Stakeholder Meeting on MDUFA III Reauthorization

August 18, 2011, 1:45 - 3:35 PM

HHS Humphrey Building, Washington, DC

Room 325A


To provide a status update of the ongoing MDUFA III negotiations.


Malcolm BertoniOffice of the Commissioner (OC)
Kate CookCenter for Biologics Evaluation and Research (CBER)
Natalia ComellaCenter for Devices and Radiological Health (CDRH)
Cindy GarrisCDRH
Elizabeth HillebrennerCDRH
Toby LoweCDRH
Arleen PinkosCDRH
Don St. PierreCDRH
Ruth WatsonOffice of Legislation (OL)
Barbara ZimmermanCDRH
Cynthia BensAlliance for Aging Research
Paul BrownNational Research Center for Women & Families
Diane Edquist DormanNational Organization for Rare Disorders
Eric GaschoNational Health Council
Suzanne HenryConsumers Union
Darby HullConsumer Federation of America
Jeanie KennedyAmerican Academy of Orthopedic Surgeons
Jenny LiljebergAmerican Society of Cataract and Refractive Surgery
Erik LontokAmerican Association for Cancer Research
Heidi MolineUnion of Concerned Scientists
Rebecca O’ConnorParkinson’s Action Network
Kate RyanNational Women’s Health Network
Andrew SperlingNational Alliance on Mental Illness
Leslie StevensSociety for Women’s Health Research
Lisa SwirskyConsumers Union
Cindy TomlinsonAmerican Society for Radiation Oncology
Additional Registered Stakeholders
Andrew MorrisUnited Spinal Association

Meeting Start Time: 1:45 pm

Status Update

FDA provided a status update of the ongoing negotiations since the last stakeholder meeting on July 27th.

July 26, 2011 Meeting

The regulated Industry (AdvaMed, MDMA, and MITA) provided its own comprehensive proposal package on July 26th. The regulated Industry’s proposal package covered the following areas: submission acceptance criteria, review of applications, qualitative goals, and audit of the medical device program. FDA did provide a preliminary response at that meeting, but noted that it provided a more substantive response on August 2nd. The preliminary response addressed: concerns about topics that were potentially outside the scope of these negotiations; the gap between current goals and the expectation for instantaneous implementation of new, more aggressive goals, without allowing time for a suitable transition period; concerns that the proposal did not have a mechanism for addressing Industry’s share of the responsibility for meeting the stated goals; and, concern that the proposal package did not appear to address other stakeholder interests. The Agency also asked for confirmation that Industry’s proposals were developed in the context of a 5 year reauthorization. Industry stated that was still subject to further discussion.

ACLA also provided a brief statement regarding its position.

August 2, 2011 Meeting

At the August 2nd meeting, FDA noted that balance and flexibility are needed to meet the key program objective of “timely access to safe and effective devices while fostering innovation.” FDA suggested that, if appropriately balanced, solutions with the following features should lead to a successful program that is more transparent, consistent, and predictable: clarity of expectations, shared risk and accountability, appropriate incentives and metrics, flexibility to achieve outcomes, and simplicity and efficiency of mechanisms. FDA’s feedback noted the Agency’s concerns, raised potential challenges, and in some instances, highlighted potential unintended consequences. During those discussions, FDA noted that there would be shared responsibility between industry and the Agency to meet the proposed goals; therefore, there needed to be a shared risk associated with the potential total time goals. The Agency also noted that it appeared that Industry’s proposal would likely require substantial additional resources -- substantially more than what the Agency initially proposed. FDA provided an overview of its comments for each of Industry’s proposals.

August 9, 2011 Meeting

On August 9th, the Agency discussed with Industry the Institute of Medicine’s (IOM) Report on the 510(k) program and the recently released 510(k) Device Modifications guidance. Only the IOM report was discussed at this stakeholder meeting.

FDA described the questions the Agency posed to the IOM: Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health? If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) clearance process? In response to these questions, the IOM made eight recommendations. FDA is currently evaluating the recommendations. The discussion with Industry in the context of the MDUFA negotiations is to consider the potential impacts of the recommendations on any future workload, which could affect review performance. FDA noted its plan to hold a public meeting on September 16 th, review any public input it receives, and then announce by the end of October what, if any, recommendations the Agency plans to adopt. FDA acknowledged that some concerns have been expressed regarding FDA’s initial reaction to the IOM recommendation; FDA clarified that it was not dismissing the report. The Agency believes that the 510(k) program is a successful program, yet there are some particular types of devices for which we may need to find an improved way of addressing. The Agency believes everyone should continue to have confidence in devices that are cleared through the 510(k) program. The Agency wants to carefully consider the recommendations provided in the IOM report as well as review public input on the report before making any decisions on how to address the IOM’s recommendations.

FDA was unable at this time to answer many of the questions raised by stakeholders due to the ongoing assessment of the 510(k) Report. Some stakeholders shared their views of the report. Some expressed support for the recommendations; while others expressed concern over some of the recommendations and what the implications might be for patient access to medical devices. Some also cautioned about believing statements in the press, noting that inaccuracies were being reported. Specifically, the American Academy of Orthopedic Surgeons indicated that it had not disparaged the report prior to release, as had been noted in the press, but rather, had voiced concerns because there were no practicing surgeons on the panel of experts.

Further Discussion

FDA provided further clarification on a variety of issues covered during this meeting. It noted that, with the exception of the working group (WG) on financial baseline issues, other WGs had yet to be established. FDA also noted it was unclear to what extent these WGs would be used throughout the negotiation process.

Some stakeholders expressed concerns over aspects of Industry’s proposal package. Those related to the potential total time goals, the flexibility required for a successful program, Industry’s request for more input in reviewer training, and its request for leveraging outside experts. In particular, with the total time goals, stakeholders questioned how FDA would be able to manage the goals without having control over Industry’s contribution to the performance goal. FDA acknowledged this would be a challenge and the lack of control over industry’s time remains a concern to the Agency. The Agency said it was being open-minded and creative in investigating various options or alternatives, but acknowledged the Agency and Industry would have to address the issues of shared responsibility and accountability before any agreement could be made on total time goals. FDA also noted that the program would need to go through a transition period as it implemented any negotiated performance goals.

Stakeholders also inquired to what extent resources had been discussed. The Agency noted that the cost of the Industry’s proposal package had yet to be discussed.

Meeting End Time: 3:35 PM