BBI Washington Editor

WASHINGTON – In late July, when Acting FDA Commissioner Lester Crawford picked Daniel Schultz, MD, to lead the agency's Center for Devices and Radiological Health (CDRH), he said Schultz had "the ideal combination of skills, experience and temperament to ensure that FDA's medical device program is second to none."

Schultz was deputy director of CDRH and was then named acting director following the departure of David Feigal, MD, who led CDRH for five years. Prior to his departure, Feigal told The BBI Newsletter that he was not sure who his successor would be, but that the selection of Schultz would be "right on target."

Now that Schultz has had a few months to settle in to his position as director in his own right, he sat down with BBI to talk about what he brings to the table at CDRH and how the center impacts the device sector.

Asked what he considered his primary strength to be, he had a concise answer: "I like to get things done."

Schultz added, "What Dr. Feigal, in the time that he was here, really provided us with were some important ideas and strategies in terms of making sure that we started to look beyond tomorrow and into the future and to decide where we want to get to as a center. As I have told people around here, I have no intention of creating a new set of strategic plans because the ones that we have are fine."

He said where he thinks he will "make his mark" is in seeing how many of those goals can be achieved, in addition to establishing a process that will allow the center to meet some of its far-reaching goals sooner rather than later.

Coming from a surgical background, Schultz said he is totally comfortable with the "problem solving" role. "That is the way that I tend to deal with things – looking at a problem and figuring out how to deal with it, solving it and moving on to the next challenge," he said.

Schultz has been with the FDA for a decade, first as a medical officer in the general surgery branch of CDRH, then as chief medical officer in the Division of Reproductive, Abdominal and Radiological Devices. He later served as division director and then as deputy director and director of CDRH's Office of Device Evaluation.

Despite his 10 years of service, it is his experience with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) that he says really may be what led to his current post. "Probably one of the reasons I was selected was because MDUFMA and its implementation was considered to be such a critical issue, not only for the premarket part of the program, but for – though I do not want to over-dramatize it – the survival of the center in terms of its fiscal wellbeing," he said. "I was involved in the negotiations. Making this program a success is something that obviously is a primary goal."

Although he called the user fee program "vital as it is to the viability of the center," Schultz said he and the CDRH staff must not forget that there are a lot of other things the center does that are "extremely important."

"We should not lose sight of the big picture in terms of total product life cycle, and all the strategic goals that Dr. Feigal had put into place," he said. "Making sure that MDUFMA is implemented and that the focus of the strategic plan is carried out are the two main things that I would like to accomplish."

Schultz explained that because the device sector includes such a wide variety of product categories, there are many challenges in addressing all needs.

"I think the challenge for devices – somewhat distinguished from drugs and perhaps even biologics – is that we do not suffer from a lack of a full pipeline," he said. "What we see is a lot of new complex technologies – computerized technology, nanotechnology, genomics, combination products, a whole variety of new technologies – and it is a matter of how we deal with those and how we make sure that the center keeps up to date with the kind of technologies that we're seeing so we can be a facilitator rather than being a roadblock."

Schultz said one of the biggest challenges for CDRH is playing what he called its "dual role." One, he said, "is to ensure that medical devices are safe and effective. The other is to make sure that products get to market in a timely fashion. So that is probably the biggest challenge that we have."

Part of that challenge is dealing with med-tech companies that are pushing for faster regulatory approvals – a number of them inevitably unhappy if their applications are rejected. And certain sectors of the industry finding the new user fee requirements to be burdensome, this charge most frequently lodged by the Medical Device Manufacturers Association (MDMA; Washington).

Asked about proposed increases in user fees and the MDMA's belief that the agency hasn't been sufficiently challenged to improve its performance, Schultz said MDUFMA is producing results. "I simply disagree with the contention that the goals are not challenging and somehow this could just happen without any additional resources," he argued. "These are goals weren't just set by us but in negotiations with industry. They told us that they wanted decision goals, as well as cycle goals, and for which types of submissions. So we looked at it and tried to come up with goals that we thought were fair and reasonable based on the additional resources that we would be getting."

Schultz said that just working toward review may provide even more improvement in the system than just the goals themselves. "This program not only shortens review times, but provides a sense of predictability, given the fact that this is the first time the agency has committed to decision goals," he said. "As I speak to members of industry, especially CEOs, that is really what their main concern is. They seem to care less about what the requirements are, but want to know that the process is predictable and clear. That is what I am hearing."

The program continues to evolve and improve, Schultz said. "The quality of the reviews – both in terms of making sure the applications are complete and provide us with the information that we need, but also in terms of trying to be selective and reasonable in terms of not asking too much – is pretty good," he said.

Though CDRH, as well as other FDA centers, have endeavored in the recent past to make the review process more transparent, more "user-friendly," Schultz said there was still room for improvement in terms of being able to communicate and share information throughout different parts of the center, especially with combination products.

"What we call knowledge management – being able to share information – I think is really the next critical element to achieving the kind of review process that we want to have, especially for complex devices."

On the topic of communication and cooperation, there has been a good deal of focus recently on cooperation between the FDA and the Centers for Medicare & Medicaid Services (CMS; Baltimore) in order to shorten product approval and coverage decision.

"It [communication] is not all that it could be, and I think there are a lot of reasons for that," Schultz explained. "Part of it is that we have different statutes when it comes to confidentiality issues and other things. I think that there is a certain amount of finger-pointing. You can look at the two agencies and say, 'Look, you guys haven't done all that you can to communicate together.' But a certain part of it also rests with the industry in terms of allowing us to share information as much as we might like to."

Schultz said the FDA and CDRH could streamline the process "significantly" if allowed to share information more freely. "Part of that is dependent on us to develop the mechanisms to do that, but part of that also is the willingness on the part of the industry to have us do that," he said. "It is something we will continue to explore. We have gotten feedback that there is concern about freely sharing information between the two agencies absent the concurrence of the particular company." He called it an issue of trust - among the FDA, CMS and industry. "I think sharing information with other centers and agencies is ultimately in everyone's best interest, so I hope that is the direction that we'll go in," he said.

Overall, Schultz said that companies have been open to the idea of a more communicative CDRH and approval process. The approval process no longer is slowed by continuous "stops and starts and deficiencies and rounds of review" that formerly existed, Schultz explained. "Ten years ago, the idea seemed to be to give the FDA the least about of information companies could get away with, hope we didn't ask a lot of questions and see if they could get by," he said.

"We have gone a long way toward changing that mentality, to making it easier and to make companies more welcome and more comfortable coming to us early in their process, sharing information with us so that we can understand what it is they are trying to do," Schultz said. And, he said, "even occasionally help in making sure that the right testing is done and the right studies are assigned."

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