Originally Published MD&DI September 2009
FROM THE EDITORS
Farewell, Dr. Schultz; Good Luck CDRH
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Daniel Schultz has resigned as head of CDRH. Given the recent—although perhaps unwarranted—criticism of Schultz, CDRH, and even the 510(k) process, it’s no surprise. More importantly, his departure will not repair the deeper troubles at CDRH.
Schultz leaves the agency with a solid record of accomplishments. He tackled some tough problems including the user-fee system and inconsistencies in inspections. “Dr. Schultz has done a great service for CDRH,” says Jonathan Kahan, a partner with Hogan & Hartson. Kahan says Schultz brought organization and common sense to CDRH. “His leaving is based on a number of misconceptions on the part of upper management at FDA,” says Kahan. He suggests that FDA’s management may have been “listening too much to whistle-blowers and other critics, and not enough to people who really know what’s going on within CDRH on a daily basis.”
In a letter to agency staffers, Schultz wrote that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency.”
But Kahan insists that a majority within CDRH supported Schultz and that only a vocal minority believed that Schultz was “too pro-industry and not scientific enough.” Rather, a handful of recent missteps became the focus of his ability to lead the center. Kahan points to controversial CDRH decisions on Cyberonics and Menaflex and notes that both led to a lot of criticism of Schultz, and ultimately may have been part of his downfall.
“He’s been a very honest, very conscientious, hard-working, straightforward public servant, and I will be sorry to see him go,” says Kahan. “I hope that [FDA] has someone who is as conscientious and as smart as [Schultz] to take the helm.” Given the turmoil swirling around Schultz’s resignation, selecting the new head of CDRH may not be so easy. But the new director should be an insider.
Kahan says there are some very good people within the Office of Device Evaluation and Office of In Vitro Diagnostic Devices who could step into the director role. The key, he says, is that the new head of CDRH must have credibility and the respect of people within the center.
“If FDA feels it has to go outside CDRH, it should find someone who understands FDA—maybe someone from another center or someone who’s previously been with FDA.” He says bringing in a total novice who has never worked at FDA would be a mistake.
Jeffrey Shuren, the assistant commissioner for policy at FDA, has been named acting CDRH director. Kahan says that Shuren, who is a neurologist as well as a lawyer and has been at FDA on and off for the last 10 years, might be a good choice for the job but that he may not even want it.
The biggest problem FDA will have in filling the job is finding someone who can relieve some of the worry and tension within the center. “Right now, from the division directors down to the newest reviewer, there’s a lot of concern and angst,” says Kahan. “That leads to a more-difficult path. For industry, it’s harder to communicate with the agency. And people are less willing to go out on a limb or do anything novel.”
With this tension has come “a clear slowdown in clearances and approvals and a clear change in direction.” Kahan also notes that some CDRH policies have changed “without a lot of forethought about the effect of some of these policy changes.” In particular, he says CDRH shifted its policy on what entails substantial equivalence in the 510(k) process. “The 510(k) process has been under incredible criticism, and it’s been called a loophole,” he says. Kahan praised Schultz for correcting this inaccuracy and for defending the 510(k) process.
Schultz’s resignation is not going to fix the problems at CDRH. Finding the right person to step in and step up is imperative. CDRH must stay focused on its mission and find ways to restore the public’s (and industry’s) confidence.
Sherrie Conroy for the Editors
Copyright ©2009 Medical Device & Diagnostic Industry
