FDA-Required Medical Devices Study Failed. Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio.
“It’s not a pretty picture,” Daniel G. Schultz, director of the FDA’s office of device evaluation, said earlier this month at a conference in Waltham, Mass. Too many of these studies are treated as “an afterthought,” he said.
At a time when the FDA is under fire for its oversight of drugs like Vioxx and Celebrex, which prompted health concerns after they were approved, Schultz’s comments show how companies that make products such as pacemakers and hearing aids also can expect more scrutiny.
Open secret in the health care industry
Post-approval studies are routine in theory but rare in practice, an open secret in the health care industry.
In a report to Congress in March, for instance, the FDA said companies had agreed to conduct 1,338 post-approval drug studies.
But 65 percent of them had not begun, and just 33 percent were on schedule or had been completed.
Schultz cited an internal FDA study tracking devices from the start of 1998 to the end of 2000. It found that during that period the FDA approved 127 applications to market new medical devices and in 45 cases required their makers to conduct post-market reviews.
But in 10 of the 45 cases, or 22 percent, no follow-up results were submitted, FDA spokeswoman Sharon Snider said.
Many devices tend to treat just tens or hundreds of patients
Joseph J. Leghorn, a lawyer who often represents the makers of devices, said a reason for a lack of follow-up studies might be that many devices tend to treat just tens or hundreds of patients, fewer than most drugs, and that devices often are used only for a few years before they are replaced by newer therapies. Both factors leave fewer patients for follow-up studies, he said. A lack of funding from devices companies might be another reason, he said.
“I doubt people are ignoring their responsibilities,” Leghorn said.
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