Full article reprinted from "The Gray Sheet"- February 16, 2009
FDA stakeholders debated Feb. 9 whether it is appropriate for the agency to compare the effectiveness of new devices to the status quo as part of its pre-market reviews. Read more...
CDRH Task Force Stirs Debate About FDA's Comparative-Effectiveness Role
Full article reprinted from "The Gray Sheet"- February 16, 2009
FDA stakeholders debated Feb. 9 whether it is appropriate for the agency to compare the effectiveness of new devices to the status quo as part of its pre-market reviews.
The discussion arose at a meeting called by a CDRH task force to reassess the way the device center incorporates "new science" into regulatory decisions.
The task force, first convened last fall by device center Director Jeffrey Shuren, is identifying strategies for incorporating scientific advances and evolving knowledge into FDA's regulatory paradigm (The Gray Sheet' Dec. 21, 2009).
"There is an unavoidable tension between predictability and adaptability," Shuren said at the Feb. 9 workshop, where CDRH staffers posed questions to a panel of experts from industry, academia and public health organizations.
"Our goal is to become 'predictably adaptive,'" he said, "to set clearer guidelines about what situations might justify a change in our decision-making, and to determine how we can communicate such changes."
FDA's Comparative-Effectiveness Mission?
One of the case studies presented to the panel questioned how FDA ought to address technological improvements over time, particularly for products cleared for marketing via a 510(k) substantial equivalence determination.
"How should CDRH treat 'first-generation' products as new and improved versions are developed?" the FDA task force asked.
Panel member Vivian Coates, a VP at ECRI Institute, suggested that older devices may be less effective but still useful.
"Hospitals can't be expected to replace them just to have the newer, better devices," she said. "We don't take older cars off the market because better ones come out. We also don't take less safe cars off the market if there's no inherently hazardous situation regarding them."
If there are serious safety concerns about older devices, FDA could issue a public notice or a safety alert, short of removing the product from the market, she added.
But panelist Steven Nissen, a cardiologist with the Cleveland Clinic, argued that FDA's standards for clearance and approval should change over time.
"When you have a device that has substantially improved on the predicate device, I think it has to be considered the new gold standard," he said.
The agency must take the lead in communicating new information about improvements in the marketplace, he said.
"Whether we like it or not, the FDA is in the comparative-effectiveness business," he said.
Patient advocate Diana Zuckerman, president of the National Research Center for Women & Families, agreed.
But, "unfortunately, the FDA doesn't really have a way to deal with comparative effectiveness," she said. Zuckerman recommended that FDA make better use of the comparative-effectiveness research coming out of organizations like the Agency for Healthcare Research and Quality, which is receiving more and more funding for this type of research.
Steven Curley, a surgeon at the University of Texas M.D. Anderson Cancer Center, also said it is reasonable for FDA to ask for this type of comparative data, where appropriate.
"If you've got a new valve, you've got to say, well, why is this better?" he said. "Is it less invasive? Great. How does it work long term? What is the effectiveness? What are the potential side effects that are unique to this?
"All of that is comparative-effectiveness research," he said.
But panelist Hanson Gifford, partner at device company incubator The Foundry, cautioned that the case study was asking FDA to go beyond its regulatory mandate and to choose "the best device."
Timothy Wright, principal scientist at the Hospital for Special Surgery in New York, concurred.
"I find this discussion very troubling," he said. "I'm not sure it's in the purview of the FDA to tell someone that a product is better or worse than another."
"I don't think the role of the agency is comparative effectiveness; I think it's public health," Wright emphasized.
- Jessica BylanderSign up for a complimentary 30-day trial of "The Gray Sheet" and get immediate, complimentary online access to our best-selling Special Report: "When is an iPhone a Medical Device?" There is no obligation and no credit card needed. Click here to sign up and get your Special Report now
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