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Lawmaker Urges FDA Not To Allow Off-Label Loophole

Law360 (November 30, 2007, 12:00 AM EST) -- The chair of the U.S. House of Representatives Oversight Committee sent a letter to the U.S. Food and Drug Administration Friday, urging the agency to rethink a recent internal draft guidance that would allow drug companies to promote drugs and devices for off-label use without FDA approval.

In his letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-Calif.) called the agency’s October draft guidance “ill-advised” and claimed it would “carve a large loophole in the law” by allowing drug and device manufacturers to...
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