Government watchdog group criticizes 'gaps' in agency's process.
For the second time in two years, the Government Accountability Office (GAO) faulted CDRH’s performance on medical device recalls. In a new report, GAO said the center’s shortcomings “span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”
The report was submitted as testimony during an April hearing in front of the Senate Special Committee on Aging. GAO healthcare director Marcia Crosse represented the government watchdog group, testifying that “GAO’s ongoing review has identified gaps in FDA’s processes that could allow unsafe or ineffective devices to continue to be used despite being recalled by the manufacturer.” The GAO counted 3510 recalls between 2005 and 2009, which is an average of about 700 per year. According to the written testimony Crosse submitted to the committee, “the GAO found that firms frequently were unable to correct or remove all devices subject to the highest-risk recalls.” In addition, “GAO’s preliminary findings indicate that FDA lacks clear guidance for overseeing recalls, which has led to inconsistencies in FDA’s assessments of whether individual recalls were implemented effectively.”
GAO’s investigation found that FDA was often slow to review recalls and did not take measures to meaningfully analyze them. “FDA is missing an opportunity to proactively identify and address the risk presented by unsafe devices,” Crosse concluded in her spoken testimony. She criticized the agency for failing to routinely examine recall data, leaving it unable to “effectively monitor and manage its recall program.”
“As a result,” Crosse said, “FDA could not provide basic information to explain trends, such as why the majority of recalls are medium risk; why high-risk recalls more than doubled between 2008 and 2009; or why many recalls have been ongoing for five years.”
CDRH deputy director for science William Maisel told the committee that the agency had recently taken action to strengthen and improve its recall process. “We’ve improved internal tracking of device recalls and decreased long overdue device reclassification decisions by over 50% in the past year,” he testified.
“Our analyses of recall data have been used to guide our targeted and strategic use of our enforcement resources to identify poorly performing devices, manufacturers, or manufacturing facilities. We have also created a tool that better integrates analyses of pre- and postmarket data, including recall information, to provide our medical device reviewers with easier access to comprehensive information that spans the device’s total product life cycle.”
Maisel said industry plays a significant role in ensuring that devices are safe and the review process is successful. He cited documentation of companies that had been less than helpful during the application process.
He said that of a sample of 510(k) submissions from 2010, more than half of the applications that were put on hold by CDRH lacked an adequate device description. In a sample of submissions that resulted in FDA making multiple requests for additional information from manufacturers, nearly 60% of submitting companies repeatedly failed to follow published FDA guidance or recognized published standards. “These shortcomings waste valuable FDA resources and lead to unnecessary delays in the device review process,” Maisel said.
AdvaMed senior vice president David Nexon said the biggest problem facing FDA right now is “the agency’s failure to make new treatments and diagnostics available to patients in a timely and consistent manner.” Nexon praised the Obama administration and FDA for recognizing that the agency device review performance is lacking. “There are a number of policy changes now in process that, if implemented effectively, could significantly improve FDA’s ability to meet the needs of patients and industry,” Nexon said. “Much must be done to restore the level of performance to where it was just a few years ago—a level that was suboptimal even then.”
Nexon said AdvaMed disagrees with FDA’s view that poor-quality submissions are to blame for increased 510(k) review times. “An informal survey of AdvaMed members indicates that the top reasons for additional information (AI) letters are unrelated to the quality of the submission,” he told the committee.
According to Nexon, the companies reported that the issues raised in AI letters “are either so minor they could have been addressed more expeditiously via e-mail or phone, or they were of an ‘academic’ nature not related to the substantial equivalence determination. The information requested in the AI letters is also often already contained in the original submissions.”
“Moreover, the timeliness of FDA reviews has deteriorated markedly since 2007,” Nexon said. “It is not likely that there has been a commensurate deterioration in the quality of submissions, since no manufacturer wants to provide a submission to FDA that is not acceptable.”
Additionally, the GAO said FDA had taken only limited action to complete recommended device reclassifications as outlined in its 2009 report. In the initial report, GAO said FDA should expeditiously take steps to issue regulations for Class III medical devices that are currently allowed on the market through the 510(k) process. The GAO wants FDA to either reclassify these devices as Class I or II or require them to get PMAs.
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