From a $20 billion industry tax to pay for healthcare reform to the Food and Drug Administration’s plans to toughen the 510(k) approval program, the medical device industry hasn’t had much to cheer about of late.
However, things were starting to look up this year. After a slow start, the industry began to mobilize its forces in Washington DC. In February, the agency announced an “Innovation Pathways” program, designed to better speed breakthrough medical technologies to market. And thanks to pressure from Sen. Al Franken (D-Minnesota), the Institutes of Medicine (IOM) recently asked the industry to vet a series of recommendations it crafted for the FDA to overhaul the 510(k). The report is due out this summer.
Time for the industry to break out the champagne, right?
Hardly, say experts allied with the industry.
First, the nice-sounding “Innovation Pathways” program. Under the proposal, the FDA would establish a Center Science Council, made up of senior managers and experienced scientists, that would complete review of device submissions within 150 days—nearly half the time it takes during the FDA’s normal pre-market approval process. The FDA said the first candidate in the program would be a brain-controlled, upper extremity prosthetic developed by the Defense Advanced Research Projects Agency (DARPA).
But Jeffrey Shapiro, an attorney with Hyman, Phelps & McNamara law firm in Washington DC, is not impressed. The program would affect only one or two devices a year, he says.
“Color us skeptical,” Shapiro writes in his FDA Law blog. “The DARPA brain controlled prosthetic obviously has amazing potential, and FDA likely would have rushed it through in any event. We’ll know if this new program has any value if additional products actually start speeding down the Innovation Pathway.”
“It will be quite some time before another product is so lucky as to be allowed to speed down the Innovation Pathway,” he continued. “We would prefer that [the FDA] work on significantly reducing the review times for all products, for both innovative and same-old, same-old technology. That would be an innovation [the agency] could be proud of.”
As for the IOM’s decision to solicit feedback from medical device companies, well, that’s just window dressing, says Mark DuVal, a Minneapolis-based lawyer with strong connections to the industry.
It would have been more meaningful if the IOM allowed the industry to help craft the report, DuVal argues. Instead, the IOM committee, which spent a better part of the year developing its recommendations, excluded any representation from medical device companies.
DuVal is bracing his clients for major changes to the 510(k). The IOM will likely recommend the FDA require medical device makers to submit a separate 510(k) application for every new use of a device, DuVal says. Under the current system, the 510(k) provided broad “umbrella” approval for multiple applications of the same device, even if the company didn’t list the specific uses in its original application.
DuVal isn’t all gloom and doom though. Faced with Congressional scrutiny, the FDA is not likely to gut the entire 510(k) program anytime soon, he says.
I guess that counts as progress.