Senator Murray Presses FDA Leaders On COVID Vaccines for Kids, Fentanyl Deaths, Lowering Costs, and More at Hearing on User Fee Programs

Statement

Today, U.S. Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, chaired a hearing with Food and Drug Administration (FDA) officials on reauthorizing the FDA user fee programs. During the hearing, Senator Murray reiterated her commitment to work in a bipartisan way to ensure the programs are reauthorized in a timely manner so the FDA isn't forced to send out pink slips--but made clear there is an urgent need to take action on a host of issues the FDA is still struggling to address, including providing lower-cost drugs more quickly and addressing the opioid crisis and the proliferation of fentanyl.

"I'm glad to be working with Senator Burr and our colleagues on the Committee to get this done, once again, in a timely manner," said Senator Murray. "But it should also be unthinkable that we would let this moment slip by without looking carefully at what is, and what isn't, working at FDA. … There are countless issues right now that families in Washington state are struggling with, but which FDA is struggling to address. We have to make sure the approval process works for families--not just pharmaceutical companies' bottom lines. That means better steps to ensure drugs work for everyone--such as increased diversity in clinical trials and pediatric drug research. It means ensuring the accelerated approval pathway benefits patients. And it absolutely means lowering drug costs that have been skyrocketing for years and leaving patients with impossible choices."

During the hearing, Senator Murray pressed FDA officials on the delay in finally allowing hearing aids to be sold over-the-counter, and pushed agency officials for clarity on the timeline for approving COVID-19 vaccines for young children. She also again called on FDA leadership to address longstanding dysfunction and delay in the agency's food safety and nutrition efforts.

"Recent reporting has put a spotlight on issues with FDA's food safety and nutrition efforts, including several that have frustrated me for a long time. … So I'm going to keep pressing for answers from FDA leadership on how they will end the pattern of delay and dysfunction here because FDA's mission when it comes to ensuring our food is safe and healthy is too important to be on the agency's back burner," said Senator Murray.

"I also want FDA to make good on the promise of a law we worked in this Committee to pass half a decade ago and finally let hearing aids be sold over-the-counter, and at lower cost, to millions of people. There's simply no good reason we are still waiting for FDA to implement this step and save millions of people thousands of dollars," added Senator Murray.

Senator Murray also continued to stress the need for Congress to provide resources for our COVID response to ensure every community has the tests, treatments, and vaccines it needs to keep people healthy and safe.

Senator Murray's opening remarks, as prepared for delivery, are below:

"Before we discuss the importance of the user fee programs to FDA's drug and device work--recent reporting has put a spotlight on issues with FDA's food safety and nutrition efforts, including several that have frustrated me for a long time.

"And while some important steps on nutrition and safety have been stalled for years, we have also seen more recent threats met with a frustratingly slow response, like arsenic and other heavy metals in baby foods or contaminated infant formula, which FDA first received complaints about last September, but was only recalled earlier this year.

"So I'm going to keep pressing for answers from FDA leadership on how they will end the pattern of delay and dysfunction here because FDA's mission when it comes to ensuring our food is safe and healthy is too important to be on the agency's back burner.

"Because people in Washington state depend on the FDA doing its job--quickly and carefully--every single day, in more ways than they even realize.

"Whether they are getting a meal, a prescription, an ultrasound, or almost anything in between, they are putting the well-being of themselves and their families in FDA's hands.

"We owe it to them to make sure FDA has everything it needs, and is doing everything it can to live up to that huge responsibility.

"And the user fee programs have an important role to play when it comes to FDA's work ensuring the safety and effectiveness of medical products families rely on to stay healthy.

"These programs make sure that as FDA gets more new drugs or devices to consider for approval--as it gets more critical work to do--it also gets more resources to support that work.

"Given the importance of these programs for keeping families safe, Congress has regularly reauthorized them in a bipartisan way. And I'm glad to be working with Senator Burr and our colleagues on the Committee to get this done, once again, in a timely manner.

"Because it should be unthinkable that, after two years when FDA's work has been more important than ever, we would fail to get this done and force the agency to send pink slips.

"But it should also be unthinkable that we would let this moment slip by without looking carefully at what is, and what isn't, working at FDA.

"That starts with looking back at this pandemic from FDA's incredible work to quickly review and approve safe, effective vaccines to the challenges it faced like misinformation and political interference from the previous Administration to other issues we saw like the constant struggle with testing shortages, the hydroxychloroquine debacle, and the ongoing frustration parents are dealing with because of unclear timelines for vaccines for young children--which I am expecting answers about at this hearing.

"We need to learn from these challenges--something Senator Burr and I have already started to work on in our PREVENT Pandemics Act.

"But we need to look beyond this pandemic as well because there are countless issues right now that families in Washington state are struggling with, but which FDA is struggling to address.

"We have to make sure the approval process works for families--not just pharmaceutical companies' bottom lines. And that patients are having their voices heard and concerns addressed by FDA.

"That means better steps to ensure drugs work for everyone--such as increased diversity in clinical trials and pediatric drug research. It means ensuring the accelerated approval pathway benefits patients.

"And it absolutely means lowering drug costs that have been skyrocketing for years and leaving patients with impossible choices.

"That's why I want to cap insulin costs at $35 dollars a month. And it's why I also want to take steps so FDA can do more to bring down barriers that block cheaper generics and biosimilars from getting to market, and stop pharmaceutical companies who game the FDA system to block competition from cheaper drugs.

"I also want FDA to make good on the promise of a law we worked in this Committee to pass half a decade ago and finally let hearing aids be sold over-the-counter, and at lower cost, to millions of people.

"There's simply no good reason we are still waiting for FDA to implement this step and save millions of people thousands of dollars.

"We also need to be looking at what more we can do to address substance use disorders and the opioid crisis--as overdose deaths keep setting record highs, and fentanyl is wreaking havoc in our communities.

"And while there is clearly more we can do to strengthen FDA's oversight of drugs and devices, there are also an alarming number of products that currently get no meaningful oversight.

"When it comes to cosmetics, we have discovered known carcinogens like asbestos and formaldehyde in baby powder, children's make-up kits, and hair products.

"And when it comes to dietary supplements, people across the country are faced with a shelf full of products that make health claims--but lack oversight.

"FDA does not have the authority to collect basic information about these products--or even to know what's on the market.

"People in Washington state buy, use, and entrust their health to these items every day. They deserve to know these products are safe, are vetted, and are subject to careful FDA oversight.

"So I hope we'll be able to make progress on all of these issues, and more, as we work to reauthorize the user fee programs.

"I look forward to hearing from our witnesses about these challenges and more today and working with my colleagues on both sides of the aisle to address them in bipartisan way.

"And as we look at how to support FDA's work, I hope we can also make progress soon on the urgently needed funding for our COVID response.

"We've got to get this done--because families are counting on us to provide communities the tests, treatments, and vaccines they need to keep people healthy, protect our hard won progress against this pandemic, and keep our country ready for whatever comes next.

"Now I'll turn it over to Ranking Member Burr for his opening remarks."

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