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Report on Decline in FDA Enforcement Activity

Committee on Government Reform Minority Office: “A new report by Rep. Henry A. Waxman examines how the Bush Administration has carried out FDA’s historic enforcement responsibilities. The report is the result of a 15-month investigation that included a review of thousands of pages of internal agency enforcement records. It finds that there has been a precipitous drop in FDA enforcement actions over the last five years. In some cases, FDA headquarters rejected the enforcement recommendations of FDA field offices despite findings by agency inspectors that violations led to multiple deaths or serious injuries.”

  • Prescription for Harm: The Decline in FDA Enforcement Activity (24 pages, PDF)
  • Letter from Professor Jerry Avorn, M.D.
  • Letter from Professor Michael Wilkes, M.D., Ph.D.
  • Letter from Sammie Young, former senior FDA enforcement official
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