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Kerry, others propose new legislation

BOSTON — Sen. John Kerry and a bi-partisan group of senators have introduced legislation to promote development and streamline the approval process for medical devices in Massachusetts.
The Patient Access to Medical Innovation Act, which Kerry cosponsored along with Sens. Al Franken (D-Minnesota), Lamar Alexander (R-Tennessee) and Kay Hagan (D-North Carolina), would allow stronger, more innovative life-saving tools into the market by updating the federal approval process to allow the best experts to weigh in.
The U.S. Food and Drug Administration (FDA) requires up to 18 advisory panels be brought in to evaluate new medical technologies when the FDA lacks “in house” expertise to do so. Current draconian restrictions on advisory panel members, however, often prevent the top leaders from reviewing a specific device or technology, significantly slowing the approval process. This legislation would allow the top experts in their fields onto those panels by requiring the FDA to comply with the same conflict of interest requirements as the National Institutes of Health and all other federal agencies, ensuring stronger, more accurate safety measures for approval while accelerating the process.
“This summer when FDA Commissioner Hamburg joined me in Boston to hear from Massachusetts industry leaders. We talked about building a new relationship where our innovators work with federal regulators to get the best medical breakthroughs to the patients that need them most,” Kerry said.
“This legislation strengthens the approval process while cutting the red tape that keeps these critical devices from the hospitals, doctors, and nurses who can use them to save lives. Massachusetts has long been at the heart of these technological innovations, and I’ll continue to do all I can here in the Senate to protect and encourage that innovation,” he added.
The Patient Access to Medical Innovation Act will:
  • Promote the development of devices to treat patients with rare diseases;
  • Improve the FDA approval process for medical devices by allowing the agency to more easily consult with experts while promoting transparency and open reporting; and
  • Lift the current profit cap on “humanitarian use devices” — devices to treat rare conditions and diseases — that go through a special approval process.
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