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  • Feature ArticlesFeature Articles

    Drug Pricing Transparency: The Conversation is Far From Over

    This article discusses the US government’s attempts to require drug pricing transparency in advertising. The authors explain the events following the Centers for Medicare and Medicaid Services (CMS) publication of a proposed rule for regulation to require drug pricing transparency. They outline recent initiatives by a number of other federal agencies to develop ways to inform the public about drug costs, efforts by the Pharmaceutical Research and Manufacturers of America (...
  • Feature ArticlesFeature Articles

    The Changing Regulatory Landscape of Advertising and Promotion

    This article provides two hypothetical “case studies“ demonstrating the impact of two recent FDA guidances for promotional communications that have the potential to change the US landscape of pharmaceutical regulatory advertising and promotion. The authors conclude that if regulatory professionals do ‘the right things,’ higher standards set forth by FDA in the new guidances will elevate the quality of pharmaceutical promotional communications to a ‘truthful and non-mislea...
  • 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...
  • Feature ArticlesFeature Articles

    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...