After years of anticipation, the US Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians.
Off-label information is regulatory parlance for materials that describe unapproved uses of a drug. Doctors are, in fact, allowed to prescribe a medicine for an unapproved use, but drug makers have long chafed at restrictions on their ability to distribute such information — reprints of medical studies, for example — and have lobbied Congress and the FDA to loosen regulations.
Despite such efforts, the FDA has taken a firm stance toward the issue. A key concern is that public health could be jeopardized if a company were to distribute information about an unapproved use that had not been proven to be safe and effective, a standard for regulatory approval.
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Hmmmm, “Can the same information be misleading to some audiences…?” Why is this a question or a concern? We are talking about marketing here – it’s supposed to be lies …. uh, I mean misleading.