Acting FDA Commissioner Andrew von Eschenbach said the agency needs to go beyond the "incremental" improvements it has made in speeding up the review of device premarket applications under the Medical Device User Fee & Modernization Act (MDUFMA).
"In most cases, there has been full compliance with regard to the targets . . . that were put into place," von Eschenbach said in testimony to the Senate Appropriations Subcommittee on Agriculture, Rural Development & Related Agencies.
However, meeting the MDUFMA performance goals has not been sufficient to "significantly reduce cycle time and streamline and accelerate the time to market" of devices, he suggested.
President Bush nominated von Eschenbach to be the permanent FDA commissioner on March 15.
Device center staffers have emphasized that the center is on track to meet the fiscal year 2006 MDUFMA targets for review of PMA and 510(k) submissions and is gearing up to meet the more stringent FY 2007 goals.
The device industry does not dispute FDA's ability to meet the objectives, but stakeholders have questioned whether the goals themselves are sufficient.
Representatives from AdvaMed and the Medical Device Manufacturers Association pointed out during a MDUFMA stakeholder meeting last November that some of the legislation's goals for 2005-2007 actually prescribe a lower performance level for application review timelines than was achieved in 2000-2002, while others provide only modest improvements.
In addition, industry has complained that the cycle goalswhich compel FDA staffers to take interim actions, such as sending a major deficiency letter or an "approvable" or "not approvable" letter, at specific points during application reviewover-manage the process and lead to unintended consequences, such as reviewers issuing "not approvable" letters more frequently than in the past.
Meanwhile, von Eschenbach said at the hearing that he is looking to work "collaboratively and collectively with industry in order to accelerate the process and make it more effective."
He suggested that FDA should put more effort into consulting with product sponsors before applications are formally submitted to minimize inefficiencies once the review process begins.
Von Eschenbach noted that this approach has worked well in the agency's review of drug applications.
"We have noticed with regard to [the pharmaceutical user fee program] that the opportunity for consultation before the application process is something that is highly attractive and very positive," he said.
The device industry also wants more interaction with the agency both prior to initiating clinical trials and before submitting applications, suggesting that more emphasis may be put on such consultations in a reauthorized MDUFMA bill.
Von Eschenbach was testifying before the Senate panel about FDA's fiscal year 2007 budget request, which includes funds to continue the device user fee program through September 2007.
At that time, the current program expires. FDA is expected to send its proposal for new user fee legislation to Congress by the end of this year.
Von Eschenbach's willingness to acknowledge inadequacies in FDA's application review efficiency is a good sign for the device industry, which is seeking significantly enhanced performance goals in the next version of MDUFMA.
AdvaMed President Steve Ubl has said that he would like to see expedited PMAs reviewed in a much-accelerated 180-day timeframe within the next three to five years.