Budget constraints "limit US FDA's ability on site inspections"

Budgetary constraints are one of the principal factors that limit the US Food and Drug Administration's ability to conduct frequent and rigorous site inspections of pharmaceutical manufacturers, according to research published in the International Journal of Business Continuity and Risk Management.

Warren Adis, associate professor of information sciences at the Hagan School of Business, Iona College, in New Rochelle, New York, has analyzed the FDA's risk methodology used for inspecting pharmaceutical manufacturing sites and reviewed its procedures, regulations, and violations as specified in the warning letters sent out by the agency. The period on which Dr Adis focused is 2004 to 2009, the time during which FDA was transitioning and formalizing its new approach to site inspections. The current research re-evaluates Adis' earlier study which compares the year 2005 when the new risk methodology was incorporated into the inspection process with the year 2008, to judge the impact of this new approach.

"A review of this composite period shows a more slowly declining using of warning letters and citations, with some leveling off in the last two to three years," explains Dr Adis. "This current review therefore presents a more balanced evaluation of FDA performance," he said. In his assessment, Dr Adis suggests that budgetary constraints have led the FDA to use the inspection process as a policy tool to alert manufacturers on the necessity for installing quality risk-based systems, rather than a detailed analysis of manufacturer's violations.