LONDON, UK (GlobalData), 10 April 2012 - In March 2012, Massachusetts Congressman, Edward Markey, released a new report to support legislation he introduced called the Safety of Untrusted and New Devices (SOUND) Act. The SOUND Act plans to close a loophole which he believes is putting patients at risk of defective medical devices. As it currently stands, medical device companies who seek FDA approval through the 510(k) process are only required to prove that the new device is “substantially equivalent’ to a predicate device. Markey’s concern stems from new devices that are approved using a predicate comparator, in which the predicate device is later recalled due to safety issues. The new legislation will allow the FDA to reject medical devices if they are based on predicate devices that were recalled or are in the process of being removed from the market due to major safety problems. It also requires companies to define their new device’s predicate lineage to determine if similar devices in the past have had any issues.
To support his argument, Representative Markey highlighted the case of Jaye Nevarez who was treated with a Gynecare TVT mesh implant to relieve her urinary incontinence. The device was approved due to its similarity to Boston Scientific’s device ProtoGen, which was removed from the market around the time that Gynecare TYT was approved. Ms. Nevarez filed a lawsuit against Johnson & Johnson, the maker of the implant, over serious complications she experienced as of a result of the device’s implantation. She was forced to quit her job as she now lives in constant pain and can only walk with the aid of a walker.
An estimated 90% of all medical devices currently on the market were approved through the 510(k) process. According to a recent study published in the Archives of Internal Medicine between 2005 and 2009, of the 113 medical device recalls, 71% had originally been approved through the 510(k) process. While the SOUND Act may help ensure patient safety, it may also have an adverse effect on innovation in the medical device industry. The legislation will add another hurdle for medical device companies attempting to gain approval, acting to lengthen the approval process and increase the price of medical devices. If device manufacturers are required to run trials the size and scope of pharmaceutical companies, it will take much more time to bring innovative medical devices to market. The increase in regulatory costs coupled with the downward pressure on reimbursement already taking place may therefore stifle future innovation in the medical devices industry.
Just recently, the medical device industry and the FDA agreed in principle to reduce approval times in exchange for an increase in user fees which fund the FDA review process. The device industry will now pay $595 million over five years, and in return wants a more transparent FDA with quicker overall approval times. It remains to be seen whether the SOUND Act will gain the required support in Congress. Representative Markey is fighting to include the bill as part of FDA legislation that Congress will consider as part of the Medical Device User Fee Act this summer.
“I will fight to include this bill in the FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects”, said Markey.
*Massachusetts Congressman sounds off on medical device approval process
This expert insight was written by GlobalData’s head analyst for medical devices, Derek Archila. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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