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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, August 31, 2011

FDA - Industry MDUFA III Reauthorization Meeting
August 31, 2011, 10:00 am - 12:30 pm
FDA White Oak Building 1, Silver Spring, MD
Room 4101-4105

Purpose

To discuss MDUFA III reauthorization.

Participants

FDA
Malcolm Bertoni Office of the Commissioner (OC)
Ashley Boam Center for Devices and Radiological Health (CDRH)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Christy Foreman CDRH
Bill Hubbard FDA Consultant
Toby Lowe CDRH
Thinh Nguyen Office of the Commissioner (OC)
Tracy Phillips CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Nicole Wolanski CDRH
Barbara Zimmerman CDRH
Industry
Susan Alpert Medtronic (representing AdvaMed)
Hans Beinke Siemens (representing MITA)
Brian Connell Medical Imaging Technology Alliance
David Fisher Medical Imaging Technology Alliance
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
Joseph Levitt Hogan Lovells US LLP (representing AdvaMed)
John Manthei Latham and Watkins (representing MDMA)
David Mongillo American Clinical Laboratories Association
James Ruger Quest Diagnostics (representing ACLA)
Patricia Shrader Medtronic (representing AdvaMed)
Janet Trunzo Advanced Medical Technology Association

Meeting Start Time: 10:10 am

AdvaMed, MDMA, and MITA jointly offered preliminary feedback on the counter-proposal presented by the Agency on August 24 th. Industry stated that they appreciated the Agency’s effort to put forward proposals that addressed the issued important to Industry. Industry stated that they were prepared to offer initial feedback, including counter-proposal language on a subset of issues, but needed more time for discussions among the associations and would be prepared with a complete counter-proposal on September 13 th. The Agency acknowledged the challenges for Industry in formulating a unified response among the associations and their members.

Industry* offered counter-proposals in the following areas: Scientific and Regulatory Review Capacity, Training, Performance Reports, and Guidance Document Development.

Scientific and Regulatory Review Capacity

Industry’s counter-proposal included the Agency reducing the ratio of review staff to front line supervisors prior to the commencement of MDUFA III, rather than using MDUFA III user fee revenue to accomplish this as the Agency had proposed. Additionally, Industry proposed using user fee revenue to leverage external experts rather than hiring additional staff with needed expertise. Industry proposed that the Agency work with Industry to benchmark best practices for retaining employees, in contrast to the Agency’s proposal of developing targeted retention bonuses to address attrition of review staff.

The Agency expressed concern that Industry’s recommendation dramatically changed the Agency’s proposal. The Agency stated that resources are required to change the staff to supervisor ratio and the Agency does not have has excess resources to do so. The Agency stated that, for the ratio reduction to be successful, it has to include hiring additional staff rather than simply taking review staff and converting them to supervisors, which would reduce the Agency’s review capacity. The Agency stated that they believe the program is not currently right-sized to achieve the necessary performance with the given workload. The Agency expressed concern that Industry’s counter-proposal did not address all of the management and staffing issues the Agency has identified.

Training

Industry’s counter-proposal included the Agency implementing a Reviewer Certification Program prior to the commencement of MDUFA III as well as committing to a specific number of Vendor Days each year, but did not propose using user fee revenues for either of these initiatives, as the Agency’s proposal had. Industry proposed applying user fee revenue to supplement management training and a MDUFA III training program, both of which the Agency had proposed applying user fee revenue to. Industry proposed applying user fee revenue to expand the Reviewer Certification program to become mandatory for all reviewers hired within the past few years as well as requiring yearly refresher courses on policies outlined by Industry and other stakeholders.

The Agency asked questions to clarify Industry’s intent, and indicated that they would analyze the counter-proposal in more detail.

Performance Reports

Industry’s counter-proposal requested even more granularity of data than the Agency’s proposal, while noting that their requests for reporting may change as negotiations continue and quantitative goals are agreed upon. Additionally, they requested detailed reporting on staff training, appeals, guidance development, and staff time spent on different activities.

The Agency asked questions to clarify Industry’s intent, and indicated that they would review the counter-proposal in more detail.

Guidance Document Development

Industry’s counter-proposal suggested that the Agency reallocate existing resources to focus on guidance development without adversely affecting the timeliness of review of MDUFA-related submissions. The Agency expressed concern that the MDUFA program is intended to provide user fees for increased performance and it is not intended for Industry to dictate the reallocation of taxpayer dollars to certain issues. Industry confirmed that was the intent of the proposal. The Agency indicated that this counter-proposal could be problematic for those reasons.

Industry also requested that the Agency maintain a list of guidance documents, updated on a real-time basis, that do not reflect current thinking, either in part or as a whole, and would require an applicant to get additional information from the Agency prior to submitting a marketing application. Industry also requested that the Agency publish a list of prioritized guidance documents that they intend to publish within the year, and that the Agency publish 90% of the guidance documents on the list.

ACLA Proposal

ACLA proposed language for inclusion in the MDUFA commitment letter consisting of a proposed statutory amendment. ACLA proposed exempting laboratory developed tests (LDTs) and the laboratories that develop and offer these clinical laboratory testing services from user fees during the period of MDUFA III regardless of whether the Agency determines to regulate LDTs and the clinical laboratories that develop them during the MDUFA III time period. Under ACLA’s proposal, MDUFA III fees would apply to any IVD test kit or IVD product that is manufactured and commercially distributed by a laboratory through interstate commerce as presently regulated and actively enforced under the Food Drug and Cosmetic Act.  ACLA explained its position is based on the uncertainty regarding oversight of LDTs during the MDUFA III period as well as the differences between clinical laboratory services and currently regulated medical devices (including IVD kits and products).  ACLA would agree to uniform FDA performance goals if FDA proceeds to regulate LDTs and clinical laboratories only if MDUFA III fees do not apply as stated above. ACLA further reiterated its alternative proposal, which would be to negotiate differential FDA performance goals for review of LDTs and currently regulated devices and differential MDUFA fees for laboratories and LDTs from those applicable to currently regulated devices and manufacturers.

AdvaMed, MDMA and MITA representatives stated that the ACLA position did not represent the position of their respective associations.

Next Meeting

The next meeting will take place September 13, 2011.

Meeting End Time: 12:30 pm


* For purposes of these minutes only, the term Industry means AdvaMed, MITA, and MDMA and does not include ACLA unless specifically noted.