• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    ‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing

    The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information. Republican Reps. Fred Upton (MI) and Joe Pitts (PA) on Thursday took FDA to task for the agency’s “inability or unwillingness to publicly clarify its current thinking” on off-l...
  • Regulatory NewsRegulatory News

    FDA Sends Warning Letter Over Anesthesia Drug's Claims, but Company Defends Ads

    New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel. FDA's letter, dated 22 September 2014, references "educational technique flashcards" and a journal advertisement the agency said created the impression that Exparel has been approved for "new uses for which it lacks approval...