Congressional Oversight “Misunderstood” By Von Eschenbach – Grassley
This article was originally published in The Tan Sheet
Executive Summary
Continued criticism of FDA Acting Commissioner Andrew von Eschenbach by Senate Finance Committee Chairman Charles Grassley (R-Iowa) suggests that chances of a Senate vote on the nominee as full commissioner during Congress' lame-duck session have not brightened
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Continued criticism of FDA Acting Commissioner Andrew von Eschenbach by Senate Finance Committee Chairman Charles Grassley (R-Iowa) suggests that chances of a Senate vote on the nominee as full commissioner during Congress' lame-duck session have not brightened. On Nov. 30, Grassley released von Eschenbach's responses to questions that arose during Senate committee consideration of the nomination. Also released was a statement by the senator asserting that "the actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of the government." Grassley also took a negative view of von Eschenbach's reliance on "long-standing policy" at FDA and in the executive branch for many answers. Questions posed to von Eschenbach focused on issues such as post-market safety monitoring, and conflicts of interest among FDA employees and Advisory Committee members. Von Eschenbach stated that the Office of New Drugs (OND) and the Office of Surveillance & Epidemiology (OSE) should not be split into separate entities because "pre- and post-marketing safety data must be viewed as integral and interrelated." "If pre-approval and post-approval functions were split, there would be a loss of continuity in the review of risks and benefits," von Eschenbach added. Grassley's dissatisfaction with many of the responses builds on the senator's existing concerns about the nominee. Grassley placed a hold on the nomination Nov. 16 after von Eschenbach "failed" to comply with a Finance Committee subpoena related to FDA approval of the antibiotic Ketek (telithromycin) (1 'The Tan Sheet' Nov. 20, 2006, In Brief). Grassley followed up with a Nov. 29 letter to HHS Secretary Michael Leavitt, requesting that the agency provide the Finance Committee with a list of all HHS/FDA officials who were involved with the review and post-market surveillance of Ketek, and also a list of all agency officials who produced documents in response to the committee's subpoena. - Bridget Behling |