FDA Chief: The Bruiser Nomination Fight

CBS News Investigative Producer Laura Strickler wrote this story for CBSNews.com.
It won't be a former first lady or a famous senator, but the person who runs the Food and Drug Administration (FDA) will inherit an agency with mammoth problems. The agency regulates a full 25 percent of the United States economy everything from grapes, dog food, aspirin and vaccines to mascara and prescription drugs.

Obama's team won't roll out his FDA pick for at least a few months according to those with knowledge of the process. An interim director is expected to be appointed once the current commissioner steps down.

Under the Bush Administration, food and drug safety scandals have been notorious: suicidal anti-depressants, Vioxx, Vytorin, Avandia to name a few.

If the next commissioner is an about face from Bush Administration policies, he or she will face a bitter confirmation fight with some key GOP senators prepared to place secret Senatorial holds. And so far the names that are circulating are sure to raise hackles in the pharmaceutical industry.

Agency critics have long complained that FDA officials are too accommodating to drug companies.

Diana Zuckerman runs the National Research Center for Women & Families and is also advising the Obama FDA transition team on policy. She says the agency struggles with antiquated information technology, "They do not have what any company would have, which is a computerized system which could analyze data on people dying or having serious side affects from a drug." But Zuckerman says everyone involved in pharmaceuticals from reformers to lobbyists agrees on one thing: the agency needs more resources.

Representatives from PhRMA, the drug industry trade association, declined to be interviewed for this story but in a statement indicated they want an "independent" candidate with "strong managerial skills" who can run an "empowered FDA that is adequately resourced."

While some expect the current head of FDA's center for drug evaluation and research, Janet Woodcock, to run the agency in the interim, insiders say she is the industry's pick and not enough of a change agent to get the post permanently.

As of today, three names keep rising to the top:

Dr. Steven Nissen is a well-known heart specialist from the Cleveland Clinic and frequent testifier at Congressional hearings where he has sharply criticized both pharmaceutical companies and FDA officials for their drug safety failures. In an effort to increase transparency at his own institution, Nissen successfully pushed for all doctors to disclose their industry ties on the clinic's website. At the clinic Nissen oversees a budget of $200 million and 800 employees.

Susan Wood is a research professor at George Washington School of Public Health and she used to be the Assistant Commissioner for Women's Health at the FDA. In 2005 she made headlines when she resigned in protest from the FDA Office of Women's Health out of frustration over the agency's foot dragging on the approval of Plan B, an emergency over-the-counter contraception. Wood is very familiar with the inner workings of the FDA and holds a doctorate in biology.

Dr. Joshua Sharfstein runs the Baltimore City Health Department with 800 employees and a $150 million budget. While a fairly young candidate at 39, Sharfstein is connected to some key figures as a member of the Obama transition team and was a former staffer for House Energy and Commerce Chairman Henry Waxman. Last month Sharfstein's outspoken criticism of children's cold medicines earned him an award as one of the top public officials of the year.

By Laura Stricker