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An MD&DI October 1999 Column

WASHINGTON WRAP-UP

James G. Dickinson

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As FDA's medical device program continues to tighten its belt, prioritization seems to be its chosen mode of survival. Put another way by new CDRH director David W. Feigal, if a new device promises a high impact on public health or provides a "novel" benefit, it will have a higher review priority than other devices.

Unfortunately, most new devices trying to enter the market belong in the "other" category, and for them the current outlook is not optimistic. In a July 27 presentation to the Health Industry Manufacturers Association (HIMA), Feigal drew an analogy between what happens to such devices and the FDA drug center's approach to so-called "me-too" drugs—namely, that the second drug in a class suffers twice the FDA review time of the first one.

Regarding devices, Feigal implied that this will mean that products with neither a high public health impact nor a novel health benefit could expect to take twice as long to review as their forerunners. In the case of 510(k) products, that would translate to an average of 110 FDA staff hours per product for the duplicative device (versus 55 for the original), and 4000 FDA staff hours (versus 2000) if the product were submitted in a premarket approval (PMA) application.

In addition, Feigal also said that CDRH will assign a lower priority to applications that were eligible for but didn't use one of the center's reengineered processes, such as the new 510(k) paradigm, the product development protocol, or the modular PMA review. But even the recent improvements in review times for compliant applications that do take advantage of one of the reengineered processes may not survive continuing flat-line budget appropriations, Feigal predicted. "Reengineering is bringing diminishing returns," he told HIMA. Without adequate funding, he said, the premarket review reforms specified in the FDA Modernization Act of 1997 (FDAMA) won't be fully implemented, and product review times may actually slip.

In other words, FDA's device program has been stripped—by time pressures, increasing demands, and diminishing resources—down to its bare bones.

A four-page Guidance on Labeling for Laboratory Tests issued in June for public comment by CDRH's Division of Clinical Laboratory Devices stirred up such a furor in the industry that its principal architect has declared that he wants to hear all the comments, even if it means being told his ideas are "stupid," if indeed that is the consensus.

The guidance states that an evaluation of laboratory test performance should compare a new test product's results to some appropriate and relevant diagnostic benchmark that can be used to correlate results from the new test with the clinical status or condition of individuals or patients for whom the test is intended to be used. Based on 20 years of review experience, the division recognizes two major categories of end points for assessing performance of new in vitro diagnostic assays: operational truth and laboratory equivalence.

Industry representatives say that their concern after reading the guidance is that it seems to imply that operational truth is the end point of choice and must be pursued if at all possible. Not necessarily so, says division director Steven Gutman: "This guidance was put out as a starting point. But there is a basic intellectual concept that if you have some real yardstick for meaningful results, which I call operational truth, it's reasonable to characterize a test as having a given set of performance parameters. I'm happy to hear from people about how to make that point clearer."

Gutman says the agency is not maintaining there is only one path to truth, but that "You have to say something is truth with a straight face. We shouldn't describe laboratory equivalence as truth, but should say it is a relative comparison."

Asked whether he intended that operational truth would take precedence over laboratory equivalence, Gutman said that companies "should be able to make choices about what they're willing to pay for, what they're willing to market, what they think consumers will want." He said he thought it was "overreading" to hold that a sentence in the guidance means that laboratory equivalence can be used only if there is no possibility of reaching operational truth. "If people are concerned, they need to provide wording and a rationale to clarify that statement."

One industry representative told this reporter that the guidance depicts the evolution of the Division of Clinical Laboratory Devices from technical specialists who are used to finding substantial equivalence through comparing results to physicians practicing administrative medicine who want a clinical answer for everything. He said the issue is how to handle discrepant results and that such results should be shown on the package insert so individual physicians can decide for themselves what they mean. He also sees the guidance as a step toward greater agency control, bucking FDAMA's notion that FDA should get out of industry's way.

Gutman's reply to such comments is straightforward: "If people think the dichotomization [between operational truth and laboratory equivalence] is bogus and stupid, they should tell us so and tell us what we should be doing instead."

District of Columbia federal judge Royce G. Lamberth in July again crushed a key element of FDA's authority to regulate medical product marketing activities, throwing out applicable portions of FDAMA and calling them "unconstitutional."

A Reagan appointee to the federal bench who has been strongly critical of many Clinton administration actions, Lamberth reinforced a ruling he made in July 1998 in the Washington Legal Foundation's action against three FDA guidance documents that limited how companies may disseminate unapproved-use information about their products. Not only did he maintain his opinion regarding the manner in which those documents violated the First Amendment, Lamberth said, but subsequent questions about the relationship of the ruling to FDAMA served to show that the act itself also violated the First Amendment when it supported FDA restrictions on the dissemination of unapproved-use information.

Lamberth described as "preposterous" an FDA plea that the new law should not be subjected to First Amendment scrutiny because it "affirmatively permits" some kinds of unapproved-use information to be disseminated by companies. In his written opinion, the judge noted that "the First Amendment is premised upon the idea that people do not need the government's permission to engage in truthful, nonmisleading speech about lawful activity." He was "similarly unpersuaded," he wrote, by FDA arguments that the dissemination of unapproved-use information was "privileged" by the new law's guarantee that it would not be considered misbranding so long as it complied with the law. "Even if FDA would be justified in bringing misbranding charges on the basis of such speech, that power cannot justify the [new law's] restrictions on commercial speech."

FDA has not said what it will do about Lamberth's order, although most observers believe an appeal is inevitable. This would likely take a while to be heard, especially since the obvious tribunal for an appeal, the U.S. Court of Appeals for the District of Columbia Circuit, has already ruled decisively against FDA in another case that presents almost identical First Amendment issues (Durk Pearson, et al., which concerned claims made about dietary supplements). FDA may feel it should try to bypass that court and appeal directly to the U.S. Supreme Court, which may not be receptive to such an approach.

In the meantime, what will be the status of FDA enforcement of its policies on the dissemination of unapproved-use information by medical device firms and other companies? At least one company, Eli Lilly, has announced that it intends to take advantage of Lamberth's order. Others may be expected to do the same.

The Medical Device Manufacturers Association (MDMA) wants FDA to issue warning letters or take other actions to stop third-party reprocessors of single-use devices from making violative advertising and promotional claims on the Internet.

In a recent letter to FDA, the association says certain reprocessors are making claims that are "tantamount to off-label promotion, as the statements made by these third-party reprocessors do not appear to be supported by the clearances or approvals granted to the original manufacturers of these devices." CDRH promotion and policy office head Byron Tart said his center was not aware of any violative Web sites operated by reprocessors, but that MDMA's complaint would be adequately investigated.

Although reprocessing has not had a high priority at CDRH because it has been rated "low risk," the center has recently said it is reevaluating its premarket review requirements for reprocessed devices. In a letter to the Association of Disposable Device Manufacturers, CDRH Compliance Division of Enforcement III director Larry Spears said the agency is "actively evaluating a myriad of options on how FDA can proceed to address the reuse of single-use devices." Without providing details as to where FDA is heading, Spears said the agency is "aggressively exploring what types of submissions may be appropriate for reprocessed devices."

FDA's position in the past has been that—absent any meaningful adverse event data on the reuse of single-use devices—holding reprocessors to GMP requirements ensures adequate public health protection and therefore premarket submissions need not be filed. However, members of Congress apparently have been putting heat on the agency to address the reprocessing issue, according to a knowledgeable source.

In addition, industry groups have lobbied for tougher FDA enforcement, as did MDMA when it recently petitioned the agency to issue a proposed regulation that would "identify" reprocessed single-use devices as banned devices." If granted, MDMA's petition would serve as the basis for only the second use of FDA's banned device authority since the enactment of the 1976 Amendments. (In 1983, according to MDMA's petition, FDA declared that prosthetic hair fibers, used for concealing baldness, represented a substantial danger to public health, and they were banned.)

FDA officials say that it will be difficult for the petition to succeed without clear evidence that there has been harm to the public—and so far there is none. They verify that FDA, in its new policy evaluation, will target not only private reprocessors but also hospitals, which account for much of the current reprocessing as a cost-saving measure.

Nor will original equipment manufacturers be spared FDA scrutiny. The agency intends to review the scientific rationale used by OEMs when they label devices for single use. Spears said that the agency will have formulated a policy on device reuse by October, if not sooner, and that it will be published in the Federal Register.

The Health Industry Manufacturers Association in July complained that CDRH's draft guidance issued under FDAMA, Resolving Scientific Disputes Concerning the Regulation of Medical Devices, fails to meet the law's intent and should be scrapped and that the independent notice-and-comment rule-making process be used to establish a procedure for the resolution of scientific controversies.

"The dispute resolution procedure should not take more than 60 to 90 days before a decision is made," HIMA said in formal comments to the agency. "Furthermore, employees of the center involved in the scientific controversy should not be involved in the dispute resolution process."

HIMA maintains that the center's dispute resolution procedure is cumbersome, lengthy, and heavily favors CDRH over the party requesting dispute resolution panel review. The industry group favors procedures established by regulation, under which sponsors could request a review of scientific controversies in a timely manner by a panel of independent experts.

HIMA indicated that it opposes the CDRH draft for a number of reasons, including the following:

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