FDA fees eyed to boost food, drug safety
— -- New fees for food and drug companies anchor draft legislation released Thursday that's aimed at improving the safety of the nation's food and drug supply.
The draft legislation, spearheaded by Rep. John Dingell, D-Mich., and other Democratic leaders of a powerful House committee, also says regulators should inspect food and drug makers more frequently.
The proposal, if enacted, would lead to major changes in food and drug oversight, and it was quick to draw rebukes.
"We should not be taxing food companies at a time of record food prices," said Scott Faber, vice president of the Grocery Manufactures Association. "Congress ought to provide the (Food and Drug Administration) with ample funding and not pass that cost on to companies and consumers."
The proposed legislation would require U.S. food facilities and those exporting food to the USA 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.
The FDA would also have to inspect food plants — and those plants' food-safety plans — every four years. Lawmakers have said food plants, on average, get inspected once every 10 years.
The first hearing on the draft is set for April 24. Others are expected with final legislation to follow.
The draft legislation, applauded by supporters as an "FDA reform bill" follows 18 months of food and drug-safety scares, including E.coli in domestically grown spinach and contaminants in Chinese-made ingredients for pet food and in the blood thinner heparin.
Titled the Food and Drug Administration Globalization Act of 2008, it builds on four existing bills, congressional probes and a groundswell of discontent about the state of the FDA. Food and drug makers and 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.
Given that, some changes are likely, supporters say. "I'm hearing that people are scared enough that they might do something," says William Hubbard, a former FDA associate commissioner.
Registration fees are also proposed for drug and medical device makers, as well as for all importers. Amounts aren't specified. Cosmetics-makers would pay $2,000 per year per facility as well.
The legislation also calls for the FDA to inspect drug facilities every two years. That's currently the standard for domestic drug facilities but not for foreign ones.
The legislation covers a broad range of other changes, including that drugmakers list on drug labels where active ingredients come from and that the FDA be able to order food and drug recalls.
The draft also calls for the FDA to accredit companies and foreign governments to certify food-safety standards of producers. The FDA would publicize the list, giving them a marketing advantage.