Stephen Ubl, president
of AdvaMed, one
of three lobbies
that negotiated the deal
of AdvaMed, one
of three lobbies
that negotiated the deal
Medical device user fee deal hailed as "game changer"
February 02, 2012
by Brendon Nafziger, DOTmed News Associate Editor
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.
Perhaps most important to the industry is the way those review time goals will now be handled. Previously, the FDA's goals were centered on "FDA days" -- meaning the number of days the FDA spent reviewing the product, typically set at around 90 days for a device cleared in the 510(k) pathway, which includes much new imaging equipment. However, the 90 days only applies to the time the FDA spends reviewing the data; if the agency asks for more information, which often happens, it pauses that countdown, even as the actual calendar days fly by.
Now, the new plan also calls for the agency to commit to a reduction in average total review time -- that is, the time from the filing of the application to the final decision from the agency.
"We think that will have the net effect of reducing total review time, the most important measurement you can make," Ubl said.
On the call, Janet Trunzo, AdvaMed's executive vice president, technology and regulatory affairs, who helped lead the negotiations with the FDA, said the process would ramp up from fiscal 2013, when the new rules take effect, to fiscal 2017, the end of the proposed program. By 2017, for instance, the final average total for a 510(k) would be 124 calendar days, she said.
More staff
On the FDA's end, the agreement gives the agency $595 million over the next five years, a boost over the $287 million it was earmarked through the program in the last reauthorization, although less than the $800 million or so the agency was originally asking, according to minutes of meetings hosted on the agency's website.
One use of the money will be increasing staff: in an announcement, MITA said the agency would hire 200 new full-time-equivalent workers, including 140 device reviewers, with the aim of also lowering the ratio of managers to reviewers at the agency.
However, although the deal was approved in principle by the trade groups and by the agency, details, such as fee structure, have to be worked out. The deadline for finalizing the agreement is Sept. 30, when the five-year program's last reauthorization expires and needs to be renewed.
"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.
Perhaps most important to the industry is the way those review time goals will now be handled. Previously, the FDA's goals were centered on "FDA days" -- meaning the number of days the FDA spent reviewing the product, typically set at around 90 days for a device cleared in the 510(k) pathway, which includes much new imaging equipment. However, the 90 days only applies to the time the FDA spends reviewing the data; if the agency asks for more information, which often happens, it pauses that countdown, even as the actual calendar days fly by.
Now, the new plan also calls for the agency to commit to a reduction in average total review time -- that is, the time from the filing of the application to the final decision from the agency.
"We think that will have the net effect of reducing total review time, the most important measurement you can make," Ubl said.
On the call, Janet Trunzo, AdvaMed's executive vice president, technology and regulatory affairs, who helped lead the negotiations with the FDA, said the process would ramp up from fiscal 2013, when the new rules take effect, to fiscal 2017, the end of the proposed program. By 2017, for instance, the final average total for a 510(k) would be 124 calendar days, she said.
More staff
On the FDA's end, the agreement gives the agency $595 million over the next five years, a boost over the $287 million it was earmarked through the program in the last reauthorization, although less than the $800 million or so the agency was originally asking, according to minutes of meetings hosted on the agency's website.
One use of the money will be increasing staff: in an announcement, MITA said the agency would hire 200 new full-time-equivalent workers, including 140 device reviewers, with the aim of also lowering the ratio of managers to reviewers at the agency.
However, although the deal was approved in principle by the trade groups and by the agency, details, such as fee structure, have to be worked out. The deadline for finalizing the agreement is Sept. 30, when the five-year program's last reauthorization expires and needs to be renewed.