The Food and Drug Administration officials have finalized guidelines that will make it easier for pharmaceutical companies to distribute medical journal articles to try and expand the market for medicines and medical devises even when they involve uses that have not been federally approved.

The FDA said, "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."

This move by the FDA comes just a week before Republican President George W. Bush leaves office to make way for President-elect Barack Obama's government. "In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, D-Calif. 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."

The policy drew objections from congressional Democrats and drug-industry critics when it was proposed last year and opponents feel it will promote usage without adequate testing. Manufacturers are prohibited by law from marketing their medicines for uses that are not authorized by the FDA. Doctors on the other hand under a practice known as "off-label" use can prescribe drugs for any use they deem fit.

The FDA had also allowed company salespeople to promote unauthorized uses if they are published in a peer reviewed medical journal under a law which expired in 2006 and drug makers have been lobbying to reinstate it since then. Alan Bennett, an attorney representing various drug makers said, the new guidelines "will clarify how and when manufacturers can provide unbiased, unembellished articles from peer-reviewed journals to health care professionals."

Under the expired law, companies had to submit the articles to the FDA before they could be sent to the doctors ensuring that the article’s accuracy could be verified. The new law however does away with this which Waxman and other Democrats feel will make it easier to promote potentially risky medical practices.

Drug companies like Pfizer Inc. and Eli Lilly defended the move by saying the guidelines reauthorized a long standing policy which benefits doctors and patients. Bennett said, "Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care."

Consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group said off-label use "means there isn't adequate evidence that the benefits outweigh the risks to have it approved by the FDA." He called for the guidelines to be reversed when Obama become president.

Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America said the FDA's guidance will help "assure that medical professionals receive timely and accurate medical information prior to the lengthy process" of securing FDA approval for wider use. He added that off label use "can save lives, especially in practice areas where there are few effective treatments."