US FDA considers relaxing off-label data rules

The US Food and Drug Administration is proposing that drug and device companies can send physicians journal articles and reference materials concerning off-label uses of their products. The proposal is strongly criticized by Representative Henry Waxman (Democrat, California), who chairs the House of Representatives' Committee on Oversight and Government Reform.

In a letter to the FDA's Commissioner, Andrew von Eschenbach, Rep Waxman wrote that 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." He added that "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."

According to the FDA's draft guidelines, 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."