FDA officials are expressing concern over the slow pace of user fee negotiations with the medical device industry, saying that the parties need to come together to hammer out the framework of a deal by the end of the month in order to meet a January 15, 2012, deadline to submit the plan to Congress.
The FDA “faces substantial uncertainties regarding budget appropriations and legislative uncertainties,” officials said, suggesting that “the best way for all parties to manage uncertainty is to accelerate progress on substantive issues in these negotiations,” according to minutes of the most recent bargaining meeting on July 15.
Officials suggested that the best way to mitigate all the uncertainties was to work with industry to “reach an understanding of what both parties want the program to look like,” get them on the table and start hammering out a deal.
The concern comes amid mounting pressure on the agency from both Congress and the medical device industry to use negotiations over user fees as a forum to try and hold the FDA’s feet to the fire over increasing decision times for device approvals and charges of an often inconsistent, unpredictable and risk-adverse regulatory environment. The current medical device user fee act is set to expire in 2012. The agency first won the authority to collect user fees under the 2002 Medical Device User Fee and Modernization Act. The program was reauthorized in 2007 under MDUFMA II. The user fees are supposed to make up for the FDA’s resource shortfall to help it review device applications more quickly and, ultimately, speed devices to market. In return for receiving industry funding, the FDA was tasked with meeting performance goals under MDUFMA, which set benchmarks for measuring improvements in the agency’s review times.
While representatives from both sides have met several times over the year in order to hammer out an agreement, there has been significant tension in trying to come to an arrangement that will please both sides.
For example, the agency has asked for an increase in user fees to continue 2010 levels of operations, which would amount to a roughly 17 percent increase from current levels. The FDA is also requesting more funding to increase its total headcount by another 254 employees in addition to its 1,230 employees. The gulf between the two parties appears to be the agency’s contention that the total workload for the FDA has increased.
For it’s part, the med-tech industry doesn’t believe that to be the case and maintains that workloads have remained at the same levels. Further, industry contends that the FDA has essentially doubled user fees over the lifetime of the program and has not met performance goals. During an early June meeting, industry proposed a two year stay at current levels (adjusted for inflation) because the agency had “not yet achieved” some of the qualitative and quantitative goals set when the user fee program was reauthorized in 2007.
At the July 15 meeting, FDA officials suggested that industry’s proposal had thrown a bit of a monkey wrench into the pace of negotiations with their plan. Officials started the meeting outlining their efforts to come to a deal, saying they had presented in May a deal they felt was a “package intended to address core program needs without any ‘frills.'”
“FDA indicated its concern, however, that Industry had introduced a new condition to be met before presentation of Industry’s remaining proposals, which it had not originally indicated was a condition for introducing its proposals,” agency officials said. “FDA stated this conditionality could further delay progress on substantive negotiations. FDA explained that timing is critical as, unlike previous MDUFA (re)authorizations, the MDUFA III process includes a sequence of statutory reauthorization process requirements.”
Both parties ended the meeting by agreeing to move forward with a plan to create a smaller “financial working group” that will “begin work as soon as possible,” with assignments of duties to be handed out at another negotiation meeting, which was held this morning.