Article preview from "The Gray Sheet" - September 15, 2010
Patient and consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.
FDA User Fee Renewal Effort Should Include Pre-Market Refinements, Industry Says
By Jessica Bylander
Patient and consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.
FDA held a public workshop Sept. 14 to hear input from stakeholders on how well the user fee program is working and what, if any, aspects of the medical device user fee program should be maintained, changed or terminated altogether.
The agency says it hopes to release draft recommendations regarding user fee reauthorization in about a year's time. Final recommendations are due to Congress by January 2012.
User fees and associated pre-market review performance goals were first instituted in the Medical Device User Fee and Modernization Act of 2002 to make device reviews more timely and predictable.
The Medical Device User Fee Amendments, enacted as Title II of the 2007 FDA Amendments Act, reauthorized through fiscal year 2012 the fees paid by industry to fund specified portions of FDA's pre- and post-market activities.
FDA's reauthorization working group, headed by Assistant Commissioner for Planning Malcolm Bertoni, includes staffers Don St. Pierre, Kate Cook, Barbara Zimmerman and others.
The public user fee meeting is a first for FDA, mandated by Congress in the prior user fee reauthorization legislation to shed light on the process.
Consumer representative Adolph Falcon, of the National Alliance for Hispanic Health, is urging FDA to establish performance goals that reflect the input of all stakeholder groups, and not just focused on the speed of reviews.
Amy Allina, of the National Women's Health Network, also expressed concerns that the device program is relying too heavily on industry-provided funds. "We believe this arrangement undermines FDA's independence," she said.
Diana Zuckerman, of the National Research Center for Women and Families, on the other hand, argued that device user fees are too low, particularly compared to the amount of user fees the drug industry doles out.
NRCWF noted that user fee funds only cover about a quarter of the funds and resources that go into a 510(k) review or a PMA review. Zuckerman suggested the companies pay the full cost of the review.
"Most device companies could afford $5,000 to $10,000 in user fees," she said.
Industry reps, on the other hand, pushed back.
Mark Leahey, president and CEO of the Medical Device Manufacturer Association, noted that the amount of user fees contributed by industry nearly doubled in the last round of negotiations, from $150 million over five years to $287 million over five years.
According to David Fisher, executive director of the Medical Imaging and Technology Alliance, his member companies are concerned that the link between the fees and FDA's performance has broken down.
Leahey agreed that device companies are unlikely to support user fee program reauthorization without needed changes.
Key shortfalls are the guidance development process and so-called interactive review, industry reps said. FDA is not getting guidance out the door fast enough, nor is it fulfilling its promise for more informal back-and-forth during pre-market reviews, speakers said.
In addition, "performance seems to be slipping," Leahey added.
According to FDA's most recent data, the agency met its user-fee performance goals for 510(k) submissions, but not for original PMAs.
"We're trying to figure out why," FDA's Bertoni said, suggesting that many of the submissions may have been for first-of-a-kind devices, or required expert panel review.
Comments on FDA's reauthorization questions are due Oct. 14.
Closed-door negotiations will begin around January 2011. Once negotiations start, FDA is also required to release a public summary of those proceedings, listing any substantial proposals or significant controversies and to hold monthly discussions with patient and consumer advocacy groups to gain additional input.
Information on how to participate in the monthly stakeholder meetings will be made available in a Federal Register notice sometime this fall, CDRH Director Jeffrey Shuren said at the meeting.
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