WASHINGTON – Citing concerns about long approval times for medical devices, Minnesota’s congressional delegation joined forces to send a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg asking the agency to speed up the approval process.
“We are very concerned that delays in this process are hindering innovation, delaying patient access to new therapies, and undermining the US medical industry’s global leadership,” said the letter signed by both Senators and eight House members.
While the lawmakers said they supported the FDA’s mission of ensuring safe and reliable treatments, they called the agency’s approval process, “often inconsistent and unreliable.”
Minnesota is one of the centers of the medical device industry and employs an estimated 30,000 Minnesotans and the state’s congressional delegation has long championed the industry.
GOP Rep. Erik Paulsen is the co-chair of the House Medical Technology Caucus and recently testified before a House panel about the FDA approval process. Paulsen also plans to introduce legislation later this summer to speed up the process.
During last year’s health care overhaul, DFL Sen. Amy Klobuchar helped cut a surtax on medical devices that was part of the final bill.
The joint letter cites FDA data pointing to slowing rates of approval for new devices. In fiscal year 2000, 76 percent of devices received approval on the first application. In fiscal 2010, just 32 percent of devices were approved on the initial submission to the agency.
The slowing approval rate comes as more questions are raised by the medical community about the safety of some devices. A U.S. Senate committee is investigating Medtronic for problems with a spinal implant and allegations that the company may have had financial ties with doctors who were aware of the problems but did not publicize them.
UPDATE: DFL Sen. Al Franken’s office wrote in to note that Franken was also actively involved in helping reduce the size of the medical device surtax during last year’s health care bill debate.