Sens. Elizabeth Warren, D-Mass., and Patty Murray, D-Wash., sent a letter to the FDA Nov. 4 expressing concerns that the agency plans to weaken approval standards for medical devices.
The letter, addressed to acting FDA commissioner Brett Giroir, MD, and director of the Center for Devices and Radiological Health, Jeffrey Shuren, MD, refers to a proposal the FDA originally pitched to senators in August to use similar standards for medical device approval as it uses to approve new veterinary drugs.
Former FDA commissioner Scott Gottlieb last year assured lawmakers that the "FDA does not believe this pathway would be suitable for human medical products." However, the FDA now argues that demand is not met to develop new medical devices for children and other underserved populations so it needs to establish better pathways for approval.
"FDA believes progressive approval would foster safe innovation in medical devices to meet many unmet needs, including the complex needs of small populations such as pediatrics," the FDA wrote.
The proposal would allow certain medical devices that treat life-threatening or irreversibly debilitating diseases to get a provisional three-year approval based on safety and performance data, according to MedTech Dive. Sponsors would then collect safety and effectiveness data to determine whether to allow the device to stay on the market after three years.
Mike Carmone, MD, director of Public Citizen's health research group, reportedly said the FDA's efforts to pass the progressive approval plan are "very troubling" and "a terrible idea," according to MedTech Dive.
"Do we want to expose our children to devices that are potentially unsafe, where we haven't established their risks and benefits to any satisfactory degree?" Carome told MedTech Dive. "They are essentially going to be guinea pigs."
The senators asked the FDA to respond to their letter by Nov. 13.
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