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The US Food and Drug Administration (FDA) is proposing that drug and device companies can send doctors journal articles and reference materials about “off-label” or unapproved uses.
Representative Henry Waxman, the California Democrat who chairs the House of Representatives’ Committee on Oversight and Government Reform, has strongly criticised the FDA’s proposal and has posted the FDA’s draft “Guidance for Industry” document on his website together with a letter that he has sent to Dr Andrew von Eschenbach, the FDA commissioner.
“Until the Bush administration, these risks of permitting dissemination of journal articles on off-label uses were recognized by the FDA,” which had expressed “grave concerns” about the practice, he wrote.
The draft guidelines “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 . . . The draft guidelines appear to be an effort by FDA to displace Congress and establish by administrative fiat a new system for use of journal articles that lacks the safeguards set by Congress.”
Waxman asked von Eschenbach not to implement the draft guidelines and to provide documents about communications between the FDA and executive branch (the White House and presidential staff) about the new guidelines.
The FDA’s draft guidelines say there are “important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles and medical scientific reference publications on unapproved uses . . . These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care.”
The guidelines propose that drug and device manufacturers can send doctors journal articles published in a journal with an editorial board and peer review, not in a supplement or publication funded by the manufacturers of the drug or device. The guidelines would also permit sending scientific or medical reference publications that are generally available and not primarily prepared or supported by a drug or device company. The information in such publications should not be false or misleading or pose a risk to public health.
Such publications should be unabridged and not highlighted and should be distributed with the approved labelling, together with a bibliography of publications discussing “adequate” and “well-controlled clinical studies” of off-label uses. When there is controversy over off-label uses, the articles should be distributed with publications opposing the off-label use. No promotional material should accompany the articles.
Representative Waxman wrote to the FDA commissioner, “The draft guidance poses multiple risks.” He cited peer reviewed articles published in major journals that had been based on studies funded by drug companies that “provided a distorted picture of a drug’s safety or effectiveness.” He mentioned studies of antidepressants, Vioxx (rofecoxib), Celebrex (celecoxib), anti-arrhythmic agents, and Neurontin (gabapentin).
Peer reviewers almost never have access to the study proposal or the underlying data, he said, and may not have time or expertise to review the information in a paper. Textbook chapters and continuing medical education material are even less likely to be validated than information in peer reviewed articles.
Furthermore, Waxman wrote, the draft guidelines “may create a disincentive” for drug and device companies to do the studies that would allow them to seek FDA approval for unapproved uses.
Rita Chapelle, an FDA spokeswoman, told the BMJ, “Currently it is against the law for drug companies to market and sell drugs for off-label uses. The FDA will be responding directly to Representative Waxman” to address the contents of his letter.
The FDA guidance document is available at http://oversight.house.gov/documents/20071130103225.pdf; Representative Waxman’s letter is available at www.oversight.house.gov/story.asp?ID=1644