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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, January 26, 2011

FDA – Industry MDUFA III Reauthorization Meeting
January 26, 2011, 12:45 – 4:15 pm
FDA White Oak Campus, Silver Spring, MD
Building 31, Room 2442

Participants

FDA

Malcolm Bertoni Office of the Commissioner (OC) Office of Planning
Nathan Brown Office of Chief Counsel (OCC)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Natalia Comella Center for Devices and Radiological Health (CDRH)
Christy Foreman CDRH
Alberto Gutierrez CDRH
William Hubbard FDA Consultant
Elizabeth Hillebrenner CDRH
Thinh Nguyen OC Office of Combination Products
Ruth Watson OC Office of Legislation (OL)
Barbara Zimmerman CDRH

Industry

Hans Beinke Siemens
David Fisher Medical Imaging and Technology Alliance (MITA)
John Ford Abbott Laboratories
Elisabeth George Philips
Donald Horton Laboratory Corporation of America Holdings
Mark Leahey Medical Device Manufacturers Associations (MDMA)
Joseph Levitt Hogan Lovells US LLP
David Mongillo American Clinical Laboratory Association (ACLA)
James Ruger Quest Diagnostics
Patricia Shrader Becton Dickinson
Janet Trunzo Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 12:45 pm

Ground Rules

The ground rules governing MDUFA III Reauthorization negotiations were discussed and agreed to without amendment.

FDA Perspective on Reauthorization

FDA expressed its commitment to achieving the goal of timely access to safe and effective medical devices, while fostering innovation. Although all stakeholders, Industry, the Public, and the FDA share this common goal, FDA has a special role in balancing a variety of considerations and diverse stakeholder opinions regarding timely access to medical device innovations while upholding legal and scientific standards for safety and effectiveness.

The Medical Device User Fee program has contributed to achieving this common goal. FDA outlined program successes during MDUFA II, including maintaining achievement of 510(k) review goals, improving performance for Pre-Market Application (PMA) review goals, and substantially completing all qualitative goals.

While progress has been made, FDA acknowledged there is more work to be done. FDA noted the device review program is currently operating at full capacity and yet, not meeting all of the goals. The current system lacks resiliency to surges in workload or unplanned absences of key reviewers, given the lack of backups in many technical areas. FDA noted that it shares Industry’s concerns about increasing review cycles and increasing time to market, given that this has the adverse public health impact of slowing access to new and improved devices. FDA and Industry have a shared responsibility to understand and address the root causes of these unintended program outcomes. FDA presented a conceptual model for analyzing how various factors influence review system performance, and suggested that the model could be used as a framework for evaluating potential program improvements.

Industry Perspectives on Reauthorization

Each association discussed its goals for reauthorization, described certain trends being observed, and noted some of the general challenges going into the coming round of negotiations. All Industry participants agreed with the goal put forward by FDA of timely access to safe and effective medical devices.

MDMA noted that despite significant increases in FDA resources from Congress and industry, FDA’s performance has been declining since 2005. The fact that industry user fees continue to represent a larger percentage of FDA’s Device Review Budget was also of concern to MDMA. The group noted that the negotiation is an opportunity to identify areas for improvement and further strengthen the program, especially with respect to the following areas of concern: missed performance goals, implementation of the interactive review process and achieving balance between user fee rates and level of performance.

In response to MDMA’s statements about FDA performance, FDA noted that industry has been expressing concern about a metric (total time to market) that is not a MDUFA performance goal, and represents joint performance of both FDA and industry. FDA has strived to achieve the review goals we agreed to, and has been meeting the vast majority of those goals. Industry and FDA have a shared obligation to look at the factors that are driving up review cycles and therefore total time to market.

AdvaMed noted that since 2003, fees paid by industry have tripled, while the CDRH appropriated budget has increased by nearly 80% and CDRH staff levels by 20%. AdvaMed expressed concern about PMA performance goals not being met and 510(k) review issues including increased number of review cycles per submission. Having surveyed its members, AdvaMed noted three areas of dissatisfaction: lack of consistency among reviewers, the increase in total time (FDA + manufacturer) to market, and amount of training received by reviewers. AdvaMed also expressed interest in discussing review times associated with Clinical Laboratory Improvement Amendments (CLIA) waiver applications, as well as the overall implementation of the interactive review process.

In response to the statement about tripling of fees, FDA noted that this characterization is based on actual fee collections for FY 2010, not authorized collections, and that excess collections are offset in FY 2012.

MITA pointed out a 167% increase in authorization levels for the user fee program between its inception and when the current law expires. MITA also noted that the $20 billion device tax is scheduled to begin in 2013 and will increase device manufacturer payments to the government by a projected $1.8 billion in that year alone.

MITA also shared an analysis of data provided by FDA which demonstrated a lengthening in the time between application and clearance since 2005, an increase from 13% to 31% in the number of 510(k) clearances between 81 and 90 FDA days and an increase in the percentage of clearances taking place greater than 60 FDA days.

MITA also expressed concerns about the implementation of the third party review program, noting that it had not performed as its industry had hoped. MITA also indicated dissatisfaction with the guidance document development process and called for greater transparency as well as stakeholder input going forward.

ACLA explained how uncertainties surrounding FDA regulation of laboratory developed tests (LDTs) may affect the medical device user fee negotiations. ACLA provided two options to consider for addressing these uncertainties. One option was to finalize MDUFA negotiations under current FDA policy, scope and projections.  If the scope changes to include clinical laboratories as medical device manufacturers and LDTs as medical devices, reopen negotiations to reflect the new scope.  The other option was to establish a separate establishment fee for clinical laboratories and user fee for LDTs review based on new FDA policy under current negotiations. FDA noted that, depending on the progress and timing of FDA policy development in this area, these issues my be considered during the course of reauthorization discussions.

ACLA further noted its participation in these negotiations shall not constitute a waiver of any legal or equitable argument or relief to which ACLA and its members may be entitled with respect to the issue of whether FDA regulation of laboratory developed tests as medical devices is permissible.

Discussion

Based on the discussions, FDA and Industry identified potential topics for future meetings. They include: training of review staff; better understanding of FDA’s management processes; transparent development of guidance documents with adequate input from outside experts; FDA’s current resource needs related to the device review program and understanding trends in financial data and any associated assumptions for future needs; discussion of quantitative performance metrics and their potential drivers; predictability, consistency, and transparency of the review process; third party reviews; strengthening of the interactive review process; total time issues, FDA root cause analysis, how implementation of the recommendations in the 510(k) and Science reports may affect MDUFA, discussion of the review of CLIA waivers; and, review of other submission types not directly associated with performance goals. Both sides agreed that this list was not meant be exhaustive and was not meant to limit topics for future discussion. Industry expressed a priority for discussing financial baseline information soon, and FDA agreed to address this at the February 23 rd meeting.

Next Meeting

All agreed to meet on the afternoon of February 9 th to discuss topics associated with PMA performance.

Meeting End Time: 4:15 pm