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Franken says U.S. can improve medical device approval process while ensuring safety

Posted by: James Walsh Updated: April 12, 2012 - 1:53 PM
The United States does not have to choose between the vitality of its medical device industry or the health of its people, U.S. Sen. Al Franken said in an interview at the Design of Medical Devices Conference hosted by the University of Minnesota. It is possible to improve both.
By bringing regulators and manufacturers together to communicate and find common ground, he said, they can find a way to get life-saving devices to market faster while not compromising patient safety. “To some degree, there is a false choice there,” said Franken, who is a member of the Senate Health Committee.
While acknowledging that the range of issues involved are “pretty complex stuff,” Franken pointed to his efforts to bring Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, to Minnesota to meet with leaders of the medical device industry.
Those meetings subsequently led to an agreement between the FDA and the industry to develop a Regulatory Sciences Partnership that will be centered in Minnesota. The idea is to help two very different cultures – regulatory and manufacturing – find common ground to improve the system while enhancing safety.
“These people better start talking to each other,” Franken said of any hoped-for improvements in the American device-approval system. “I want to be a bridge there.”
Franken has introduced legislation, included in a larger medical device bill now being considered by the U.S. Senate, that has two provisions: the first would make it easier for the FDA to work with experts from around the country in the review of proposed medical devices, providing a deeper well of technical expertise. The second would remove the profit prohibition for medical devices that are developed to treat patients with rare diseases, essentially streamlining the development and approval of such devices.
“The longer things take to get to market, it makes the thing not cost-effective to do in the first place,” Franken said Thursday. “There are people who need these devices.”
 

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