FDA’s 2013 Budget is a User Fee Buffet- Grab a Plate
Tags: 2013, biosimilars, budget, committee on appropriations, congress, cosmetics, FDA, fees, food contact notification user fee, food establishment registration fee, food safety, transforming food safety, user fees
FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap between budget and its ever-increasing responsibilities. As the agency attempts to launch new procedures and regulations in coming years, a primary source of funding will be from user fees, according to the justification set forth. It’s not that FDA is unfamiliar with user fees (ref: The Prescription Drug User Fees, Medical Device User Fees, Tobacco Product User Fees), it’s that FDA falsely assumes that the only way they can execute on their mandate is to user-fee the industry to death.
Death and Taxes (User-Fees)
Through the new Generic Drug User Fees and the Biosimilars User Fees, FDA seeks to support review and related activities for generic drugs and biosimilars. The Cosmetics User Fee aims at strengthening FDA’s efforts to ensure the safety of cosmetics and removing unsafe cosmetics from the market. FDA is also proposing to expand the existing Food and Feed Establishment Reinspection User Fee to include medical product establishments. If this change is effected, medical product establishments will incur fees for all reinspections and related follow-up work.
Particularly noteworthy is FDA’s “Transforming Food Safety Initiative,” which focuses primarily on prevention of food-borne illness in domestic and imported foods. This initiative asks Congress for the authority to collect novel user fees including the International Courier User Fee, the Food Establishment Registration Fee, and the Food Contact Notification User Fee.
Not only will businesses have to save up to be able to pay these user fees, but consumers will also be affected. As a result of these novel fees, consumers should be prepared for a likely increase in the costs of food, medical, and cosmetic products. FDA thinks user fees will “make it all better” when in reality they’re getting the industry to pay for a bigger ship that’s still loaded with holes. And we all know what happens to big ships….