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Jan
26
Written by:
Marc Ullman
1/26/2009 4:20 PM
Many media reports have suggest that the search for a new FDA Commissioner has narrowed to two candidates. Neither of them gives me a warm, fuzzy feeling.
The apparent leading contender is Joshua Sharfstein, who is currently Baltimore's Health Commissioner. Dr. Sharfstein, who graduated Harvard Medical School in 1999 and completed a residency in Pediatrics, is perhaps best known as a critic of FDA who was instrumental in pushing FDA to pull many children's cough-cold medications from the market. What may be less health policy advisor on the Democratic staff of the Government Reform Committee of the U.S. House of Representatives for Congressman Henry A. Waxman where he particpated in public hearings designed to force FDA to remove ephedra from the market.
The other apparent finalist is Dr. Robert Califf, Director of the Duke Clinical Research Institute. Dr. Califf also has a well developed reputation as a critic of FDA's drug approval process and has frequently call for reform at the Agency. As far as supplements are concerned, he was one of the authors on a recent study decalirng St. John's Wort ineffective for treatment of major depression. (Commenting "Just because St. John's Wort is for this type of depression does not mean it is harmless . . . ."). Dr. Califf was also one of the authors of the final report of the National Advisory Council for Complementary and Alternative Medicine's Ephedra Working Group.
I would not expect either of these gentlemen to be "good news" for supplements.
One other potential name that may signal some stormy times ahead for supplements is that of William Schultz, author of A Hard Pill to Swallow Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Mr. Schultz's name has appeared as the leading candidate for General Counsel at the Department of Health and Human Services. He was formerly Deputy Commissioner for Policy at the FDA . Prior to that he was Counsel to the House Subcommittee on Health and the Environment, which was chaired by Congressman Henry A. Waxman. He was a well known opponent of DSHEA.
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