Article preview from "The Gray Sheet"- May 28, 2012
FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.
Article preview from "The Gray Sheet"- May 28, 2012
Reauthorization of FDA user fees is on track to be adopted well before the programs expire this fall following Senate passage of the Food and Drug Administration Safety and Innovation Act
on May 24 and plans for the House to take up its version of the bill this week.
The Senate bill, which, like the similar House legislation, contains numerous reforms to FDA’s regulatory regime, was approved 96-1 after 10 amendments were added by the chamber.
The bill retains the user fee reauthorization agreement previously negotiated between FDA and the medical device industry, including $595 million (plus inflation) in industry user fees to be paid to the agency between 2013 and 2017, about double the total of the past five years. In return, FDA has agreed to pre-market review performance goals intended to increase early interaction between reviewers and device application sponsors, to hold FDA responsible for the total time to market for a device, and to make sure that FDA follows up with sponsors on reviews that take longer than the performance goal timelines.
The new user fees will support 35% of FDA’s medical device pre-market review activities, up from 20% supported by the current fee program, which expires Sept. 30, according to the agency.
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