Saturday, January 31, 2009

Obama's FDA Pick Coming Soon

Maybe one of the TV networks could secure the rights for the FDA extreme makeover. This agency seems to be in the pocket of the drug industry and has failed to protect the public from peanut butter, tomatoes and spinach. And they work at a snail-like pace. 
Reuters: President Barack Obama will announce in coming days his pick to lead the struggling Food and Drug Administration with the aim of strengthening the agency's regulatory muscle, the White House said on Friday.

The news comes amid a recall of hundreds of products tied to salmonella bacteria-tainted peanuts that have sickened more than 500 people in at least 43 states, including numerous children, and possibly led to eight deaths.

"The president hopes in the next few days to announce a pick for commissioner at FDA," White House spokesman Robert Gibbs told a press briefing.

Companies and consumer advocates have been anxious for Obama to name the next leader at the agency, which regulates roughly a quarter of the nation's products, including pharmaceuticals, medical devices and dietary supplements.

Names floated for the post include Joshua Sharfstein, head of Baltimore's health department; Robert Califf, cardiologist at Duke University; Cleveland Clinic cardiologist Steve Nissen; and Susan Wood, former head of the FDA's Office of Women's Health.
Who is Joshua Sharfstein?
But Sharfstein may have the inside track. He’s now leading the assessment of the troubled FDA for the Obama transition committee, a role that could boost his chance of being nominated.

What’s more, he’s got a powerful patron in Rep. Henry Waxman, the guy who just beat out John Dingell for chairman of the House Energy and Commerce Committee. Sharfstein used to be an investigator on Waxman’s previous committee, Government Reform and Oversight.

In that role, he worked on one of Waxman’s favorite causes: putting the tobacco industry under the regulation of the FDA. And a bill along those lines seems poised for passage next session.

Sharfstein can’t talk to the media because of his role in the presidential transition. But some of his published work gives you an idea of his approach.
Here's Duke Califf.
Califf has served on the Cardiorenal Advisory Panel of the U.S. Food and Drug Administration (FDA) and the Pharmaceutical Roundtable of the Institute of Medicine (IOM). He also served on the IOM Committee that recommended Medicare coverage of clinical trials, which Congress recently approved. He is director of coordinating center for the Centers for Education & Research on Therapeutics™ (CERTs), a public-private partnership among the Agency for Healthcare Research and Quality, the DCRI, academia, the medical products industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products.
Oprah's doc Mehmet Oz writes about Steve Nissen in 2007. Nissen is big on transparency:
WSJ: Barack Obama most definitely doesn’t have time to read the journal Nature right now. But maybe can spare a minute for a quick read of the Health Blog? We’ll save him some time with the high points from some letters by prominent researchers about what he should do on a bunch of scientific and medical issues.
The one that really caught our eye comes from Steven Nissen, a Cleveland Clinic cardiologist who’s in favor of significant reform of the FDA.
Nissen, himself a potential candidate for FDA commish and often viewed as an enemy of Big Pharma, sounds off in favor of a fixed six-year term for the FDA chief to make the agency less susceptible to political pressures.
He also wants reconsideration of the system in which the drug industry funds a lot of the FDA’s budget through user fees: a system criticized by some for giving the industry too much sway over the agency.
Another Nissen call: Transparency when it comes to those letters the FDA sends when it’s decided on whether or not to approve drugs. Right now, most of the contents of the letters are secret.
Susan Wood:
On Capitol Hill, in the Department of Heath and Human Services, and now at SPHH's Project on Scientific Knowledge and Public Policy, Professor Susan Wood has dedicated her career to applying scientific evidence to health policy decisionmaking. She joins the School from the FDA, where she was Assistant Commissioner for Women's Health and Director of the Office of Women's Health until 2005, when she resigned on principle over the continued delay in approving emergency over–the–counter contraception.