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U.S. Department of Health and Human Services

Medical Devices

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Minutes from Negotiation Meeting on MDUFA III Reauthorization: May 4, 2011

FDA – Industry MDUFA III Reauthorization Meeting
May 4, 2011, 10:30 – 4:30 pm
FDA Switzer Building, Washington, DC
Room 1007

Purpose
To discuss Industry’s feedback on FDA’s proposal package, any proposal ideas raised by Industry, and FDA’s preliminary estimate of resources needed to support FDA’s proposal package presented on April 13, 2011.

Participants

FDA
Malcolm Bertoni Office of the Commissioner (OC)
Lisa Berry Office of Financial Management (OFM)
Ashley Boam Center for Devices and Radiological Health (CDRH)
Nathan Brown Office of Chief Counsel (OCC)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Natalia Comella CDRH
Christy Foreman CDRH
William Hubbard FDA Consultant
Elizabeth Hillebrenner CDRH
David Miller OFM
Daniel Montgomery CDRH
Tracy Phillips CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Industry
Susan Alpert Representing AdvaMed
Hans Beinke Siemens (representing MITA)
David Fisher Medical Imaging Technology Alliance (MITA)
John Ford Abbott Laboratories (representing AdvaMed)
Elisabeth George Phillips (representing MITA)
Donald Horton Laboratory Corporation of America Holdings (representing ACLA)
Tamima Itani Boston Scientific (representing MDMA)
Mark Leahey Medical Device Manufacturers Association (MDMA)
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
John Manthei Latham and Watkins (representing MDMA)
Jim Ruger Quest Diagnostics (representing ACLA)
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:30 am

Industry Response to FDA’s Proposal Package

Industry offered comments prepared jointly by AdvaMed, MDMA, and MITA. Industry provided their understanding of the MDUFA II goals and provided some feedback on the April 13, 2011 FDA proposal package. Industry noted that the key goal is to provide timely access to safe and effective products, and that user fees were not meant to supplant appropriations. Industry noted that FDA’s spending on the process for the review of device applications (“process”) had more than doubled since the inception of user fees (2002 obligations were $120M and 2010 obligations were $293M). User fees doubled from MDUFA I to MDUFA II as well, pursuant to the agreement between FDA and Industry in the MDUFA II negotiations. When taking into account increased cost of doing business, the real increase in process spending since 2002 in equivalent 2010 dollars is less than 50%. Industry noted their disagreement with FDA’s assertion that workload has increased over time, and asserted that workload appears to have remained flat over the past 10 years. FDA later provided data showing that workload has increased. Industry also asserted that other FDA activities have diverted resources away from the “core review functions. FDA asked for examples. Industry responded with the CDRH 510(k) and Science reports (“CDRH Preliminary Internal Evaluations, Volumes I and II”) and a report on FDA’s review of ReGen Menaflex ®. FDA explained that “core review functions” include more than just application review.

Industry noted that during the last round of negotiations, FDA requested elimination of the cycle goals and industry agreed. Therefore, cycle goals were removed to allow FDA to focus on final decision goals. Industry also noted that for 90% of 510(k)s, the MDUFA II goals did not require FDA to improve performance at all from the timelines companies experienced under MDUFA I. Yet, industry noted that NSE rates had doubled from FY 2009 to FY 2010, and asserted that saying “no” quickly does not meet the goal of timely patient access. FDA clarified that the Agency is meeting the 510(k) performance goals and noted that the user fee program objectives are tied to performance, not to the outcomes of a specific decisions.

Industry stated that FDA committed to modest changes to PMA goals under MDUFA II, and that FDA and Industry established a two-tiered system to address issues concerning PMAs needing to go to Panel. Industry asserted that PMAs that go to Panel were not to be counted in the Tier 1 cohort. FDA explained that it currently includes such PMAs in the Tier 1 cohort when measuring performance. Both sides agreed this was a topic for further discussion. FDA also asserted that the changes to the PMA goals in MDUFA II reflected more than modest changes.

Industry noted that given the increase in fees under MDUFA II and the relief provided by removing cycle goals, Industry focused on qualitative goals in MDUFA II, of which Interactive Review (IR) was the most important to Industry. Industry does not believe that IR has worked as intended, as it is inconsistently applied. FDA expressed its view that IR has worked when applied correctly, but can be improved. Industry also expressed concern over the lack of formal training on IR since 2007. FDA clarified that since 2007, FDA has provided informal training through mentoring of new reviewers.

Industry also referenced the MDUFA II agreement and noted that FDA committed to meeting all the quantitative and qualitative goals with 1064 process FTEs and to maintain the current performance on submissions that currently did not have goals. Industry asserted that IDE performance has slipped; however, FDA noted that the Agency continues to meet the statutory 30 day review time for all IDEs. Industry noted that FDA currently has 1230 “Device Review” FTEs for the device review process, and questioned why FDA believes that the current performance may not be sustainable at that FTE level. FDA noted that the increases in FTE were due to increases in Budget Authority appropriations that were targeted by Congress for specific activities, some of which are part of the process for the review of device applications. Industry also referred to specific slides FDA presented during MDUFA II negotiations which referenced FDA’s ongoing activities to achieve “efficiencies,” including more experienced staff, improved training and improved IT systems.

Industry then provided preliminary feedback on FDA’s proposal package. Industry began by expressing concerns about developing goals and a user fee package with a premarket review program that may have potential changes to it as a result of FDA’s internal review and the pending IOM report.

Industry responded to FDA’s proposal about needing more resources to retain staff, noting this issue was discussed during the last negotiations. Industry acknowledged that the commitment letter does not include any mention of retention incentives. Industry agreed that there is a need to “enhance FDA expertise in special areas” and the need to improve training. Industry asserted that the user fees under MDUFA II were intended to allow FDA to hire additional experts and/or consultants and provide additional training. However, the MDUFA II financial assumptions provide for maintaining 1064 FTE. The MDUFA II commitment letter provides for applying user fees to training only “as resources allow.”

Regarding improving review management, Industry agreed that good management tools were important, but asserted that many of these should already be in place and none should be conditioned on additional user fees. FDA indicated that some of these management changes would require additional resources, and that without those additional resources, they will not happen. FDA also pointed out that they would use some of the user fee funding requested to obtain an independent audit of the program.

Industry stated that it disagreed with FDA’s “broad claims” about submission quality being a significant reason for missing some MDUFA goals. Rather, Industry asserted that more likely reasons for missing MDUFA goals included: imbalanced risk-benefit calculation, less experienced reviewers and the need for more management oversight. FDA did not claim that submission quality is a significant reason for missing some MDUFA goals; FDA has noted that its analysis of a representative sample of Additional Information letters demonstrates that poor submission quality unnecessarily delays the total elapsed time to decision and diverts scarce resources toward unproductive activities. Industry also noted that FDA currently has the authority to refuse to file or accept incomplete submissions and should apply this authority based on pre-defined objective criteria. FDA agreed with this statement and explained that it was being brought up in negotiations because FDA currently loses the 15 days it takes to determine of the submission is inadequate per the checklist. FDA would like to reset the review clock to day 0 and increase specificity of the checklist such that it results in complete submissions for review.

Industry outlined issues worth discussing further. Those issues include: goals based on total calendar days (FDA + Manufacturer); objective refuse to accept/file policies for incomplete submissions; mandatory early interaction goals; and, communication of data requirements prior to submissions. In addition to those topics, Industry proposed streamlining the GGP process, optimizing the third party review, putting more emphasis on the 510(k) program and impact of potential policy changes, discussing the pre-IDE and IDE processes, improving tracking of the premarket review process, adding goals around the CLIA Waiver application process, and requested more detailed reporting during the quarterly meetings.

FDA asked preliminary questions regarding the issues introduced by Industry. FDA noted that it had expected Industry’s progress toward presenting detailed proposals to be more advanced by now. FDA asked Industry if they were planning to provide specific proposals regarding these issues. Industry agreed to provide detailed proposals at the next meeting.

ACLA provided separate comments. ACLA noted that it remains unclear whether the FDA's proposal assumes the inclusion of fees from labs and LDTs, and that if such fees are not accounted for in the current negotiations and labs and LDTs are subsequently regulated, the MDUFA negotiations should be reopened at that time. ACLA stated that if laboratory developed tests (LDTs) are regulated as medical devices in the future, ACLA advocates establishing differential performance goals with faster timeframes for LDTs, and phasing in the fee structure.  Industry asked if FDA’s proposals take into account LDTs in the proposal package. FDA explained that its proposals were based on an expectation of moderate growth in applications and other submissions and that FDA has not stated any assumptions either way regarding what proportion of the workload is projected to be LDTs.

FDA Assessment of Shared Areas of Interest

FDA presented ideas on how mutually agreed upon problem areas could be addressed. First, FDA supported the concept of timely feedback, but noted that scheduling timely meetings is challenging due to Branch Chiefs and Medical Officers being spread thin. FDA agreed with Industry that consistency in communication of data requirements is important. FDA pointed to current challenges in achieving consistency, including new staff members, new managers, loss of experienced staff, lack of backup in key areas of expertise, and limited time for professional development. FDA also agreed with Industry that training is important. Training is currently offered; however, staff need time to take training. Currently, staff often prioritize review work ahead of training in order to meet MDUFA goals.

FDA suggested that these issues could be addressed through improvement of what FDA calls “scientific review infrastructure.” This would include a reorganization and hiring of additional managers to reduce staff-to-manager ratios, targeted addition of experts to ensure availability, targeted retention to keep experienced and high performing reviewers and managers, hiring additional reviewers to achieve a better workload balance and minimize attrition, and providing additional training opportunities as well as sufficient time for staff to participate (including a new reviewer curricula). FDA also suggested that Industry more routinely identify previous interactions with FDA (such as Pre-IDE discussions) in new submissions.

FDA acknowledged the significance of the 510(k) program and noted that FDA’s proposals include measures that would improve this program. The proposal to develop and publish as guidance Good Review Management Practices applies to all products. A revised “refuse to accept” policy that is clear and objective should improve the efficiency of 510(k) reviews. Organizational restructuring will provide better oversight and consistency in 510(k) reviews. Updates to device-specific guidances would address issues for many devices falling under the 510(k) program. An additional interaction goal for 510(k)s should facilitate getting to a final decision sooner.

FDA also agreed with Industry that further streamlining of the guidance process could be worthwhile, and noted FDA’s current agency-wide process to address good guidance principles, in addition to FDA’s proposals to address timely guidance development.

Preliminary Estimate of Resource Needs

FDA presented its preliminary estimate of resources needed to support the proposal package outlined on April 13, 2011. FDA explained its approach of modeling workload, review effort (from time reporting data), and planned performance goals. FDA also employed professional judgment from division directors and branch chiefs to understand current staffing gaps and inadequate managerial support. FDA noted the following caveats: resource estimates are sensitive to both financial and performance assumptions, and the estimates do not incorporate feedback from Industry or any Industry proposals. In addition, the estimates do not include resources for an additional proposal which FDA anticipates making regarding the accredited persons (third party) inspection program.

FDA estimated the proposal package (excluding the third-party inspection proposal) will require an additional 254 FTEs and some additional operating costs, using the current set of assumptions. FDA stated that these resources will support the performance goals outlined in the proposal package FDA presented on April 13, as well as improved outcomes related to timely access to safe and effective medical devices that Industry is looking for. Industry asked preliminary questions about the estimate, and discussion ensued. Industry stated they plan to respond further to this resource estimate at a later time, and FDA agreed to answer additional questions about the estimate.

Next Meeting

FDA and Industry agreed that each side would submit a complete set of proposals at the next meeting, generally including draft commitment letter language. The next meeting will take place June 1, 2011.

Meeting End Time: 4:30 pm