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Lawmakers propose legislation to bolster FDA oversight


WASHINGTON The Energy and Commerce Committee has proposed draft legislation that would bolster the strength of the Food and Drug Administration’s global safety oversights for food, drug and cosmetic products, according to published reports.

The bill would create a registry of domestic and international drug, medical device, food and cosmetic facilities that either sells products in the United States or import products into the country. The bill, which was proposed by Reps. John Dingell, D-Mich., Frank Pallone, D-N.J., Bart Stupak, D-Mich., and Diana DeGette, D-Mich., would impose annual registration fees on those firms to help cover the agency’s enforcement costs.

For example, the proposed legislation would require U.S. food facilities and those exporting food to the United States to pay $2,000 per facility, per year to register with the FDA. The fee would generate about $600 million, more than doubling the FDA's current food safety budget.

Under the provisions of the bill, the agency would have the same recall authority for drugs that it has with medical devices, meaning it would be able to order recalls. The legislation also covers a broad range of other changes, including that drug makers list on drug labels where active ingredients come from and calling for the FDA to inspect drug facilities every two years. That's currently the standard for domestic drug facilities, but not for foreign ones.

Titled the Food and Drug Administration Globalization Act of 2008, the legislation builds on four existing bills, congressional probes and a groundswell of discontent about the state of the FDA. Food and drug makers, as well as consumer advocates, have increasingly lobbied for more FDA funding, saying the agency is not adequately policing the huge universe of foods, drugs and other products it regulates. But federal budget proposals have fallen short of what they say is needed.

The first hearing on the draft is set for April 24. Others are expected with final legislation to follow.

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