FDA draft guidelines issued today would permit the marketing of FDA-approved drugs and devices by the use of scientific reprints that discuss unapproved indications — currently a forbidden practice.
But before they even hit the Federal Register, the draft guidelines drew fire from Rep. Henry Waxman (D-Calif.). He accused the FDA of proposing to “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.” (See: Waxman Says FDA Plans to Ease Restrictions on Off-Label Marketing)
Randall Lutter, Ph.D., the FDA deputy commissioner for policy, said in a statement that articles that discussed unapproved uses “can contribute to the practice of medicine and may even constitute a medically recognized standard of care.”
If finally approved, the new guidelines would supplant Section 401 of the FDA Modernization Act, which allows dissemination of the reprints as long as they are not used to promote off-label use.