Alexander Introduces Bill to Get Medical Devices to Market More Quickly and Safely

Says bill “will give patients who suffer from rare medical conditions a much better opportunity for treatment or cure”

Posted on November 16, 2011

WASHINGTON – U.S. Senator Lamar Alexander (R-Tenn.) today announced he was a lead cosponsor of the Patient Access to Medical Innovation Act, a bill introduced by Sen. Al Franken (D-Minn.) to get innovative medical devices to market more quickly and safely.

“This bill will remove two obstacles to innovation in medical care: It will give patients who suffer from rare medical conditions a much better opportunity for treatment or cure by allowing the companies that develop medical devices for those conditions to earn a profit from their innovations, and it will simplify rules for those who sit on the FDA’s advisory panels so that the agency can access the technical expertise it needs.”

The 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.

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