An MD&DI September 1999 Column
- Quality Plans Speed Audits
- At High Risk for Y2K Problems
If first impressions carry any weight, the new director of the Center for Devices and Radiological Health (CDRH), David W. Feigal, will be easier to get along with than his predecessorand, indeed, more accommodating than many other senior FDA managers dealt with by industry. The energetic Minnesotan came across in a one-hour interview with this reporter as a "people person" with a disarming enthusiasm for his work.
His approachability has been similarly noted by officials of both the Health Industry Manufacturers Association (HIMA) and the Medical Device Manufacturers Association (MDMA), who also met with him during his first month in office. HIMA, in fact, had six contacts with Feigalall of them agreeable, according to the organization's executive vice president, James Benson.
Not that there was anything disagreeable about Feigal's predecessor, Bruce Burlington, who now works for Wyeth-Ayerst as director of drug regulatory affairs. Although perceived by some to be prickly, Burlington nevertheless worked well with industry and earned its respect for his remarkable reengineering accomplishments in the centersomething that Feigal vows to continue.
Those accomplishments may be all the more significant given the fact that Burlington had to achieve a top-to-bottom culture change at CDRH and do it against a backdrop of suspicion over his being a physician from FDA's drug center who might impose the dreaded "drug model" on devices.
With this frosty ice having been broken for him, Feigalanother physician, this time from FDA's Center for Biologics Evaluation and Research (CBER)takes over a less difficult operation. Unlike Burlington in his first days, Feigal has been able to look outside the center and deal with external constituencies like the device industry. And in so doing, he already has an inkling of FDA's fallibility. Instead of approaching stakeholders from the standpoint of a presumptively fault-less regulator, Feigal does so from the standpoint of a former CBER ombudsmana role he enjoyed.
Taking an ombudsman's point of view, Feigal stated that he expects to find in favor of some companies when they complain about unfair treatment. "If someone thinks that they have not been treated well," he said, "they may find that I'll agree with them from time to time. There may be good reasons why it happened, but I guess my philosophy usually is, 'Let's move forward.'"
Most commonly, Feigal has found that problems between FDA and industry seem to be rooted in communication difficulties. Such problems were especially prevalent when a novel product had been presented and FDA took too long getting back to the sponsor. When the agency finally responded, the sponsor often felt that the ground rules had changed from those of the original agreement it thought it had with FDA. Another common scenario involved changes in desired outcomes when agreed-upon studies didn't meet expectations, Feigal said. He indicated that such situations present a challenge to both sides that usually can be resolved through openness and better communication.
Feigal referred to several cases involving CBER in which sponsors had been concerned about their interactions with reviewers. "Sometimes it was that they thought the person had a fixed scientific position and they weren't going to change it and couldn't argue for something else. Typically, the way to solve that is to make sure that you are talking to multiple layers within the structureso if you are stuck at the division level then you can get the office director involved in the discussions."
Feigal acknowledged that it can take courage on a sponsor's part to reach beyond the reviewer, "but you often can ask for that involvement." In such cases, Feigal recommends that device companies not present an "I want you to overrule this guy" argument, but rather that they take more of an "I know that you have been interested scientifically in this area" approach. Sponsors can present the issues as ones they acknowledge to be tough policy decisions, in essence saying to the supervisor or higher official, "We may have to agree to disagree on some of these areas, but we would like your input." Then, Feigel explained, "When the reviewer comes in, you can still be respectful of the amount of time and consideration that the division staff has given, and the opinion of the division director, but you can often rediscuss issues. Sometimes that works and sometimes the office director agrees."
A different twist on the communication issue has been presented by HIMA in its protests to the agency about lack of collaboration in the development of guidance documents and policies in the wake of the FDA Modernization Act .
Feigal's position may not be much different from that of his predecessor in this area, although HIMA can expect him to be more sympathetic. The problem is at least partly one of industry's own making, he pointed out. If the Indiana Medical Device Manufacturers Council had not petitioned FDA several years ago to develop its guidance documents in accordance with the Administrative Procedures Act's requirement for formal notice and public comment phases, more informality might have survived in the guidance development process.
In fact, Burlington was more sympathetic to HIMA on this issue than has been publicly revealed. This correspondent has been told that Burlington wanted to accommodate HIMA's requests for informal collaboration, but had to comply with a legalistically proper ruling on the issue from former associate commissioner for policy William Schultz (a lawyer). Schultz has responded to the Indiana petition by electing to bring guidance development more in line with regulation development and the rules of the Administrative Procedures Act.
On the subject of medical device user fees, Feigal explained in our interview that his bottom line is that CDRH needs more resourceswherever they come from. "Whether the income comes from user fees or comes from appropriated dollars doesn't make any difference to me," he said.
Feigal's experience at CBER has led him to see one clear benefit to user fees. In the drugs and biologics area, user fees have protected the program base (product reviews) from the across-the-board belt-tightening that a succession of so-called flat-line budgets from Capitol Hill have necessitated. When inflation and mandated salary increases are taken into account, flat-line budgets actually translate into program cuts at all agencies.
With or without user fees, however, Feigal sees it as unlikely that CDRH will make much progress toward achieving biennial plant inspections, which had been one of Burlington's recently announced goals. Annual numbers have shrunk from more than 2000 56-hour module inspections to a current figure of less than 1000. CDRH's focus on the new quality systems inspection technique and the soon-to-follow Hazard Analysis of Critical Control Points program will put more responsibility on company management and thus conserve FDA resources.Combining these approaches with for-cause inspections and inspections for conformance to standards will allow CDRH to still have a "very robust inspectional program," Feigal said. "In part because we reengineered and in part because the world is changing, we can do it in a different way than we did it before."
Another option is third-party inspections, such as those which will be done for foreign companies under the European mutual recognition agreement, but Feigal said this will require industry acceptance. "It is going to rest on what the economics arewhat it's going to costand on how well we are performing. If we are performing fairly well and have no cost associated, I would probably ignore the third party."
Feigal came to FDA in 1992 by way of the University of California, San Diegowhere he was a faculty member in the department of medicineto head the division of antiviral drug products in the agency's Center for Drug Evaluation and Research. In 1997, he became medical deputy director of the biologics center, where in addition to serving as ombudsman he focused on blood and tissue products, including medical devices. Feigal's only other connection with devices was his involvement at the University of Cali-fornia, San Francisco, as a principal investigator in the studies that led to FDA approval of aerosolized pentamidine, a drug-device combination and an early therapy for AIDS-related pneumonia.
Device quality system inspections are accomplished much faster when device firms submit their quality plans to investigators before FDA arrives at manufacturing facilities, CDRH Office of Compliance director Lillian Gill told a Food and Drug Law Institute meeting in Washington at the end of June. Results from FDA's pilot inspection program last year, which tested its recently adopted quality system inspection technique (QSIT) showed that 66% of the firms inspected had submitted quality plans in advance and that 96% of both the investigators and manufacturers polled said that this helped to speed up the inspections.
According to Gill, the new QSIT inspections seemed to have targeted management controls; 40% of the violations cited on the pilot program's FDA 483s were in this area. Corrective and preventive actions accounted for 30% of the violations, while production process controls and documents and records made up 20% and 10% of the findings, respectively. Gill warned companies that management controls will continue to be a primary focus during inspections, and that "we think companies ought to pay attention to that area."
Saying that it wants to help focus activity related to the possible impact of Y2K date problems on medical devices, CDRH in June released a list of types of computer-controlled, potentially high-risk medical devices. The center said that it will focus oversight activities on manufacturers of these devices, which would have the most serious consequences for patients if they failed because of date-related problems.
CDRH cautioned, however, that inclusion of a type of device on the list does not mean that all devices of that type are Y2K noncompliant or that they will necessarily pose a significant risk to patients if they are noncompliant. Rather, the center explained, the list "includes those types of devices that could pose a risk to patients if the date-related failure affects the function or operation of the device."
Potentially high-risk devices were defined as those that are:
- Used in direct treatment of a patient in such a manner that device failure could compromise the treatment or injure the patient.
- Used in monitoring vital patient parameters and whose data are immediately necessary for effective treatment.
- Necessary to support or sustain life during treatment or patient care.
The center said it will identify manufacturers of devices on the list and that the companies will be "candidates for further oversight to provide increased assurance that product Y2K status has been carefully assessed and that any Y2K upgrade has been developed and tested in accordance with the quality system regulations." Agency oversight efforts could include facility inspection or audit. FDA also will determine whether the companies have made Y2K status information available to device users and whether users have received notification of any necessary remedial action.
CDRH staff noted that the list should not be considered definitive for all high-risk devices and that it may change as comments on the various devices listed are received.
The list of at-risk devices may be viewed in full on CDRH's home page.