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FDA puts business interests above public health, congressman charges

This article was originally published in The Silver Sheet

Executive Summary

Rep. Henry Waxman, D-Calif., is challenging FDA's priorities for writing rules and guidances, saying the agency appears to be more interested in loosening marketing restrictions and reducing product liability for device and drug manufacturers than in protecting public health. Prompting Waxman's ire and an investigation by his House Oversight and Government Reform Committee is an internal FDA e-mail listing eight regulation and guidance priorities compiled in June 2007 by Scott Danzis, special assistant to then-Chief Counsel Sheldon Bradshaw. "All appear to prioritize industry desires over consumer protection," Waxman writes in a Sept. 17 letter to FDA Commissioner Andrew von Eschenbach. The congressman wants to know "why FDA would need to act on each initiative at this point in time, given the other public health challenges and priorities you have identified," including findings by the FDA Science Board that the agency neglects facility inspections, oversees a broken import system and needs more scientists who understand emerging technologies ("The Silver Sheet" December 2007)
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