The FDA is considering a policy change that would allow pharmaceutical companies to give physicians journal articles that detail off-label uses of drugs, according to Rep. Henry Waxman (D-Calif).
If approved, the FDA proposal “would allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said.
Waxman has posted a copy of an FDA draft document that web site, along with his letter to FDA Commissioner Andrew C. von Eschenbach, M.D., protesting the proposed change.
Moreover, Waxman said, the House Committee on Oversight and Government Reform, which he chairs, will “be examining the draft guidance and the process that led to [its] development.”