Category Archives: Agency Insight

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
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Adaptive Trial Design and Combo Drugs Needed in Alzheimer’s

FDA’s head of neurology products told industry execs at the Prix Galien Forum that the agency is open to alternative clinical trial designs in Alzheimer’s disease, and would like to see more combination products in clinical testing.
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Advancing Pharma's Social Media Listening Analytics

Big Pharma’s tin ear for social, user-generated content online is softening despite regulatory anxiety. In the quest to better understand what patients and doctors need, pharma – thanks in part to a bevy of third-party service providers – is beginning to recognize and incorporate insights from social media into their development and commercialization programs, according […]
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Naughty Localities Need to Obey NICE, or Else!

Like governors in the US vowing to block Medicaid expansion in their home states, local primary care trusts (PCTs) in the UK don’t always follow national guidelines on drug access due to budgetary concerns. But that may change in 2013; according to comments made by Minister David Willetts last month, NHS could face monetary penalties […]
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Comply or Die: Introducing GSK's New Corporate Integrity Agreement

Big pharma talks a lot about the changing business model and placing a new emphasis on patients, but the fact remains that quantity of medicines sold, not quality of care provided, is how to get paid (and how to keep investors happy). Despite its egalitarian trappings, the healthcare “ecosystem” is still dominated by the most […]
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