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Last Updated: Aug 1, 2008 - 10:24:18 AM |
SATURDAY FEB 16, 2008 (foodconsumer.org) -- The FDA proposed guidelines Friday to allow drug companies to disseminate medical journal articles on use of drugs to doctors so that they may use the drugs to treat diseases that are not covered under the agency's approval.
Normally, the FDA approved a drug for treatments of a specific disease. For instance, a medicine indicated to treat breast cancer cannot be marketed for lung cancer even if some studies indicate that this medicine may help lung cancer patents as well.
Proponents of the rule said the FDA approves drugs too slowly and medical journal articles distributed to doctors can remind them of the use of medicines that may save lives.
Opponents of the rule said this rule would allow drug companies to bypass the necessary, but expensive trials and promote the existing drugs on the market for unapproved uses, an approach that could put many patients at serious medical consequences.
Dr. Steven Nissen, a distinguished heart physician at the Cleveland Clinic, was quoted by the New York Times as saying "Companies could openly promote products for unapproved indications without testing these drugs."
Dr Nissen added "I’m astonished that this rule would even be considered."
For more information, read the New York Times article.
FDA Seeks to Broaden Range of Use for Drugs
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