Senate overwhelmingly passes FDA Reauthorization Act
Today’s vote culminates negotiations spearheaded by Senate HELP Chairman Alexander, Ranking Member Murray
New user fee agreements will take effect October 1st; Agreements reflect input from FDA, industry, patient and consumer groups
In floor speech, Murray hailed bill as “chief example of how Congress can actually work together on health issues”
(Washington, D.C.) – Today, the U.S. Senate overwhelmingly passed the FDA Reauthorization Act of 2017, bipartisan legislation spearheaded by Ranking Member Patty Murray (D-WA) and Chairman Lamar Alexander (R-TN) of the Senate HELP Committee to reauthorize FDA’s so-called “user fee agreements.” These agreements allow industry to support the FDA’s work to facilitate the development and review of new drugs, generics, biosimilars, and medical devices and uphold the agency’s mission to protect the public by assuring these products are safe and effective for patients and families.
These agreements reflect years of thorough negotiations and support urgent priorities, such as: restructuring the generic drug user fees to help more small businesses compete in the market, placing a goal review date on all backlogged generic applications, building up the biosimilars program to provide clarity and support for product developers, making sure patients’ perspectives are considered in drug and device development, and advancing many of the policies passed as a part of 21st Century Cures.
“I’m very pleased that we were able to show people across the country just what is possible when Democrats and Republicans put partisanship aside and work together to put patients and families first,” said Ranking Member Murray. “With this bill, we have taken an important step in the right direction to advance safe, effective, and innovative medical products for patients and families across the country. I appreciate the work put in by the Obama administration to negotiate the user fee agreements and the work by Chairman Alexander and so many of my colleagues on both sides of the aisle to get this bill across the finish line. I am hopeful that we can build on this bipartisan action and keep working to make health care more affordable, more accessible, and higher quality.”
By passing this bill, Murray and her colleagues prevented layoff notices from being sent to more than 5,000 FDA employees and delays in the reviews of critical drugs and devices. In a floor speech before the bill’s vote, Murray applauded members for coming together “toward the common goal of ensuring our health care system works for families and puts their needs first.”
Full text of Senator Murray’s floor speech:
Thank you, M. President.
I am very pleased that we are moving forward on the FDA Reauthorization Act today.
This is a chief example of how Congress can actually: work together on health issues, compromise, and solve challenges by putting patients and families first.
As my colleagues know well, these so-called user fee agreements are essential to supporting FDA’s operation and mission.
They allow FDA to meet the complex challenges of 21st century technology and the movement toward precision medicine.
And they help ensure that FDA upholds the gold standard of approval, while evaluating new drugs and devices efficiently.
Put simply, passing the FDA Reauthorization Act is absolutely necessary if Congress wants to advance safe, effective, and innovative medical products for patients and families across the country.
And I would add, M. President, when we pass this reauthorization today, more than 5,000 employees at FDA will be able to continue their critical work without worry of interruption—employees that work every day to protect the health of our families and advance medical innovations to patients.
And so I’m very pleased to have worked alongside the Chairman of the HELP committee, the senior Senator from Tennessee, and all our colleagues on and off the committee to bring to the floor these finalized agreements.
These agreements reflect truly years of thorough negotiations between FDA and industry, incorporate input from patient and consumer groups…
And support some of our most urgent priorities, such as restructuring the generic drug user fees to help more small businesses compete in the market, and placing a goal review date on all backlogged generic applications; building up the biosimilars program to provide clarity and support for product developers; making sure patients’ perspectives are considered in drug and device development; and advancing many of the policies we passed as a part of 21st Century Cures.
In addition to the agreements, M. President, the FDA Reauthorization Act includes priorities and provisions from members across the political spectrum.
And so I want to thank again Chairman Alexander and my colleagues for all their efforts, in particular Senators Casey, Franken, and Warren on their work to improve medical device safety; Senators Hassan and Young on their provision to get better information to providers about opioids; Senators McCaskill, Franken, and Collins for their commitment to improving the generic drug market; and Senators Bennet, Van Hollen, and Rubio for their drive to get new medicines for kids with cancer.
I also want to thank my staff and Chairman Alexander’s staff, who worked so well together over many months of hard work to get us to this critical point—thank you.
So M. President, this bill advances several significant, bipartisan priorities that I’m proud to support.
As many know, the HELP committee has a strong tradition of bipartisan success in these user fee agreements.
I’m proud to say that we’ve kept it that way.
And once more, M. President, this bill demonstrates that we can come together—Democrats and Republicans—toward the common goal of ensuring our health care system works for families and puts their needs first.
We can make real progress, and deliver the results that so many families desperately need.
Thank you and I yield the floor.