FDA Commissioner Margaret Hamburg has hired from the outside and promoted from within in naming two deputy commissioners. Stephen Spielberg becomes deputy commissioner for medical products and tobacco, while Deborah Autor has been tapped as deputy commissioner for global regulatory operations and policy.
The agency's moves follow recent congressional scrutiny, public criticism and budget-cut threats. At the same time, the Center for Devices and Radiological Health has been struggling with its relationship with medical device makers as it attempts a revision to its 510(k) premarket notification process.
Both Hamburg and CDRH director Jeff Shuren were in Boston on Monday. Hamburg, escorted by Sen. John Kerry (D-MA), met with biotech and medical device companies. Separately, Shuren engaged in a Q&A session at a meeting of about 250 medical device executives.
New Deputy Commissioner Spielberg, a pediatrician and pharmacologist most recently with Children's Mercy Hospital in Kansas City, will oversee Shuren's CDRH domain in addition to the centers for drugs, biological products and tobacco, according to the Wall Street Journal.
Autor, formerly the director of the drug center's compliance office, takes on the heavy lifting of regulating drug and raw material imports.
Former deputy commissioner Murray Lumpkin becomes a senior adviser and representative for global issues, while John Taylor moves from his post as acting principal deputy commissioner to a counselor in the commissioner's office.
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