Flood of drugs, little oversight

Chicago Tribune, March 3, 2008

A congressional committee is asking whether the FDA's recent lapse in allowing a plant it never inspected to export to the U.S. is part of a larger problem of poor oversight and a shortage of resources at the agency. Although FDA officials insist the agency inspects every foreign plant sending medical products to the U.S., the agency's own data make it appear unlikely. An FDA-appointed commission that studied the agency's inspection record found the FDA is short of financial resources, has cut personnel, has rickety data management systems and is struggling to meet its oversight obligations.