Senator Dan Coats (R-Ind.) today issued the following statement after voting for the five-year reauthorization of the Food and Drug Administration (FDA) Safety and Innovation Act, legislation that approves user fee agreements negotiated by the FDA with the drug and medical device industries and includes proposals to streamline FDA's review and approval of medical products. The bill also establishes new user fee programs for generic drugs and generic biologics or biosimilars.
"This bipartisan bill is a win for Hoosier patients, the drug and device industries and the agency," said Coats. "This legislation will improve patients' access to advanced medical devices, enable the pharmaceutical and medical device industries in Indiana to continue to be a global leader, and help address the growing drug shortage crisis in our country."
"Passage of this bill is also a great example of how Congress should work. Both parties drafted the legislation in committee, debated it on the floor, offered amendments and voted to send the bill to the president," added Coats. "The Senate works when the Majority Leader allows it to work."
The legislation passed the Senate today 92 to 4 and now will head to the president to be signed into law.