US Congress Views User Fee Extensions

New US user fees for the medical device, generic drug and groceryindustries are unlikely, say Republican lawmakers. House appropriations subcommittee chairman Joe Skeen feels it would be very difficult to get the fees passed, but a spokesman for Representative Skeen told the Marketletter that this does not affect the expected reauthorization of the Prescription Drug User Fee Act.

Lawmakers have generally opposed large-scale user fees since the idea first came up over 10 years ago. Several members of the committee, which has jurisdiction over the Food and Drug Administration budget, called the Clinton plan for user fees for these industries a "hidden tax," devised to help balance the budget over the next five years. If the fees were adopted, the issue would probably become tied up in a tangle of lawsuits by industries that do not want them, says Rep Skeen.

However, acting FDA Commissioner Michael Friedman told the subcommittee that the fees are justified since the industries benefit from FDA operations. They should absorb some of the costs, he said, and the fees are so broad-based that they would not hurt any one industry. But the Health Industry Manufacturers Association says the plan "makes severe and dangerous cuts" in the FDA's medical device program budget authority.