Internet-Focused Promotion, Warning Letters Both Up As FDA Guidance Nears
As pharmaceutical companies await FDA guidance to help them navigate the pitfalls of Internet and social media promotion, firms are steadily increasing their participation on the Internet in general.
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FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.
Website suggested that the unapproved cancer immunotherapy was safe and effective, FDA says.
FDA should not delay draft guidance on Internet and social media promotional activities while it studies how consumer understanding of a drug’s safety and efficacy is affected by the techniques used to present information on branded websites, according to comments on the proposed studies.