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The Latest Developments for MDUFA III BY LAUREN UZDIENSKI, OCTOBER 12, 2011
The back-and-forth between industry and the FDA continues over the re-authorization of MDUFA, which grants industry user fees to the FDA. In the latest set of minutes from the ongoing negotiations, stakeholders address proposed changes to the process and how to achieve goals like shorter review times and a more transparent, predictable path to market.
One of the most-discussed issues in this round of negotiations has been how days count toward time goals, and how the agency should calculate, for example, days where the FDA has submitted questions to an applicant and is waiting for a response. The FDA is willing to accept a "total time" goal, which means the clock won't start and stop once an application is submitted. The agency says this change is a "concern" for them, but they're open to a total-time approach because "this particular element is important to Industry." A portion of the time will be allocated to the agency, and another portion will be allocated to the applicant; this is contentious because the time allotted to the applicant is shorter than it has been in the past, which could increase withdrawn applications or appeals.
A more structured review period will also enable the agency to establish milestones, which will let an applicant know where they're at in the process and help them better predict when they'll receive a decision. The FDA also proposed adding more structure to the pre-submission process, at a price; the agency suggested a "Product Development Fee" to accompany a pre-submission or IDE application. The cost would be returned to the applicant in the form of a discount on their marketing application, but the fee would allow a company to meet with the FDA to clarify data needs and other application specifics before submission. This is designed to support transparency and predictability in the process.
User fees would also support "scientific review capacity", reduce the ratio of review staff to supervisors and fund increased training. Present at the meeting were 13 representatives from FDA and a number of industry stakeholders and organizations, including MDMA, AdvaMed, Boston Scientific and Medtronic.