Spielberg Named FDA Medical Products Deputy

The FDA’s top device regulator, Jeff Shuren, M.D., has a new boss.

According to a Reuters story on July 13, former Dartmouth Medical School Dean Stephen P. Spielberg, M.D. has been named to a newly created FDA position of deputy commissioner for medical products and tobacco.

In a letter sent to FDA staff and obtained by Reuters, FDA Commissioner Margaret Hamburg, M.D., said, “The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category…. In this role, Dr. Spielberg will serve as both advocate and a support for center directors in their important work for FDA.”

Hamburg also promoted Deborah Autor, currently a director of the agency’s compliance office, to the job of deputy commissioner for global regulatory operations and policy.

An FDA spokesperson told OTW on July 15 that Shuren will report to the new deputy commission, but still have access to Commissioner Hamburg.

In addition to his academic background, Spielberg, who most recently served as director of personalized medicine at Children’s Mercy Hospital in Kansas City, also previously worked with Johnson & Johnson and Merck & Co.

David Nierenberg, doctor of pharmacology at the Dartmouth Hitchcock Medical Center, told The Dartmouth in an interview on July 15 that he thinks Spielberg will be “terrific” in his new post. Spielberg has many qualities that make him well suited for his recent FDA appointment, Nierenberg said.  “He has very strong ties to industry, and they respect him.” He’s fair, he’s balanced and he’s respected in academia.”

Spielberg “really knows the ins and outs of drug development and testing for safety, especially in kids, ” which will be particularly useful for his future work with the FDA, Nierenberg said. He added that Spielberg’s previous work experience will help him in his new role.

“Since Dr. Spielberg has spent years with Johnson & Johnson, a well-respected drug and device company, he’s perfect for the job, ” Nierenberg told The Dartmouth.

The Wall Street Journal reported that 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.