A bill presently moving through Congress fails to include badly needed reforms to the U.S. Food and Drug Administration’s (FDA) process for approving medical devices, the consumer advocacy nonprofit Public Citizen said in a statement May 10.
Most notably, the proposed legislation would not make urgently necessary changes to the FDA’s 510(k) process, which permits the FDA to approve medical devices for marketing if they are similar to devices already on the market. This process has resulted in the approval of a number of devices that later harmed and even killed patients.
As the U.S. House of Representatives Energy and Commerce Committee deliberated on the bill, Public Citizen called on the committee to add to the legislation provisions closing the dangerous loopholes that allow the FDA to OK moderate- to high-risk medical devices without commonsense premarket review.
“Ensuring that the medical devices and drugs used to treat patients in the U.S. are safe and effective should be the paramount goal of any new medical device and prescription drug legislation,” Dr. Michael Carome, the deputy director of Public Citizen’s health research group, said in the statement. “Patients in the U.S. deserve legislation that strengthens the FDA’s review and oversight of these medical products to ensure their safety and effectiveness, not legislation that seeks to promote the corporate interests and profits of industry by weakening such review and oversight.”
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