User Fees
This article was originally published in SRA
Executive Summary
Draft legislation would impose user fees on US drug imports
Draft legislation would impose user fees on US drug imports
A draft bill introduced in the US House of Representatives at the beginning of August 2007 would introduce a user fee on drug importers, with the revenue to be spent on adding personnel to strengthen inspection capabilities.
The Food and Drug Import Safety Act of 2007, which is aimed at reinforcing the safety of imported food and drugs1-3, would provide the Food and Drug Administration (FDA) with funding for inspections at ports of entry into the US and laboratory testing of import samples, with the greatest priority on tests and inspections to detect the intentional adulteration or misbranding of drugs. The fees would be assessed based on the number of line items, with the amount not exceeding $1,000 per item.
The draft also calls for increased civil penalties for manufacturers or importers who violate the act. Representative John Dingell (Democrat - Michigan), who introduced the bill, said that it is a response to concerns about unsafe and adulterated imports and is important because of the growing amount of incoming products.
In addition, the legislation would prohibit the FDA from “terminating” or “consolidating” any of its 13 laboratories or its 20 district offices and their respective inspection or compliance functions. There have been concerns about an FDA plan to close down several of its facilities as part of a proposed reorganisation. In a letter to agency commissioner Andrew von Eschenbach, Mr Dingell and fellow congressman Bart Stupak (Democrat - Michigan) voiced their concern about the planned closures, saying the agency had failed to produce a credible rationale for them4.
Since the bill was introduced, the FDA has announced that it is “temporarily suspending” plans to close laboratories and change methods of import entry review5.
References
1. Food and Drug Import Safety Act of 2007 (discussion draft), www.strtrade.com/wti/2007/august/09/dingell_bill.pdf
2. Press release, Committee on Energy and Commerce, US House of Representatives, 3 August 2007, http://energycommerce.house.gov/China%20Food%20Safety/080307.DearColleague.Import%20Legislation.pdf
3. Summary of draft Food and Drug Import Safety Act of 2007, http://energycommerce.house.gov/China%20Food%20Safety/Summary%20of%20Food%20and%20Drug%20Import%20User%20Fee.pdf
4. Letter from Congressmen Dingell and Stupak to FDA, 31 July 2007, http://energycommerce.house.gov/Press_110/110-ltr.073107.von%20Eschenbach-test%20pilot.pdf
5. Internal FDA communication, 1 August 2007, www.militarytimes.com/static/projects/pages/080107glavinemail.pdf