WASHINGTON (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 and Merck & Co 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.
The FDA in its guidelines said “public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses.”
Industry critics say distribution of the journal articles promotes untested uses of drugs and may be dangerous. It also may deter manufacturers from doing more tests of the new uses and subjecting them to FDA scrutiny for possible approval.
Off-label use “means there isn’t adequate evidence that the benefits outweigh the risks to have it approved by the FDA,” said consumer advocate Sidney Wolfe, director of Public Citizen’s Health Research Group. He called for the guidelines to be reversed once Democrat Barack Obama becomes president.
Unapproved use of medicines is common. A doctor may prescribe an antidepressant, for example, to treat insomnia, or a cancer drug for a type of cancer beyond what is approved.
About one of five prescriptions in the United States was written to treat a condition for which the drug was not approved, according to a 2006 study published in the Archives of Internal Medicine. The researchers said most off-label use occurs without scientific support.
Handing out journal articles on off-label uses had been permitted under a legal provision that expired in 2006. The new guidelines “will clarify how and when manufacturers can provide unbiased, unembellished articles from peer-reviewed journals to health care professionals,” said Alan Bennett, an attorney representing various drugmakers.
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, said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America.
Off-label use “can save lives, especially in practice areas where there are few effective treatments,” he added.
The FDA said articles circulated by companies should come from peer-reviewed journals that require disclosure of conflicts of interest for researchers. It also encouraged companies to seek FDA approval for unapproved uses.
The guidelines also apply to medical device makers.
The FDA proposed the guidelines in February 2008 and took public comments before finalizing them.
Reporting by Lisa Richwine; editing by Derek Caney, Brian Moss, Leslie Gevirtz