President Obama announced his choice as the new FDA commissioner – Margaret Hamburg – during his most recent (3-14-09) weekly radio and video address. Hamburg is a former New York City health commissioner, while newly named deputy commissioner Joshua Sharfstein is former Baltimore health commissioner. Both are doctors and FDA outsiders, and pending Senate confirmation (for Hamburg, Sharfstein’s position doesn’t require it), they will be faced with the challenge of turning around the troubled agency. Insiders believe Obama made good choices. The Trust for America’s Health reports that Hamburg – a Harvard-trained physician and bioterrorism expert who served during the Clinton administration as assistant health secretary – is said to be a proven manager who turned around the New York City health department.
“She restored morale among workers and the agency’s credibility among citizens,” says Lowell Weicker, Jr., a former Connecticut senator and president of the Trust’s board. “And she has shown she can reach across party lines, having worked for both Democratic and Republican mayors in New York City.” Sharfstein, a pediatrician, served as a former health policy aide to Rep. Henry Waxman, D-Calif. Ellen Bloom of Consumers Union says Sharfstein’s experience is “just what the doctor ordered for FDA.”

It is likely that Hamburg and Sharfstein will re-evaluate the FDA's handling of medical- device approvals. Before doing so, however, it would be a wise move by Hamburg – assuming she is confirmed – and Sharfstein to reach out to the medical-device community and meet with representatives from start-ups and industry giants alike to get their take on the FDA approval process.

If you were invited to participate in such a meeting, what would you say? What would you ask? Let us know. We’ll do our best to forward your concerns and questions to the FDA, and we will, of course, share their responses. Please send your FDA-related comments and questions to joe.jancsurak@penton.com.

And while you’re at it, please take a moment to answer this month’s Reader Poll question about lean manufacturing. Your input is greatly appreciated.