Experts told lawmakers that the U.S. Food and Drug Administration’s (FDA) process for medical device approval needs strengthening to adequately protect consumers from safety risks, reported Reuters, which noted that a medical device can be anything from “tongue depressors to artificial hips.”
According to Representative Frank Pallone (democrat)—chair of a House Energy and Commerce subcommittee—who said he was trying to determine if there were issues that need correction via new legislation or increased FDA oversight, “There is evidence of an approval system that is broken—that its standards, its procedures, and its rules don’t meet modern needs of getting medical devices to those in need with confidence in their safety,” quoted Reuters. Marcia Crosse—healthcare director for the nonpartisan Government Accountability Office (GAO)—said that the issues “raise concerns … that are necessary for ensuring the safety and effectiveness of medical devices,” referring to the agency’s process for pre-approval reviews and post-approval monitoring, said Reuters.
New FDA Commissioner Margaret Hamburg said she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency’s medical device division, reported The Wall Street Journal, previously. “There obviously have been some problems,” said Dr. Hamburg in an interview discussing the agency’s Center for Devices and Radiological Health, calling it “a high priority,” quoted the Journal. At the time President Obama named Dr. Hamburg as his pick to head the FDA, she announced plans to overhaul the ailing agency and restore confidence in the FDA, said the Journal previously.
The agency—responsible to ensure drugs, medical devices and products, some human and animal food products, cosmetics, and other consumer goods are safe to Americans—has been widely faulted for all manner of problems, including that it had no permanent commissioner for the majority of former President Bush’s eight-year term.
Under the former administration, the FDA was accused of letting politics minimize science and, it was during that time, that some of the most notorious drug safety and food borne illness outbreaks and recalls originated, such as Medtronic Sprint defibrillator leads, Baxter infusion pumps, faulty heart stents, and squeaky hip replacements. In addition to countless drug and medical device recalls, there have been issues with toxic ingredients in consumer products, controversies over physician and researcher gifting by industry, inappropriate medical devices and medication marketing, and a system rife with corruption.
Former FDA Commissioner David Kessler described the device center as “dysfunctional,” and “in meltdown,” noting that he has spoken with Dr. Hamburg, said the Journal.
Recent investigations revealed the FDA did not mandate its strictest review process be followed for the most “risky” devices, said Reuters, adding that the agency was also working to look at “tens of thousands of reports” it received each year that alleged harm from medical devices, said Reuters, citing Crosse’s statement to lawmakers.
Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal earlier this week. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal. Industry disagrees, saying changes to the approval process could delay medical devices reaching patients, said the Journal, noting that the medical device sector represents a nearly $200 billion industry.
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