Generic Review Times, Medicaid Rebates On 2007 HHS OIG Agenda

Up to speed on OGD: HHS Office of the Inspector General will continue to "determine the extent to which FDA reviews applications for generic drugs in a thorough and timely manner within statutory requirements" and examine what savings were lost by Medicaid in 2004 and 2005 due to the lack of generic availability, according to the office's 2007 FY 1Work Plan. OIG maintains that the average review time for generic drug applications exceeds 20 months, well beyond the 180-day statutory limit. According to the work plan, the delays have resulted in a backlog of approximately 1,000 applications, with 250 exceeding the 180-day limit. FDA has downplayed concerns over the backlog, but the agency projects the median ANDA review time to increase from 16.9 months in 2006 to 17.5 months in 2007 (2"The Pink Sheet" Feb. 13, 2006, p. 7)...