Calling it "one of the hardest" among many "difficult" decisions in his 35-year career, CDRH director Daniel G. Schultz told Center employees 8/11 that he has resigned, effective the end of this month. His announcement said this decision was based on discussions with commissioner Margaret Hamburg "and a mutual agreement that my stepping down at this time would be in the best interest of the Center and the agency." The activist Project on Government Oversight (POGO) called it a "long-awaited opportunity for openness and reform." Although unacknowledged by either Schultz or Hamburg, the “best interest” cited by Schultz is the need for CDRH to get out from under a cloud of controversy that erupted earlier this year over staff dissidents’ allegations of corrupt product reviews. Schultz’s message seemed almost to recognize this when it  said "it is a decision that I am convinced is the right decision for me and for the special people at CDRH, who, over the last 15 years, have been my colleagues, friends, and second family."

In an all-hands memo, Hamburg ignored the cloud and instead lavished praise on Schultz’s "tremendous legacy," saying he had "worked tirelessly to advance the public’s health through the approval and monitoring of innovative and safe medical devices. The staff he has led for five years are among the world’s leaders in the evaluation of the design and the development of the next generation of advanced diagnostics and medical interventions".

"Under Dan’s leadership, CDRH enhanced our understanding of the risks and benefits of using medical devices in pediatric populations, increased the agency’s safety efforts by expanding MedSun, and led the agency in the Postmarket Transformation process, which has provided an opportunity to fundamentally rethink the way risk/benefit information is collected, analyzed, and executed."

Schultz’ announcement comes four months after nine dissident CDRH scientists and physicians sought the intervention of Sen. Charles Grassley (R-IA) to bring what they said were "sweeping measures … needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the agency far too long." Their appeal to Grassley followed the apparent disinterest of the Obama FDA transition team in digging up the past. To Grassley, the dissidents provided documented criticisms focused on CDRH — but other anonymous FDAers alleged that political corruption of scientific product reviews had also permeated the rest of FDA as well. A month earlier, FDA Webview editor Jim Dickinson had called for Schultz’ removal, and for the removal of those people around him who had been willfully complicit in the Center’s dysfunctionality.

No mention of such problems was made in Schultz’s announcement. Instead, it reflected a sunny view of his five years as Center director, and 10 more years before that in lesser positions. His record is "is something that I will cherish and carry with me for the rest of my life," Schultz told his co-workers. “Working side-by-side with dedicated professionals from diverse academic and career backgrounds for a common goal of protecting and promoting the public health of this nation is the greatest privilege that anyone could ask.

"Anyone who has followed the course of medical care over the last two decades as an analyst, care provider, or patient will recognize the impact that device technology has had in improving health care delivery through advanced diagnostics, minimally invasive interventions, smart drug delivery systems, etc. What often goes unrecognized is the impact that CDRH staff have had on the design, manufacturing, refinement, and labeling of those products, which have made them safer, more effective, and more user-friendly.

"When I look back over the last five years, I see many CDRH accomplishments to reflect on and many unfinished tasks still ahead. The implementation of device user fees with its influx of resources and people has led to a more efficient and consistent premarket review process. Scorecards, project management plans, and extensive IT innovations have allowed us to track, measure, and adjust our programs while adding increased accountability. Science prioritization has both strengthened our research enterprise and ensured that science and regulation are firmly integrated in all of our many activities. And the Postmarket Transformation process has provided an opportunity to fundamentally rethink the way that risk/benefit information is collected, analyzed, and acted upon using all available resources within the center and utilizing available data and opportunities for collaboration outside the center as well. The Matrix as both a construct and a concept is identifying and implementing new paths to a more effective CDRH and better risk management for the products we regulate".

"There is always more to be done. Developing methodologies for quantitative decision making across the product lifecycle will not only allow us to make better decisions but will enhance our ability to explain and replicate those decisions. Working within the Center and with other agency colleagues to prioritize and streamline the processes for regulation, policy, and guidance development will provide greater clarity both internally and externally as to the responsibilities that each of us has in maximizing the safety and effectiveness of the products that we regulate. Linking internal performance goals to public health outcomes and budget allocations in a way that can be measured and communicated will enhance the Center’s fiscal strength and our ability to advance public health through access to better and safer medical devices and radiological products."

Hamburg’s all-hands memo said associate commissioner for policy and planning Jeff Shuren, a neurologist and lawyer in his 10^th year at FDA, will serve as acting CDRH director. A national search will be conducted for a permanent director.

A late-night POGO statement said Schultz was "resigning by "mutual agreement" with FDA commissioner Margaret Hamburg. This appears to be a polite way of saying he was forced to resign.  This is welcome news. This important FDA Center has been in desperate need of new leadership.

"Dr. Schultz’s resignation," POGO’s statement continued, "offers a long-awaited opportunity for openness and reform. This was a critical first step, but FDA commissioner Margaret Hamburg still has significant work ahead. Among the needed reforms is dealing quickly and openly to correct the harm caused by retaliation against the extraordinary number of CDRH whistleblowers who have reached out to the Congress, the media and public interest groups including POGO. It is also essential to investigate the allegations made by these insiders, particularly of improper influence over FDA decisions to approve medical devices. Until it is clear that the culture of fear at CDRH is over, it will be impossible to restore integrity to the important work of the CDRH."