Murray, Stakeholders Meet to Discuss User Fee Reauthorization, Ensure FDA Maintains “High Bar of Safety and Effectiveness” for Patients
Murray: “Moving forward with these agreements is absolutely necessary if Congress wants to advance safe, effective, and innovative medical products for patients and families across the country”
During a hearing on the user fee agreements, Murray warned of efforts by the Trump Administration to “undermine” and “alter” these agreements
Murray called the hearing an “important opportunity” to highlight the need for action on prescription drug prices
Murray also called for additional steps to “prioritize consumer safety and protection”
(Washington, D.C.) – Senator Patty Murray (D-WA), the top Democrat on the Senate Health, Education, Labor, and Pensions (HELP) Committee, today delivered opening remarks at a hearing with stakeholders to discuss the reauthorization of the FDA’s user fee programs, allowing industry to support the FDA’s work to approve drugs, generics, biosimilars, and medical devices while upholding its gold standard of approval and evaluating these products efficiently. In her opening remarks, Murray said she is closely reviewing the user fee agreements to “protect and uphold the deep trust that families place in FDA.”
Senator Murray said the user fee agreements “reflect thorough negotiation” and highlighted key progress in several areas. Senator Murray urged further action on post-market surveillance of medical devices to make sure they are safe and effective for patients. She also highlighted that these agreements can help “foster a robust drug marketplace” to bring down the price of some high cost prescription drugs.
ICYMI, click HERE to watch the full video of today’s hearing: “FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients, Part II”
Key excerpts from Senator Murray’s remarks:
“As we discuss today’s reauthorization, I want to make my priorities very clear: upholding a high bar of safety and effectiveness to protect the public health and drive the development of innovative products, and ensuring FDA has the resources to carry out this important work. A critical part of this is maintaining FDA’s gold standard of consumer safety and protection—a standard patients and families have come to trust—around the world—when making decisions about their health. I hope that’s a goal all of us share. And I am glad that today, we will be able to ask key players from the industry, about the ways you all can—and must—step up to the challenges, not only to help make sure we develop life-saving treatments, but also to make sure these treatments are safe and affordable for patients and families.”
“I am glad that you and I agree that we need to move forward, because these agreements advance several significant priorities. For one, we have restructured our generic agreements to help more small businesses compete in the market. We’ve also put a goal review date on all outstanding generic applications from the backlog, and prioritized products that can have the biggest impact on costs for consumers. For biosimilars—we continue to build the program up, and provide greater clarity and support for product developers. We have worked to increase accountability, reduce administrative burden.”
“While I was pleased that some of the medical device user fees will support this system, I am very disappointed that the medical device industry has explicitly refused to support any post-market safety activities through fees. Patients and families in my home state of Washington and nationwide deserve to know that the devices used in their care are safe and effective. And I am going to continue fighting for this until we get meaningful safeguards in place so we can detect problems early.”
“Critically, today’s hearing is also an important opportunity to discuss the related, larger issue of prescription drug affordability in our country. The astronomical cost of prescription drugs is a financial hardship for so many patients, families, and communities. And we need to face up to the tough questions. We need to come together across the aisle to address a system that’s not working, hurting patients and families, and adding to the increasing cost of our health care system…this is something this Committee must address this Congress. While we work on the User Fee Reauthorization I will continue to work with my colleagues on both sides of the aisle on solutions to address this issue facing too many American families.”
Full text of Senator Murray’s opening remarks:
Thank you, Chairman Alexander, all of my colleagues, and our witnesses for joining us.
I am glad we are able to move forward with today’s important discussion—without the dark cloud of Trumpcare looming over us—at least for now. Millions of families spoke out clearly about how Trumpcare would have been an absolute disaster for them. It would have kicked millions off their health care, spiked premiums, gutted Medicaid, and I could go on.
And, as Democrats on this Committee made very clear, had Republicans jammed Trumpcare through the Senate, without this Committee holding a single hearing, would have continued this Committee's move into partisanship and gridlock—which has started with our rushed nomination process—and put at grave risk our ability to work together on shared priorities.
So I am very glad that Trumpcare was roundly rejected—and that more and more Republicans are finally accepting what so many of us had been saying for years: that we should be working together to make health care more affordable, accessible, and higher quality.
Because people are looking to us, particularly in this Committee, to come together on real, bipartisan solutions. And the issue before us today—User Fee Reauthorization—is a chief example of how we can work together to help patients and families.
As we discuss today’s reauthorization, I want to make my priorities very clear: upholding a high bar of safety and effectiveness to protect the public health and drive the development of innovative products, and ensuring FDA has the resources to carry out this important work.
A critical part of this is maintaining FDA’s gold standard of consumer safety and protection—a standard patients and families have come to trust—around the world—when making decisions about their health. I hope that’s a goal all of us share. And I am glad that today, we will be able to ask key players from the industry, about the ways you all can—and must—step up to the challenges, not only to help make sure we develop life-saving treatments, but also to make sure these treatments are safe and affordable for patients and families.
The finalized user fee agreements for drugs, generics, biosimilars, and medical devices reflect thorough negotiation between FDA and these industries, and incorporate input from patient and consumer groups. While Congress should be providing the FDA with greater investments to support its critical work, the user fees paid by the industry are essential to supporting FDA’s operation and mission.
These fees help FDA meet the complex challenges of 21st century technology and the movement toward precision medicine. And, especially in today's budget environment, the agreements help ensure that FDA can uphold its gold standard of approval, while evaluating new drugs and devices efficiently.
Moving forward with these agreements is absolutely necessary if Congress wants to advance safe, effective, and innovative medical products for patients and families across the country. Without these agreements, the agency would be unable to do its job effectively. So I oppose efforts by the Trump Administration to take unprecedented actions to alter these agreements, or to undermine the important public health work of the agency.
I am also concerned that the Administration is hampering the FDA by depriving it of key staff and blocking its ability to issue the guidance and regulation needed to foster innovation. And I was disturbed that the Trump administration went so far as to muzzle the FDA Center Directors that were before our Committee to discuss the user fees two weeks ago, from being able to discuss the crippling consequences of these dangerous proposals.
Mr. Chairman, I am glad that you and I agree that we need to move forward, because these agreements advance several significant priorities. For one, we have restructured our generic agreements to help more small businesses compete in the market.
We’ve also put a goal review date on all outstanding generic applications from the backlog, and prioritized products that can have the biggest impact on costs for consumers. For biosimilars—we continue to build the program up, and provide greater clarity and support for product developers. We have worked to increase accountability, reduce administrative burden.
And, these agreements advance many of the policies we passed as a part of 21st Century Cures, like making sure patients’ perspectives are considered in drug and device development, and advancing the science on biomarkers. But as I’ve talked about before, we must take additional steps to prioritize consumer safety and protection by increasing the post-market surveillance of medical devices.
The medical device industry produces amazing innovations for patients, and I am proud to have a robust medical device sector in my home state of Washington. The National Evaluation System for Health Technology, known as NEST, is a project started by FDA and several health care industry partners to better harness information from registries, electronic health records, and medical claims to inform product development and safety.
While I was pleased that some of the medical device user fees will support this system, I am very disappointed that the medical device industry has explicitly refused to support any post-market safety activities through fees. Patients and families in my home state of Washington and nationwide deserve to know that the devices used in their care are safe and effective. And I am going to continue fighting for this until we get meaningful safeguards in place so we can detect problems early.
Critically, today’s hearing is also an important opportunity to discuss the related, larger issue of prescription drug affordability in our country. The astronomical cost of prescription drugs is a financial hardship for so many patients, families, and communities. And we need to face up to the tough questions.
We need to come together across the aisle to address a system that’s not working, hurting patients and families, and adding to the increasing cost of our health care system.
Mr. Chairman, while drug pricing is outside of the FDA’s jurisdiction and the most robust solutions likely involve HHS and CMS, this is something this Committee must address this Congress. While we work on the User Fee Reauthorization I will continue to work with my colleagues on both sides of the aisle on solutions to address this issue facing too many American families.
These user fee agreements will accelerate implementation of the biosimilars pathway and improve the generic drug approval process. These steps will foster a robust drug marketplace that may help to bring down the price of some high cost drugs. But let’s be clear—these tweaks alone will not solve the problem.
More work is needed—outside the FDA context and outside this Committee’s jurisdiction—to address the root cause of high prices. And I will be speaking with you, Mr. Chairman, and Chairman Hatch about where we can address this issue as this and other related legislation moves forward in the weeks ahead.
To conclude, as we all know, this Committee has a strong tradition of bipartisan success in these user fee agreements, and I’d like to keep it that way. I am hopeful we can move beyond the failed Trumpcare proposal and work together to build on the progress we've made in our health care system.
I am confident that if we all join together—toward the common goal of ensuring our health care system works for families and puts their needs first.
We can make real progress, move toward a bipartisan discussion draft, and deliver the results that so many families are desperately waiting for.
I’ve laid out some key principles that I will be very focused on to protect and uphold the deep trust that families place in FDA. And again, I look forward to a robust conversation with our witnesses on these priorities.
Thank you, Mr. Chairman.
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