The US Food and Drug Administration has issued guidance that will allow pharmaceutical companies to distribute medical and scientific information to doctors on off-label usage of their treatments.
The new recommendations are a finalised version of the FDA’s draft guidance linked to ‘good reprint practices’which was issued in February 2008. The agency said that it “recognises that the public health can be served when healthcare professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products”.
As such, the FDA stated that the medical articles should be “published by an organisation that has an editorial board that uses experts who have demonstrated expertise in the subject of the article under review”. The organisation needs to be able to “review and objectively select, reject, or provide comments about proposed articles.”
They must also have “a publicly stated policy, to which the organisation adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organisation”. The FDA concluded that “if a manufacturer engages in other conduct that unlawfully promotes an unapproved use of a medical product…such other conduct may result in enforcement action.”
The agency’s move has been criticised in some quarters and Senator Henry Waxman (Democrat), chairman of the House of Representatives Energy and Commerce Committee, issued a statement saying that “in the final hours” of the Bush administration, “political appointees at FDA have given drug companies a long-coveted parting gift”. He added that “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”.
However, the Pharmaceutical Research and Manufacturers of America’s senior vice president Ken Johnson, said the FDA’s guidance will help assure that doctors receive “timely and accurate medical information prior to the lengthy process” of securing approval for wider use.
