(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA) spoke on the Senate floor about the urgent need to pass the Food and Drug Administration (FDA) Safety and Innovation Act. In her speech, Murray discussed the significance of providing the FDA with the necessary tools to support innovation and provide access to live-saving medicines. Murray also highlighted her Better Pharmaceuticals and Devices for Children Act, which was included in the overall legislation. This provision will make sure children are prioritized in the drug development process.
“Failure to pass this legislation poste-haste will put drug and medical device approval at a standstill — not only halting innovation, but putting the lives of many Americans at risk while they wait for approval of potentially life-saving medicine,” said Senator Murray. “I am thankful my legislation aimed at protecting children in the drug development process was also included. This bipartisan provision will help drug labels provide clear, detailed information about the proper use and dosage of medications for children and it will push to make sure children are never an afterthought when it comes to the safety and effectiveness of our nation’s drugs and medical devices.”
The full text of Senator Murray’s speech follows:
“Thank you, Mr. President.
“I think many of my colleagues here know that we’ve been working together — and with stakeholders and advocates — for over a year on this reauthorization package.
“I would like to commend Chairman Harkin, as well as Ranking Member Enzi, for working together – in a truly bipartisan fashion – to get this to the floor today.
“And I hope my colleagues understand the critical importance of moving forward on this bill as efficiently as possible.
“Because as many of you know, if we do not make this legislation a priority –
“By the end of September, over 2000 employees at the Food and Drug Administration will be sent packing with pink slips.
“And what’s just as important – if not more important –
“Failure to pass this legislation poste-haste will put drug and medical device approval at a standstill –
“Not only halting innovation, but putting the lives of many Americans at risk while they wait for approval of potentially life-saving medicine.
“No one knows the importance of this approval process quite like Seattle Genetics – from my home state of Washington.
“In August 2011, Seattle Genetics received FDA accelerated approval of a drug intended to treat Hodgkin lymphoma – the first of its kind approved by FDA in more than 30 years.
“As a biotechnology company, Seattle Genetics’ relationship with the FDA was vital to the work they were doing to bring this new drug to patients in need.
“Ultimately, Seattle Genetics received FDA approval 11 days earlier than expected.
“This 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 awaiting the drug.
“Mr. President, this kind of collaboration would not have been possible had the FDA lacked the resources necessary to make it a reality.
“And I believe Clay Siegall, President and CEO of Seattle Genetics, was truly able to underscore the issue of what we are discussing here today when 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.
“Mr. President, I’d also like to quickly highlight another part of this legislation I have been very focused on:
“And that is the need to ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children.
“This is so important for families and doctors across America.
“So I 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 proud to work with Senators Reed, Alexander, and Roberts to put this common-sense legislation together.
“This bipartisan language will make sure 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 children don’t expire.
“It will push to make sure children are never an afterthought when it comes to the safety and effectiveness of our nation’s drugs and medical devices.
“Mr. President, as you’ve heard here today, this a bill that has already received bipartisan support and holds the livelihood of so many Americans in its balance.
“I urge my colleagues to move quickly and support this legislation.
“Thank you.”
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