Drug Inspections Expected to Decline in Fiscal 2006

The number of domestic field inspections conducted by the FDA's Office of Regulatory Affairs (ORA) will decline across the board in fiscal 2006, with the biggest drop coming in good manufacturing practice (GMP) inspections, according to figures contained in the agency's proposed budget request.

Total ORA drug inspections would decrease from 2,815 in fiscal 2005 to 2,668 in fiscal 2006.

The FDA's proposed budget calls for ORA inspections of domestic drug facilities to decrease by nearly 5 percent in fiscal 2006, compared to fiscal 2005 levels. GMP inspections will decrease by roughly 5.5 percent, according to the estimates, which forecast that ORA will conduct 1,355 GMP inspections in fiscal 2006, compared to 1,430 inspections estimated for 2005.

Inspections of foreign drug facilities are also expected to decline next year, with 485 inspections estimated for fiscal 2006, compared to 515 predicted for fiscal 2005.

The reduced inspection estimates come amid an anticipated budget cut for ORA's human drugs program. The FDA's budget requests $80.72 million for the human drugs program, down slightly from $80.96 million in fiscal 2005. The human drugs program and the biologics program, which would have its funding cut by $77,000, were the only ORA components to receive less funding in the agency's budget proposal.