Pallone calls for user fees to fund overseas inspections

WASHINGTON While some members of the medical device industry are opposed to the Food and Drug Administration receiving additional funds from user fees, one lawmaker believes it is essential.

The FDA’s need is “so great, there is going to be a need for user fees in addition to whatever is appropriated,” said Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee’s Health Subcommittee, at a hearing last week.

A draft bill concerning foreign inspections, co-sponsored by Pallone and Reps. John Dingell, D-Mich. and Bart Stupak, D-Mich., is aimed at preventing imports of unsafe products. The draft requires the FDA to inspect all overseas device-manufacturing plants once every two years instead of continuing its risk-based approach.

AdvaMed president and chief executive officer Stephen Ubl testified at last week’s hearing, saying inspections are a core function of the FDA and funding should come from appropriations, not industry fees. The draft would impose an additional facility registration fee and a $10,000 importer registration fee.

“Many of our members, particularly small companies, do not have foreign facilities, yet through their fees they would effectively subsidize inspection of foreign companies exporting their products to the U.S.,” AdvaMed said.

The bill is expected to move to markup soon, according to Pallone.