FDA’s Device Program Really is in Crisis

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In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what it called the “financial and strategic threats” confronting CDRH’s regulatory science and engineering programs.

 

Composed of seven academic and industry outsiders, the subcommittee could say things no FDA employee would be allowed by political considerations to say.

 

 

Foremost among these was the warning that politically imposed loss of federal investment in CDRH regulatory science “will interfere with the regulatory approval of emerging technologies and in doing so cost lives.” It noted that the device industry is “setting record pace in advancing life-saving technology” and that FDA’s primary pressing need is to fund a “robust and successful CDRH science program.”

 

I’ll admit to being among those who have been highly skeptical of commissioner Margaret Hamburg’s constant harping about the importance of regulatory science. That skepticism was largely fueled by her inability to clearly define the term when I asked, soon after she came aboard, about its application to field enforcement.

 

Perhaps the concept was still less than half-baked at the time.

 

Anyway, this latest report has made me a believer. The subcommittee says it made two site visits, interviewed and visited with CDRH leadership, directors of all Office of Science and Engineering Laboratories and Office of Surveillance and Biometrics division, leaders of individual laboratories, toured facilities and considered “a large amount of data and information.”

 

All this showed, among other things (including much scientific excellence among existing staff), that there are focus deficits in that “the existing spectrum of projects is not sustainable in the current environment. We advocate for continued vigilance about the need for a focus of CDRH on research that directly impacts regulatory science and serious consideration of reorganization in structure and leadership in the research arm of CDRH and in particular OSEL to achieve this goal.”

 

Carefully and mildly, the report chided (although not by name) CDRH director Jeffrey Shuren and his associate director for science, Michelle McMurry-Heath, for not ensuring that the Center’s core mission and strategies for research had “fully penetrated across the whole of CDRH’s research team. The subcommittee was confronted with some members of the research team providing different explanations of the mission statement that spanned the extremes from concentration on science in support of regulation to science in search of expanding disciplinary excellence. In addition, there was insufficient clarity regarding to what extent research should be directed to support reviews.”

 

In my experience of FDA, there could hardly be a more astute description of what chronically ails this agency, and especially its device program.

 

As the subcommittee report readily acknowledged in prefacing this criticism, both Shuren and McMurry-Heath “carefully and eloquently described the core mission and strategies for research at CDRH” ─ yet their vision did not properly penetrate the bureaucracy below them.

 

This is a chronic problem, now become critical. “CDRH,” the report says, “must immediately focus its endeavors in such a way as to absorb the inevitable changes in how they invest in regulatory science.” Without recognizing that there is no such thing as “immediately” at FDA, it goes on to rub salt in its instructional wound: “Prior reviews have suggested similar or identical needs, but those prior reviews were produced in response to different challenges and opportunities.”

 

In the bureaucracy, there is no peripheral vision to let prior remedies instruct different challenges and opportunities.
Emphasizing its view that CDRH’s diminishing resources must be channeled into regulatory science and engineering science that no other organization is equipped for or capable of performing, the subcommittee insists that this “cannot be over-valued and exists irrespective of budgetary limitations.”

 

The subcommittee says it found that “The threats to regulatory science at CDRH are extreme and the only effective strategy moving forward is to protect the already underfunded program to the maximum extent possible and to sharply focus the research mission and strategy through an effective organizational structure and portfolio mapping.”

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