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US Senate passes FDA drug, device safety bill

US Senate passes FDA drug, device safety bill

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A bill that would revamp the way the Food and Drug Administration reviews and inspects drugs and medical devices has passed the Senate by a wide margin.

The FDA Safety and Innovation Act, S. 3187, passed the Senate on a 96-1 vote.

The changes are included in a reauthorization bill that provides money for essential FDA safety approvals and reviews.  The bill would increase the ability of FDA regulators to oversee and respond to safety issues involving prescription and over-the-counter drugs, and speed up the approval process for some potentially life-saving breakthrough drugs by allowing shorter clinical study times.

The bill would also allow the FDA to use outside inspectors to monitor manufacturing facilities, and require the agency to provide an explanation for denying approval for some low-risk medical devices within 30 days.

“This bill’s passage is a victory for the millions of Americans who need medicines or medical devices, and for the kind of bipartisan cooperation that we see all too rarely in Washington,” co-sponsor Sen. Mike Enzi, R-Wyo., said in a statement. “This is why the committee process is so important. By bringing together Republicans and Democrats, industry leaders and advocacy groups, we were able to put together a truly bipartisan bill that is non-controversial and reflects input from everyone.”

But some say the legislation still falls short.

“Tens of thousands of patients have been seriously harmed by dangerous and defective medical devices in recent years because our current system fails to ensure they are safe and effective,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a statement. “The Senate bill makes some improvements in the law but fails to address some longstanding flaws in our medical device oversight system that endanger patient safety.

“Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market and limits the FDA’s ability to protect patients when problems arise.”


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