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Senate approves FDA's 'breakthrough pathway' for medical devices

by Gail Kalinoski, Contributing Reporter | March 23, 2016
Business Affairs Medical Devices Population Health
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A bipartisan Senate committee has approved three bills that could help get medical devices to patients sooner by creating a “breakthrough pathway” through the U.S. Food and Drug Administration, but not everyone is happy about the actions.

Diana Zuckerman, president of the National Center for Health Research, wrote on behalf of the watchdog group that it was “concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective.” The group’s letter added: “Whether creating a new breakthrough pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software, for example, patients will be at risk.”

The group said it strongly opposed one of the bills passed, the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, (S. 1101) known as MEDTECH, stating it would remove “potentially lifesaving and life-threatening health IT software entirely from the FDA’s regulatory oversight, and could possibly eliminate recalls for IT devices with life-threatening flaws.”

But the Advanced Medical Technology Association (AdvaMed) applauded the bills approved earlier this month by the Senate’s Health, Education, Labor & Pensions (HELP) Committee.

“AdvaMed commends the Senate HELP Committee for advancing three medical technology-related bills that will help ensure more timely patient access to the latest medical innovations and improve the efficiency of the FDA’s device review process,” JC Scott, senior executive vice president, government affairs, for AdvaMed, said in a statement.

Scott said the MEDTECH act “will codify FDA’s current regulatory paradigm for medical technologies that utilize software and allow the agency to concentrate its resources on medical devices containing software that has the greatest potential on public health.”

AdvaMed also supported the HELP committee’s work on the Advancing Breakthrough Devices for Patients Act (S. 1077) and the Combination Product Regulatory Fairness Act (S. 1767).

“Taken together, these three bills will help improve patient access to some of the latest medical advancements and foster a more efficient, predictable and transparent review process within the FDA, all the while maintaining the agency’s strong standards for safety and effectiveness,” Scott stated.

Zuckerman’s group disagreed, once again opposing the bills for lowering standards and undermining or micromanaging the FDA. Her letter stated that the vague language on what classified a device as “breakthrough” may “encourage many device companies to apply for ‘breakthrough’ status, overwhelming the resources of the FDA."

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