Diagnostics & Imaging Week Washington Editor

Daniel Schultz, MD, director of the Center for Devices and Radiological Health (CDRH) at FDA, has the task of guiding the FDA center that oversees the most technologically dynamic industry base of any at the agency.

While he has not had to face the kind of blistering Congressional and media criticism that Commissioner Andrew von Eschenbach has, Schultz has nonetheless ridden herd on CDRH during some of the most tumultuous times in CDRH history, including the controversy over drug-eluting stents and the continuing distaste the agency's critics have toward the use of the 510(k) mechanism.

Former Commissioner Les Crawford appointed Schultz to the job in July 2004, prior to which he served as the center's deputy director. Schultz also directed the Office of Device Evaluation, and started his FDA career as a medical officer at the General Surgery Branch of CDRH in 1994.

Schultz is a New York City native and earned an undergraduate degree in political science as well as a medical degree at University of Pittsburgh in 1974. He is board-certified in general surgery and family practice and is a fellow of the American College of Surgeons.

Diagnostics & Imaging Week caught up with Schultz earlier this week for a one-on-one, and while he struck a conciliatory tone toward industry, he nonetheless asserted that the current view of the safety/efficacy calculus at CDRH is not going to relax anytime soon.

D&IW: There is a widespread perception that CDRH is much more demanding of industry on the safety question than it was 20 years ago. Public and congressional scrutiny of FDA has grown in recent years and some say that has a lot to do with the increasingly stringent demands the agency imposes on industry.

Would you agree with that, or do you think that device makers have actually improved the overall safety of their devices and hence fed the demand for greater safety as well?

Schultz: "I would see [technological advances] as a prime driver. Devices are much more complicated and intimately involved in patient outcomes than they used to be." He pointed out that in times gone by, medical devices "were tools, but are now influencing outcomes to a much greater extent. People don't expect devices to fail because they've become so much better and so much safer," he said, adding that the kinds of failure rates seen in bygone times are "no longer considered to be acceptable." He added that thanks in part to the Internet, "it's much easier to get the information than it used to be."

This last fact tends to complicate life at FDA, Schultz said, noting that CDRH staffers "spend a fair amount of time looking at clips from various news outlets and trying to match the clip to what we actually said and put up on our web site." He described this work as time-consuming, adding that "there's always a little bit of a tilt one way or the other, and we expect that."

All the same, when CDRH staffers see "messages that lead to the public taking actions that we think are contradictory to public health, that's when we feel we need to respond."

D&IW: What is your biggest bone of contention with the device industry's perspective on the safety/efficacy calculus?

Schultz: "I think part of it is that from industry's perspective, they see all the progress they've made" in terms of reducing adverse events. "They take this defensive approach to criticism" because of the view that "the public just doesn't understand" how much improvement there has been over the past couple of decades.

He said industry has a hard time grappling with the need for more transparency and is not sufficiently aware that the public is often inclined toward "the perception that something was hidden" when the problem is a lack of effort to reach out to the public. Not taking the time to communicate more clearly "just doesn't work anymore," even in instances in which the information is too detailed for the layperson. Relying on physicians to convey the information is all good and well, he said, but "one thing that doesn't help is when you have doctors saying that they're not getting the full story" from the device maker.

Schultz recommended that industry simply accept that secrets are hard to keep and that even innocent-seeming secrets often boomerang. "There are some people who seem to think that just by saying the system is unfair and continuing with business as usual that it's all going to become fair and things will go back to the way they were." He said "that's not going to happen."

D&IW: How effective do you think CDRH is in communicating its perspectives to industry on how safety should be balanced against efficacy?

"In general, we make it pretty clear," he said, while pointing out that most at the CDRH see safety and efficacy as "almost as a single word." Upon considering the question further, he added, "Our mantra is they are essentially one word. Are we 100% successful [in communicating this perspective]? Probably not, but I think we do a pretty good job at it."

He hinted that CDRH's pleas for industry to be proactive about communication often fall on deaf ears. "We talk over and over again about companies coming in to meet us," he said, adding that the center is "trying to be much more efficient in our guidance program."

D&IW: Adverse events connected with medical devices can overshadow the lower efficacy of the previous approach to treatment and lead to the erroneous conclusion that a new device is worse than the existing standard of care. Is CDRH in a position to tell physicians and the public at large that a recall might work against public health, despite the conspicuousness of device failure?

Schultz: "Not only is it difficult to calculate risk-versus-benefit" in many such situations, it can also be nearly impossible to calculate the relative risk side, he said, because the true number of people treated with the device and with the previous treatment regime are not always available.

"We try to be cognizant of the public health fall-out," so a product might be left out there "because of shortages and lack of alternative," he said, raising the example of infusion pumps. "We've done recalls, but we haven't just gone out and removed all these infusion pumps."

CDRH has "tried to reach an appropriate middle ground," and assured that the agency's personnel "recognize that having an infusion pump with some failure rate is better than a thumbscrew with an incredibly overworked nursing population."

He also said the same sort of calculus is employed with regard to ICD leads and other things, but the simple fact of uncertainty means the agency is not going to bat 1.000. "We have to use our best judgment in the face of that uncertainty."

D&IW: Some recent FDA advisory committee hearings have led to some pretty lopsided votes some unanimous in favor of an approvable recommendation, which may feed speculation that the advisory committee is used to shield CDRH reviewers from criticism. Is there a reason industry should not see a problem?

Schultz: There is more than just one reason for assembling an advisory committee, he said. "I think there are times when we take [a hearing] on the basis of new scientific questions," but there are also "times when we think there's enough of a change and impact on medical practice that having a public hearing" is legitimate.

He insisted that such hearings are anything but a drag on the regulatory system in the U.S. "In fact, one of the great strengths of our system is that we do have these discussions. What's the benefit? It's very hard to quantify, but having that kind of transparency is very important" to both public confidence and to the lines of communication between industry and physicians.

"I'm sure we could all agree that there have been instances" in which a hearing was not absolutely necessary, Schultz said, but a hearing that results in a unanimous vote for approval "is not necessarily a bad thing," he said. In most such situations, "there's usually some nuance, some new issue that brings people to the conclusion that this ought to go to an advisory committee."

D&IW: FDA seems inclined to issue guidances that are specific to device types. The assumption is that this is the consequence of the increasing technological sophistication of devices. Does CDRH assume it will be forced to develop more guidances that are specific to device types in the future?

Schultz: "I've said it before, our goal is to try to make things as clear to industry as possible because we recognize that in general, the [medical] progress that's been made has been positive." He added that CDRH works hard to anticipate technological developments in order to avoid creating gotcha' situations."

Device-specific guidances, he said, are "in industry's benefit ... and benefits the public." However, he asserted that such guidances "take time, and that's the thing that people need to recognize. There's a lot that goes into development and clearance, but at the end of the day, it is time and effort well spent."