FDA PHARMACOECONOMIC DATA REGULATION REPLACING OFF-LABEL PROMOTION AS KEY ISSUE; PDUFA/FDA REFORM ON DUAL TRACKS -- HOUSE MAJORITY COUNSEL COHEN
Executive Summary
FDA regulation of pharmacoeconomic data is a more important long-term FDA reform issue than dissemination of journal reprints involving off-label uses, House Commerce Committee Majority Counsel Howard Cohen asserted at a May 20 Food & Drug Law Institute meeting in Washington, D.C.