Vioxx Aftershocks
Did you think that approved medical devices are honky-dorry when it comes to safety and performance? Well, think again. According to a senior regulator at the Food and Drug Administration, 22% of medical device follow-up studies [are] left undone:
“It’s not a pretty picture,” said Daniel G. Schultz, director of the FDA’s office of device evaluation, earlier this month at a conference in Waltham. 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 can also expect more scrutiny.
Since Schultz has been pressing for more follow-up studies for over a year, his plans to improve the situation through public disclosure or bureaucratic reforms could be a model for the way the FDA treats drug companies in the future.
Exactly how much oversight the FDA has given to approved products is becoming a political issue. Post-approval studies are routine in theory and rare in practice, an open secret in the healthcare industry.
Scarry? You bet.