Sen. Carper Celebrates Final Passage of FDA Safety and Innovation Act

WASHINGTON – Today, Sen. Tom Carper (D-Del.) celebrated the final passage of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), which would reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). The bill now goes to the President’s desk for his signature:

“A top priority for Congress and the Obama Administration is job preservation and job creation. The American people want both parties in Congress to work together to create a nurturing environment for businesses large and small to create more jobs. I am encouraged that my colleagues in both Chambers were able to put partisanship aside to pass another critical bill that not only helps foster a nurturing environment for businesses to thrive, but also saves lives and reduces our deficit by $311 million over 10 years.

“This bill helps ensure that Americans get access to the life-saving medications and medical devices that are developed in this country – including Delaware – as soon and as safely as possible. It improves the Food and Drug Administration’s ability to review and regulate drugs and medical devices for adults and children. This legislation also helps to protect patients’ access to critical medicines by creating new programs to incentivize the development of new antibiotics and reduce drug shortages. Patients, health care providers, and the pharmaceutical and medical device industries will all benefit from a more responsive and effective Food and Drug Administration– a win-win for Delaware consumers and businesses.

“Moreover, this bill encourages a strong environment for research and innovation in biotechnology and biosciences in this country, crucial to the continued success of local companies like Incyte, Siemens, and AstraZeneca. As a result, this bill leads to the creation of new pharmaceutical and medical device industry jobs, and enhances America’s global leadership in biomedical innovation.

“This bill is the kind of action that we need more of in Congress today and I was proud to champion this legislation on behalf of Delaware’s consumers and businesses. I look forward to its enactment.”