Waxman: Planned Guidance Could Open Promotion Loophole

Rep. Henry Waxman (D-Calif.) is urging the FDA not to release a guidance allowing drug and medical device companies to use journal articles to promote off-label use of their products. Waxman recently released a copy of the draft guidance, which has not yet been issued by the agency, and sent a letter to the FDA requesting that it not continue work on the document until it provides further information to the House Oversight and Government Reform Committee.

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