US FDA Inspections: The Future, As Funds Dwindle

Fiscal 1998's probable decline in the US Food and Drug Administration'sbudget to $900 million, including Prescription Drug User Fee Act funds, will mean a cut for its inspection field force from $40 million to $28 million, FDA Deputy Associate Commissioner for Regulatory Affairs Gary Dykstra told the annual Pharm Tech conference.

If this curve continues, the FDA will not have the operating dollars to support its people in the field, he said; it is already losing staff and will lose them even faster. This challenge will mean the FDA having to become more efficient, targeting its activity better and improving its information systems. It has already undertaken an investigator certification program to provide consistency in inspection, he said, with its first 50 medical device inspectors having just been certified. If all goes well, the program should be expanded to drugs and biologics. The idea of third-party inspections is not dead either, he added.

More inspectors are being sent abroad, but the Mutual Recognition Agreements should help leverage resources. The issue of pre-inspection approvals needs to be worked out and European inspectors brought up to the right level, he said. The current MRAs do not cover pre-approval inspections or Good Manufacturing Practices, but the EU wants to get involved here. The savings potential is huge, he noted, but the pre-approval report's precise format needs to be worked out.