It takes 20 percent longer to obtain a final decision on a 510(k) submission than it did in 2002, despite the millions the Food & Drug Administration has collected from medical device makers in so-called "user fees," according to AdvaMed’s Janet Trunzo.
Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs, was one of several industry association speakers who expressed disappointment in the medical device user fee program at a Sept. 14 workshop held to gain stakeholder input on the program.
"Our companies are concerned that the link between performance and fees has broken down," said Medical Imaging and Technology Alliance executive director David Fisher.
"FDA’s medical device program has benefited from significant funding increases in recent years," Trunzo added, noting a 37 percent percent budget increase and a 14 percent rise in staffing levels to FDA’s device program since 2007. "The 2007 re-authorization for the user fee program doubled the industry’s contribution to the agency’s funding."
- Part II: Industry pushes for better guidance
The FDA first gained authority to collect user fees under the 2002 Medical Device User Fee and Modernization Act. Since medical device user fees were reauthorized in 2007 under the Medical Device User Fee Amendments, the federal watchdog agency has met some of its performance goals — for 510(k)s, 180-day and real-time pre-market approval supplements — but has failed to meet others for original and expedited PMAs and their panel track supplements, according to a recent fiscal 2009 performance report to Congress.
But the agency stands behind the user fee program, which must be reauthorized before its September 2012 expiration date. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, underscored that "while user fees provide a stable source of funding, [industry money] accounts for less than 20 percent of funding for CDRH activities covered by the user fee program and only roughly 1/12 of the user fee funding provided for the agency’s human drug program."
Industry has been particularly focused on the 510(k) program because FDA is now considering more than 70 changes to the process in response to concerns from healthcare professionals, patient and third-party payer groups. They argue that the program allows devices to enter the market without sufficient evidence of safety and effectiveness. AdvaMed recently released a related analysis to demonstrate that the program works just fine as is, citing the fact that less than 1 percent of 510(k)-cleared devices were involved in Class I recalls since 1998.
Through increased funding from both user fees and higher Congressional appropriations, the FDA now reviews more than 90 percent of 510(k)s within 90 days, compared to 75 percent prior to 2003, Shuren said. "This means nearly 500 more 510(k)s receive a timely review each year than at the pre-user fee performance level."
But the agency’s performance report for 2009 (PDF), which shows that the agency’s 510(k) performance goals were met for fiscal 2008 and 2009 and are on track for 2010, fails to tell "the whole story related to the 510(k) review system," Trunzo said.
Per submission, the average number of review cycles — the times when FDA stops the review clock and asks for additional information — has increased by 36 percent since 2002, she noted.
Companies are also now taking almost three times as long to respond to FDA’s questions when the agency stops the clock to ask for additional information — from an average of 19 days in 2002 to 51 days now, according to Trunzo.
"As a result, the average total time from receipt of the 510(k) at FDA to the decision made by FDA has risen 20 percent since 2002," she said.
Industry: The interactive review process needs work
The FDA has yet to make good on its commitment during the 2007 re-authorization to formalize the interactive review process, according to MITA’s Fisher and Medical Device Manufacturers Assn. president and CEO Mark Leahy.
"We feel like today isn’t that much different than it was four, five, six years ago, and as a result, feel like the agreements that we reached back in 2007 haven’t, ultimately, been met," Fisher said.
Leahy pointed to "more and more examples of where that interactive collaboration and cooperation is falling short, where phone calls aren’t getting returned, emails aren’t being responded to, [resulting in] these dark periods of three to four months."
Such communication problems tend to occur with new reviewers, Leahy acknowledged, and the agency "is doing an extraordinary job trying to provide additional training through their various programs … but these are things that we just need to keep working on … to restore that collaborative partnership environment versus the adversarial, confrontational environment," he said.
In response to some stakeholders’ suggestions that medical device companies fund an even higher share of the FDA’s medical device center budget (on par with the drug industry’s heftier contributions), Leahy underscored the differences between the medical device and drug industries.
While the average market size for a medical device is about $120 million, for a drug it’s about $1 billion, he noted.
And while drugs can enjoy market exclusivity for around a decade, medical devices remain exclusive for a much shorter period, generally a couple of years, Leahy said.
"From venture capitalists’ perspective, if the costs to bring a product to market exceed what they can recoup in sales, guess what? The medical innovation ecosystem collapses as we know it."
Separately, MITA’s Fisher pointed out that device companies will have to begin paying a 2.3 percent device tax in 2013, which will leave "less money available for other things, such as user fees."