GAO Fires Volley in 510(k) Debate

According to investigators at the Government Accountability Office (GAO), the U.S. Food and Drug Administration (FDA) is putting patients at risk with its current 510(k) program.

The GAO claims too many devices are approved through the 510(k) route—which is a track for less-invasive or “me too” devices already on the market—instead of the premarket approval process reserved for novel or more complex technology.

It’s the “me too” part of the 510(k) process that concerns many. According to current regulations, high-risk devices that already were on the market in 1976 (when the medical device classification system began), such as certain types of defibrillators and orthopedic implants, can go through the faster 510(k) system if manufacturers can show they are “substantially equivalent” to their precursors. In 1990, Congress ordered the FDA to end the practice, but it has continued. According to the FDA, at present, only 10 percent of 510(k)-cleared devices require clinical data for approval.

The U.S. Senate’s Committee on Aging held a hearing on April 14 examining the FDA’s 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 healthcare team at the 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 post-market surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”

The GAO previously faulted the FDA in 2009 for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the 510(k) system.

The FDA has faced complaints from medical device manufacturers that the speed of U.S. device reviews lag behind other countries. At the same time, public safety advocates point to reports by GAO and others that suggest the agency is being too lenient in clearing critical devices that keep patients alive.

William Maisel, M.D., deputy director for science in the FDA’s Center for Devices and Radiological Health, told lawmakers that the FDA would reclassify the 26 types of high-risk devices cited by GAO before the end of 2012.

“FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patient health,” Maisel said in his testimony to the committee.

According to the GAO, FDA has reclassified only one group of devices since 2009, leaving 26 remaining.

The medical device industry is concerned that these management problems have slowed medical device innovation. In his testimony, David Nexon, senior executive vice president of the Advanced Medical Technology Association, said 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.”

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 the 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.”

Sen. Herb Kohl (D-Wis.), chairman of the committee, said he would be advocating for further reforms at the FDA and urged Maisel to push forward with an effort to classify high-risk devices now defaulting through the agency’s “fast track” approval system.

“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. 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.

During the recent annual meeting of the Florida Medical Manufacturers’ Consortium in St. Petersburg, Fla., Heather Rosecrans, former director of the 510(k) premarket notification staff at the FDA, and current vice president of regulatory affairs at the Medical Device Manufacturers Association, told the gathering that the 510(k) program has been misrepresented as overly flawed.

“It’s the most misunderstood program at the agency,” she said. “It isn’t a ‘fast-track’ program as many media outlets have said. It has always been a risk vs. benefit review, not a rubber stamp. But we need to keep up with the pace of technology and it’s good to have a new look at things.”

Medtronic’s Regulatory Chief Retires; Vows to Stay Involved

Susan Alpert, M.D., Ph.D., senior vice president and chief regulatory officer at Medtronic, Inc., retired at the end of April. She will stay on with the company as a consultant. Alpert joined Medtronic in 2003.

“Being the innovator in a changing regulatory world is hard,” Alpert told Orthopedic Design & Technology of her time at Medtronic. “Breaking molds is hard.”

During an interview with ODT, Alpert discussed some of the biggest challenges she faced during her tenure at the company, including changes in the regulatory environment and the impact the U.S. Food and Drug Administration’s (FDA) focus on quality has had on the product development process.

“Large organizations that are well engaged are often hard to move,” Alpert said. “We have, however, put in place processes that will keep Medtronic prepared for whatever comes globally in the regulatory environment moving forward.”

Brian Henry, a spokesman for the Minneapolis, Minn.-based medical device giant, praised Alpert for both her service and her knowledge of the device industry. “It’s been an absolute pleasure working with [Alpert]. Her knowledge of the industry, of regulatory agencies and of the importance of collaboration between the two for the benefit of patients, is unsurpassed.
Her guidance and counsel have been extremely valuable and we’re pleased that she plans to continue to offer both in her retirement.”

Though her role with Medtronic officially changed on April 29, Alpert is not planning to rest on her laurels in her retirement. She told ODT that she still plans to remain active in the industry and voice her opinions about the issues impacting the device sector.

“It seems to me the best way to retire is to ease into it slowly, so you can still expect to hear from me for awhile,” said Alpert, adding that she is complying with Medtronic’s mandatory retirement age requirement. “I plan to continue to work with the industry as we negotiate the next round of user fees with the FDA. I’m going to stay engaged with the 510(k) changes, as well as the regulatory changes being planned for the E.U.[European Union].”

Those are not the only issues Alpert plans to tackle in her retirement, though.

“The one [issue] we continue to face is that many regulators and other stakeholders are still not recognizing that the device industry is not pharma,” she said. “We are a very different industry with different needs and costs and different ways of serving patients. Because many companies are small the issues are not seen as large—but they are.”

Prior to joining Medtronic, Alpert, who also is a microbiologist and a pediatrician, was vice president of regulatory sciences at Murray Hill, N.J.-based C.R. Bard, Inc. Alpert also held various positions with the FDA, including six years as the director of the office of device evaluation.

Alpert has served on various committees, including the board of the Food Drug Law Institute in Washington, D.C., the Medical Technology Leadership Forum in Indianapolis, Ind., Women Business Leaders, and the Clinical Trials Transformation Initiative, a public–private partnership between the FDA and Duke University to identify practices that will increase the quality and efficiency of clinical trials. Alpert also is a past chair of the Regulatory Affairs Professional Society and a fellow of that organization.

Alpert’s experience enabled her to witness countless changes in the industry. “When I started, regulation on medical devices was not a front-line topic,” she said. “It wasn’t even considered to be very important inside or outside of the [FDA]. Today, regulators, healthcare professionals and patients around the world are engaged in discussions about devices, their impact on public health, their pathways to market and what we learn about products after they are distributed. It’s a huge change. The advantage of this change is that there is a greater understanding and awareness of how medical devices improve the quality of life for people every day. All of the stakeholders are interested in continued advancement of these technologies in order to extend and restore healthy lives.”

Medtronic has chosen Regulatory Affairs Vice President Patricia Shrader for Alpert’s replacement. Shrader is the former regulatory senior vice president at Becton, Dickinson & Co.