FDA Announces Top Personnel Changes

US Food and Drug Administration (Rockville, MD) Commissioner Lester M. Crawford has solidified the agency’s temporary management structure as one of his first actions in his new post.

Most significant for drug manufacturers, the commissioner made Janet Woodcock, MD, his permanent deputy commissioner for operations and chief operating officer, ending any speculation that she might return to her old job as the head of the Center for Drug Evaluation and Research (CDER). Steven Galson, MD, gets that position at CDER on a permanent basis as a result. Galson has been CDER’s acting director for almost two years, since Woodcock was detailed to the commissioner’s office. Galson was appointed CDER deputy director in 2001, coming from the Environmental Protection Agency, where he was involved with product safety and risk management activities. He faces the daunting task of overseeing CDER’s move to White Oak, Maryland, and other related organizational changes.

Crawford also named Murray Lumpkin, MD, the permanent deputy commissioner for international and special programs, which includes pediatric therapeutics, combination products, and public health issues. Associate Commissioner for Legislation Patrick Ronan becomes Crawford’s chief of staff and liaison to the Department of Health and Human Services. Scott Gottlieb, MD, who served as a deputy to former commissioner Mark McClellan, MD, and followed McClellan to the Center for Medicare and Medicaid Services, returns to FDA as deputy commissioner for medical and scientific affairs. Gottlieb is well positioned to help FDA access Medicare drug safety data and deal with drug coverage and cost issues.