Senator Murray Stresses Importance of Putting Families First, Lowering Drug Costs at Hearing on Reauthorizing FDA’s User Fee Programs
Senator Murray: “We have to make sure the approval process works for families—not just pharmaceutical companies’ bottom lines.”
(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a hearing on reauthorizing the Food and Drug Administration’s (FDA) user fee programs. At the hearing, Senator Murray made clear she is working in a bipartisan way to reauthorize the user fee programs, which expire this fall, in a timely manner—to avoid the FDA having to hand out pink slips if the Senate fails to get this done.
“Congress has regularly reauthorized the user fee programs 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,” added Senator Murray.
However, Senator Murray made clear that, as these programs are reauthorized, business as usual won’t cut it—steps must also be taken to ensure a stronger FDA response to challenges like skyrocketing health care costs, public health emergencies, and oversight of cosmetics and dietary supplements, and more.
“Just as it should be unthinkable that we would fail to learn the lessons of this pandemic—including lessons for FDA… And beyond pandemic response, it’s clear we can’t simply settle for business as usual. Because when you look at issues like the exorbitant cost of prescription drugs, the lack of diversity in clinical trials, the scourge of opioids, especially fentanyl, the lack of oversight for dietary supplements and cosmetics, and how long it took to get contaminated baby formula off the market—it is clear to me, and to people back in Washington state, that business as usual isn’t good enough,” said Senator Murray.
During her questions, Senator Murray focused on the importance of bringing down health care costs, and pressed witnesses on the importance of getting cheaper generic drugs to market and the need to stop pharmaceutical companies from gaming the system to block competition.
Senator Murray’s opening remarks, as prepared for delivery, are below:
“Every day, families in Washington state, and across the country, count on the Food and Drug Administration to keep them safe—more times than they even realize.
“Whether we are getting a meal, a prescription, an ultrasound, or almost anything in between, we have the FDA to thank for reviewing the data, inspecting the supply chain, holding companies accountable, and taking unsafe products off the market.
“It’s no small task ensuring the safety of nearly 80 percent of our nation’s food supply, inspecting thousands of food, drug, and device manufacturing sites each year, and, of course, quickly and carefully reviewing the data on new, and potentially lifesaving medical products.
“And as we’ve seen throughout this pandemic—this work is incredibly important.
“Which is why it is also important we reauthorize the user fee programs—which ensure as FDA gets new drugs or devices to consider for approval, as it gets more potentially lifesaving work to do, it also gets more resources to support that work.
“Congress has regularly reauthorized the user fee programs 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.
“Just as it should be unthinkable that we would fail to learn the lessons of this pandemic—including lessons for FDA—like how we can get tests to families sooner or how we can avoid political interference like we saw during the Trump Administration, including the reckless push for unproven treatments like hydroxychloroquine.
“Or how we can improve transparency and communication to prevent some of the confusion and frustration we’ve seen around the timelines for booster shots, and vaccines for young children.
“And beyond pandemic response, it’s clear we can’t simply settle for business as usual.
“Because when you look at issues like the exorbitant cost of prescription drugs, the lack of diversity in clinical trials, the scourge of opioids, and especially fentanyl, the lack of oversight for dietary supplements and cosmetics, and how long it took to get contaminated baby formula off the market—it is clear to me, and to people back in Washington state, that business as usual isn’t good enough.
“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 lower costs. Because even a miracle cure is no help if it’s too expensive for people who need it.
“We need to fight skyrocketing health care costs with every tool in our arsenal—from stopping pharmaceutical companies who game the FDA system to block competition and keep cheaper drugs off the shelves, to bringing down barriers that block cheaper generics and biosimilars from getting to market, to finally making good on legislation Congress passed to let hearing aids be sold over the counter, and at lower cost, for millions of people.
“I worked with many colleagues on this Committee to pass this into law half a decade ago, and I’m incredibly frustrated FDA has not been focused on helping so many Americans.
“There’s just 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 do more to protect families from dangerous products that have gone for too long with too little scrutiny.
“When it comes to cosmetics, products people put on their face, rub into their skin, and more, 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 who are looking to make healthy choices, are faced with a shelf full of products that make health claims, but lack rigorous oversight.
“Yet FDA does not have the authority to collect basic information about these products—or even to know what’s on the market.
“That just makes no sense. 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 the same type of careful FDA oversight people rely on when it comes to food, drugs, and medical devices.
“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.
“All of us on this Committee are grateful for the tireless work of FDA scientists during this pandemic to review and authorize safe and effective tests, treatments, and, of course, vaccines for COVID-19.
“And we’re grateful for the constant work they do to ensure the safety of our food supply, provide people with the information they need to make healthy choices, and to uphold the gold standard of safety and effectiveness for drugs and medical devices.
“But the FDA doesn’t run on gratitude.
“So I look forward to today’s conversation on the user fee programs—and to working with my colleagues on bipartisan legislation that supports—and strengthens—FDA’s ongoing work by reauthorizing these programs, and taking additional steps to lower drug costs, increase diversity in clinical trials, ensure the safety of cosmetics and dietary supplements—and more.
“Now, I’ll turn it over to Ranking Member Burr for his opening remarks.”
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