Food and Drug Administration Safety and Innovation Act

Floor Speech

BREAK IN TRANSCRIPT

Mr. BENNET. Mr. President, I came to the floor tonight to talk about the FDA reauthorization bill that is before the Senate. I was sorry we could not get it to a vote today. I am hopeful that tomorrow we will be able to because from my perspective, as someone who has only been here for a few years, the process, the committee process that led to the creation of this bill, is a model for how this town ought to be working.

The conversation we have had for so many months and even years has felt decoupled from the conversations I have been having in my townhall meetings and across the country about the challenges we need to address. This gap has been miles apart. But in this piece of legislation, I think we have actually found something responsive to patients, responsive to consumers, and responsive to the bioscience industry that is so important to my State and so many States across the country.

Chairman Harkin and Ranking Member Enzi deserve enormous credit for running an excellent process that has enabled this Senator and others on the committee to be responsive to what our constituents say they want, which is a modern FDA with improved patient safety and innovation. We have also had committee members who were interested in rolling up their sleeves and doing hard work together irrespective of which party they were in. We have been able to work through a markup with virtually no partisanship.

This has been a uniquely fine process, which is why we have had such great momentum toward a full extension in what I call the Land of Flickering Lights. The standard of success around here has become: Keep the government running for 1 more month, keep this extension in place for 2 more months. We actually have on the Senate floor a rational and responsible bill that is a 5-year extension of the Food and Drug Administration authority.

Tonight I only want to talk about two aspects of the bill. There are a number we worked on, but tonight I spare you with the rest. In 2010 I introduced a bill called the Drug Safety and Accountability Act. Chairman Harkin and Ranking Member Enzi took notice, and we were able to form a working group to address serious problems in the FDA's statutory authority.

FDA laws that are supposed to protect our domestic drug supply were created in 1938 and desperately needed to be updated for the 21st century. Back then the lines of commerce were based on 48 States. Now we live in an era where over 80 percent of the active ingredients in our pharmaceuticals and our drug supply are being manufactured abroad. Couple that with the FDA laws that force them to inspect American facilities every 2 years but they have no mandates on how often they inspect facilities overseas. The GAO has found that FDA can only keep pace with inspecting the most high-risk overseas facilities, the places where our moms and dads are getting their pharmaceuticals for our children, once every 9 years.

So patients taking their pills have no idea whether the ingredients in their drugs were made in China or India or if they were ever inspected. Our American manufacturers are operating on an uneven playing field. They have to expect a surprise FDA inspection every 2 years on average here and make sure they are following all of their good manufacturing practices, when their foreign counterparts do not have to worry about FDA visiting them for a decade, if ever, because they can delay or refuse FDA inspection because they are overseas.

Patient groups and the industry came together to try to change that, and this bill does change all of that. It would implement a risk-based inspection schedule for both foreign and domestic manufacturing sites. It would make sure that drug manufacturers know who is in their supply chain every step of the way. And for the first time, if you are abroad and you refuse or delay inspection without a fair reason, the FDA can refuse to let your product into this country.

These are all the steps American families already think we have in place to protect them. I cannot tell you how many townhalls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected by anyone. This will change that. It is a thoughtful, commonsense approach I think all of the constituents to this debate support.

So we need to make sure that happens. I also want to talk about something called track and trace. American families also want to know what happens to their pills, pills that can mean the difference between life and death, once they leave the manufacturer, enter the country and change hands several times. Right now we can know a lot more from a bar code on a gallon of milk than from a bar code on medication. That seems absurd to people at home.

I take a moment again to thank the Chair and ranking member for their commitment to working together to meet the challenge of developing a uniform traceability system. This is something that has been worked on for over a decade in this town, and we are finally this close to making it the law of the land.

I thank, in particular, my colleague, Richard Burr, a Republican from North Carolina, for being such a great partner in this work. FDA, the HELP Committee staff, Pew, and other stakeholders across the supply chain have been meeting for weeks with my staff and with Senator Burr's staff, all in good faith. Our goal is to finalize a plan after we wrap up this Senate bill.

Let me talk about another very exciting part of this bill. If we pass this bill, for the first time the FDA is going to be able to apply 21st-century science to the approval of drugs, particularly drugs that are breakthrough medications, drugs that we know will work in one subset of populations even if they might not work so well in another.

This is very important to cancer patients all across the United States who are looking to access these breakthrough therapies. So from the standpoint of driving an industry in this country that in my own State has a median salary of roughly $74,000, and from the point of view of patient health and protecting our supply chain, this FDA reauthorization is a must pass.

I thank the members of the committee and especially the chairman and the ranking member for establishing a model for how this Senate should operate.

BREAK IN TRANSCRIPT

Source