Legislation introduced by House Energy and Commerce Committee members Sept. 20 to improve food and drug import safety would authorize user fees to be directed at hiring more FDA inspectors and other officials for import analysis in the U.S. and abroad.

According to the committee, the Food and Drug Safety Import Act, H.R. 3610, would also target the funds from user fees to support research into new techniques for testing import samples.

The legislation sponsored by committee Chairman John Dingell, D-Mich., and Reps. Frank Pallone, D-N.J., and Bart Stupak, D-Mich., is scheduled for discussion by the subcommittee on Health on Sept. 26.

The Consumer Healthcare Products Association says raising fees on imports across the board is not how Congress should increase funding for FDA inspections.

CHPA Senior Vice President of Legal and Governmental Affairs Andy Fish said the fees amount to a tax on drug firms.

Further, the fees would fund a search for a limited number of imports that pose risks, but most suspect imports still would not be inspected, Fish said. "So, the so-called 'user' is not actually getting service for the so-called 'user fee'," he said.

Priorities of the legislation include ensuring FDA's 13 field laboratories continue operating; giving the agency authority to issue mandatory recalls and require country of origin labeling; and limiting the number of ports of entry for food items. Also, the bill will halt imports of products by a foreign firm until it can demonstrate it has taken significant steps to correct identified problems.

In additions made to a draft Dingell proposed in August, the bill includes a provision to require FDA to promulgate regulations within 180 days of the bill's enactment to require the labeling of foods, drugs and devices to identify the country of origin.

More additions to the draft include allowing food imports only by foreign firms that provide proper certification for products; and granting certification to a foreign country only when FDA finds it has effective laws enforcing food safety and has a program to monitor the safety of its food exports to the U.S.

- Katie Stevenson (K.Stevenson@elsevier.com)

Dingell Import Safety Bill Includes User Fees To Fund Foreign Inspections

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