FDA OK's describing off-label drug uses

WASHINGTON - Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.

The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors - even when they involve uses that have not been federally approved. The FDA document was posted online yesterday.

For their part, companies like Pfizer Inc. and Eli Lilly said the guidelines merely reauthorize a longstanding policy that benefits doctors and patients.

"Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care," said Alan Bennett, an attorney for the pharmaceutical industry.

Companies are not allowed to advertise products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, FDA has allowed company salespeople to distribute articles about such uses if they are published in a peer-reviewed medical journal.

The law permitting that practice expired in 2006, and drug makers have been lobbying the agency to renew it ever since.

The reliability of medical journal articles came into question last year when Merck & Co. was accused of ghostwriting articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons.

The FDA said the new guidelines are designed to discourage ghostwriting and recommend companies disclose financial relationships with article authors.