FDA Reorganizes at the Top, Taps Ex-Dartmouth Dean for Post (Wall Street Journal)
WASHINGTON—The Food and Drug Administration, whose relations with medical companies have been strained of late, named a former senior drug-company official and Dartmouth Medical School dean as its new deputy commissioner overseeing much of the agency’s operations.
Commissioner Margaret A. Hamburg selected Stephen P. Spielberg to the new position of Deputy Commissioner for Medical Products and Tobacco. The appointment was part of a reorganization at the top of the nation’s leading medical- and food-safety agency. Dr. Spielberg, a pediatrician and pharmacologist, most recently has served as director of personalized medicine at Children’s Mercy Hospital in Kansas City.
Previously, he served as dean of Dartmouth Medical School and vice president for health affairs at Dartmouth College in Hanover, N.H. From 1997 to 2003, Dr. Spielberg was Johnson & Johnson‘s vice president for pediatric drug development and, prior to that, was at Merck & Co.’s research laboratories in senior positions. During that time he was chairman of the pediatric task force of PhRMA, the drug industry’s trade association.
In an interview Wednesday, Dr. Spielberg noted that he served on the FDA’s scientific advisory board in the past two years and said he “very excited to work on issues such as how to enhance regulatory science.” He said it was during this scientific advisory role that he came to know Dr. Hamburg and that it’s still uncertain exactly when he will take over his new role.
Dr. Spielberg will oversee the bulk of the FDA’s operations, including the centers for drugs, medical devices and biological products, as well as the relatively new tobacco center. The one major area over which he won’t have primary authority is food regulation, which will continue to be overseen by Deputy Commissioner Michael Taylor.
Dr. Hamburg also promoted Deborah M. Autor, an attorney who now is director of the drug center’s compliance office, to the job of deputy commissioner for global regulatory operations and policy. Ms. Autor played a prominent public role in investigating deaths linked to heparin made in part with raw materials from China; the agency concluded a Chinese ingredient played a role in the deaths. She faces an especially tough challenge in regulating drug and raw-material imports, as FDA officials have testified in recent congressional hearings that they lack the manpower to adequately inspect overseas facilities.
Murray Lumpkin, who has been deputy commissioner for international programs, will become a senior adviser and representative for global issues. John Taylor, who has until now served as acting principal deputy commissioner, will remain as a counselor in the commissioner’s office.
Write to Thomas M. Burton at tom.burton@wsj.com