President Obama recently announced Margaret Hamburg as his choice for FDA commissioner. Hamburg is 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-CA. Ellen Bloom of Consumers Union says Sharfstein's experience is “just what the doctor ordered for FDA.”

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood “urges the Senate to move swiftly to confirm her” because “the FDA needs a strong, confirmed commissioner to effectively fulfill its expanding obligations, advocate for sufficient agency resources, ensure the integrity of scientific decisions, and promote morale and a sense of mission at the agency.”

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. E-mail me your thoughts and we will forward your concerns and questions to the FDA. Then, of course, we will share with you their responses. If you have thoughts on other articles and news in this issue, please e-mail those as well.

And while you're at it, please take a moment to visit www.medicaldesign.com and answer this month's question about lean manufacturing. Your input is greatly appreciated.

Cheers!