Sen. Franken Introduces Bill to Get Medical Devices to Market More Quickly and Safely
Tuesday, November 15, 2011
Today, U.S. Sen. Al Franken (D-Minn.) introduced the Patient Access to Medical Innovation Act to get innovative medical devices to market more quickly and safely. Sens. Lamar Alexander (R-Tenn.) and John Kerry (D-Mass.) are the lead cosponsors of Sen. Franken’s legislation.
“After speaking with countless patients, doctors, and members of the medical device industry in Minnesota, I’ve learned that certain barriers in the regulatory process are making it harder to get patients the medical devices they need,” said Sen. Franken. “My legislation would remove unnecessary barriers so that these critical medical devices get to the patients that need them as quickly and safely as possible.”
Sen. Franken’s Patient Access to Medical Innovation Act would:
- Promote the development of devices to treat patients with rare diseases;
- 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;
- Lift 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.
Yesterday, Sen. Franken visited Medtronic in Mounds View, MN, and met with several hundred company officials and employees to discuss his new legislation. While there he also met with doctors and patients who may be helped by his legislation. They all agreed on the need for these reforms during his visit. Today, Sen. Franken is also participating in a hearing on medical devices in the Senate health committee, of which he is a member. And Minnesotan Ralph Hall, a law professor at the University of Minnesota and the CEO of MR3, a start-up medical device company, will testify before the committee.
Patient Access to Medical Innovation Act
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Sen. Franken Introduces Bill to Get Medical Devices to Market More Quickly and Safely