Not long ago, FDA deputy commissioner Joshua Sharfstein criticized the process his Agency used to approve ReGen’s Menaflex knee device, claiming that “extreme” pressure from New Jersey Congressmen had compromised its integrity.
He added that the skullduggery was a factor in prompting his decision to review the FDA’s 510 (k) program, which fast-tracks approval of medical devices by requiring less rigorous clinical testing than the standard process.
“It’s autumn, and change is in the air. This is particularly true for our 510k program,” echoed Donna-Bea Tillman, head of the device evaluation office, in an email to her staff that was obtained by The Wall Street Journal.
The very thought of change to 510k goes over like a lead balloon for device makers like Johnson & Johnson, who warn that tampering with it would end up robbing the public of rapid access to a stream of live-saving, quality improving (not to mention money making) instruments.
J & J spokesperson Carol Goodrich said that 510k streamlines clearance for devices deemed “substantially equivalent” to those on the market, “builds on ever-expanding knowledge,” and accelerates innovation.
Tighter approval standards, she said, “would raise development costs substantially while also creating barriers to market entry that would reduce competition.”
About a third of J & J’s $64 billion in annual world-wide revenues derives from the sale of medical devices and diagnostic equipment.
The FDA’s move was just the latest bad news for the device industry.
Congressional Democrats for example, are pitching a tax on device makers to help pay for health reform. If passed, the proposal could cost the industry $40 billion over 10 years.
To be sure, the Advanced Medical Technology Association, a lobbying group that represents device makers, is working overtime in Washington to set things straight on both counts.