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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: July 15, 2011

FDA - Industry MDUFA III Reauthorization Meeting
July 15, 2011, 10:20 - 2:10 pm
FDA White Oak Building 1, Silver Spring, MD
Room 4101-4105


To discuss MDUFA III reauthorization.


Malcolm Bertoni Office of the Commissioner (OC)
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
Toby Lowe CDRH
Thinh Nguyen OC
Tracy Phillips CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
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)
David Mongillo American Clinical Labs Association (ACLA)
Jim Ruger Quest Diagnostics (representing ACLA)
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:20 am

To provide context for FDA’s proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the status of where MDUFA reauthorization discussions stand. From January through April, FDA provided more data and analysis on program performance than ever before. While FDA and Industry did not always agree on the interpretation of these data, the parties engaged in a robust exchange of viewpoints that furthered FDA’s understanding of program performance and Industry’s concerns. Based on these discussions, FDA developed a comprehensive proposal package, which FDA presented in April. In May, FDA presented an initial estimate of resources needed to support the proposal package. Although Industry stated that they do not support the initial estimate, FDA noted that the proposal package was carefully designed to address the concerns identified during the program analysis and voiced by Industry. It represented FDA’s good faith estimate of what is needed to address the needs of an under-resourced program to improve transparency, consistency, and predictability, and to achieve the public health outcomes on which all agree. FDA also noted that the proposal package was intended to address core program needs without any “frills,” and was prepared by FDA without having the benefit of seeing Industry’s detailed proposals. FDA believed that on May 4 th Industry had agreed to present at the next meeting its detailed proposals for a 5-year program based on the topics Industry had presented on May 4th. On June 1 st, Industry proposed a different approach, which FDA indicated on June 17th that it could not accept. FDA expressed appreciation for Industry’s June 27 th presentation, which FDA believed reflected forward movement. FDA stated that its proposed approach for today’s meeting was intended to build on that forward movement. 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: agreement on the uncertainty mitigation plan. 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. FDA described this tight timeline to Industry dating back to September 2010, and the FDA remains committed to meeting the statutory timeline despite missed milestones.

FDA responded to Industry’s June 27 th proposal for mitigating uncertainties. FDA indicated that uncertainties will always exist in the oversight of innovative technologies; nobody can predict the exact nature, scope, quality, or volume of submissions over a future five-year period. In the June 17 th meeting, FDA provided a detailed assessment of those initiatives identified by Industry as sources of uncertainty, indicating that they are not expected to have a significant impact on workload or performance in MDUFA III. FDA, in turn, faces substantial uncertainties regarding budget appropriations and legislative uncertainties. FDA suggested that the best way for all parties to manage uncertainty is to accelerate progress on substantive issues in these negotiations.

FDA’s proposed plan for mitigating uncertainties therefore begins with advancing negotiations to reach an understanding of what both parties want the program to look like in MDUFA III, such that the impact of uncertainties can be evaluated in that context. To this end, FDA recommended discussing proposals based on current assumptions and discussing potential impact on workload of initiatives as they are released. FDA asked Industry to present their complete set of detailed proposals on July 26 th so that FDA and Industry can move forward on substantive negotiations, with the goal of reaching an agreement, based on best available information and current assumptions, by the end of August. This timeline would allow FDA to seek expedited Administration clearance prior to publishing draft recommendations in the Federal Register (FR) in October, in order to meet the statutory requirements for public input before delivering final recommendations to Congress by January 15, 2012. FDA is targeting a public meeting in early November during the public comment period. Industry asked what the Agency believed would happen if it transmitted the recommendations to Congress after the statutory deadline. FDA indicated that it is committed to meeting the January 15, 2012 deadline, and that key members of Congress have specifically emphasized this deadline with the Commissioner.

FDA noted that the draft recommendations can be appropriately characterized in the FR notice to accurately reflect contingencies regarding the assumptions underlying any draft agreement. FDA clarified that negotiation meetings may continue after the draft recommendations are published, to the extent necessary to address any potential workload or performance impacts that could arise as more information becomes available during the Fall and FDA resolves several key pending initiatives identified by Industry in their June 27 th presentation. FDA would follow the statutory process currently in place for MDUFA negotiations, including publication of meeting minutes, and concurrent monthly meetings with patient and consumer advocacy groups to obtain ongoing input. If there is a need to revisit any draft recommendations based on workload or performance impacts of newly released initiatives, or in response to public comments or other changes in assumptions (including FDA’s budget authority appropriations), then negotiation meetings would continue. At such meetings, both parties would come prepared with their analysis of a given initiative’s implications for workload and performance. FDA noted that issues unrelated to workload and performance, such as policy, would not be discussed within the MDUFA negotiations but rather, through public comment and meetings directly with Center staff.

FDA reiterated that the Agency does not expect any of the areas of uncertainty identified by Industry to have a significant impact on workload or performance during MDUFA III. Industry asked FDA to define “significant.” FDA clarified that no significant impact refers to impact within the normal level of submission variance or fluctuations experienced from year to year, and they therefore fall within FDA’s ability to manage. Industry also asked what percentage increase in submissions would constitute a “significant” impact. FDA indicated that it is not referring to any fixed percentage change in submissions, and that the size and complexity of submissions would also factor into impact. Industry indicated the need to consider all potential changes, such as those stemming from the 510(k) modifications guidance, 510(k) paradigm guidance, and IOM report together. FDA noted that these documents discuss high-level principles that frame how the program is applied and do not address data requirements. Industry suggested that the 510(k) paradigm guidance could result in an increased number of pages per submission if clinical data are required in more situations. FDA explained that this document simply outlines current practices in more detail. For example, the Agency has historically required clinical data to support a new indication (but not intended use, as that would be NSE). Industry also inquired about the timing and substance of the LDT guidance documents. FDA noted that the Agency had provided information that was available about LDTs on June 27 th, and that this topic could be discussed further prior to reaching a final agreement, once there is more information or the LDT policy is announced. While FDA believes that all initiatives raised to date collectively are not likely to have a substantial impact on workload or performance in MDUFA III, FDA offered to meet with Industry to discuss their concerns with workload or performance after the initiatives in question are released. FDA offered some potential meeting dates in the Fall to hold if further negotiations are needed after the release of draft recommendations.

FDA also noted that the level of budget authority (BA) appropriations for fiscal year 2012 represents a substantial uncertainty for FDA, and could trigger the need for an additional negotiation meeting as it could affect FDA’s ability to meet performance goals at the end of MDUFA II and adversely affect the baseline for MDUFA III going forward. Industry questioned why the FY 2012 appropriations should impact resources available during MDUFA III. FDA responded that the FY 2012 budget will serve as the starting point for the budget at the beginning of MDUFA III, and any significant reductions could affect FDA’s ability to meet goals. Industry questioned whether the proposed House bill with a 12% cut to CDRH would hit the appropriations trigger reauthorized in MDUFA II for the Devices and Radiological Health program line of the FDA budget. FDA indicated it would not; the trigger would only be reached at a 27% cut. Industry indicated that, based on concerns of missing triggers in MDUFMA I, the language in MDUFA II was specifically written to allow minor variation so that the Agency could continue to collect fees under those circumstances and Industry supported that. FDA noted that the appropriations triggers no longer provide their intended level of protection for the program because of increases to BA appropriations in recent years. . FDA also noted the concerns expressed by many outside observers that the Agency has been chronically underfunded. FDA noted that the Government Accountability Office (GAO) criticized the Agency for not doing a better job of identifying the resources needed to address our full set of statutory and regulatory responsibilities. In response to that criticism, the Agency commissioned a study by Booz Allen Hamilton to develop an evidence-based estimate of the resources needed to accomplish all of our medical product oversight responsibilities, which was completed last year. Results showed that all medical product areas, including CDRH, are significantly under-resourced. Industry responded that any chronic under-funding of FDA is a matter for the Administration and Congressional appropriators to address.

FDA provided a formal response to Industry’s June 27 th presentation on proposed enhancements and the use of working groups. FDA agreed with Industry that working groups may be helpful and noted that the Agency initially proposed such groups in April. Based on the current timing, FDA suggested that the purpose of these groups should be to accelerate the process by allowing technical experts on various topics to work in parallel between negotiation meetings. FDA agreed that not all proposal areas may need working groups, and proposed that the structure of the working groups be decided only after Industry has presented its remaining detailed proposals so that an efficient and coherent work plan can be developed taking into account the full scope of discussions. FDA proposed that the negotiators provide a charge to each working group and that each group report back during negotiation meetings.

FDA also agreed to further discuss all proposed enhancements from Industry’s June 27 th presentation: pre-Submission meetings, Refuse to Accept (RTA) procedures for 510(k)s, Refuse to File (RTF) procedures for PMAs, and an independent analysis of review process management. FDA noted, however, that further discussion should take place in the context of a complete set of proposals. Given that many topics are inter-related and resources are limited, FDA suggested that an efficient and coherent approach would mean deferring initiation of work on these proposal areas until the full scope of negotiations has been identified after Industry presents the remainder of their detailed proposals.

FDA proposed a specific path forward and associated timeline. FDA first suggested that a financial working group begin work as soon as possible. Once all proposals are on the table, FDA suggested that both parties agree on the structure and charge for each working group by August 2 nd and that all groups begin work as soon as possible thereafter. FDA noted that some topics may be addressed collectively by a single working group. The working groups should accelerate the process towards a draft agreement which can be cleared by HHS and OMB in time to be published in October.

Industry provided an initial response to FDA’s presentation. Industry stated that the information provided by FDA was encouraging, particularly the Agency’s willingness to meet quickly after issuance of IOM report, 510k modifications guidance, and other important relevant milestones to discuss workload impact. Therefore, Industry will put forward a substantive proposal to cover performance goals, both qualitative and quantitative, on July 26 th. Industry also plans to prepare financial estimates relating to the proposals it shares on July 26th, but it would not be able to provide its financial estimates until after the financial working group is initiated. Industry therefore agreed with FDA that a financial working group meeting should take place soon. Industry indicated their need to discuss FDA’s proposed plan for mitigating uncertainties with their members and ratifiers prior to formally responding; however, Industry stated their agreement on the need to move forward in good faith and come to agreement on a package.

The concept of working groups was discussed further and both parties agreed to establish a financial working group as soon as possible. This group will discuss the MDUFA II spend plan and estimated cost per FTE for MDUFA III.

Next Meeting

The next meeting will take place July 26, 2011.

Meeting End Time: 2:10 pm