More Inspectors a Top Priority for FDA

Hiring additional inspectors for manufacturing facilities would be a top priority for the FDA if funding were available, Janet Woodcock, the agency’s deputy commissioner for scientific and medical programs, said at a recent congressional hearing. (Woodcock has since been named CDER director.)

Although much of her testimony centered on drugs, the FDA said the same holds true for inspections of medical device operations. During the hearing, Woodcock could not say how many inspectors are needed.

A day after the hearing, FDA Commissioner Andrew von Eschenbach said the agency needs to ramp up its foreign inspections program, in part by establishing overseas offices and increasing the use of risk-based inspections.

He discussed the FDA Without Borders initiative, which includes establishing offices in at least five regions, beginning with China. The FDA is working with the State Department and potential partners in other countries, he said, and anticipates opening offices in China, India, the Middle East and Central and South America.

The commissioner said overseas inspections have been targeted toward new products and those with the greatest risk. The FDA is developing a system to enhance the amount and type of information it gathers under its risk-based inspections model, which will enable it to better identify where to target inspection resources.