Originally Published July 2000
CDRH's goals for its home page enhancements include posting simple, clearly written device labeling on its site.
- A "Collective FDA-483"?
- Criticism Greets Breast Implant Approvals
- FDA Guidances for Special Controls
- FDA Raps Allergan over Lens Claims
Simplified, patient-readable device labeling on FDA's Web site is the goal of CDRH director David Feigal. It is the center's "role in knowledge management," Feigal says. "Patients have made it very clear that they are players."
If this latest initiative comes to pass (Feigal has only just started discussing it with his colleagues in the center), it will likely track something that's much more developed in FDA's Center for Drug Evaluation and Research (CDER): an ambitious project to rewrite every drug label in patient-friendly language and place it on that center's home page within 18 months.
The idea in both arenas is to give FDA a more active role in empowering patients. In turn, FDA hopes that the caregiving community would become more responsive both to patients and to current technological issues. The initiative might also cause payers like HMOs and managed-care programs to be more receptive to new medical technologies, in response to new pressure from informed patients and caregivers.
According to Feigal, FDA has a responsibility to make better use of the vast amount of publicly releasable device information it possesses; the logical venue for doing so is its Web site.
Feigal maintains that several public signs point toward a shift in consumer-based healthcare. Legislation such as the recent dietary supplements law, the formation and growth of disease- and treatment-oriented interest groups, and the proliferation of related Web sites and chat rooms all illustrate that "people want to have their own say in healthcare and that they are questioning mainstream medicine," he says. There is even increasing support for the idea that the patient's medical record is his or her own property, rather than the property of the professional who compiled it, Feigal says.
It is "sad," he adds, that CDRH has "this great repository of information about medical devices, and yet people don't consult us." Feigal believes that an area for new device users or even for patients (he's thinking first about health professionals) on CDRH's Web site could overcome this waste, however.
Unlike CDER, which is posting on its site every drug label ever approved, Feigal says CDRH would probably begin only with new approvals—it doesn't have either the relatively small label inventory or the funding that CDER enjoys. And a Web display of several devices' labels— hospital tubing sets, for example—would not be particularly useful.
Feigal sees this initiative as something that would need industry cooperation. In some cases, he says, he foresees the CDRH site linking to specific company sites (a privilege that could be revoked if a company fell out of grace at FDA). Industry's cooperation with FDA in Y2K preparations provided a model for the kind of cooperation Feigal believes could accompany the labeling initiative.
If the proposed site became popular with device users and patients, Feigal says that numerous benefits—beyond the simple exposure of product information—could result. The site could become a resource for private and other interests that monitor the efficiency of decision making in managed care; it could also help people gain access to experimental products in clinical trials and help in the recruitment of subjects for those trials.
"I think it's really important that we continue to nurture the willingness of people to participate in trials and in studies of new devices," Feigal says. "There are times when that's very popular and very well accepted in some disease areas—like pediatric oncology, where almost all the children with pediatric cancers participate in trials—but there are times when that really gets frayed at the edges and people mistrust experiments."
He sees the Web as FDA's most cost-effective tool for reaching all kinds of different constituencies.
While CDER has many well-organized constituencies it uses to reach users in effective partnerships, CDRH is not as well endowed, Feigal acknowledges. One way CDRH might compensate for this is to build up its e-mail distribution lists of physicians, manufacturers, patient groups, and Internet newsgroups; utilize its potential access to pharmacy profile systems; and then coordinate the use of these on-line resources with print communications.
Feigal cites the experience of the Institute of Medicine, which expanded its Web site's usage from 7 million to 100 million, and then from there to over 350 million searches a year, with hardly any advertising effort. "The issue for us is to figure out, 'What is the same threshold that you cross?'" he says. "For us, it's probably a type of information or a type of service that—if we can provide it—will develop its own momentum."
A "Collective FDA-483"?
CDRH director Feigal's proposals do not stop with posting device labels on the Center's Web site; he also suggests an enforcement innovation that could alleviate the backlog in some device facility inspections—a "collective FDA-483" for Class I–exempt devices.
Under this concept, he says, FDA would conduct GMP inspections at a scientific sampling (say 1%) of manufacturers of Class I–exempt products, aggregate the observations, and write a "collective FDA-483" report for the entire industry.
Feigal says Congressional budget writers are telling FDA, in effect, that it hasn't made a good enough case for more enforcement dollars. As a result, the agency is being forced to cover its regulated product inventory differently.
Says Feigal, "We have to seriously ask ourselves: 'Is there a different way to do this that will cover the industry and identify the problems so we can take corrective actions?'" Instead of attempting to do inspections to cover each of the 4500 Class I–exempt devices that enter the market annually, as mandated by statute, FDA could use the sampling and collective 483 approach. "We could give a report card on the industry and say: 'This is where you're falling down in this area—what are we going to do about it? Which of these things concern us?'" he says. "Maybe we'll find some things that they do very well—it wouldn't hurt us to talk about the good stuff."
Feigal says the same approach could be tried for the approximately 50,000 clinical investigators in the United States—too many for FDA to inspect even once every 10 years. "We clearly should be doing a sampling, especially in the high-risk areas where we expect people to be paying the most attention to the rules," he says. "Then we could work on corrective actions by leveraging through the American Association of Medical Colleges, training programs, and other ways."
Feigal says he expects FDA to begin this method of inspecting Class I–exempt device manufacturers within 18 months, assuming Congress doesn't provide funding relief for device inspections.
In the last five years, Feigal says, FDA's routine GMP inspections at device companies have dwindled from about 2600 to about 700 annually. For foreign firms, which supply 40% of the U.S. medical device market, a routine GMP inspection is likely only once every 10 years; for domestic firms, once every four years.
To illustrate how serious the current backlog is, he cited the recent Clinipad Corp. (Rocky Hill, CT) sterile products GMP failure, which had caused the recall of 4 billion products, including those made by 140 device manufacturers. Feigal says Clinipad had a history of GMP problems, but had been inspected by FDA only on a 4 1/2-year frequency because it was able to deflect critical attention through the submission of corrective action plans. These plans, however, did not resolve the company's problems. Now the firm is out of business and unable to administer any recalls.
This example could give industry leaders reason to support the increase of CDRH's resources for field inspections.
Criticism Greets Breast Implant Approvals
FDA's approval of PMAs from Inamed Corp. (Santa Barbara, CA) and Mentor Corp. (Santa Barbara, CA) in May for those companies' saline-filled breast implants provoked criticism from women's health advocates. "The standard of safety is at a new low at FDA," says Diana Zuckerman, spokesperson for the National Center for Policy Research for Women and Families. "Here you have a benefit that is cosmetic and risks that are serious health problems."
FDA commissioner Jane E. Henney, MD, says: "Although some women benefit from having breast implants available, there is now a much clearer understanding of the risks involved. With the data that have been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks." FDA has prepared a booklet on the risks involved and ordered plastic surgeons to give a copy of the booklet to each potential patient before the day of surgery.
CDRH director David Feigal says data submitted by the companies indicate that "there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications. Women should understand that breast implants do not last a lifetime," he says, "and they should be aware that women who choose not to replace their implants after removal may have cosmetically unacceptable dimpling or puckering."
Cumulative risk rates found in an Inamed three-year breast-implant study included 21% for additional surgeries, 16% for breast pain, 11% for wrinkling, 10% for asymmetry, 9% for capsular contracture, 8% for implant removal, and 5% for leakage or deflation. Some women in the study experienced more than one of these complications. An FDA talk paper says the risk rates were higher for women who received Inamed implants for reconstruction following surgery for breast cancer or other medical problems. Comparable risk rates, again higher for those following surgery for breast cancer or other medical problems, were also reported from a Mentor study.
FDA says that despite the complications experienced by some, the majority of the women still in the companies' studies after three years reported being satisfied with their implants. That does not include women who had their implants removed because of problems and were then dropped from the studies.
The FDA approval applies only to saline-filled breast implants and does not affect silicone gel–filled implants, which cannot be commercially marketed. Inamed says it expects to complete enrollment of nearly 1000 women in a silicone gel trial within two months, and it expects to submit a silicone gel PMA to FDA by the fourth quarter of 2002.
Variance for Unprotected Pin Connectors
In May, FDA approved a citizen petition from Biosense Webster (Diamond Bar, CA). The petition was asking for a 60-day variance from compliance with the performance standard for electrode lead wires and patient cables. The variance was for the firm's electrophysiology (EP) catheters, and allowed the company to continue distributing catheters with unprotected pin connectors from current inventory until July 9. FDA said it approved the request only because of concern about the potential for a shortage of EP catheters in healthcare facilities.
"Note that for a cardiac catheter in direct contact with the blood pool in the heart, FDA considers the risk of electrical shock to be significantly greater than for the active electrode of an electrosurgical device," the FDA letter said. "Therefore, for purposes of compliance with the performance standard, we do not consider any cardiac catheter to be exempted as an electrosurgical device."
FDA Raps Allergan over Lens Claims
FDA's CDRH recently cited Allergan Inc. (Irvine, CA) for using professional promotional materials for its AMO PhacoFlex II intraocular lens that allegedly contained unsubstantiated and misleading claims. According to CDRH, the materials made the lens "adulterated and misbranded." In an April 19 warning letter, Compliance Office director Lillian Gill said that several promotional pieces indicated that the lens could be inserted through unenlarged incisions of 2.6, 2.8, and 3.0 mm, smaller than the PMA-approved incision size of 3.2 mm. "Allergan has not documented the claims of insertion through smaller incisions," Gill said. "There are also several references to benefits of 'true microincision surgery,' which is an unsubstantiated claim."
Gill also said the company never received approval to make benefit claims, such as that the product produced no induced astigmatism, offered long-term wound stability, and reduced complications associated with wound enlargement. She also faulted the company for making comparisons between its lens and others that were not included in the safety and effectiveness data on which the lenses' PMA approval was based.
The lens is adulterated and misbranded, Gill said, because of the claims being made that are not covered by an approved PMA and because of false or misleading representations. Because the lens is restricted to prescription use, all advertisements and other promotional materials are to include a brief statement of the intended uses of the device and its relevant warnings, precautions, side effects, and contraindications. Referring readers to the product labeling is not a substitute for the required information, she said.
Allergan was told to respond in writing with a statement of the specific steps taken to correct the violations.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.
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