U.S. Sen. Al Franken (D-Minn.) said today that two key provisions he authored to get life-saving medical devices to patients more quickly and safely are soon expected to become law. Sen. Franken made the below statement after the Senate approved the final version of the Food and Drug Administration (FDA) Safety and Innovation Act today and sent it to the President for his signature.
"Because of this bill, Minnesotans will now be able to access to innovative and potentially life-saving medical devices more quickly and safely," said Sen. Franken. "I'm pleased that the provisions I wrote into the bill will improve the way medical devices get to the patients that need them, and I urge the President to sign this critical bill into law as soon as possible. I am proud that Minnesota is a world leader in producing life-saving devices, and I will continue to champion a more transparent and predictable FDA approval process."
Sen. Franken was a key member of a bipartisan group of Senate 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 withdraw guidance released by the FDA that could have created new and burdensome requirements for companies making changes to their approved devices, which would cause even more delays.