On the recordMay 22, 2012
Mr. President, I rise in support of the Food and Drug Administration Safety and Innovation Act, which will help speed safe and effective drugs and medical devices to the patients who need them. This bipartisan, consensus bill was developed through a long and collaborative process involving the FDA, stakeholders, and Senators from both sides of the aisle. I commend the chair and ranking member of the HELP Committee for their tremendous leadership and hard work on this very important bill. The legislation we are considering today reauthorizes existing user fee programs for prescription drugs and medical devices and creates new user fee programs for generic drugs and biosimilar biological products. In addition, the bill reauthorizes programs that have helped make medicines safer for children, upgrades the FDA's tools to police the global supply chain, increases incentives for the development of new antibiotics, and expedites the development and review of certain drugs for the treatment of serious or life-threatening diseases and conditions. I particularly want to commend my colleagues for including provisions based on legislation I sponsored with Senator Klobuchar to address the shortages of drugs that are causing significant disruptions in care and putting patients at risk. I continue to hear from doctors, emergency medical personnel, and other medical professionals in Maine who are extremely concerned about this issue.…





