By: Robert Capps
Almost immediately after complaining to a congressional subcommittee that it was unfairly treated by the FDA during its first 510(k) submission, Biocontrol Technology, Inc. announced that it submitted a new revised 510(k) pre-market notification for its Diasensor 1000 non-invasive glucose sensor.
The announcement came in early October, not even two weeks after Biocontrol CEO Fred Cooper testified to a congressional oversight and investigations subcommittee that the FDA had inappropriately handled Biocontrol’s original submission.
Biocontrol originally filed a 510(k)-a pre-market notification which must be filed with the FDA for any new medical device-on the Diasensor in January of 1994. The request was rebuffed by the FDA over two years later when an FDA advisory panel expressed serious doubts about the machine’s ability to accurately read blood glucose levels.
The FDA panel cited concerns that the Diasensor, a device to measure blood glucose by shining near-infrared light through a person’s forearm, only worked within a 50 percent margin of error on 8 of 23 patients studied. The panel also suggested fluctuations in the meter’s readings could be dangerous for people with diabetes.
Biocontrol was asked at that point to submit a revised version of their 510(k) after doing further studies.
Biocontrol cried foul, claiming, among other things, that members of the panel had conflicting financial interests and were inexperienced with the techniques used to judge the device’s accuracy. The company also explained that the $8,000 device is designed to be sold by prescription only. It should also be closely monitored and calibrated for the first 30 days, according to Biocontrol, tested against finger sticks three times a week, returned to a calibration site every 30 days, and is only expected to work on a quarter to a third of diabetic patients.
As Biocontrol was recoiling from its rejected 510(k) the Pittsburgh Post-Gazette reported illegal stock maneuvering by the company and its subsidiary Diasense. The Pittsburgh Post-Gazette stories (one of which was later reprinted in DIABETES HEALTH) also revealed executive salaries of upwards of three-quarters of a million dollars in a company $66 million in debt with almost no revenue.
As a result of the Pittsburgh Post-Gazette stories, several investors have filed lawsuits against the company.
Biocontrol issued statements refuting the Pittsburgh Post-Gazette story, and turned to the U.S. government for help.
On September 28, 1996, Biocontrol made its case to a congressional oversight and investigations subcommittee at a hearing designed to investigate the FDA’s handling of medical devices.
Fred Cooper told the subcommittee that at least one panel member, Dr. Julio Santiago, had a conflict of interest because of his strong ties to Johnson & Johnson, who’s subsidiary, LifeScan, manufactures finger-stick blood glucose meters and is working on a non-invasive meter of its own. Santiago reported these conflicts of interest to the FDA before the original panel review, but the FDA did not feel they warranted dismissing Santiago from the panel.
Cooper also suggested that panel members were not given enough time to review Biocontrol’s data, and were inexperienced with the statistical methods Biocontrol used to determine accuracy.
According to a DIABETES HEALTH source who attended the September hearing, Biocontrol did not get a reprieve from the congressional subcommittee, but rather was told that it still needs to prove to the FDA that the Diasensor works.
“That’s the bottom line (proving the Diasensor works),” Rep. Ron Klink (D-Penn.) said, reported a September 28 Pittsburgh Post-Gazette article. “They can’t sit back and keep bashing the FDA… They’re going to have to deal with the FDA.”
At press time the FDA had not replied to the revised 510(k) submission.