Amy Klobuchar: “I rise today to talk about the importance of passing the Food and Drug Administration Safety and Innovation Act, more…”

“I rise today to talk about the importance of passing the Food and Drug Administration Safety and Innovation Act, more commonly known as the user fee reauthorization bill. This bipartisan legislation would reauthorize the user fee program for the medical device industry, incredible important in my home State of Minnesota, as well as the pharmaceutical industry. This bill represents over 1 year of negotiations between the FDA, Congress, and the industry. I believe we have achieved a good balance in terms of the improved performance, incentives through increased accountability, more meaningful goals, important process improvements, better metrics, and additional resources. Not only does this legislation include the user fee agreements negotiated between the industry and the FDA, it also includes several reforms that will benefit the entire health care system and improve public health. The bill will make medicines safer for children. It will protect the global drug supply chain. It will improve access to safe, innovative medical devices and treatments, and it will tackle the drug shortage crisis that is spreading across the country. On Monday I talked about the work I did leading the effort on drug shortages. I am so pleased that Senator Harkin and Senator Enzi included this provision in this bill. But I also believe it is important to talk about the guts of the bill; that is, the improvements with the FDA and the work that needs to be done.…”