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Internal FDA Guidance on Off-label Uses of Drugs Released by House Cmte.

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House Government and Oversight “Chairman Waxman today released a draft of an internal FDA guidance that would allow drug companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval.”

  • Letter to FDA Commissioner von Eschenbach from Chairman Waxman: “I have obtained a copy of an October 2007 internal draft of new FDA guidance that would allow drug companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval. It is my understanding that the FDA intends to issue this guidance without significant changes in the very near future. I urge you to refrain from going forward with this ill-advised guidance. A fundamental tenet of our drug and device laws is that a manufacturer cannot market a drug or device for a therapeutic use without FDA approval. The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products without first obtaining FDA approval by passing out journal articles about the off-label use to physicians. Published reports of company funded studies can be biased in favor of the company’s product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products.”
  • FDA Draft Guidance
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