More FDA funds needed for foreign inspections

The US Food and Drug Administration's Center for Drug Evaluation and Research Director Janet Woodcock has pulled back from specific recommendation as to the funding requirements for the agency to improve the inspection of foreign drug manufacturing sites. The issue has gained greater prominence after a Government Accountability Office report last year identified gaps in the FDA's inspection coverage, as well as the issues surrounding the contaminated blood thinner heparin (see page 13 and Marketletters passim). First, Dr Woodcock said the FDA would need $225.0 million to conduct inspections properly, but later declined to name a figure to a congressional panel.