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Executive Summary

REP. DINGELL's FDA OVERSIGHT HEARING POSTPONED FROM JULY 11 due to a scheduling conflict with the House vote for majority whip. The House Energy & Commerce/Oversight Subcommittee hearing was slated to discuss agency enforcement issues with witnesses including FDA Commissioner Kessler, HHS General Counsel Michael Astrue and HHS Inspector General Richard Kusserow. The hearing previously had been rescheduled from its original date of May 1. Subcommittee Chairman Dingell is actively supporting fellow Michigan Democratic Rep. Bonior in his bid for the majority whip's post, which was made available after Rep. Gray (D-Pa.) resigned to head the United Negro College Fund. The subcommittee is exploring late July for possible hearing dates. However, it is possible the hearing will be delayed until September, after Congress returns from the August recess. The Oversight Subcommittee reportedly wants to ask Kessler about the regulatory tools he is willing to use in enforcing the FD&C Act and to discuss his ideas about allowing FDA's regional offices greater autonomy in enforcement actions ("The Pink Sheet" May 27, p. 6). Kusserow was invited to testify about the need for greater criminal investigative authority for violations of the FD&C Act, and Astrue was expected to be questioned about delays in FDA enforcement actions due to General Counsel review. FDA lawyers report to the HHS General Counsel rather than to the commissioner. The subcommittee also may want to ask the commissioner about the subject of another recent oversight hearing -- the generic drug approval process ("The Pink Sheet" June 10, p. 10). Three FDA officials -- Center for Drug Evaluation and Research Director Carl Peck, MD, Deputy Director Gerald Meyer, and Generic Drugs Office Director Roger Williams, MD -- were unable to give their scheduled testimony at that earlier hearing because it was cut short by House floor votes. However, they will not appear with Kessler, having opted instead to provide the committee with written responses.

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