UPDATE 4-US lets drugmakers advise doctors on unapproved uses

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By Lisa Richwine

WASHINGTON, Jan 12 (Reuters) - U.S. health officials finalized guidelines that make it easier for pharmaceutical companies to tell doctors about unapproved uses of medicines, a practice opposed by critics of industry marketing.

The Food and Drug Administration (FDA) guidelines explain when manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) may distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.

The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.

"In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, chairman of the House of Representatives Energy and Commerce Committee.

"This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective. I hope this policy will be carefully re-examined by the new administration," added Waxman, a California Democrat.

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, 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.