• 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...
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    Press Releases - Another Tool for Promotion?

    This article discusses the regulatory oversight and recent precedent in evaluating whether or not press releases should be considered a form of promotional labeling. Introduction Across all industries, companies have long depended on the press release to announce important milestones, such as a merger, new product or special event for the media to increase publicity. Press releases or media releases are statements issued by companies to highlight and publicize a ...
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    Celebrity Endorsements—Lights, Camera, Enforcement Action?

    This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  Celebrities grab attention everywhere they go. In fact, it is what they are paid to do when they endorse a pair of sneakers or an underwear brand. Just look at William Shatner, best known as Captain James Kirk from Star Trek, who has everyone humming “Price-Line-Negoti-ator!” Or hear Samuel L. Jackson asking, “What’s in your wallet?” each time someone t...
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    Mapping Safe Harbor for Off-Label Communications

    Imagine a time when pharmaceutical companies did not need to submit evidence in the form of adequate and well-controlled trials to demonstrate their drugs were both safe and effective. Imagine then being able to sell those drugs to the public within a few months after filing as long as the US Food and Drug Administration (FDA) did not object. This was the standard through the 1960s, until the thalidomide tragedy outside the US caused thousands of severe birth defects and ...