Testimony: FDA should pay more attention to how well pending drugs actually work

Share this content:
Federal regulators should put more emphasis on comparative effectiveness research when considering premarket approval for new medications, according to experts who spoke at this week' s International Society for Pharmacoeconomics and Outcomes Research. While Food & Drug Administration approval is heavily weighted toward safety and effectiveness, it often gives comparative effectiveness inadequate attention, according to Mark McClellan, M.D., a senior fellow and director of the Engelberg Center for Health Care Reform at the Brookings Institution. McClellan previously served as FDA commissioner and administrator of the Centers for Medicare & Medicaid Services.