Originally Published MDDI September 2004

NEWSTRENDS

Daniel Schultz

Erik Swain

FDA in July named Daniel Schultz to lead CDRH on a permanent basis. Industry applauded the move and encouraged him to address problems with the user-fee system and inconsistencies in inspections. Industry leaders added, however, that Schultz's extensive experience at FDA makes him well equipped to take on those and other challenges. 

Schultz joined CDRH in 1994 as a Public Health Service medical officer. He rose to become chief medical officer and then director of the Division the Reproductive, Abdominal, and Radiological Devices. He later became deputy director, and finally director, of the Office of Device Evaluation. He was named acting CDRH director in April following David Feigal's departure. 

“Dan Schultz brings a true insider's perspective to running CDRH,” said AdvaMed President Pamela G. Bailey. “This expertise will serve the center well as it continues to implement the important provisions of the Medical Device User Fee and Modernization Act. Dan has been instrumental in preparing the center's review staff to meet the user-fee program's strict performance goals.”

“While we may disagree with him from time to time, we've always felt that the lines of communication are open with Dan,” said Mark Leahey, executive director of the Medical Device Manufacturers Association. “In all our dealings with him, he has been professional and capable. He has experience dealing with all the different players, from industry to public interest groups to Congress, and that will allow him to delve into the crucial issues right away.”

Hiring an insider was the right move because the center is more in need of someone who can implement policy and streamline operations than someone who needs to change policy, said device law expert Jonathan Kahan, a partner at Hogan & Hartson (Washington, DC). 

“The biggest challenge facing CDRH is keeping it on track,” Kahan said. “He knows where the skeletons are buried. He's very savvy.”
He said Schultz will have to focus immediately on fixing the user-fee program, which has produced double-digit increases for the second straight year. “This is something that is coming to a head right now. AdvaMed and MDMA are all over it.”

Where Schultz may need assistance in getting up to speed is on the compliance side, where there are “some issues that require his personal involvement and direction,” said Larry Pilot, a partner at McKenna, Long & Aldridge (Washington, DC) and MDMA's general counsel. “He needs to evaluate whether FDA is uniformly implementing and applying the laws and regulations, particularly GMPs. There is inconsistency. One way to address it is to examine the types of warning letters issued by the center and the districts.”

Schultz also needs to understand how to put into proper perspective the views of industry, which he may hear infrequently, and the views of CDRH staff, which he may hear continuously, Pilot said. “I believe he exercises good judgment, which is an essential characteristic of any responsible administrator in government.”

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