Wall Street Journal Examines Leader Of Obama's FDA Assessment Team, Potential Agency Heads

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 15 Dec 2008 - 2:00 PST

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Joshua Sharfstein -- commissioner of the Baltimore City Health Department and a physician -- is leading President-elect Barack Obama's team to assess FDA, "boosting his chances of becoming" the agency's next commissioner," the Wall Street Journal reports. The Journal reports that the "commissioner's spot may prove among the most hard-fought of the new administration," as the agency has been under "bipartisan fire." According to the Journal, "no decision [on the next commissioner] appears imminent."

Potential Commissioner Candidates
Sharfstein, a former staffer for incoming House Energy and Commerce Committee Chair Henry Waxman (D-Calif.), "has tangled with the pharmaceutical industry," according to the Journal (Mundy, Wall Street Journal, 12/12). Sharfstein supports childhood vaccinations and increased regulations on over-the-counter cough and cold medicines for children. As an investigator for the House Government and Oversight Reform Committee, Sharfstein worked on legislation that would have allowed FDA to regulate tobacco products (Mundy, "Health Blog," Wall Street Journal, 12/12).

In addition, as a medical student at Harvard University, Sharfstein in 1997 wrote a letter in the New England Journal of Medicine about an event sponsored by Pfizer to promote products to physicians (Wall Street Journal, 12/12). He also wrote articles published in NEJM and the American Journal of Public Health that questioned campaign contributions from the American Medical Association to candidates who opposed policies that most physicians supported ("Health Blog," Wall Street Journal, 12/12).

Steven Nissen, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, is also a contender. In a speech this week, Nissen cited the need for reforms at FDA. He said that FDA more often should require pharmaceutical companies to provide clinical evidence that their medications can save lives, adding that the agency often awards priority reviews to treatments unnecessarily. Nissen also has called for full transparency in the relationships between FDA and the pharmaceutical industry. In addition, recent concerns about the safety of the diabetes medications Avandia, manufactured by GlaxoSmithKline, and Vytorin, marketed by a joint venture of Merck and Schering-Plough, have provided Nissen with "a platform to criticize the agency that approved them," the Journal reports.

According to the Journal, pharmaceutical companies "particularly worry" about Sharfstein and Nissen as potential FDA commissioners, as they have "affected FDA policy and corporate bottom lines."

Some "close to the [pharmaceutical] industry" have been floating other names-- such as Janet Woodcock, director of the Center for Drug Evaluation and Research at the agency -- but "no decision appears imminent," according to the Journal. Some Democratic aides have recommended that Obama name Woodcock as interim FDA commissioner until he selects a permanent commissioner (Wall Street Journal, 12/12).

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