Article reprinted from "The Gray Sheet" - July 5, 2010
FDA is considering some "out-of-the-box" ways to get needed device technologies in doctors' hands faster while still ensuring patient safety.
Article reprinted from "The Gray Sheet" - July 5, 2010
FDA is considering some "out-of-the-box" ways to get needed device technologies in doctors' hands faster while still ensuring patient safety.
For example, the agency could tap into CMS's coverage-with-evidence-development pathway, which allows Medicare reimbursement for promising technologies while they undergo further clinical study, CDRH Director Jeffrey Shuren said at a June 24 meeting in Gaithersburg, Md.
As such studies produce more data for CMS to determine whether the device is reasonable and necessary (the standard for full, national Medicare coverage), they might also produce data for FDA to determine whether the device is safe and effective (the standard for FDA pre-market approval), Shuren suggested.
Another idea, Shuren said, would be for FDA to give limited approval to "test drive" technologies within selected military or veterans hospitals before full market release.
The process likely would still require informed consent, but not the strict protocols of a clinical trial. Safety and effectiveness data based on day-to-day clinical use of the device would be generated for use toward an eventual full FDA approval, Shuren explained.
During this limited-approval phase, the device would be paid for by the government hospital. "That allows more cash to flow into the company to continue the production of that technology while we are gathering information," Shuren said.
"Smarter" Government
Both ideas rely on interagency collaboration - in the first case, between FDA and CMS, and in the second, between FDA and the Department of Veterans Affairs or the Department of Defense.
"These are the out-of-the-box ways of thinking we can do if we are working together, as opposed to the more siloed approach we traditionally have," Shuren told reporters.
Shuren raised the ideas at the first meeting of the Council on Medical Device Innovation, a new government group including representatives from FDA, CMS, DOD, Veterans Affairs, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality.
The council's mission is to find ways to encourage the development of innovative medical devices that address unmet public health needs.
While it is not always possible to strike the "perfect balance" between fostering innovation and protecting consumers, Shuren said, "we can be smarter about how we do it."
FDA and CMS took a step toward minimizing bottlenecks for new devices with the June 23 signing of a memorandum of understanding that would allow data to be shared routinely between the two agencies, Shuren noted.
The agreement could be a first step toward simultaneous FDA pre-market review and CMS reimbursement coverage determinations for new technologies, Shuren noted.
"One of the potential collaborations that we are seriously exploring is the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at the FDA - what we call parallel review," he said.
The device chief emphasized that the agencies would leverage their authorities without changing their respective missions.
"We're not going to make decisions that pertain to payment; they're [CMS] not going to make decisions that pertain to coming on the market," Shuren underlined.
VCs Discuss New Pathway For Review, Payment
Also at the meeting, the National Venture Capital Association gave more details on its vision for a separate, more efficient review pathway for novel devices.
The VC proposal calls on FDA to establish a formal "novel" device category and then deploy a high-level team of reviewers and consultants to more quickly review the submissions.
But CMS and the other agencies should play a role in the novel pathway, as well, said Jack Lasersohn, a partner with the Vertical Group and NCVA board member.
NIH and DOD should establish rapid funding processes to support pre-market clinical trials for the designated "novel" technologies, he said.
And because trials would be designed to address CMS evidentiary requirements as well, "products approved by FDA under such a program should have presumptive coding and coverage decisions," Lasersohn said.
The interagency council discussed several other areas where government intervention could help companies address unmet public health needs.
Council coordinator Jonathan Sackner-Bernstein, associate director for post-market operations in FDA's device center, says the group will review comments from the meeting and public dockets over the next month.
"We'll start piecing together the targets we want to focus on in the coming months," CDRH's Shuren told "The Gray Sheet."
- Jessica Bylander
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