“I’ve got a thin bench, ” Jeff Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health (CDRH), told the packed conference room in Minnesota at a Town Hall meeting early this summer.
Jeff Shuren, M.D.Shuren said the complexity of medical device science is increasing so quickly, it is difficult for the agency’s reviewers to keep up. And when someone leaves for better paying jobs in industry or is temporarily out, it is very hard for a new reviewer to fill in.
Inadequate Resources for Technologies of the Future
According to an August preliminary report by an internal CDRH task force:
“The Center’s scientific staffing level is not optimal to meet the anticipated demands of the future, particularly the challenges presented by novel technologies.”
In 2007, the FDA Science Board’s Subcommittee on Science and Technology reported that ‘CDRH does not have the personnel or resources in place to adequately support the science needs in the regulatory review process for the planned technologies of the future….’
These shortcomings have hampered the agency from fulfilling its mission of “promoting” medical innovation for the benefit of patients.
510(k) Retooling
To tackle this, as well as management problems within the agency’s 510(k) clearance program, Shuren convened two internal work groups to come up with recommendations to improve the clearance program. He also asked the Institute of Medicine to review the program. The Institute’s recommendations are expected next summer.
What did the internal task force recommend to strengthen Shuren’s bench and tackle “technologies of the future”?
CDRH Science Council
In this final installment of our three-part series where we’ve analyzed the agency’s recommendations for retooling the 510(k) process, we look at one recommendation that has already been implemented: the establishment of the Center Science Council and the appointment of William H. Maisel, M.D., MPH, as its first Director. Maisel has become Shuren’s right hand man for science. Technically, he is the newly appointed Deputy Director of the FDA’s Center for Devices and Radiological Health.
The task force recommended the establishment of a Center Science Council as a new governance model to assure quality and consistency in CDRH’s science-based decision making.
This standing body would be responsible for overseeing science-based decision making across the Center. Functions include:
- Premarket review
- Periodically auditing decisions
- Assessing program performance
- Acting as a resource for staff on scientific questions
William Maisel, M.D., MPH
“Get to know Bill Maisel, ” said University of Minnesota Law Professor Ralph Hall. “Maisel and the Science Council have the potential to have a big impact on how devices will be evaluated and allowed onto the market.”
William Maisel, M.D., MPHWilliam Maisel, M.D., MPH, Deputy Director of the FDA’s Center for Devices and Radiological Health./Washington.edu
Before getting drafted to shore up Shuren’s bench, Maisel was the Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School. He had an active cardiology practice and also directed the Pacemaker and Defibrillator Service at Beth Israel Deaconess Medical Center.
His research interests, according to his biography, involve the safe and effective use of medical devices, and he has published extensively on the safety of pacemakers and defibrillators, drug-eluting stents and other cardiovascular devices.
Maisel received his M.D. from Cornell University, his MPH from the Harvard School of Public Health, and completed his internal medicine and cardiovascular training at Brigham and Women’s Hospital. Maisel was also an FDA consultant and former Chairman of the FDA’s Circulatory System Medical Device Advisory Panel.
Maisel: “Higher Standard for Device Clearance”
Maisel’s public statements regarding the FDA’s success in protecting the public’s health may shed some light on how he will act as Shuren’s right hand science guy.
In testimony before Congress in May 2009, Maisel said:
“…Device malfunctions and software glitches have become modern ‘diseases’ that will continue to occur. The failure of manufacturers and the FDA to provide the public with timely, critical information about device performance, malfunctions, and ‘fixes’ enables potentially defective devices to reach unwary consumers.”
And this testimony a month later:
It is evident that to best protect the health of American medical device users, the FDA must promote and enforce a higher scientific standard for device clearance and approval—particularly for higher risk devices whose abnormal performance is likely to have adverse effects on patient health.
As we reported in Part One of our series, orthopedic devices have had a phenomenal safety record. Cardiovascular devices, according to Professor Hall’s research, have not fared quite as well.
Live-Saving vs. Life-Enhancing
Orthopedic physician leaders have urged the FDA to distinguish between “life-saving” and “live-enhancing” devices. Those leaders can hope that recommendations, supported by AdvaMed, to create a Class IIb category, will make getting new devices to patients more predictable and less burdensome.
In addition to the creation of a Science Council headed by Maisel, Shuren’s science task force recommended further changes to the way CDRH will deal with a changing scientific landscape.
Recommendations for Predictability
Shuren asked the task force to identify steps the agency should take to ensure regulatory predictability while adapting to emerging science.
This means helping CDRH become more predictably adaptive, setting clearer guidelines about when new scientific information might prompt a change in how CDRH treats a given product, including how that product might be reviewed before it goes to market.
Predicate and Substantial Equivalence
For example, the explosion of scientific advancements has challenged the agency’s definition of terms like “predicate” and “substantial equivalence.”
Shuren said a survey of agency staff found that employees didn’t agree on “substantial equivalence, ” which led to “inconsistency in decision making.” The agency proposes to clearly define the term, he said.
These tensions of definition and expertise played out during the last year of the Bush Administration as then FDA Commissioner von Eschenbach faced a rebellion from whistle blowing agency scientists who claimed senior managers were overriding their scientific judgment.
The agency was also challenged by ReGen Biologics’ 510(k) application for its Menaflex surgical mesh. The application exposed a dysfunctional internal appeals process when reviewers applied an illegal predicate standard to the device. Even after two Orthopaedic Device Panels determined the device was safe, the agency still fumbled the application and likely denied the company due process.
Other Recommendations
In addition to the creation of the CDRH Science Council, the task force also recommended the following:
Enhance science-based professional development for CDRH staff.
Recommends that CDRH enhance training, professional development, and knowledge-sharing among Center staff, to assure that appropriate scientific expertise and regulatory experience are brought to bear in decision making. Both groups recommend that these efforts include providing greater opportunities for staff to stay abreast of recent scientific developments and current clinical practice.
Establish a network of external experts to better inform the review of cutting-edge technologies.
Recommends that the Center continue ongoing efforts, in keeping with the Center’s FY 2010 Strategic Priorities, to develop a network of external experts using web-based social media technology. Such a network would allow Center staff to more efficiently and effectively leverage outside knowledge in order to answer important scientific questions, but would not serve in an advisory capacity.
Clarify the meaning of key terms in the 510(k) “substantial equivalence” review standard to improve the consistency, transparency, and timeliness of the review process.
Recommends that CDRH more clearly define these terms in guidance and training for review staff and industry.
In addition to these specific recommendations, the task force also noted a situation that has caused great friction between reviewers and applicants:
Interpretation of the “Least Burdensome” Provisions
According to the CDRH Ombudsman, concerns about whether or not premarket evidentiary requirements are consistent with the “least burdensome” provisions have consistently been a leading reason for complaints, disputes, and/or inquiries from industry.
The task force recommends that CDRH revise and clarify its 2002 “least burdensome” guidance.
“CDRH should clearly and consistently communicate that, while the ‘least burdensome provisions’ are, appropriately, meant to eliminate unjustified burdens on industry, such as limiting premarket information requests to those that are necessary to demonstrate reasonable assurance of safety and effectiveness or substantial equivalence, they are not intended to excuse industry from pertinent regulatory obligations nor to lower the agency’s expectations with respect to what is necessary to demonstrate that a device meets the relevant statutory standard.”
Agency reviewers expressed concern to the task force that the “least burdensome” provisions have created a culture in which it is “difficult for premarket reviewers to obtain evidence to consistently provide reasonable assurance of a device’s safety and effectiveness. This is particularly challenging in the context of the 510(k) process, in which reviewers report that 510(k) submitters, relying on the substantial equivalence standard, are often reluctant to provide additional information that was not required for a predicate device.”
Shuren’s Changes
CDRH Director Shuren has been transparent, clear and explicit about the challenges he inherited to protect and promote public health. Clearly, many of the problems experienced by industry in trying to gain clearance for their devices can be traced back to disagreements with reviewers over science, definitions and authority.
Perhaps with Shuren strengthening his bench, this will be the change industry has been waiting for.
