The HHS Office of the Inspector General (OIG) says in its FY 2008 work plan that it will "assess FDA's oversight and review of allowable off-label drug promotion and enforcement." Lately, the federal government has won numerous pharmaceutical company settlements under the False Claims Act that are centered on off-label drug uses.
The work plan also says CDER's generic drug approval process will come under the microscope in 2008, particularly the reasons for the growing backlog of submissions.
“We will review FDA's timeframes for reviewing original generic drug applications and identify factors that affect the timely review of these applications,” it says.
Despite regulations mandating review actions within 180 days after submission, over 1,000 generic drug applications are currently pending, with one-third of these exceeding the statutory time limit.