Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Continued

Floor Speech

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Mrs. MURRAY. Mr. President, I too wish to thank the Senator from Tennessee, as he referred to how we are working together on a bipartisan basis on the Better Pharmaceuticals and Devices for Children Act--a very critical piece of this legislation that I will talk about in just a few minutes as well. But I would like to thank him for working with us, and really I want to thank all of the Senators who worked very hard on this piece of legislation, working with stakeholders and advocates for over a year on the bill that will be on the floor later this afternoon. I commend Chairman Harkin as well as Ranking Member Enzi for working together in a bipartisan fashion to get this to the floor today.

I hope all of our colleagues really understand the critical importance of moving forward with this bill as efficiently as possible because, as many people know, if we do not make this legislation a priority, by the end of September over 2,000 employees at the Food and Drug Administration are going to be sent packing with pink slips. But what is just as important, if not more important, is that failure to pass this legislation will put drug and medical device approval at a standstill. That will not only halt innovation but it will put the lives of many Americans at risk while they wait for potentially lifesaving medicine.

No one knows the importance of that more than Seattle Genetics, a company in my home State of Washington. In August of last year, Seattle Genetics received FDA accelerated approval of a drug intended to treat Hodgkin's lymphoma, the first of its kind approved by the FDA in more than 30 years.

As a biotech company, Seattle Genetics' relationship with the FDA was really vital to the work they were doing to bring this drug to patients who were in need. Ultimately, Seattle Genetics received FDA approval 11 days earlier than expected, and that meant they were able to anticipate the timing of its approval, organize their sales teams, and ship the first business day following approval for a patient already waiting for that critical drug. That kind of collaboration would not have been possible had the FDA lacked the resources necessary to make it a reality.

I believe that Clay Siegall, who is the president and CEO of Seattle Genetics, was truly able to underscore the issue of what we are discussing here today. I want to tell you what he said.

It is only through working with an FDA--that has the resources and dedication to achieve thorough and timely reviews--that we are able to fulfill our promise to improve the lives of people through innovation. Passage of this bill helps to provide both the resources and incentives for FDA to rapidly review and approve important therapeutic breakthroughs for patients in need.

That highlights the importance of this legislation.

I also wish to highlight another part of this bill that I have been very focused on, as the Senator from Tennessee just talked about, and that is the need to make sure drugs and medical devices are specifically tested and labeled and proven to be safe and effective for our children. This is so important for families and doctors across America.

I really want to thank Chairman Harkin as well as Ranking Member Enzi for including my bill, the Better Pharmaceuticals and Devices for Children Act, in the broader legislation we are considering here today.

I was very proud to work with Senator Alexander, along with Senators Reed and Roberts, to put together this commonsense legislation. This bipartisan language will make sure our children are prioritized in the drug development process and that drug labels provide clear, detailed information about the proper use and dosage of medications for children. It will give parents and doctors more information, and it will make sure the key programs we count on to protect our children do not expire. It will push to make sure children are never just an afterthought when it comes to the safety and effectiveness of our Nation's drugs and medical devices.

Mr. President, as you have heard today, this is a bill that has received bipartisan support. I commend all of the Senators who have worked on it in a bipartisan way. We don't get credit for that enough in this country. But this is certainly one where everybody came together and worked together in committee. This bill holds the livelihood of so many Americans in its balance.

I urge the Senate to move forward quickly and support the legislation and get it passed.

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