Lutter to fill in for Gottlieb as acting FDA policy head

FDA commissioner Andrew von Eschenbach named Randall Lutter to serve as acting deputy commissioner for policy, replacing Dr. Scott Gottlieb, who leaves the agency Jan. 16 to rejoin the American Enterprise Institute (AEI). Lutter was most recently associate commissioner of policy and planning. Before he joined the FDA in 2003 as chief economist in the office of planning, he was a resident scholar at AEI and a fellow with the AEI-Brookings Joint Center for Regulatory Studies. His recent works include a study on the impact of accelerated approval times on pharmaceutical R&D investment, which concluded that PDUFA contributed $13.5 billion to R&D spending from 1992 to 2001, and a study on how routine genetic screening might improve outcomes in patients on warfarin (coumadin).