Monday, September 9, 2013

Did FDA Just Announce A Major Reorganization?


FDA Commissioner Peggy Hamburg announced Friday, in an interal email (pasted below) that she was forming a “Program Alignment Group” charged with “identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives.”
By the sounds of it, the new task force (which comprises the agency’s most senior leaders) is going to look for ways to bring better alignment between the FDA’s different offices and medical product centers. This is a critical endeavor since more of the products that FDA is tasked with regulating don’t fit into the traditional categories in which FDA has historically divided its work.
Many new medical products transcend boundaries between drugs, devices, and biologics. Many cosmetics contain particles that mirror the nano-technology found in devices. Many foods have drug-like features. In such a world, the boundaries between FDA’s different centers may no longer make as much sense.
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