GAO report to Congress suggests FDA severely underfunded

WASHINGTON A Government Accountability Office report on foreign-drug inspection delivered to Congress Tuesday suggested that the FDA is woefully underfunded in its mission to regulate the manufacture of medicines outside the U.S.

The issue has come to a head in light of the distribution of the contaminated blood-thinner heparin out of a Chinese facility that had escaped FDA inspection.

The report, delivered to Congress by Marcia Cross, GAO director of health care, estimated that the FDA would need to spend between $67 million and $71 million annually in order to reach the minimum requirement of biennially inspecting the 3,249 foreign drug establishments identified by the FDA.

And those are conservative estimates, Cross noted—there may be more manufacturers that should be inspected than the FDA currently has on its roll call. Where the FDA’s Drug Registration and Listing System lists more than 3,000 foreign establishments as registered with the FDA in fiscal year 2007, FDA’s Operational Administrative System for Import Support system has indicated that about 6,800 foreign establishments actually offered drugs for entry into the U.S. last year.

With each inspection costing the government more than $41,000, that would effectively double the FDA’s minimum requirements necessary to inspect each facility every two years—to almost $145 million—if the OASIS figures were used instead of the DRLS. “FDA’s databases do not provide an accurate count of foreign establishments subject to inspection,” commented Cross during a Congressional hearing.

Under current budgetary constraints, data from the FDA suggested that the agency may inspect approximately 8 percent of foreign establishments in a given year. “At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection,” Cross said.

The GAO report seems to support critics of FDA’s chronic underfunding—President George Bush’s fiscal 2009 budget allotted $2.4 billion to the FDA, an in increase of 5.7 percent. (see Drug Store News March 3 cover story).

And it’s an issue that commissioner Andrew von Eschenbach has publicly stated could possibly place the FDA mission—protecting America’s food and drug supply—in danger of not being executed effectively. (see related Drug Store News March 17 cover story).