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An MD&DI May 1999 Column
WASHINGTON WRAP-UP
File Closes on Document Leak: Final investigation leaves key questions unresolved.
James G. Dickinson
Also:
- New Rule on Reclassification
- Fertility Device Makers Given FDA Deadline
- FDA Buys Unapproved Device
- HIMA Seeks Binding Arbitration
- CDRH Warns against Glass Capillary Tubes
The thought of FDA giving highly sensitive documents about your product to your competitor before you go to market is about the worst nightmare a medical device maker could have. It's also a serious criminal matter.
The only time it is known to have happened—the infamous 1995 Visx Inc. document leak to rival Summit Technology—resulted in multiple investigations, none of which reached any definitive conclusions.
In February, four years and three months after the crime, the last of those investigations was revealed to have been quietly closed two months earlier, by way of an unpublicized December 16 letter to FDA commissioner Jane Henney from (then) House Commerce Committee oversight and investigations chairman Joe Barton.
The bottom line was buried in the dryly factual, inconclusive 4Þ-page report—that former CDRH reviewer of ophthalmic lasers Emma J. Knight was probably responsible for the leak, and that the reviewer who was fired as soon as the scandal broke (and thus became a public suspect), Mark Stern, was not responsible for it.
Knight, the report said, received on her fax machine by special request at least one of the Visx documents in a package of 128 pages that was delivered to (then) Summit president David Muller four days after Knight received them and two days after she had a 14-minute telephone conversation with Muller from her home.
The report stated that Knight had earlier been transferred from CDRH to FDA's Center for Biologics Evaluation and Research (CBER) and that Stern had taken over the Visx review at the time of the leak. Although Knight was still finishing up CDRH review work on a part-time basis at her new location, she would not normally have been sent the Visx document she asked for—an "approvable" PMA letter for a laser.
It has never been explained why Knight wanted the Visx approvable letter, but the report describes numerous efforts she made to get it, including use of a different fax machine to receive it after first attempts to send to her usual machine apparently failed. The CDRH official sending it, Jan C. Callaway, was apparently wary about doing so, the report said, because she handwrote the notation "Not Releasable" on each of its pages. This precaution was taken specifically because of Knight, who had on a prior occasion been verbally reprimanded for improperly releasing a Summit approvable letter to an official of the American Academy of Ophthalmology.
Barton's report details numerous contacts and attempted contacts Knight had with Muller or his vice president for government affairs, Kimberly Doney, immediately before and after the document leak. When he received the package of documents, Muller lost the envelope, which would have borne the postmark of the mailing point. Barton's report said that Muller tore off the tops of the Visx approvable letter bearing Callaway's fax ID. Four days after receiving the documents, he sent them to Summit's outside counsel, Jonathan Kahan of the Hogan & Hartson law firm in Washington, DC, for return to FDA.
The day after FDA received the returned documents, agency investigators questioned Knight, who then called Summit Technology, Barton's report said. Six days later, on December 6, 1995, Muller sent a nine-page "confidential" letter to FDA ombudsman Amanda Norton (then Pedersen) containing "a detailed analysis of the FDA documents that were sent to me which concern the Visx PMA and a variety of other issues regarding refractive surgery. I did not ask for these documents but now that I have read them I simply cannot ignore them. . ." The point of Muller's letter was to urge FDA to overturn Visx's approval based on his view of deficiencies as revealed in the documents he had seen. His attempted intervention was not to be successful, however.
Although not stated in the report, it is apparent that had Muller not returned the documents he received and just kept quiet, the leak might never have been discovered. However, he could not have remained silent about the documents while at the same time protesting the Visx approval to Norton, so his only way of pursuing his complaint was to acknowledge what had happened. That meant taking the risk of exposing Knight, who in fact was promptly investigated.
The Barton report states that "No evidence was found to show that Dr. Emma J. Knight received compensation or gifts from Summit Technology." Why might she have done it? The report offers no hints, and Knight herself has left FDA and can't be found. In any event, throughout the investigation, she consistently refused to answer questions except under the advice of counsel. Knight repeatedly rebuffed this writer's requests to interview her, relayed through her lawyer.
One possibility is that Knight, who had a reported social relationship with Doney and an empathy for the firm, felt the Visx approval was somehow unjust to Summit and sought to "level the playing field" on her own initiative, even though she had been reassigned outside the Center. Was she thus acting out of conscience, or even altruism?
In January 1998, the FBI declined to continue its investigation of the matter, contending that the value of the stolen documents (just a few dollars' worth of paper) did not reach the bureau's $5000 threshold for such investigations. Law enforcement obviously has difficulty assessing the monetary value of commercial information.
The staff investigation of the Barton committee, which took over from the FBI, was stifled by Knight's unwillingness to cooperate (under legal advice) and by the emergence of other important matters. Concurrently, internal measures taken by CDRH to more closely supervise reviewers' access to documents on which they are not working—and their relationships with product sponsors—promised to alleviate the risk of something like this happening again.
New Rule on Reclassification
FDA is proposing a device reclassification that relies on data from PMAs approved at least six years ago. The use of such data is permitted in FDAMA section 216, which replaces a never-used provision from the 1990 Safe Medical Devices Act called the "four-of-a-kind" rule.
The four-of-a-kind rule allowed FDA to rely on data after four of the same kind of PMAs submitted after 1990 were approved. However, the rule was never really implemented, because agreement could not be reached on what "of the same kind" meant, according to CDRH scientific reviewer John Baxley. The current case represents the first time FDA will rely on this type of data, whose use is being proposed in the reclassification of extracorporeal shock-wave lithotripter devices from Class III to Class II (see the February 8, 1999, Federal Register).
Baxley sees this six-year-old-data provision as benefiting new PMAs for which a history of related approvals exists. For example, a new PMA candidate could do some sort of bench testing and feasibility testing (either animal or clinical testing), and then apprise FDA of the long history of use of the type of device.
FDA could then evaluate the bench testing and see whether the new device conforms to currently approved devices. If so, says Baxley, FDA could apply the knowledge on success rates, risks, and complications from the other PMAs to this new device. "This would speed review and approvals," he says.
Fertility Device Makers Given FDA Deadline
Makers of already-marketed but unapproved devices for in vitro fertilization and other "assisted reproduction procedures" were in February given 60 days to submit 510(k)s for each device, to register their facilities and products, and to establish that they are in compliance with the QSR and all other regulations. Continued marketing is permitted until CDRH makes a "substantially equivalent" determination, but devices that do not qualify must be removed from the market pending approval of a PMA, according to the Center.
FDA Buys Unapproved Device
FDA says it is purchasing a Diasensor 1000 noninvasive blood glucose monitor from Biocontrol Technology Inc. (Pittsburgh) in order to "understand its behavior and the behavior of other types of remote sensing technology," according to FDA public affairs specialist Sharon Snider. Biocontrol failed at least twice to gain FDA clearance of its device in 1996.
The company says FDA will not use the monitor in the type of clinical investigation that would support market authorization, but rather to gain knowledge of the functioning of such devices over their full range of performance.
Scientific and engineering personnel from the company are to hold a seminar to educate agency staff on the use and maintenance of the device. A home-use instrument that eliminates the need for finger pricks, the Diasensor 1000 is not approved for sale in the Unites States but is being sold in the 15-nation European Union.
HIMA Seeks Binding Arbitration
The Health Industry Manufacturers Association plans to work to see that FDA adopts a dispute resolution procedure that gives industry the opportunity to present its case in a scientific dispute to a third party who can "make a decision and come close to requiring the agency to adhere to that decision." HIMA executive vice president for technology and regulatory affairs James S. Benson says that something like binding arbitration is the kind of approach the organization would like to see.
"Such disputes only come up in a very small percentage of cases," Benson says, "but when they do hit, they can really hurt companies. There needs to be a clear-cut mechanism to address these disputes."
FDA has delegated responsibility for handling disputes to its centers, Benson says, and it is HIMA's understanding that a draft guidance will be issued shortly. "If that guidance meets our needs, that will be fine. But if it doesn't, we will be submitting comments and will consider whether we should approach some people in Congress to ask if they believe what the agency did was adequate."
Another HIMA initiative for 1999 is to establish a database on consensus standards that companies can meet and then file compliance reports to FDA in lieu of submitting test data. "There's a multitude of consensus standards out there," Benson said. "The idea of the database is to be able to improve communications by letting people know what standards are available and who they can talk to in various companies and organizations about standards they've used." Benson said the database could be maintained by a third party or kept on HIMA's Web site.
A series of meetings with CBER officials has also been undertaken with the goal of improving communications between industry and that center's regulators. "We've had very good meetings with some of the people who are regulating devices for CBER," Benson reports. "We've mapped out steps for improved communications. They are willing to set up vehicles to get a better handle on the review process. Since there are no user fees supporting device review, it often ends up on the bottom of the heap. We know CBER is trying to turn this situation around and get some management controls in place."
Benson notes that HIMA has "done the same kind of things on some issues with CDRH and it has worked very well. Good things happen when you are able to sit down around the table and work through issues."
CDRH Warns against Glass Capillary Tubes
In a joint advisory dated February 22 with CDC and OSHA, CDRH warned health practitioners of the risk of injury or infection due to accidental breakage of glass capillary (blood collection) tubes. The advisory—which follows the death from AIDS of a physician who contracted the disease from a broken tube—urges use of safer products, such as tubes not made of glass or those wrapped in puncture-resistant film.
