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Executive Summary

HHS SECRETARY SULLIVAN SCHEDULED TO TESTIFY AT JULY 18 HEARING on generic drugs before Rep. Dingell's (D-Mich.) House Oversight Subcommittee. The focus of the hearing will be primarily on the department's role in the generic drug crisis. Dingell is expected to question Sullivan regarding the HHS secretary's extension and subsequent withdrawal of authority to the HHS Inspector General for enforcement of felony violations of the FD&C Act. In addition, the subcommittee is expected to ask the secretary about the continued slowdown in ANDA reviews and approvals. ANDA approvals came to a virtual halt after findings of fraud and corruption in the process were disclosed last summer. FDA cleared only three ANDAs in April, and after approving 12 in May, dropped to seven or eight in June. Sullivan will also be questioned about his reasons for removing former Commissioner Frank Young, MD, from FDA last fall without having a permanent successor ready to take his place ("The Pink Sheet" Nov. 20, p. 3). The subcommittee expressed regret that the agency was left leaderless in the midst of a regulatory tempest. The subcommittee is said to be further troubled by the fact that two key agencies under Sullivan's authority, FDA and the National Institutes of Health, remain without permanent appointed heads. The staffs of the Oversight Subcommittee and Rep. Waxman's (D-Calif.) Health Subcommittee met on July 13 to schedule a Health Subcommittee markup of HR 4810, Dingell's FDA generic drug enforcement bill. However, they reportedly could not find a mutually convenient date. Waxman's bill to amend the Orphan Drug Act, however, may be ready to move forward. Dingell's full Energy & Commerce Committee could schedule a markup of the legislation (HR 4638) as early as July 17.

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