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults ...
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    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
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    FDA Questions Need for Looser Off-Label Promotion Restrictions

    Officials from the US Food and Drug Administration (FDA) last week questioned industry arguments for looser regulations on off-label promotion for drugs and devices at a two-day public hearing at FDA's White Oak campus. Currently, FDA limits companies' ability to promote products to their approved indications, and restricts the types of data companies can share that steps outside of the products' approved labeling. Background Earlier this year, FDA announced it was un...
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    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...
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    Off-Label Promotion: Researchers Call on Courts to Reject Caronia

    Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia . The call comes during a time of uncertainty for the future of off-label promotion and just one week before FDA's upcoming two-day public hearing on off-label communications. In Caronia , the Second Circuit Court of Appeals reversed the ...
  • Feature ArticlesFeature Articles

    Do Recent First Amendment Court Developments Deal a Blow to the Government?

    This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. Introduction The US Food and Drug Administration has suffered two widely-publicized setbacks relating to off-label promotion oversight. In both cases—one involving a pharmaceutical company (Amarin) and the other a medical device firm (Vascular Solutions) and its chief executive officer—the governmen...
  • Feature ArticlesFeature Articles

    Regulatory Advertising and Promotion: Exploring the Past and Present to Understand the Future

    This article provides a chronological overview of legislative milestones shaping the landscape of regulatory advertising and promotion. It reviews standards for prescription drug promotion and summarizes important cases involving off-label promotion with the purpose of showing that while interpretation for what is considered truthful and not misleading has been changing, regulations defining them have not changed. Introduction For those working in regulatory advertisi...
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    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...
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    FDA, Amarin Propose to Settle Landmark Off-Label Marketing Case

    Amarin and the US Food and Drug Administration (FDA) late Tuesday announced the proposed settlement terms of a major First Amendment lawsuit over the off-label promotion of a drug. The settlement comes as FDA and Amarin have been battling in court for a little less than a year over Amarin’s dissemination of promotional materials to doctors on an unapproved indication for its triglyceride lowering drug Vascepa (icosapent ethyl). The lawsuit was linked to Amarin’s int...
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    DTC Drug Advertising: FDA to Launch First Public Survey Since 2002

    Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads. The survey will question respondents about their knowledge of FDA's authority over prescription drug advertisi...