FDA’S MEDICAL DEVICE REVIEW SCRUTINIZED AT SENATE HEARING

WASHINGTON - Today, U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, held a hearing examining the Food & Drug Administration's (FDA) role in protecting patient safety as part of the medical device approval process. The panel featured testimony from Marcia Crosse, Ph.D., Director of the Health Care Team at the Government Accountability Office (GAO). Crosse's testimony outlined the preliminary findings of an ongoing GAO investigation into the FDA's management of medical device review, post-market monitoring and recall processes.

"Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective," Crosse said in her testimony. "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled."

Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation."

"The drive toward getting new technologies to market shouldn't be done at the risk of patient safety," Kohl said. "Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them."

Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved. The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.

The medical device industry is concerned that these management problems have slowed medical device innovation.  In his testimony today, David Nexon, Senior Executive Vice President of the

Advanced Medical Technology Association, criticized that there are, "inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology."

"I am encouraged by the numerous initiatives that FDA is implementing for more effective medical device approval and post-market surveillance," Kohl said. "Nevertheless, I'm concerned that the agency's oversight of medical products still remains on the GAO's 'high risk' list… and that is unacceptable."

GAO flagged the FDA's management of medical devices with a "high risk" designation in 2009.

The hearing highlighted the story of Ms. Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.

A recent study, led by Diana Zuckerman, Ph.D. and published in the Archives of Internal Medicine, found that "from 2005 through 2009, the 113 highest-risk device recalls involved 112.6 million recalled products." Zuckerman testified at today's Senate hearing that, "In the first six months of 2010, the FDA recalled more than 437 million additional products because of high risks, including death… in just six months there were 1.4 medical devices recalled for every person living in the U.S."

Kohl said he would be advocating for further reforms at the FDA and urged Dr. William H. Maisel, Chief Scientist at the FDA's Center for Devices and Radiological Health, to push forward with an effort to classify high-risk devices now defaulting through the agency's "fast track" approval system. 

"FDA has had over 20 years to tackle these high risk devices," Kohl said.  "As we have seen with the Johnson & Johnson hip implant today, it's high time to protect patient safety and correctly classify these devices." 

Kohl also suggested that FDA develop a "more robust post-market surveillance program" signaling his interest in addressing this concern in the Medical Device User Fee and Modernization Act reauthorization next year.