Agency's Approval Plan Flawed
The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance, which he said was close to being finalized. “[It] … would, in effect, 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. “This und ercuts the prohibition on marketing of unapproved uses of drugs and devices.” He requested detailed information on development of the new policy.