In a 13-9 vote, HELP Committee approves comprehensive legislation to reauthorize FDA’s user fee programs, keep families safe, lower drug costs, and bolster innovation
In FDA bill, Murray strikes historic, bipartisan deal to allow prescription drug importation from Canada to lower costs for patients across the country
Legislation also includes new steps to hold FDA and manufacturers accountable to address infant formula shortage
HELP Committee passes RISE & SHINE Act—the Committee’s most comprehensive retirement security package in a decade
***WATCH: Senator Murray’s opening remarks***
(Washington, D.C.) – Today, the Senate Health, Education, Labor, and Pensions (HELP) Committee—led by Chair Patty Murray (D-WA)—advanced five bipartisan bills out of committee, including the most comprehensive Food and Drug Administration (FDA) legislation the committee has considered in years, which includes historic provisions to allow prescription drug importation from Canada to lower costs for families. The Committee also advanced legislation to strengthen Americans’ emergency savings and retirement security—the most comprehensive retirement security package the Committee has considered in a decade.
FDA Safety and Landmark Advancements (FDASLA) Act
Today, the Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act by a vote of 13-9. The comprehensive package, which was based on legislation Chair Murray and Ranking Member Richard Burr (R-NC) introduced last month following release of their discussion draft, reauthorizes the FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements to ensure the agency has the resources it needs to fulfill its mission and protect families’ health and safety, and includes historic provisions to allow prescription drug importation from Canada to lower costs for families.
The bipartisan legislation will:
“Families in Washington state, and across the country, desperately need the FDA to live up to its responsibility,” said Senator Murray. “This legislation will make for a stronger FDA, with more resources to carry out its work, more authority to oversee products families entrust their health to every day, and more accountability to guarantee FDA is fulfilling its mission and putting patients and families first.”
Speaking on the inclusion of a bipartisan provision to allow for the safe importation of prescription drugs from Canada, Senator Murray said, “Let’s be clear, this bill will help peoples across the country, from Washington state to Vermont, get safe drugs at cheaper prices by allowing importation from Canada—that’s a really big deal. This policy is a significant change that will meaningfully lower costs for patients. To my knowledge, this is the first time ever that a user fee reauthorization bill has included policy expanding importation of prescription drugs, and I believe it will set us up well to make further progress in the future.”
Legislative text of FDASLA as introduced last month is available HERE.
The managers’ amendment the Committee passed is available HERE.
A section-by-section that reflects the managers’ amendment passed today is available HERE.
Text of the following amendments that the Committee passed is available HERE:
Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act
The Committee also passed the Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act by a voice vote. The broad, bipartisan package strengthens families’ emergency savings and retirement security—including by allowing employers to offer emergency savings accounts, expanding access to employer-provided retirement plans, and ensuring people have access to the information they need to make consequential financial decisions and plan for retirement. Chair Murray and Ranking Member Burr introduced the legislation last week, building on the discussion draft they released last month.
“I’ve heard from people in Washington state who were forced to raid savings meant for their futures, just to make ends meet. And then there are the countless people across the country who never even had access to a retirement plan or were never even paid enough to make ends meet—let alone save for the future. We need to help people get back on their feet. That’s why I’m glad we were able to take so many steps in this bill to bolster families’ retirement and emergency savings,” said Senator Murray. “This bipartisan package tackles a wide range of issues that will help families in Washington state, and across the country, get on solid financial footing.”
Legislative text of the RISE & SHINE Act as introduced is available HERE.
A section-by-section of the RISE & SHINE Act as introduced is available HERE.
Text of the following amendments that the Committee passed is available HERE:
Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act, The Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act, & The Early Hearing Detection and Intervention Act
Lastly, the Committee advanced the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act, which helps ensure families—especially those in rural and remote communities—can get the essential health care services they need, by a voice vote. The Committee advanced the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act, which supports life-saving research and education on valvular heart disease, by a voice vote. And the Committee advanced the Early Hearing Detection and Intervention Act of 2022, which supports research on hearing loss in newborns and young children, by a voice vote.
Senator Murray’s opening remarks, as prepared for delivery, are below:
“Families in Washington state, and across the country, desperately need the FDA to live up to its responsibility.
“They are counting on it to address the formula crisis.
“They are waiting eagerly for an update on COVID vaccines for kids.
“They need it to do more to fight fentanyl and the ongoing opioid crisis, skyrocketing drug costs, and so many other issues.
“And beyond these urgent challenges, every time families sit down for a meal, every time they get a prescription filled, they are putting their wellbeing in the hands of FDA’s experts.
“Which is why it’s so important we work on this Committee to provide the resources and authority to set FDA up for success, and the accountability the American people need to rest assured FDA is fulfilling its important mission.
“And I’m pleased to say the bipartisan legislation we are voting on today strikes that balance effectively, with a wide range of ideas and reforms from members on both sides of the aisle.
“This is the most comprehensive FDA legislation to come out of this Committee in many years and that’s the result of hard work by my colleagues on both sides of the aisle.
“I’d particularly like to thank Senator Burr for working with me to ensure FDASLA not only reauthorizes the prescription drug, generic drug, biosimilar, and medical device user fee agreements, which provide needed resources to the agency, but to include so many other productive steps.
“Following so many alarming reports in the past of known carcinogens in products like baby powder, hair spray, and kids’ make up kits—and so many years of dietary supplement manufacturers making unsupported health claims without any serious FDA oversight—I’m glad we were able to work in this legislation to ensure FDA can at long-last provide meaningful oversight to cosmetics and dietary supplements.
“Families in Washington state turn to so many of these products every day—and people deserve to know they are truly safe and effective.
“I’m also grateful to Senators Durbin and Braun for their work on regulating dietary supplements.
“And Senators Feinstein, Collins, and Baldwin for their leadership on cosmetics reform. Senator Kennedy began to work on cosmetics in this Committee 25 years ago, and I’m proud that we are finishing it here today.
“It is also important to me we ensure FDA’s approval process is driven by what is best for patients—not pharmaceutical companies.
“Which is why I’m glad FDASLA includes steps from Senator Kaine and Senator Collins to modernize the accelerated approval pathway, and steps from Senators Kaine, Hassan, Smith, Collins, Marshall, Cassidy, and Romney to make it easier for cheaper generic and biosimilar drugs to get to market.
“These changes will help ensure FDA prioritizes patients and will help bring down health care costs, which so many families are struggling with.
“We were also able to take action in this bill to provide a path for safe prescription drug importation from Canada.
“This is going to be a big deal for families in Washington state, and across the country, who will have access to safe drugs at lower prices, and I’d like to thank Senator Sanders for his leadership on this.
“And we’ve also included language from Senators Warren, Grassley, Hassan, and Blackburn to set a deadline for FDA to issue a final rule on over-the-counter hearing aids.
“I’m incredibly frustrated it is taking FDA so long to take a step that will lower costs for millions of people across the country.
“So I’m glad we can include language in this bill that will require them to finally get this done.
“And in addition to lowering costs, FDASLA includes several steps to help spur innovation for patients, like the VALID Act from Senator Burr and Senator Bennet which will help support the next generation of medical products.
“This pandemic has shown how important it is FDA’s regulatory framework keeps pace with medical innovation.
“Which is why I’m so grateful to Senator Burr for his leadership in this bill to make sure that happens, particularly when it comes to improving and modernizing how we regulate tests—including COVID tests.
“And there are other steps in this bill, from our colleagues on and off the Committee, to support innovation as well.
“Senators Kelly, Collins, and Sinema have worked to reauthorize FDA’s Critical Path initiative, a public-private partnership focused on improving how medical products are developed, evaluated, and manufactured.
“Senator Lujan has worked to provide for alternatives to animal studies for biosimilar products.
“Senator Casey and Tim Scott have included steps to support the review and development of drugs for rare diseases.
“And Senator Reed has worked to support pediatric drug and device research.
“Also, I hope to continue working with Senator Bennet and Senator Rubio on a proposal to support cutting edge pediatric cancer treatment. This is so important to families across the country.
“I’m also glad this legislation updates language from our bipartisan opioids bill in 2018 to increase safe disposal of opioids and other drugs that pose serious risks.
“I’m grateful to Senator Hassan and Senator Braun for their work on this.
“And I look forward to building on these steps with even more bipartisan progress in the mental health and substance use disorder package we are working on right now.
“Because the opioid crisis is devastating our communities.
“I’ve heard from folks on the frontlines back in Washington state—and they need all the help they can get to stop the very real threat of fentanyl.
“So I am going to remain focused on what else we can do here to save lives and keep people safe.
“And finally, this bill improves transparency and accountability at the FDA and helps the agency function more smoothly.
“I’d like to thank Senators Rosen and Scott for their work on provisions to enhance coordination on inspections at FDA, Senators Smith and Cassidy for their work to make our nation more competitive on the global stage and facilitate the export of medical devices and Senators Smith and Marshall for their efforts to clarify FDA regulation of contrast agents, radioactive drugs, and over-the-counter monograph drugs.
“And Senator Burr and I have also worked hard to address FDA’s workforce challenges by enhancing FDA hiring authority so it can better recruit the top-notch talent it needs to fill out its ranks, and requiring it to put forward a workforce plan and report.
“As we continue to deal with the infant formula shortage, we have seen how crucial it is to have transparency and accountability at the FDA and in the industry—and that’s what this bill delivers.
“I’m glad Senator Burr and I were also able to work over the last week to include steps to further address this by requiring a report from FDA to ensure it resolves the mailroom issues that hindered its response to reports of contaminated formula from an Abbott employee, and by including provisions from Senator Casey and me to require infant formula companies to notify FDA of manufacturing issues that are likely to cause disruptions to supply, and FDA to put forward a clear plan and take concrete steps to get formula back on shelves as soon as possible.
“Every new development we discover seems to make this whole debacle even more infuriating—last week we learned FDA and Abbott both heard concerns about formula manufacturing issues as early as February 2021—essentially a year before the recall happened.
“I have been pressing hard for answers, and action from FDA on this—and have asked Dr. Califf specifically for a plan.
“I’m absolutely going to keep pushing to hold FDA and industry accountable so we can get answers on the formula crisis, and ensure this never happens again.
“And the steps in this bill are an important part of that work. Overall, this legislation will make for a stronger FDA, with more resources to carry out its work, more authority to oversee products families entrust their health to every day, and more accountability to guarantee FDA is fulfilling its mission and putting patients and families first.
“I look forward to passing it out of Committee today—and into law soon.
“Today, we will also vote to advance the most comprehensive retirement package this Committee has considered in a decade—the RISE & SHINE Act. And not a moment too soon.
“The COVID pandemic upended our economy—and with it the finances of so many people back in Washington, and across the country.
“Before this pandemic, a study found nearly two-in-five Americans would struggle to come up with $400 dollars in an emergency.
“COVID-19 was exactly the kind of emergency families couldn’t afford.
“I’ve heard from people in Washington state who were forced to raid savings meant for their futures, just to make ends meet.
“And then there are the countless people across the country who never even had access to a retirement plan or were never even paid enough to make ends meet—let alone save for the future.
“Now, families are trying to recover—all while paying more at the grocery store and the gas pump.
“We need to help people get back on their feet. That’s why I’m pushing for steps to bring down everyday costs for the basics—like health care, child care, gas, and more.
“And it’s why I’m glad we were able to take so many steps in this bill to bolster families’ retirement and emergency savings.
“On emergency savings accounts, this bill includes a proposal from Senators Booker and Young to help families put money away for an emergency, so sudden expenses don’t upend their lives in ways that undermine their finances for years to come.
“On retirement, it makes it easier for employers to offer retirement plans thanks to proposals from Senators Hassan, Hickenlooper, Cardin, Grassley, Lankford, Collins, and Portman.
“It makes it easier to manage plans thanks to steps from Senators Rosen, Cardin, Portman, and Tim Scott, and easier to improve participation by allowing for auto-reenrollment thanks to Senator Kaine.
“And in addition to helping companies set up traditional retirement plans, it makes it easier for people to establish new employee-owned businesses thanks Senator Sanders and Senator Moran.
“I’m also especially pleased it makes more workers eligible for employer-sponsored retirement plans by expanding steps we took in the SECURE Act, something I’ve been pushing for, along with Senators Casey, Cardin, Portman, and Tim Scott.
“The RISE and SHINE Act will also help protect workers and retirees by providing much-needed information and transparency.
“That includes reports, reviews, and other steps to ensure retirement products are working effectively as they should be, and as they are advertised.
“Like proposals from Senators Cardin, Murphy, Luján, and Portman on target date funds, efforts to de-risk pension plans, and how fees are disclosed to people.
“And it includes steps like the INFORM Act—from me, Senator Baldwin, Senator Smith, and Senator Cassidy—which will ensure people get the information they need when forced to consider whether to take a lump sum buyout and trade a lifelong pension, for a one time payout.
“Overall, this bipartisan package tackles a wide range of issues that will help families in Washington state, and across the country, get on solid financial footing.
“I’d like to thank Senator Burr and so many others for all the hard work, and thoughtful ideas that have gone into this bipartisan legislation.
“I look forward to passing this bill out of Committee, and working with our Senate and House colleagues to pass it into law along with other steps to strengthen the financial security of workers, retirees, and families in Washington state and across the country.
“We will also be voting to advance the MOBILE Health Care Act which Senator Rosen and Senator Collins have worked so hard on.
“We have seen throughout this pandemic how important it is we make a concerted effort to ensure critical primary health care services are available to families across the country, especially in our rural and remote communities.
“The MOBILE Health Care Act will get us closer to that goal by providing greater flexibility to community health centers so they can improve health care delivery and access for the families they serve—families who often have very limited health care options close to home.
“I know how important this bill will be to patients living in rural parts of Eastern and Central Washington state.
“Thank you both for your leadership here.
“We will also be voting to advance the CAROL Act today, which Representative Barr championed in the House on behalf of his wife who tragically lost her life to valvular heart disease.
“This bill will support life-saving research, education, and awareness activities on valvular heart disease—which, according to CDC, affects around one-in-forty Americans.
“I’d like to thank Senator Sinema and Senator McConnell for their work on this legislation which provides hope of new discoveries and treatments to people across the country experiencing this condition.
“We will be voting on the Early Hearing Detection and Intervention Act, or EHDI Act, today as well.
“This bipartisan legislation will support research on hearing loss, and strengthen programs that help detect, diagnose, and treat hearing loss in newborns and young children.
“It is so important we get kids with hearing loss the care they need to grow and thrive—especially in their earliest years—and that we get parents the tools and information they need to support their kids as well.
“And this bill from Senators Hassan, Hickenlooper, Portman, and Cassidy, will help make that happen.
“Thank you all for your work on this.
“As I think I’ve made clear by now, the legislation we are passing today really represents a lot of hard work from so many members on and off this committee, on both sides of the aisle.
“And it includes meaningful steps to make life better for families back in Washington state, North Carolina, and across the country.
“I’m so grateful for everyone who has worked to make this mark up possible.
“And, of course, that absolutely includes the many members of my staff, Senator Burr’s staff, and others’ who worked on these bills.
“This has seriously been an around-the-clock effort, especially by my staff and Senator Burr’s staff—and we both appreciate it so much.
“Truly, thank you.
“And now I’ll turn it over to Senator Burr for his remarks.”