U.S. Senator Kay R. Hagan (N.C.) in November cosponsored the bipartisan Patient Access to Medical Innovation Act to get innovative medical devices to market more quickly and safely. Hagan cosponsored the bill alongside Sens. Al Franken (Minn.), Lamar Alexander (Tenn.) and John Kerry (Mass.).
“This bipartisan legislation will cut unnecessary red tape in the medical device industry, helping to get innovative treatments to the patients who need them most,” said Hagan. “North Carolina’s Research Triangle Park is a national leader in developing these life-changing tools. Passage of this bill will ensure these products reach patients as quickly and safely as possible.”
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.