FDA ISSUES DRAFT GUIDANCE ON OFF-LABEL DRUG USE

FEBRUARY 01, 2008

The FDA has issued draft recommendations allowing drug and medical device manufacturers to distribute reprints of peer-reviewed research from reputable medical journals on unapproved uses for their products, with the stipulation that the material not be written, edited, or otherwise influenced by manufacturers or individuals with financial ties to them.

In its draft guidance, the FDA notes that "off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care." The FDA's Good Reprint Practices are being provided, "in recognition of the public health value to health care professionals of receiving truthful scientific and medical information," according to the document.

In a letter to FDA Commissioner Andrew von Eschenbach, MD, Rep Henry Waxman (D, CA), chairman of the House Committee on Oversight and Government Reform, called the guidance "ill-advised" and urged that the FDA not move forward with it, pending the committee's own inquiry into the draft guidance and the process that led to its development.

The FDA's guidance documents, including this draft guidance, describe its current thinking on a topic and should be viewed only as recommendations, according to the agency. It can be accessed at oversight.house.gov.



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