The United States Food and Drug Administration (FDA) recently finalized guidelines which will allow pharmaceutical companies to inform doctors about unapproved uses of medicines and medical devices. This new policy will allow drug makers to market their medicines for uses not approved by the FDA.
In its guidelines the FDA stated "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."
By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. However, doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.
The "off-label" practice allows a doctor to prescribe a drug to a patient beyond what it is approved for. Alan Bennett, an attorney representing various drug makers in the US stated that the new guidelines, "will clarify how and when manufacturers can provide unbiased, unembellished articles from peer-reviewed journals to health care professionals."
According to a 2006 study published in the Archives of Internal Medicine, one of five prescriptions in the United States was written to treat a condition for which the drug was not approved.
Further support for the new guidelines was offered by Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America when he stated that the 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 and can save lives, especially in practice areas where there are few effective treatments."
In its guidelines the FDA indicated that articles circulated by companies should come from peer-reviewed journals that require disclosure of conflicts of interest for researchers and encouraged companies to seek FDA approval for unapproved uses.
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