U.S. Rep. Rosa DeLauro says the Food and Drug Administration is favoring corporate interests over those of patients in new changes to its process for approving medical devices.
DeLauro, who has a hip implant, is ranking member of the subcommittee with jurisdiction over the FDA. She expressed belief that “industry concerns” kept the agency from adopting stronger requirements of manufacturers of medical devices.
‘While I agree that safe and effective medical devices should be brought to market as soon as possible, the emphasis needs to be on the ‘safe and effective’ part of this equation,” said DeLauro, a Democrat who represents Connecticut’s 3rd Congressional District. “If the FDA is going to improve safety standards for medical devices, it should do so based on scientific evidence and not industry popularity, she said.” DeLauro is ranking member of the Appropriations Subcommittee on Labor, Health and Human Services, and Education. She received a hip implant for benign arthritis of the hip in 2007.
Patient advocacy groups have been clamoring for the FDA to strengthen its most commonly-used process for approving medical devices for market. There have been significant problems with some devices, including a widely reported recall by DePuy Orthopaedics Inc. of hip implant systems that had been used in some 93,000 patients worldwide.
Last fall, DeLauro expressed support for FDA reform of its approval process, urging the agency to “resist efforts by the industry to expedite the approval of potentially unsafe products.” She cited a report by the Government Accountability Office (GAO) which concluded that high-risk medical devices, such as heart valves, pacemakers, and metal hip implants, were approved with only minimal review, “to the industry’s benefit.” She also said that “the American people would be shocked to learn that some in the industry believe that FDA should not have the authority to pull ineffective products from the market.”
Dr. Stanley Wolfe, of Public Citizen, a national advocacy group, agreed with DeLauro that the new changes tip the regulatory balance to the “so-called innovation side” of the equation over safety and effectiveness. Wolfe, director of Public Citizen’s Health Research Group, accused the FDA of not being forceful enough with the industry.
In FDA hearings and meetings around the country, the medical device industry has argued against stronger oversight prior to approval, saying it would deter innovation and force American companies to move overseas.
The FDA process in question pertains to devices mainly considered lower risk and requires companies to show that a new product is substantially equivalent to one already on the market. About 3,000 new devices are cleared for use annually under this process, according to the FDA.
Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement, the amended process balances the interests of industry with patient safety. It will both “foster medical device innovation and assure the safety and effectiveness of medical technologies used by and on patients in the United States.”
However, the FDA has postponed actions on several proposed changes to the process, asking the Institute of Medicine to study them. Patient advocacy groups claim those proposals would provide more protections to patients by requiring more information and scrutiny of devices that are implantable, life supporting and life sustaining.
In December C-HIT reported DePuy had paid millions of dollars in fees to surgeons that used their medical devices. In Connecticut several patients were told last year that their hip implants had been recalled and could fail. A few have undergone second surgeries.