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	CDRH
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.

SOURCE