Late Breaking News
FDA Starts Early MDUFA Reauthorization Talks
HYATTSVILLE, MD—Even though the Medical Device User Fee Act is not scheduled to expire until September 2012, FDA is already beginning the process of soliciting comments on how the act has worked to date, and how it might be improved. FDA’s goal is to have broad support from industry and consumers by the time the agency begins drafting its recommendations for how the act should be revised.
MDUFA, first authorized in 2003, is the legislation that allows FDA to collect user fees from medical device manufacturers. Prior to MDUFA’s enactment, FDA suffered what agency officials described as a “long-term, significant loss of resources that undermined the program’s capacity and performance.” MDUFA provided an injection of resources that allowed FDA to hire more staff and speed up and improve the review process. It also added a series of negotiated performance goals between FDA and medical device manufacturers. Congress reauthorized MDUFA in 2007, decreasing the number of performance goals, but making them more demanding.
“For success to happen in the medical device industry, there needs to be a very smart and agile regulator,” explained Joshua Sharfstein, MD, FDA’s deputy director at a public hearing on MDUFA last month. “We are very serious about making improvements to the device program that will work for patients [and] will also work for companies.”
Obviously MDUFA is a very important source of funding for the device program. We have a goal of an agreement with broad support, which will make the job of Congress to reauthorize the program much easier.”
In early August, an FDA working group released a preliminary report containing recommendations on how MDUFA might be improved going forward. The report’s authors were particularly concerned with the regulations for 501(k) authorizations—the process by which the vast majority of devices get approved. Under this process, a device’s manufacturer must show that the device is substantially equivalent to an already-approved device. Last year, FDA conducted over 4,000 501(k) approvals, with 90% being reviewed within 90 days.
The working group believed that the language in MDUFA currently is not specific enough when it comes to 501(k) approval, leading to inconsistency. FDA needs to define the 501(k) review standard more clearly, the report states. There is also a need for better access to information among FDA reviews, particularly since the 501(k) process it is predicated on relies on comparisons with an already-approved device. Overall, the reviewers noted, there is a need for better quality assurance in the program.
At the public hearing in September, Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health—the center responsible for the majority of medical devices reviewed—admitted that the process has received criticism from industry representatives accusing the process of a lack of predictability, consistency, and transparency. He has also received complaints that the process “stifles innovation in medical device research” and sends talent and money overseas.
FDA believes it will come to terms with industry representatives well before the current act sunsets in September 2012. The agency will be conducting negotiations with industry associations, with the goal of reaching an agreement on fee structure and performance commitments. Another goal—this one mandated by an administration bent on increasing government transparency—is to extensively document those negotiations. FDA will be required to release minutes of the agency’s meetings with industry, and those minutes must include any substantive proposals made, as well as any significant controversies or differences in opinions. “This will be a new and interesting aspect to the negotiation process,” quipped Malcolm Bertoni, assistant FDA commissioner for planning. “We’re hoping that [by summer 2011 we] will have a set of recommendations that has broad support with minimal need for revisions.”
FDA will be soliciting initial public input through January. The development of draft recommendations will run through next fall, when there will be another public meeting to discuss them. A public review of the draft will run through winter 2012. Agency officials hope that this timeline will give them more than enough leeway to iron out any problems with the reauthorization prior to their September 2012 deadline.