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.
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.
The guidelines also apply to medical device makers.
Steve - what a parting gift, Mr. Bush. Thanks a lot. So I guess now, any drug prescribed for health problems or symptoms NOT identified by the manufacturer should be avoided. Otherwise, you'll be a guiniea pig and Big Pharma will drive our health costs even hiigher.
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