Sen. Carper Commends Senate Passage of FDA Safety and Innovation Act

WASHINGTON – Today, Sen. Tom Carper (D-Del.) commended the Senate 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):

“A top priority for Congress 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. Over the last year, the Senate has worked productively across party lines to pass a series of bills that will create that nurturing environment. I am encouraged to see that the Senate has once again put partisanship aside to pass another critical bill that not only helps foster a nurturing environment for businesses to thrive, but also saves lives.

“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. By adding important new user fee programs for generic and biological drugs, the measure delivers safer drugs and a speedier process that brings new and less expensive drugs and medical devices to market more quickly – a win-win for Delaware consumers and businesses. This bill also makes medicines safer for millions of children, improves the FDA’s tools to police the global drug supply chain, incentivizes the development of new antibiotics, and reduces drug shortages.

“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. It expands patient access to new therapies, 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 commend Senators Harkin and Enzi for their tireless leadership in getting this bill passed in a bipartisan manner. I am proud to continue to fight for this bill on behalf of Delaware’s consumers and businesses and I hope my colleagues in the House act quickly to pass this legislation.”