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Sen. Franken’s Medical Device Legislation Clears Key Hurdle; Now Heads to Full Senate for Debate

Senator’s Provision to Get Patients Access to Medical Devices More Quickly and Safely Passes out of Senate Health Committee

Wednesday, April 25, 2012

The medical device approval process bill championed by U.S. Sen. Al Franken (D-Minn.) cleared a key hurdle today, after he and his colleagues on the Senate Health Committee passed the bill out of committee. The legislation that Sen. Franken has been working on for the past year includes his provisions to get medical devices to patients more quickly and safely. The bill, including Sen. Franken’s provisions, now heads to the full Senate for debate. 
“The bill we passed today will address the frustrations I’ve heard from doctors and patients in Minnesota—that innovative and potentially life-saving devices out there aren’t getting to people in time,” said Sen. Franken. “I’ve spent the last year working on the Senate Health Committee’s bill to improve the way medical devices get to the patients that need them, and I’m proud of the bipartisan legislation we’ve crafted. And I’m pleased that the final bill includes my provisions to speed up the approval process so that critical devices get to the patients that need them as quickly and safely as possible.”
Over the last year, Sen. Franken has been participating in the Senate Health Committee’s bipartisan working group to develop policy to improve the medical device approval process. His two provisions, originally introduced as a standalone bill last November, were included in the larger medical device approval process bill drafted by the Health Committee. Sen. Franken’s provisions would:

  • Help improve the federal Food and Drug Administration’s (FDA) approval process for medical devices by allowing the agency to more easily consult with experts; and
  • Promote the development of devices to treat patients with rare diseases by lifting the current profit cap on "humanitarian use devices" -- devices that treat rare conditions -- that go through a special approval process. Eliminating this red tape will support the development of treatments for people with rare conditions.

During a hearing in March, FDA’s Director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, confirmed that he believes Sen. Franken’s provisions will help get patients access to life-saving medical devices more quickly and safely. You can see video of Sen. Franken questioning Dr. Shuren during last month’s hearing here.
The Health Committee’s bill will be attached to an agreement between FDA and the medical device industry that must pass the Senate before September.

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