Today, U.S. Sen. Al Franken (D-Minn.) issued the following statement after the Senate passed legislation reauthorizing the Medical Device User Fee Act, which will improve the process by which the Food and Drug Administration (FDA) evaluates medical devices. As a member of the Senate Health Committee, Senator Franken worked with key stakeholders to help author the legislation, which also included three key provisions that he championed. The bill passed by a strongly bipartisan vote of 96-1.
"Millions of people all over the world depend on medical devices to keep them alive, and thousands of people in Minnesota depend on this industry to support their families," said Sen. Franken. "I'm pleased that this legislation passed the Senate with such strong bipartisan support, and I'm especially pleased that it included my provisions, which will help people get high quality treatment more quickly than ever before."
Sen. Franken was a key member of a bipartisan group of Health Committee members that authored the bill. Additionally, he personally authored three significant provisions that were included in the legislation passed by the Senate. The first was a provision that would allow the FDA to tap a deeper well of expertise from the medical device industry during the approval process, allowing devices to get to market more quickly. The second would encourage medical device makers to develop treatments for rare diseases, making it easier for patients with those diseases to get treatment. Sen. Franken's third provision would require that the FDA rescind guidance released by the FDA that would increase overly burdensome paperwork for companies seeking approval for their devices, which would cause even more delays.