As mentioned in yesterday’s post, the FDA has signaled that due to work burden, the agency will be allowing PDUFA dates to be missed…
The RPM Report got the lowdown from John Jenkins, director of the Office of New Drugs at FDA about the matter. With the kind permission of the Senior Editor and author of the article, I’m running a part of the quote from Dr. Jenkins:
"…we are faced with the increased workload related to the implementation of FDAAA and FDA’s Safety First/Safe Use initiative. In addition to the resource increases under PDUFA IV, FDA also saw increased appropriations for FY2008 to help meet the growing workload. The new resources will have a significant impact on our workload/staffing balance in the long term, however, in the short term CDER is approximately 550 FTEs below its ceiling for FY08…To that end, I have granted permission to OND division and office directors to make decisions to bring their unit’s workload into better balance with their existing resources. These decisions will be made on a case-by-case basis since the balance is not the same in all divisions or even the same over time in any given division…In the short term our ability to meet PDUFA goals is expected to decrease. In some cases we may have to cut back on work by declining requests from sponsors for guidance (e.g., meetings, multiple cycle SPA reviews) and in other cases we may decide to go past the PDUFA goal date for review of an application. In cases where we decide to go past the PDUFA goal date the sponsor will be notified by the division management of that plan.
To say the least, this is perplexing. First of all, PDUFA charges user fees to industry in exchange for making approval times shorter, not longer. Secondly, the PDUFA fees just went up. How can industry be charged more, for less? Moreover, what criteria will be applied to the postponements? Will it be based on the perceived need for a compound? Will New Molecular Entities have priority? And why is CDER short staffed with increased funding?
To critics of PDUFA, and there are many, at the very least, one could reply that the fees made the approvals run on time. Now, not even that can be said. This is a development that will benefit no one.