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FDA To Hold Two-Day Meeting On Off-Label Drug Marketing



11/9/2016 7:47:04 AM

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The FDA, however, has avoided doing so. The agency has regularly voiced concern that public health could be jeopardized if a drug maker distributes information about an unapproved use that has not been proven safe or effective.

As we have reported previously, the industry effort accelerated after a 2012 ruling by a federal appeals court that overturned the criminal conviction of a Jazz Pharmaceutical sales rep, who was prosecuted for encouraging doctors to prescribe a drug for unapproved uses. The court ruled his speech was protected, since the information was truthful and not misleading.

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