FDA lets drugmakers advise doctors on unapproved uses

WASHINGTON (Reuters) - U.S. regulators issued guidelines on Monday that make it easier for drug companies and medical device makers to advise doctors about unapproved uses of their products.

The Food and Drug Administration finalized a proposal issued in February 2008 that lets companies distribute medical journal articles describing unapproved uses.

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for unapproved uses, a practice known as “off-label” use.

Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.

The new guidelines say the FDA “recognizes that the public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products.”

The agency said it added a statement encouraging companies to seek FDA approval for the unapproved uses.

(Reporting by Lisa Richwine; editing by Derek Caney)


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