By Mike May

In an agency-wide e-mail message on 13 July, US Food and Drug Administration Commissioner Margaret Hamburg unveiled a massive reorganization of the regulatory watchdog’s 41-year-old management structure. “The most obvious change you will see,” she wrote, “is that the Agency’s programs, in terms of a reporting chain to me, will be divided into ‘directorates’ that reflect the core functions and responsibilities of the Agency.” In addition to the existing offices, she said the FDA would also create a new Office of Operations as well as a deputy commissioner for Global Regulatory Operations and Policy “focused on grappling with the truly global nature of today’s world.”

For the pharmaceutical industry, the most important change could be the addition of the Office of Medical Products and Tobacco, which will be directed by Stephen Spielberg, who will assume the new post by the end of September. Speilberg is tasked with helping to coordinate work across the FDA’s centers for drug, biologics, medical devices and tobacco products. In the past, each of these centers reported directly to the commissioner.

(Click here to continue reading.)