The FDA could be softening its stance on sweeping changes to the way most medical devices go to market, according to comments made by agency officials at a recent negotiation meeting over user fees.
Representatives for the watchdog agency told negotiators for the medical device industry that it was “not bound to adopt IOM recommendations” on the 510(k) program. The IOM was tasked by the FDA to do a soup-to-nuts review of the program in late 2009 and is expected to release a long awaited report at the end of the month. Many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.
Read more of our comprehensive coverage of changes being made to the 510(k) program
However, the agency is saying that it “will consider them and make its own decisions,” according to minutes of a June 17 meeting between medical device industry and agency officials.
“FDA indicated that it would review the IOM report and identify priorities for policy development by October, prior to publication of MDUFMA reauthorization recommendations and before the start of the public comment period and public meeting.”
The statements show some softening in the FDA’s language about the need for a complete overhaul to the program by which more than 3,000 medical devices are cleared for market. Or, they could be a negotiating tactic because the agency realizes it might not have the political capital to ram massive changes down the industry’s throat at a time when it is asking for more money from medical device companies.
Either way, FDA officials said that they agreed with industry that there are concerns over the total time it takes for medical devices to go through the 510(k) program and suggested that those expanding decision times should be addressed in the next user fee reauthorization.
Officials said that, while they haven’t seen an increase in review time on their end, an examination of the 510(k) process found that increased total times were “driven by a combination of increasing numbers of cycles and increasing time Industry takes for each cycle,” officials said.
“FDA believes the solution is not simple and involves investing resources in the program to support the changes outlined in FDA’s proposal package. FDA does not believe Industry’s June 1, 2011 proposal will result in a reversal of this trend.”
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 the 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.
The FDA said that industry’s proposal would actually amount to an 11 percent cut in user fee resources for fiscal year 2013 and create “even greater uncertainty about long-term program stability which would exacerbate the turnover problem and reduce staff morale,” officials said.
“It does not address Congressional intent for a 5-year reauthorization, increases the cost of the reauthorization process, and creates uncertainty by de-linking MDUFMA reauthorization from PDUFA reauthorization.”
Device industry reps disagreed with the agency’s assertion and said that there was “no support within the industry for the increase in fees” contained in the agencies plan for reauthorization.
The tenor of the meeting did appear to soften by the conclusion, with the FDA saying it would re-think its two year proposal and come back to the negotiation table with a counter proposal “for addressing the uncertainties identified by Industry and detailed proposals for enhancements to the MDUFMA program.”
That meeting was held on June 27th, minutes from that session are expected to be released in the coming weeks.