Category Archives: social media

New Social Media Guidelines: What FDA Says, and What It Means

By Simon Beins is Associate Director, Strategy, Heartbeat Ideas & Heartbeat West. Earlier this year, FDA promised three sets of guidelines to clarify using social media for pharma marketing. Last week it delivered two of them The first, Internet/Social Media Platforms with Character Space Limitation—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, […]
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Abrams Talks Social Media at DIA

“It doesn’t turn me on to send a warning letter.” –Tom Abrams, during a Q&A at DIA.  Instead of repeating his yearly Drug Information Association (DIA) conference claim that social media guidance remains among the FDA’s Office of Prescription Drug Promotion’s (OPDP) “highest priorities,” to be published in due course, Tom Abrams, director of OPDP, […]
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Social Media Questions Pharma Companies Should Be Asking

For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less. Social media poses a regulatory and litigation maze that must be carefully navigated. Here, Mathew dos Santos and Lori Leskin provide some insight into the most pressing questions companies are, […]
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Digital Technology: A Double-Edged Sword

Technology offers the promise of engaging patients on a level never seen before. The benefits of an engaged patient start with increased compliance—a great thing for pharmaceutical companies—and extend to a more active and empowered consumer of healthcare, and ultimately to better and more affordable outcomes. But technology is a double-edged sword. Its increasing complexity leads […]
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FDA, Drug Companies Struggle with Compassionate Use Requests

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval. As 7-year-old cancer patient Josh Hardy gained relief from a life-threatening infection following a bone marrow transplant thanks to […]
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