Critics Top Shortlist for FDA Head

[Guest guest]

By ALICIA MUNDY

WASHINGTON -- A doctor who once denounced Pfizer Inc. for holding a marketing event in a pool hall is leading President-elect Barack Obama's team formally assessing the troubled Food and Drug Administration, boosting his chances of becoming the next FDA commissioner.

Health Blog: Who Is Sharfstein?

Sharfstein, now head of the Baltimore Health Department, has tangled with the pharmaceutical industry on several occasions and would likely lead the agency to get tougher on drugs. Companies might benefit from his strong support of childhood vaccinations, however.

Several other candidates remain in the running for the top FDA post, and no decision appears imminent.

Dr. Sharfstein, 39 years old, is a former staffer for Rep. Henry Waxman, the California Democrat who recently won the chairmanship of the powerful Energy and Commerce Committee. Dr. Sharfstein visited the FDA several times in recent weeks and discussed controversies involving the agency, according to people familiar with the discussions. He declined to comment on any current or future involvement with the FDA.

View Full ImageBloomberg News/Landov Sharfstein, health commissioner for the city of Baltimore, holds up data listing examples of adverse reactions to over-the-counter cough and cold medicines for children, at a joint meeting of the Nonprescription Drugs Advisory and Pediatric Advisory committees of the U.S. Food and Drug Administration, Oct. 18, 2007.

Congress is investigating many FDA issues, such as its approval of some blockbuster drugs that had to be withdrawn or re-evaluated for safety reasons. The agency is also under bipartisan fire for its handling of contaminated milk products and a widely used blood thinner that were imported from China.

The FDA commissioner's spot may prove among the most hard-fought of the new administration, with members of Congress from both parties promoting their candidates in letters and talks with the transition team. The pharmaceutical industry's lobby donated about $10 million to Democrats this election, breaking a heavily pro-Republican giving pattern.

Drug companies particularly worry about two contenders for the top job whose crusading has affected FDA policy and corporate bottom lines.

One is Dr. Sharfstein, who successfully pushed the FDA last year to block drug makers from selling over-the-counter cough and cold medicines to small children. The other is Nissen, 60, head of cardiovascular medicine at the Cleveland Clinic. Dr. Nissen's questions about the safety of two popular drugs, the diabetes medicine Avandia and the anticholesterol pill Vytorin, have hit their makers' sales hard and given him a platform to criticize the agency that approved them.

People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted.

As a medical student at Harvard University in 1997, Dr. Sharfstein wrote the New England Journal of Medicine to complain that Pfizer was offering free alcohol and billiards games to doctors in Boston while promoting its products.

The New York pharmaceutical giant's ad for the event urged doctors to "rack 'em up and toss 'em down." Pfizer responded to the journal that its slide presentations at the pool hall "provided useful medical information to attendees," but conceded that it "created a poor impression."

As a Waxman staffer, Dr. Sharfstein helped get a bill passed amid a Republican majority that reversed an FDA decision allowing the makers of colored contact lenses to classify them as "cosmetics." A number of people suffered blindness after wearing the lenses. The bill reclassified them as medical devices.

Dr. Nissen outlined in a speech this week specific changes he wants at the FDA. He said the agency should more often require companies to prove their drugs save lives, rather than merely show they achieve some presumed beneficial goal. For example, Avandia lowers blood sugar but has been linked to heart attacks.

"The ultimate purpose of that drug should be to prolong life. So, isn't that what we should be measuring?" he said in an interview. Dr. Nissen also said too many medicines are put on a fast track for FDA approval as ostensible life savers, even though they aren't that important. He has called for complete transparency in the agency's interactions with industry and criticized it for sometimes delaying public disclosures of potential dangers based on corporate claims that "proprietary information" is at stake.

However, Dr. Nissen has also suggested giving early limited-term approval for truly life-saving and innovative drugs, an idea industry supports.—Easha Anand contributed to this article. Write to Mundy at alicia.mundy@...