Indiana’s Donnelly joins Burr’s breakthrough devices bill

Indiana’s junior senator yesterday signed on to a bill that would create a fast-track program at the FDA for breakthrough medical devices.

The bill, S. 1077 or ” A bill to provide for expedited development of and priority review for breakthrough devices,” was introduced in April by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.).

Yesterday Sen. Joe Donnelly (D-Ind.) signed on to the measure, which has been assigned to the Senate Health, Education, Labor & Pensions Committee.

The S. 1077 bill would create a priority review program at the FDA’s Center for Devices & Radiological Health for devices “representing breakthrough technologies,” “for which no approved alternatives exist” or which offer significant advantages over existing treatments. The designation would also be available to devices “the availability of which is in the best interest of patients,” according to the bill.

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