An MD&DI October 1997 Column
WASHINGTON WRAP-UPFor the medical device industry, FDA's new labeling initiative is just another case of treating devices like drugs. For FDA, it's just a modest attempt to help device users.
FDA Reform Bill Stalls
HIMAFDA Workshop Successes
Medical devices are not like drugs; FDA agrees with industry on that. But on the question of whether devices should be treated a little bit more like drugs, FDA and industry begin to part company.
The gulf widened in July during a Health Industry Manufacturers Association (HIMA) device submissions workshop with FDA in Washington, after Susan Alpert, director of the Office of Device Evaluation at CDRH, and Dan Spyker, deputy director of cardiovascular, respiratory, and neurological devices, described the center's new initiative to establish an abbreviated "essential prescribing information" (EPI) section in device labeling.
Until they did that, everything at the three-day meeting (HIMA's seventh such annual event) had been moving along just fine. It went well enough, in fact, to be ranked among the best U.S. regulatory meetings yet, regardless of product or industry category, because of its excellent regulator-manufacturer interactivity.
But you can snuggle up to FDA just so far before you find there are barbs of different kinds under the soft fuzz. In this case, the barb was FDA's well-meaning intention to solve the universal problem of health-care practitioners simply being oblivious to medical product labeling.
Alpert pointed out that FDA has conducted focus groups that demonstrate this to be the case, and in the spirited discussion that followed, nobody from industry disagreed. Alpert assured the HIMA workshop audience that "we don't have all the answers." She wants to work out a solution cooperatively with industry and practitioners, putting forth the draft EPI document as the basis for discussion. For most devices, she suggested, this modest concept would result in a summary of the most important information consisting of less than one page, although perhaps a bit more space would be required for extremely sophisticated devices like MRIs.
Although the document "Medical Device LabelingSuggested Format and Content: Draft Document" was first exposed in April on the Internet, it seems few in industry noticed it there. Thus, the HIMA workshop was most manufacturers' first direct encounter with the draft, which was stuffed into every attendee's registration kit.
Lou Mazzarese, vice president for quality and regulatory affairs at U.S. Surgical Corp. (Norwalk, CT), greeted the Alpert-Spyker show with a blast that would be just the first of many. "We're in Washington," he observed acidly, "and to borrow from Reagan, 'Here they go again!'"
Mazzarese agreed with Alpert that health-care professionals do not read the existing labeling for medical devices. "But beyond that," he said, "we start to sustain some significant differences of opinion. This is disguised under the old practice-of-medicine [issue]. The FDA is continuing to focus on putting the onus of getting physicians to do [their jobs] on the backs of device manufacturers under the guise of these wonderful terms, essential prescribing information, abstracts, important information.
"I would submit," he continued, "that words like essential and important exist in the eyes of the beholder. I can't begin to design a label for my product that's going to be essential or important to every physician or every user of my product." In a dash of dark humor, Mazzarese suggested that "future sessions of Congress will accuse FDA of singular responsibility for eliminating what's left of the rain forest! We need to step back and focus on the need. I would submit that the need espoused by FDA is seriously flawed, so much so as to preclude any further discussion of when we do the EPI, or where or how. Let's get back to the need. Ever since the Temple Report [critiquing CDRH's device review processes], things like this at CDRH are part of trying to make devices more like drugs."
HIMA's Marlene Tandy thought the center's efforts would be better spent in medical schools encouraging or training doctors to do a better job of reading existing labeling, rather than creating another piece of labeling. Eve Ross of W.L. Gore & Associates (Newark, DE) took a less direct tack, professing confusion over the mixed messages FDA was sending about cooperation with industry. She agreed that device labeling simply isn't read and noted that physicians had stayed away in droves from FDA's focus groups about labeling, "which shows how important they think this topic is." Nurses, who account for 80% of those who do read medical product labeling, mainly for drugs, also told FDA they don't read device labeling, Ross said, and that if they were to read the labels, they would want them to be shorter.
"I am very concerned about Dr. Spyker's labeling guidance," Ross said. "Except for dental floss, I can't imagine putting the labeling into less than 12 pages. We do clinical studies for this labeling to produce information that, frankly, will never be read. I wonder how all this fits together."
And so it went. Nobody had a kind word to say about the CDRH device labeling initiative. Again and again, the theme came out of the audience: Devices are not like drugs.
The outnumbered Alpert and Spyker earnestly strove to turn the tide. Need had already been shown, Alpert protested, in FDA focus groups. The evidence showed, she said, that device users "simply don't know what's on the label. And we are not trying to make this education job the responsibility of manufacturers. What we're trying to do is make this information accessible."
Most important, she asked, when will the device industry admit that "labeling isn't a drugs issue, labeling is a products issue"? CDRH is "not trying to make drugs out of medical devices," she asserted. "What we are trying to do here is provide some consistent access to certain kinds of information that are useful to practitioners, like adverse events, contraindications, important things about precautions in handling patients. It's not to make them drugswe know they're not. There are lots of devices where the practitioner knows you don't need much on the label except the name of what it is, and we're not trying to change that. We're trying to say where and when you need this information, how you organize it. Nothing more than that."
A skeptical questioner continued to see this as a burden being unreasonably put on the backs of device companies. "Why not put it on your Web site," he asked Alpert, "and publish it, and give people one place to go for the contraindications?"
Alpert replied that FDA might just do that. "Maybe not on our Web site, but someplace. I think that's a great idea. Maybe there's a way to globalize this information. I totally agree." Another questioner, however, rose to call this whole Web idea ridiculous. To avoid product liability lawsuits, no manufacturer would dare separate the product from its labeling in this way, he scoffed.
Exasperated by the rising wall of industry resistance to what FDA was trying to say, Spyker at one point countered Mazzarese's Reagan quip by invoking George Bush: "Read my lips: No new policies! One size does not fit all." After the lengthy presentations he and Alpert had made, Spyker seemed bewildered that their points had not come across. The draft guideline was not a new burden, he said, and there was no new labeling being proposed. "It's not our intention to make this an onerous task. It's not our intention to change what you're currently doing." Instead, the two maintained, FDA's intention is simply to have companies create a brief summary of their existing product labelingan addition rather than a change.
Devices, of course, are not like drugs. But there is something very familiar about this device industry reaction to an FDA plan to make product labeling more useful to users. Industry can find nothing good to say about itwhich is precisely what put the kibosh on FDA's 1979 plan to require patient package inserts in every dispensed pharmacy package of prescription drugs. The industry saw that as an unreasonable burden, and incoming president Ronald Reagan agreed immediately.
Maybe, then, devices are just a little bit like drugs?
The much-hoped-for FDA reform legislation was swept from the Senate's scheduled floor debate by the Democrats, led by Edward Kennedy (DMA). The Democrats feared, among other things, that language aimed at keeping FDA out of off-label uses of medical devices would automatically prevent the agency from effectively regulating tobacco as a drug-delivery device.
Until this 11th-hour upset, senate passage of a bipartisan consensus bill before Congress adjourned for the summer had seemed assured. That would have left the House with little to do after the recess but join the parade. The president's signature seemed certain.
At the time of this writing, everyone was waiting to see what would happen, fearful that the loss of momentum would give outnumbered opponents all they needed to derail the bill by making a partisan squabble after the recess. The pharmaceutical industry, which had hitched its wagon to a broadly based bill that included device reforms, was rumored to be unhitching it in order to push through uncontentious renewal of prescription drug user fees, until now part of the overall bill, as a separate bill, unencumbered by medical device or other issues.
In its total spread of business, HIMA's July device submission meeting did far more in its three days than air dissension over FDA's labeling ideas. A great deal of constructive discussion, for example, occurred in six break-out sessions focusing on the reengineering efforts of the main reviewing divisions in the Office of Device Evaluation, with each of the division directors present. HIMA special counsel Nancy Singer, who is mainly responsible for the success of this annual event, asked participants to recognize that it's a hard thing for FDA managers to sit in these break-out sessions and hear all the suggestions "It's like listening to your customers!"
U.S. Surgical Corp.'s Lou Mazzarese reported on the final day on his group's lively discussions with Lillian Yin about her division of reproductive, abdominal, ENT, and radiological devices. Mazzarese said Yin has set review-time targets for 510(k)s and premarket approval (PMA) applications and exceeded many of them. Confidentiality is a big concern with Yin's new product development protocol (PDP) initiative, since manufacturers must go to panel early, in open public hearings. FDA is looking into that problem. Reviewers' questions to companies appear to be reasonable and pertinent to an application, but they aren't always consistent with public health. "There is still a tendency," Mazzarese said, "to address individual reviewer issues and preferences. Sometimes those particular types of questions may not necessarily [relate] directly to public health." Among the group's suggestions were improving reviewer-to-reviewer consistency, empowering reviewers to make scientific judgments, ensuring early dialog between sponsors and reviewers regarding review expectations, and urging manufacturers to make their initial submissions more complete.
Andrew Balo of St. Jude Medical (St. Paul, MN) reported on his group, which dealt with cardiovascular, respiratory, and neurological devices. Division director Tom Callahan told the group of a tenfold increase in investigational device exemption supplements in the last two years. He also reported that with more prePMA submission meetings to improve submission quality, CDRH could triple its output. Already this year 11 PMA applications have been approved compared with 6 for all of 1996, and Callahan expects the center will approve another 6 by year's end.
Requirements and expectations for submissions have not been clearly explained to companies by FDA, and reviewers' questions differ from person to person and division to division, Balo reported. The group was nearly unanimous that much of the information companies are required to provide doesn't bear directly on public health. Callahan feels that if companies were more cooperative with FDA reviewers and less antagonistic, that would eliminate many problems, because a lot of the questions arise from distrust.
Balo said his group also feels that the 510(k) process for these types of devices has slowed down since last year. According to the group, the reviewers need a better understanding of product technology, to make their questions to companies more pertinent. "A lot of the questions companies are getting back from FDA seem to be rote questions used before. FDA is just not looking into the specific device and the specific technology."
Representatives of the other four sessions reported similar assessments of the review process in their respective divisions. Virtually all agreed that the review process within FDA has become more reasonable, but that too many questions to companies bear little on public health.
Office of Device Evaluation director Susan Alpert said later that device reviewers' questions to sponsors are not supposed to be limited to matters bearing on the public health. She conceded, however, that reviewers should explain the reasons for their questions"We don't do a good job of that," she said.