Tuesday, January 13, 2009

UPDATE 3-US lets drugmakers advise doctors on unapproved uses

U.S. health officials finalized guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their medicines, a practice opposed by critics of industry marketing.

The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) to 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.

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.


No comments: