Over-the-counter drug makers: learn why Joshua Sharfstein, Baltimore's commissioner of health (and the lead petitioner to take OTC pediatric cough/cold drugs off the market) may be on the short list to head the Food and Drug Administration.
Read below, or in this week's issue of The Tan Sheet, about Sharfstein and about the qualities needed in an FDA Commissioner, as described by former commissioner David Kessler.
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Former Commissioner David Kessler says President-elect Barack Obama needs to keep the F in FDA in mind when selecting the next commissioner...
Speaking at a Nov. 19 meeting hosted by Fleishman Hillard, Kessler gave a profile of the best individual to succeed Andrew von Eschenbach.
The commissioner should be a physician with expertise in foods as well as drugs, with Washington experience and a background that includes managing a large organization, Kessler said.
Kessler, who served as FDA commissioner from 1990 to 1997, did not specify whether he had anyone particular in mind for the post.
One important criterion for FDA commissioner is a broad expertise across the regulated industries, Kessler said. "Please whatever you do, don't bring me an academic doc who doesn't understand foods, who doesn't understand the agency," he said. "We just can't afford learning on the job."
"Melamine, salmonella - those issues alone are a lifetime of work. So you need to know about food, you need to know about drugs."
Kessler was himself an academician before his appointment at FDA. But he had a background in both food and drugs, having taught food and drug law at Columbia University. Since leaving FDA he has served as dean of the Yale University School of Medicine and dean of the School of Medicine at the University of California, San Francisco.
During the meeting, Kessler also weighed in on potential candidates for commissioner.
Sharfstein's Connections
Baltimore Health Commissioner Joshua Sharfstein will play a major role in the development of the new administration's health policy as a member of the HHS transition team. His name was posted on the transition team's Web site Nov. 26.
A potential leg up for the commissioner post may come from Sharfstein's links to Rep. Henry Waxman, D-Calif. He worked as a health policy adviser to the congressman's Committee on Oversight and Government Reform.
Waxman's health policy influence is rising. He became chairman of the Energy and Commerce Committee after ousting Rep. John Dingell, D-Mich.
Another former Waxman staffer, Bill Corr, is head of the HHS transition team. Corr, now executive director of the Campaign for Tobacco-Free Kids, served 12 years as counsel to the Subcommittee on Health and the Environment under Waxman. Sharfstein's ties to Corr could give him an edge in the commissioner vetting process.
Sharfstein also has worked for Kessler; he did a rotation at FDA while a medical student in 1996.
Sharfstein gained prominence over the past two years as the lead author of a citizen petition to remove pediatric cough/cold products from the market. The petition helped prompt a voluntary withdrawal by industry and revised regulations from the FDA.
Kessler noted Sharfstein has not run any organization as large as FDA. His experience with food regulation is also thin by Kessler's standard.
Nissen Doesn't Fit Kessler's Profile
Kessler questioned whether Steve Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, is a viable choice. While Nissen understands drug safety, he said, "What does he know about foods? What does he know about running Washington? Has he been there before?"
As for Michael Taylor, who was FDA deputy commissioner for policy under Kessler, the former commissioner credited him as an expert in food safety. While Taylor is an attorney, Kessler did not discount him, and suggested that Obama might pick someone without a medical degree, a rarity. Taylor is a research professor at The George Washington University's School of Public Health Services.
William Schultz, a former deputy commissioner for policy who is at the law firm Zuckerman Spaeder and Shultz, Kessler noted, is probably as knowledgeable as anyone about FDA, but is not a doctor.
Kessler's name has also been bandied about, and in presenting his ideal profile for an FDA commissioner, he was essentially describing himself.
But when asked if he would be interested in taking the helm again, Kessler shook his head no. "That was an historic period," he said. "I don't know how we'd do it again."
- Brenda Sandburg (b.sandburg@elsevier.com) and Christopher Walker (c.walker@elsevier.com).
