An MD&DI March 1997 Column
Center for Devices and Radiological Health director Bruce Burlington reveals new strategies for reforming the agency from within.
It's a whole new way of life at FDA these days. As Washington, DC, gropes for a broader middle ground in the aftermath of both the November elections and David Kessler's resignation, FDA is far along the road toward reinventing itself to reach its own new middle ground with industry.
Conceptually, at least, nothing is off the table--even FDA's statute-driven, regulation-bound approach to its core mission, the assurance of product safety and effectiveness. The end won't change, but the means will.
The agency demonstrated its new attitude at the medical device sessions of FDLI's educational conference last December, an annual megaevent traditionally regarded as the tribal gathering of all who do business with FDA.
Center for Devices and Radiological Health (CDRH) director Bruce Burlington, for instance, publicly called for an industry-FDA "consensus" process to develop "focused" FDA reform legislation in tandem with internal administrative reforms. By focused he means changing only a few areas--which he declined to name--with legislation and correcting all other problems administratively.
FDA's main focus will be on achieving greater device approval efficiency without pressing for user fees. Perhaps the agency considers Kessler's farewell speech at the FDLI meeting, boasting of a stellar drug approval performance made possible by user fees, sufficient inducement to device industry leaders to reevaluate their opposition to device user fees (and there are covert signs that some will do just that).
Representing the enforcement side, CDRH Office of Compliance director Lillian Gill also showed unprecedented openness by announcing that her office will seek public input on a compliance strategy to examine 4 out of the 15 most-recalled, most-complained-about types of devices from 1991 to 1995. She identified those 15 as apnea monitors, cardiac monitors, cardiology catheters, defibrillators, electrosurgical devices, hexokinase-glucose strips, implantable pacemakers, infusion pumps, intraocular lenses, intravenous administration sets, linear accelerators, patient examination gloves, radiation therapy devices, surgical lasers, and ventilators.
Many earned their place on the list because of the agency's medical device reporting (MDR) regulation, Gill indicated, vindicating an expensive CDRH program that has drawn more than a few bitter complaints from industry sources, along with charges that it has been unproductive.
The fact that any FDA enforcement office, whether Gill's or any other, would submit its police work to public scrutiny speaks volumes for the new way of life that is evolving at the agency.
Traditionally, FDA's detective work to find wrongdoers was often conducted in tight secrecy out of fear they would be tipped off and would paper over their misdeeds, thereby foiling FDA investigators. FDA seems to have junked that tradition, concluding that misdeeds really can't be papered over. And if advance information of a raid does impel violators to mend their ways, society benefits even if the investigation never takes place.
By choosing only 4 out of 15 device categories for comprehensive compliance review, Gill was candid in acknowledging that that's all her office can afford to tackle at one time. That, in itself, was an unprecedented confession.
After speaking at the FDLI meeting, CDRH director Burlington elaborated further on his new approach to the review of medical devices. On the topic of product safety, he explained that CDRH is reassessing how it categorizes risk. Devices in Class III, Burlington said, pose two types of risk--the risk inherent in the product itself, and the risk presented by a lack of knowledge about the product. "There are products about which we know precious little because they embody new concepts but for which the inherent risk is not necessarily very high. You can reason some things deductively, and you don't have to base everything on experience. If the inherent risk in a Class III product is small, then we shouldn't be putting the same effort into it that we should put into one that has high inherent risk."
CDRH is reassessing all device categories, not just Class III, Burlington explained. The initiative is not a typical, bureaucratic, top-down exercise, either. As Burlington put it, "the people who know where the real problems exist are the people who do the work. They know where work is organized inefficiently, they know where work is misdirected." CDRH is trying to tap such internal expertise and use it creatively to maximize efficiency. It is also talking with industry as it proceeds.
There's no time frame for producing results from this process, Burlington said. "I think it's a new way of life....Learning the lessons that many in industry and large sections of the government have already gone through, you don't change processes once and say, 'OK, we did that, let's get on with our lives.' You have to be engaged in continuous process improvement. Not all processes come up in the first round. You stagger when you start reassessing them, because you can't commit all your resources to process improvement. You review where you have made progress and where you haven't. You pick up new topics where they become timely and as resources become available to do it. If it's done right, you can get your mission accomplished with fewer resources and greater satisfaction among the people you're dealing with."
By empowering lower-level managers to make decisions, thereby improving efficiency, FDA is constrained by an element that rarely hinders industry when it engages in process improvement--the need to maintain consistency in decision making while delegating those decisions, Burlington said.
"The one thing that, to my mind, is most different between working inside the government and working in the private sector is that, being a mission-oriented rather than a profit-oriented organization and working in a regulatory context, we have to set a higher level of consistency of decision making than most people in industry would. If your local long-distance carrier treats different customers differently, they can switch--they don't have to go back. On the other hand, we have to treat similarly situated applicants the same, or else we have to have a distinguishable reason why we're treating them differently. So we have to build in mechanisms to achieve consistency."
One vivid example of CDRH's success in this area is the real-time review of premarket approval (PMA) supplements, Burlington noted. While only about 15 supplements have so far undergone this resource-intensive process, the results have been "strikingly successful," encouraging the center to expand the concept "significantly." He believes that a "high fraction" of CDRH's 400-some PMA supplements can be handled this way, thereby yielding review decisions in about a week, or even the same day.
Candidates for real-time review so far have been supplements of "limited complexity" that don't involve clinical data (such as product improvements and labeling changes). The supplements are presented and reviewed interactively in person or by video- or teleconference.
"We're rolling it out to the rest of the program so all PMAs can take advantage of it," Burlington said. An internal PMA review team is now looking at whether original PMA applications might also be reviewed this way. On the surface, at least, it seems that the agency could afford this procedure only for a limited number of applications, simply because it is resource intensive. But Burlington isn't so sure. "It's not obvious," he said carefully, "that our existing approach is more efficient than real-time reviews." PMA supplements traditionally average about 180 days, each involving about one-and-a-half rounds of questions, plus minor questions. "That has involved a lot of passing the application around, a lot of queue time. In aggregate, the number of hours we spend doing that seems higher than when we ask four people to sit in a room for an afternoon."
How far this concept may be stretched beyond PMAs remains to be seen. For 510(k)s, the sheer volume of applications would seem to preclude real-time reviews, but the appeal of greater efficiency through decreased handling surely exists. Burlington said the center is reassessing the presubmission requirements it presently demands of industry, as well as the time it spends determining whether those requirements have been met in each submission.
FDA could also trim review time by using published data on a sponsor's own device or on a similar product to satisfy clinical data requirements for 510(k)s. There is a caveat, however, Burlington warned. The sponsor must be able to establish a bridge between comparable data and his own device.
"When we look at literature in the public domain, we look for two things that are not necessarily easy to accomplish. One of them is whether there is a redundancy of data. If you have five or six reports, all headed in the same direction, that would be far more compelling than if you had only one. If there isn't a redundancy, the other thing we consider is whether you have the full reports. Are we able to look behind the published article, get the original data listings, and give it an independent, full scrutiny?"
The changes have been discussed with a "number of folks in industry" that Burlington declined to identify, other than Fred Halverson, Medtronic's vice president, corporate regulatory affairs, whom Burlington called "very helpful."
It's up to industry to request grassroots meetings if it wants to provide input on the process, but Burlington is anxious to move quickly without unnecessary delays. "We need to get started now. The management literature on process improvement clearly indicates that it doesn't happen overnight. It takes time to develop a clear vision of what the new process will look like. You have to analyze it, develop standard operating procedures, and then teach people the ways to do the new process. You have to institutionalize it. That takes time."
In every area that CDRH is examining as it reinvents itself, it is assessing the need for new legislation, and its recommendations will be forwarded to the commissioner's office for consideration in the Clinton administration's own FDA reform legislation. But the changes being made now won't wait for that effort. Burlington emphasized that CDRH is proceeding on the assumption that the present law will remain.
On another note, the third-party review pilot program, while disappointing in terms of the number of companies that have submitted products for approval through third parties, has gone "very smoothly," with third-party reviews tak-ing half the time FDA takes, Burlington explained.
He doesn't buy the argument that companies would rather wait for FDA to review a device more slowly for free than pay a third party to review it twice as fast--although he does not claim to understand the commercial implications of such time savings. He believes industry's hesitancy may be more attributable to caution in the face of something new than to the program's failure to include higher-risk devices.
The list of candidate devices for third-party review is, however, being expanded, and more guidances are being written to facilitate submissions to third-party reviewers.