Medical device user fee deal hailed as "game changer"

by Brendon Nafziger, DOTmed News Associate Editor | February 02, 2012
Stephen Ubl, president
of AdvaMed, one
of three lobbies
that negotiated the deal
The Food and Drug Administration said Wednesday it reached a tentative deal with the medical device industry on user fees. The deal would let the FDA collect more than half a billion dollars from companies over the next five years, double what it got in the last user fee renewal, but in return would agree to a faster, more transparent device review process.

"We believe this agreement is a potential game changer for the FDA, for industry and most importantly, for patients and the American economy," Stephen Ubl, president of the Advanced Medical Technology Association, one of the three trade lobbies that helped negotiate the deal, said on a conference call Wednesday. The other two lobbies were the Medical Imaging & Technology Alliance and the Medical Device Manufacturers Association.

The 10-year-old user fee system lets the FDA draw money from device companies to pay for its review of new devices, and has so far been renewed for two five-year blocks. However, the medical device industry has long complained that the agency is slow and inefficient, and that their businesses suffer as new devices languish in bureaucratic limbo while they await the agency's approval.

But after a year of talks, and after the agency missed its self-imposed Jan. 15 deadline to submit a deal to Congress, the FDA and industry representatives have, it seems, at last hammered out a compromise: one that raises money for the FDA, while speeding up review times for industry.

And the effects of the deal could be felt by the imaging sector, too. Lindsay Morris, acting executive director of MITA, which represents manufacturers of CT and MRI scanners, among other equipment, said these changes could help bring radiation therapy and imaging devices to market quicker.

"The increase in resources to the agency under this agreement corresponds to a more timely approval process, which will benefit patients and the manufacturers who develop these innovative technologies," she said in a statement.

No device left behind

The new agreement calls for the FDA to meet a variety of goals by fiscal year 2017, the last year of the proposed program, which is a reauthorization of a plan that first began in 2002 with the passage of the Medical Device User Fee and Modernization Act.

Among the new goals is what AdvaMed calls "leave no submission behind," which requires the FDA to meet with companies if submissions run into trouble. The deal also requires the FDA to hire a third-party consulting organization, as yet unnamed, to audit its review process. Also in the spirit of transparency, the agreement requires the FDA to provide quarterly and annual reports on progress made towards meeting its review time goals.

Ted Huss

Increased Device User Fee, Really?

February 03, 2012 10:09

A lobbyist puts forth a "game changer" in a positive light? How unusual. Clearly an unbiased viewpoint, right.

Wonder how real end users will like the additional Medical Device Tax of 2.3% that will impact them in 2013 as more and more ObamaCare takes effect? How will mfrs. like that, probably on top of increased state sales taxes?

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