|Rep. Henry Waxman, D-Calif.
Draft guidance by the FDA allows drug companies to use journal articles to market potentially dangerous off-label uses of drugs and medical devices without prior FDA review and approval. If Congress gets its way, that practice may stop.
On Tuesday, Rep. Henry Waxman, D-Calif., chair of the Oversight and Government Reform Committee wrote a letter to FDA commissioner Andrew von Eschenbach, MD, requesting documents related to the draft guidance.
An FDA memo previously turned over to Waxman showed that FDA officials, including former chief counsel Dan Troy, and pharmaceutical industry representatives urged von Eschenbach to issue the draft guidance.
Waxman wants more information but the FDA has refused saying the documents are pre-decisional and, therefore, privileged information.
“This is no basis for withholding from the Committee communications about the use of journal articles that FDA received from private drug companies,” Waxman said in the letter. “This is also no basis for withholding internal FDA communications where — as in this case — there is evidence that FDA's actions may be unduly influenced by regulated companies.”
Waxman has demanded to receive by Feb. 5 all documents since Jan. 26, 2001, relating to the new draft guidance and all documents between January 26, 2001 and April 13, 2007, including internal FDA communications, relating to the dissemination of reprints and textbooks.