The FDA says that it not only wants to be the first to approve medical devices, but also the first FDA-like agency in the world to reject them. Agency officials also argue that Jeffrey Shuren, the FDA’s director of the agency’s medical device division, hasn’t changed his stance since telling Congress back in 2011 that he would not “use our people as guinea pigs” in the United States.
And yet, as the Associated Press reports, the next year the FDA launched its first in the world approval policy. The AP says that under Shuren, annual new device approvals have more than tripled. Meanwhile, warning letters to device manufacturers about product safety and quality issues have fallen about 80%.
Critics charge that the FDA is using smaller and less rigorous studies to approve devices. Part of the motivation, say critics, is to keep manufacturers from taking their business overseas. It’s feared that the agency may also be influenced by lobbying from the $400 billion medical device industry.
“The assortment of medical devices now on the market includes spinal rods that can leave metal shards in children and a nerve-zapping obesity implant that may not work for many patients,” the AP reports. “The cheaper and faster medical device approvals began despite multiple, high-profile safety problems involving pelvic mesh, hip replacements and other implants.”