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Safety Takes Back Seat To Medical Device Approvals

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Safety first sign

Legislation to close the loophole in the U.S. Food and Drug Administration’s medical-devices approval process has gotten a lot of publicity since it was introduced in February. At the same time, many bills that focus on a faster approval process instead of consumer safety are moving forward with much less discussion.

The Minneapolis Star Tribune describes pending legislation that favors the medical devices industry.

U.S. Legislation to Change Medical Device Industry

A bill in the U.S. House would change the FDA’s mission statement to include job creation as well as safety. Another bill, introduced by Rep. Erik Paulsen, R-Minn., gives outside reviewers expanded authority in the approval process for some life-sustaining and permanently implanted medical devices. In the Senate, Minnesota Democrat Amy Klobuchar authored legislation that would loosen conflict-of-interest rules for people who review medical devices.

Rules to create an ID system for medical devices have stalled, months after they should have been published.

But the big question, obviously, is whether the federal government is bowing to the interests of the medical-devices industry at the expense of consumers. After reading this newspaper report, it certainly would seem so.

Sacrificing Safety for Innovation

Government officials and medical-device companies say that fast-tracking drugs and devices that Americans need outweighs excessive safety concerns. They say the U.S. already lags behind other countries, especially those in Europe, when it comes to human health technology.

“Today, we’re discussing the role of FDA regulation in the context of innovation, investment, economic growth and global competitiveness,” said Steve Ubl, president of AdvaMed, which calls itself “the world’s largest medical technology association.”

But consumer advocates say we need to take a step back and ensure safety first. One of the ways to do that is passing a bill introduced in the U.S. House by Rep. Edward Markey (D-Mass.). It would allow the FDA to refuse approval to medical devices that are based on products that have been or are in the process of being recalled by the agency. In addition, manufacturers would have to explain how their devices are different from the failed ones.

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