James G. Dickinson

January 1, 1998

8 Min Read
A Troubled Affair

Medical Device & Diagnostic Industry Magazine
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An MD&DI  January 1998 Column


FDA fails to apologize for mishandling Myo-tronics device evaluations.

How new is the new FDA? Not new enough for Roland Jankelson, who, despite impressive victories in his three-year battle with the agency to repair FDA-inflicted damage to his small dental devices firm, continues to demand more.

FDA's wrongdoing—which lead deputy commissioner Michael Friedman called "procedural and judgmental errors" in an October 20, 1997, letter—cost Jankelson's tiny, Tukwila, WA—based Myo-tronics, Inc., several million dollars in canceled sales and legal expenses. These errors began when one of FDA's reviewers, during the height of Kessler-era regulatory excess, accepted the findings of an element in orthodontics academia that denigrated the technology in Myo-tronics' jaw- and face-muscle monitors.

Found the Myo-tronics devices to be no longer substantially equivalent to devices and uses grandfathered by the Medical Device Amendments of 1976.Placed the company's 510(k) application—submitted as a consequence of the above finding—in indefinite limbo.Staged an advisory committee meeting in October 1994 that was loaded with academic opponents of Myo-tronics.Seized Myo-tronics' products and initiated three internal efforts to have civil monetary penalties imposed on the company; each effort was rebuffed by FDA's Office of Chief Counsel but only after long delays.Jankelson wants a full, public admission of wrongdoing—better yet, an apology—and an explicit account of what went wrong, why it went wrong, and what safeguards are being set up to prevent such actions from happening again. He needs the apology and account to convince insurance companies that his devices should be fully and retroactively reimbursable and to answer product liability lawsuits that cited his devices for having been FDA-unapproved.However, after exhausting all other FDA remedies, including an appeal to the agency's ombudsman, Jankelson secured a belated turnabout in FDA's attitude only after taking the problem to Capitol Hill. The subsequent investigation's findings were prepared in a report by the Office of the Inspector General (OIG) in FDA's parent Department of Health and Human Services. The OIG report found that a former CDRH general and restorative devices reviewer concealed documents proving that, with one exception, Myo-tronics' label claims existed before the effective date of the Medical Device Amendments of 1976 and were thus grandfathered and legal. Therefore, FDA's warning letter to Myo-tronics alleging that the devices were misbranded, and the ensuing product seizure, were not legitimate.The OIG investigation also found that a second FDA employee, a former dental products advisory panel executive secretary, was unable to explain how confidential Myo-tronics materials came to be distributed to panel members. As a result of that leak, the panel voted to up-classify the device. Myo-tronics' vigorous complaints caused CDRH Office of Device Evaluation director Susan Alpert to later officially vacate the panel's recommendation, a first in FDA history.Based on Myo-tronics' allegations and the OIG findings, Alpert also secured the voluntary resignation of the advisory panel chair, who had been a former competitor of Myo-tronics and had brought an unsuccessful lawsuit against the company over the very products the panel was reviewing. Alpert also declined to renew the appointment of a nonvoting advisory panel consultant whom Myo-tronics identified as a well-known opponent of its technology. In a deferred sequel to these actions, just last October Alpert revoked the impanelment of two new panel members after Jankelson identified them as possible opponents of his company, as well.On the same day that Friedman wrote to Jankelson denying deliberate employee impropriety and promising new safeguards against other judgmental and procedural errors, Alpert wrote to formally reinstate four of Myo-tronics' product label claims. Alpert reported that "a systematic evaluation of the procedures for managing medical device advisory panels" was under way and that the final classification of Myo-tronics' products would be dealt with by the advisory panel in spring 1998.Jankelson acknowledged both letters without yielding. Although four FDA employees and temporary government employees had been removed from FDA service and four wrongfully denied product claims had been restored, Jankelson still asked Alpert to "let me tell you what the FDA has not done."First, he stated, the agency has not acknowledged what the OIG, FDA Office of Internal Affairs, and House subcommittee on oversight and investigations had made clear: "The abuses (the flawed warning letter, the failure to process 510(k)s [one 510(k) took 842 days], the product seizure, the attempt to impose civil money penalties, the Dental Products Panel process, and many other irregularities), were the result of a deliberate agenda by [the CDRH reviewer] and other FDA employees to advance the agenda of a private outside group with which they had sympathies," he wrote to Alpert."It is outrageous, although consistent with the agency's history of denial on such matters, that it continues to avoid acknowledging that these acts were deliberate, carefully planned and orchestrated, and involved coordination and participation by multiple FDA employees," Jankelson continued.Second, Jankelson argued that FDA had failed to discipline or punish officials in its Seattle district office whose "participation in the disclosed misbehavior was as egregious, if not more so, than those who you have separated from FDA service."Third, Jankelson complained that FDA had not initiated the vacating of its consent decree against Myo-tronics. "If the FDA has any sense of responsibility for the disclosed abuses, it will quickly and of its own volition vacate the consent decree without requiring Myo-tronics to incur additional legal expenses," he wrote.Jankelson was even more severe in his reply to Friedman, accusing him of a significant lack of understanding on your part of the events you address. I assume this is because senior FDA officials continue to mislead and lie about the events, which have been the subject of ongoing investigation for almost two years. This is not a new experience for us. If you will review Dr. Kessler's testimony of November 15, 1996, before the House Subcommittee on Oversight and Investigations, and compare that testimony to the facts now known, you will see that he, too, was badly misinformed by his advisers about the facts in this case.Objecting to Friedman's phrase, "procedural and judgmental errors," Jankelson wrote that the agency "deliberately failed to process the company's 510(k)s" and "rigged" a panel to assure a predetermined outcome. Moreover, he claimed, the exonerated Seattle district office knew it was collaborating with the CDRH reviewer in the denial of legal predicate claims: "How can you assert that Seattle senior officials were acting properly? You are obviously acting under very bad information. This is not an agency trying to reform itself. This is the same FDA, steeped in the same 'old' culture."Myo-tronics is not the first company to have serious problems with the FDA review process. In 1988, after failing to get any satisfaction from FDA, Mylan Pharmaceuticals (Morgantown, WV) took its complaints about an FDA reviewer to Capitol Hill. This was the first time any company dared take its problems outside the FDA system. The resulting congressional investigation revealed that several FDA reviewers had accepted bribes to facilitate some reviews while obstructing others. The reviewer went to jail, and the event quickly became known as the FDA generic drug scandal.The most important difference between that scandal and the Myo-tronics case is that no suggestion of bribery has been made against any FDA employees. What is similar about the Myo-tronics case and perhaps two other current device cases (the Biocontrol noninvasive glucose monitor and the Visx eye laser) is that individual FDA employees and special government employees working for FDA on advisory panels have been accused of subverting the review process by deliberately retarding a disfavored company's product. As in the generic drug scandal, the behavior of certain FDA employees has left a lot to be desired and cost individual firms dearly, and the culpable employees have been repeatedly protected by their superiors. Even with ombudsmen established in various FDA centers and the office of the commissioner—primarily in response to recent criticisms from Capitol Hill—Jankelson is surely not the only industry leader who feels there is no effective relief from the FDA bureaucracy.On the other hand, some in industry argue that there is a new FDA in the making with a far more helpful demeanor to industry. One such proponent is former COBE Industries (Lakewood, CO) senior vice president Wendell Gardner, whose company received four warning letters for manufacturing problems at the same time that Myo-tronics was having its troubles with FDA. With far more corporate resources at his disposal than Jankelson has, Gardner resolved the problems and became a leader of the FDA grassroots regulatory partnership movement that has already done so much to improve agency-industry interactions.There's much more work to be done, however, and Gardner is among the first to acknowledge that this far-flung bureaucracy is reforming itself unevenly. That's only to be expected as Congress heaps more burdens on the agency while simultaneously pegging or actually removing financial resources from it. Meanwhile, the sordid affair of Myo-tronics reminds us all of what's at stake with FDA reform.Copyright ©1998 Medical Device & Diagnostic Industry

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