Floor Statements
Everything Jack Reed said on the floor, from the Congressional Record
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Showing 15 of 1593 statements
- Senate Floor·December 18, 2024·p. S7133
- Senate Floor·December 17, 2024·p. S7104
Executive Reports Of Committee
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive…
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive Calendar that these nominations lie at the Secretary's desk for the information of Senators.
- Senate Floor·December 10, 2024·p. S6900-S6902
Tribute to Benjamin L. Cardin (Executive Calendar)
Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I ask unanimous consent that the scheduled vote occur immediately.
Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.
Mr. President, I ask unanimous consent that the scheduled vote occur immediately.
- Senate Floor·December 10, 2024·p. S6902-S6903
Vote on Dixon Nomination (Executive Calendar)
Mr. President, I ask for the yeas and nays.
Mr. President, I ask for the yeas and nays.
- Senate Floor·November 19, 2024·p. S6628-S6629
Tribute To Francis J. Flynn
Mr. President, I rise, on behalf of myself and Senator Whitehouse, to congratulate Francis J. Flynn, president of the Rhode Island Federation of Teachers and Health Professionals, on his upcoming retirement and to thank him for his nearly…
Mr. President, I rise, on behalf of myself and Senator Whitehouse, to congratulate Francis J. Flynn, president of the Rhode Island Federation of Teachers and Health Professionals, on his upcoming retirement and to thank him for his nearly five decades of service to Rhode Island students, educators, and working families. Frank's kindness, expertise, and commitment to lifting up educators and the communities they serve have made him an indispensable resource for public servants at all levels of government across our State.
A proud graduate of Rhode Island College, Frank started his career in Cranston as a special education teacher. He served at all levels from elementary school through high school and worked to ensure that students with special needs had the supports necessary to fully participate in academics and the school community. Frank's devotion to his students and the community put him on a leadership path where he could focus his advocacy in support of students and educators. The skills and values he developed as a special education teacher--a focus on inclusion and the ability to address people's unique needs--served him well as he assumed a leadership role in the Cranston Teachers' Alliance, where he served as president for 8 years. During that time, he worked with the district to establish new teacher mentoring programs, a professional development institute, and other reforms, looking for ways to collaborate on things that were, in his words, ``good for the kids and good for the district.''
In 2010, Frank was elected president of the Rhode Island Federation of Teachers and Health Professionals, where he continued his pragmatic approach to leadership, maintaining open lines of communication and looking for areas to collaborate. His steady leadership helped Rhode Island educators navigate the once-in-a-generation pandemic, moving to online and hybrid learning and providing the extra support that students needed to stay connected to their studies and their communities.
Frank's leadership is widely recognized and valued across the labor
movement. He has served on the executive committee of the Rhode Island AFL-CIO, Working Rhode Island, the Providence Central Labor Committee, and as a national vice president for the American Federation of Teachers. He was recently awarded the Dante F. Mollo Labor United Award from the United Way of Rhode Island.
We thank him for his friendship and kindness over many years and for his great inspiration. Frank always demonstrated that, even during the most contentious times, you can find ways to work collaboratively. That is a lesson that resonates during these challenging times and an example that we should follow.
We join countless other Rhode Islanders in wishing Frank a happy and healthy retirement in the company of his wife Sharon and their children and grandchildren. He has earned it.
- Senate Floor·November 19, 2024·p. S6633-S6634
Executive Reports Of Committee
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive…
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive Calendar that these nominations lie at the Secretary's desk for the information of Senators.
- Senate Floor·November 13, 2024·p. S6558-S6559
TRIBUTE TO JOANNE McGUNAGLE
Mr. President, I rise to honor an extraordinary constituent, Joanne McGunagle, on her retirement as the chief executive officer of the Comprehensive Community Action Program (CCAP), which serves the communities of Cranston, Scituate,…
Mr. President, I rise to honor an extraordinary constituent, Joanne McGunagle, on her retirement as the chief executive officer of the Comprehensive Community Action Program (CCAP), which serves the communities of Cranston, Scituate, Foster, Warwick, and Coventry. As the leader of one of Rhode Island's largest anti-poverty nonprofit organizations, Joanne has embodied the spirit of President Lyndon Johnson's War on Poverty, mobilizing resources to address human needs while empowering the community to chart its own course to greater prosperity.
Joanne demonstrated a passion for service from her earliest days as a sociology student at Rhode Island College. During her junior year, she participated in an internship as a summer camp counselor at the Thornton Center, and she found her calling. In 1979, as a newly minted graduate, she went to work for CCAP as the manager of its Fiskeville Center. With her strong commitment to the community and her prodigious organizational skills, Joanne quickly rose up the ranks at CCAP. By 1985, she was named chief executive officer.
Under Joanne's leadership, CCAP expanded its reach and services to the community. Her approach to leadership was to involve the community, collaborate with partners, and streamline administrative costs in order to maximize resources available for direct services. When she took the reins, CCAP had a budget of just over $3 million and a staff of 60. Today, it has a budget of over $40 million and a team of 350 employees who serve over 40,000 people annually.
The growth of CCAP under Joanne's leadership has resulted in partnerships to create affordable housing, expand childcare and preschool programs, establish new opportunity homes for pregnant and parenting teens, create the first parent/child center in Rhode Island, build a community youth center in partnership with the city of Cranston, develop a fully integrated family health model, and open several health centers. CCAP has done all of this while also providing workforce development, home heating and weatherization assistance, and a food bank for residents in need.
Just as Joanne has left an indelible mark on CCAP and the communities it serves, CCAP has shaped her life. She carries out her work with joy and gratitude. In her words, ``CCAP has given me boundless gifts and rewards I never imagined. Professionally, with my team, we have created a system of care designed to provide services while focusing on poverty and the alleviation of it. Personally, I met my husband when creating housing at St. Matthew's Church with CCAP. All my life milestones have involved CCAP at some level. I could never begin to give back to CCAP what it has given me.''
As someone who shares Joanne's deep connection to the Cranston community, I have seen firsthand how her friendship and kindness has transformed lives. Her genuine empathy for those most in need is an inspiration, and her lifetime of action helping those experiencing poverty is an example that we should emulate.
I join countless other Rhode Islanders in wishing Joanne a happy and healthy retirement, filled with new adventures, in the company of her husband Kenny and her daughters Maddie and Annie. She has earned it.
- Senate Floor·September 25, 2024·p. S6426
Tribute To George Nee
Madam President, I rise today to congratulate George Nee, president of the AFL-CIO of Rhode Island, on his upcoming retirement and to thank him for his years of service and unwavering dedication to improving the lives of working people.…
Madam President, I rise today to congratulate George Nee, president of the AFL-CIO of Rhode Island, on his upcoming retirement and to thank him for his years of service and unwavering dedication to improving the lives of working people.
For George, organized labor serves as the ``People's Lobbyist,'' ensuring that the concerns of working people are given due consideration when critical decisions are made. In his retirement letter, he wrote that ``organized labor has a right and a responsibility to exercise our voice when and where decisions are made at every level of government. These decisions impact the quality of life and economy of our state, and we must be there.''
His leadership--tenacious but pragmatic and always with decency and integrity--has contributed to the vibrancy of the union movement in Rhode Island, making it one of the States with the highest percentage of union workers in the Nation.
From the beginning, George acted on the belief that working people have a right to have a voice, no matter if they are working in the fields, on the factory floors, in offices, in healthcare facilities, in schools, or on construction sites.
As a young man, he left the comfort of Boston College to earn $5 dollars per week, plus room and board, to join farmworkers in organizing successful grape and lettuce boycotts. He was inspired by Cesar Chavez, and joined him on a pilgrimage across the farmlands of California, serving as his personal bodyguard.
Rhode Island called him back. In 1976, he organized jewelry workers, clerical workers, and healthcare workers and founded SEIU Local 76, where he served as president until he joined the Rhode Island AFL-CIO in 1983 as a staff representative. George quickly rose through the ranks at the Rhode Island AFL-CIO. By 1985, he was elected secretary- treasurer and, in 2009, president--a role that he will step down from on October 11.
George's strong moral compass and steady leadership has been a beacon for public servants and community leaders across the State. He has been a mentor and a trusted adviser to me and to so many others who share his goals of a just and prosperous Nation where workers' rights are always protected.
In a 2018 interview with Rhode Island Public Radio's Scott MacKay, George said: ``We have a solemn obligation to the people who came before us to fight back and protect these rights for future generations.''
As he begins his next chapter, George can rest assured that he fulfilled that solemn promise and has equipped a new generation for the battles and the challenges ahead. Rhode Island is a stronger State, and we are a better Nation because of George Nee's leadership.
I thank him and his wonderful family, especially his beloved wife Ann, for their great friendship and kindness over many years and for their great inspiration. George always reminded us, by his actions, that hard work for a just cause was the greatest and most satisfying contribution that we can make.
I wish George a happy and healthy retirement. He has earned it.
- Senate Floor·September 25, 2024·p. S6426-S6427
Remembering J. Michael Downey
Madam President, I rise today to honor the life of one of Rhode Island's great champions for working people, J. Michael Downey, president of Rhode Island Council 94 of the American Federation of State, County, and Municipal Employees. Mike…
Madam President, I rise today to honor the life of one of Rhode Island's great champions for working people, J. Michael Downey, president of Rhode Island Council 94 of the American Federation of State, County, and Municipal Employees.
Mike was known as a family man, an organizer, a tough negotiator, and a fierce protector of his members' wages, working conditions, and benefits. He was a loving husband to his wife of nearly 50 years, Claudette, a devoted father to his three children, and a doting grandfather to his nine grandchildren. He was also a beloved brother to his brothers and sisters in the union movement.
Mike came from a family of union organizers. His father was the president of Local 28, the Plumber's Union and executive director of the Allied Building Trades. His grandfather was president of the Bricklayer's Union, Local 1. Mike was a master plumber and practiced his trade at the University of Rhode Island for 27 years, during which he also served as the president of Local 528.
He later brought his expertise to the Rhode Island Department of Labor and Training, where he served as the chief plumbing investigator. In 2005, Mike was first elected president of Council 94, and he was re- elected five times. He also served on the executive board of the Rhode Island AFL-CIO and the Institute of Labor Studies. Under his leadership, Council 94 increased member participation, expanded and enhanced its political activities, and prioritized organizing, adding new locals.
Just days before his passing, Mike helped negotiate a new 3-year contract with the State that boosted wages and enhanced benefits. The contract was overwhelmingly approved by the rank-and-file members--a final addition to his long list of accomplishments as a union leader.
Mike was known for his kindness and compassion. He is remembered for his
special passion for supporting the lowest paid members of the union. He believed in the dignity of work and creating pathways for all workers to advance. He embodied the spirit of solidarity.
We will miss him and will strive to live by his example.
- Senate Floor·September 25, 2024·p. S6427
Tribute To J. William Middendorf Ii
Madam President, today I rise to recognize the 100th birthday of Ambassador J. William Middendorf. Ambassador Middendorf is an extraordinary Rhode Islander and an extraordinary American. Last Sunday, we had a chance to celebrate his…
Madam President, today I rise to recognize the 100th birthday of Ambassador J. William Middendorf. Ambassador Middendorf is an extraordinary Rhode Islander and an extraordinary American. Last Sunday, we had a chance to celebrate his birthday at his home in Little Compton, RI, and he was as sharp and insightful as ever. Today, along with Senator Whitehouse, I would like to take a moment to honor his impressive career in service to our country.
Ambassador Middendorf, now a resident of Little Compton, RI, was born in Baltimore, MD on September 22, 1924. As a young man, he attended the College of the Holy Cross in Worcester, MA. In 1945, as World War II raged in Europe, Ambassador Middendorf interrupted his education to serve in the Navy as an engineering officer and navigator aboard the landing craft support ship USS LCS-53. After the war, Ambassador Middendorf continued his education and graduated from Holy Cross with a bachelor of naval science. He later attended Harvard College, where he graduated with a bachelor of arts degree, and in 1954, he earned an M.B.A from New York University's Stern School of Business.
Ambassador Middendorf then became an investment banker. Eventually, as a cofounder of the prominent Wall Street firm Middendorf, Colgate and Company, he began to involve himself in politics. He took on important roles within the national Republican Party, including as treasurer of the Republican National Committee from 1965 to 1969.
Eventually, Ambassador Middendorf left his investment firm and began his long career in public service. In 1969, President Nixon appointed him to be U.S. Ambassador to the Netherlands, where he represented our Nation with distinction. In 1974, he returned to the U.S. to serve first as Under Secretary of the Navy, and then as the 62nd Secretary of the Navy, a position he held until 1977.
As Secretary of the Navy he pushed for the development of four new Navy programs, particularly the Ohio-class submarine program. He also led the way on developing and fielding the AEGIS missile system, Trident missile program, CH-53E heavy-lift helicopter, and the F/A-18 Hornet attack aircraft. The introduction of these programs resulted in major improvements for the Navy and remain key national defense assets to this day. The Navy's growth under Ambassador Middendorf's leadership is in large part thanks to his relationships in Congress and reputation as a respected leader.
After serving as Secretary of the Navy, Ambassador Middendorf returned to the private sector. He served as the president and chief executive officer of Financial General Bankshares, which eventually became First American Bank.
After the 1980 election, Ambassador Middendorf led the CIA transition team for President Reagan's incoming administration. President Reagan then nominated him to be U.S. Ambassador to the Organization of American States in 1981. He served in this position until accepting an appointment as U.S. Representative to the European Community, now known as the European Union.
In retirement, Ambassador Middendorf has remained a person of tremendous intellect and achievement and has become a prolific writer. Ambassador Middendorf continues to share his strong and insightful opinions as a frequent contributor to the ``Providence Journal.'' While we don't always agree, his columns always make for a lively and interesting read. He has also written several books, and his newest title, ``On My 100-Year Watch: Tyrants and Patriots,'' is set to be released later this year.
Following the tradition of naming naval destroyers after U.S. naval leaders and heroes, the future Arleigh Burke-class guided-missile destroyer--DDG-138--will be named USS J. William Middendorf. Once commissioned, the USS J. William Middendorf will join U.S. naval forces in protecting our country for years to come. And today, I am proud to rise in recognition of Ambassador J. William Middendorf, an exceptional Rhode Islander and American, and wish him a happy 100th birthday.
- Senate Floor·September 25, 2024·p. S6427-S6428
60th Anniversary Of The Community College Of Rhode Island
Madam President, I rise today on behalf of my colleague Senator Whitehouse and myself, to recognize the 60th anniversary of the Community College of Rhode Island--CCRI--which opened its doors on September 24, 1964. Over the last six…
Madam President, I rise today on behalf of my colleague Senator Whitehouse and myself, to recognize the 60th anniversary of the Community College of Rhode Island--CCRI--which opened its doors on September 24, 1964. Over the last six decades, CCRI has grown into New England's largest public, 2-year degree
granting college, expanding educational opportunities for hundreds of thousands of Rhode Islanders.
From its modest beginning in Providence with just 325 students, CCRI opened its Knight Campus in 1972 to nearly 3,000 students, after Royal Webster Knight gifted 80 acres of his estate in Warwick to the college. CCRI has grown to nearly 20,000 enrolled students each year and now has four campuses across Rhode Island, including an education center and online classes, ensuring that residents throughout the State have access to educational and career development opportunities.
Students have more than 20 academic departments to choose from--from the arts, to science and mathematics, to business, and more--all at an affordable price. In 2017, the Rhode Island Promise Program was launched, making CCRI tuition-free to recent high school graduates seeking opportunities.
But CCRI also understands that education is a lifelong journey, and it is never too late to learn something new. The adult education team at CCRI offers a wide range of classes to prepare adults to join the workforce, including GED classes, English language studies, and corporate language training. By working in close collaboration with industry and business leaders, CCRI ensures students are meeting workforce needs in the Ocean State. Just last year, CCRI was selected by the Biden administration as one of just 17 new Industrial Assessment Centers, working with the Department of Energy to expand clean energy workforce training opportunities, for in-demand, high-quality jobs.
CCRI is a pillar of hope for the community, consistently rising to the challenge of meeting the educational and workforce needs of the present and the future. In the last 20 years alone, CCRI has guided students and employers through the Great Recession and COVID-19 pandemic and earned the designation as a Hispanic-serving Institution, reflecting its commitment to meeting emerging community needs. Its campuses also serve as community hubs, connecting residents to vital services and activities, job preparation workshops, free flu and COVID shots, and more. This is all thanks to the dedicated faculty and staff, who work tirelessly to carry out the mission of the college every day.
CCRI is a bedrock institution to the State of Rhode Island, and we are so proud of the hard-working people who have changed the lives of so many individuals over the last 60 years. Along with Senator Whitehouse, I would like to congratulate the entire CCRI community on this important milestone.
- Senate Floor·September 24, 2024·p. S6366-S6368
Executive Reports Of Committee
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive…
Mr. President, for the Committee on Armed Services I report favorably the following nomination lists which were printed in the Records on the dates indicated, and ask unanimous consent, to save the expense of reprinting on the Executive Calendar that these nominations lie at the Secretary's desk for the information of Senators.
- Senate Floor·September 23, 2024·p. S6329
140th Anniversary Of The U.S. Naval War College
Mr. President, today I rise to offer remarks on behalf of my colleague Senator Whitehouse and myself in recognition of the 140th anniversary of the U.S. Naval War College, which was established on October 6, 1884, in Newport, RI. For the…
Mr. President, today I rise to offer remarks on behalf of my colleague Senator Whitehouse and myself in recognition of the 140th anniversary of the U.S. Naval War College, which was established on October 6, 1884, in Newport, RI. For the past 14 decades, it has played a critical role in shaping the leadership of our Armed Forces. While the Naval War College's mission has grown over the years, it remains a place of cutting-edge scholarship, helping to strengthen maritime security cooperation, support combat readiness, and develop the future of the Navy.
The Naval War College is a center for research and academic excellence. It provides an advanced course of study for both military officers and civilians and has served as the home of some of our military's most important strategic developments. Students and faculty work closely with the Navy Warfare Development Command and the Chief of Naval Operations Strategic Studies Group in analyzing national security issues and developing innovative solutions. In addition, the Naval War College has pioneered war-gaming to support combat readiness since its founding and continues to evolve with the modern world offering over 50 events per year to include scenarios beyond the maritime domain such as space, cyber, and humanitarian disaster relief.
The oldest institution of its kind, the Naval War College has played an important role in the education and professional development of some of our country's most accomplished and impactful military officers and civilian leaders. Since the Naval War College's founding in 1884 by Rear Admiral Stephen B. Luce, more than 50,000 students have earned advanced degrees. Most have gone on to have impressive military careers, leading U.S. servicemembers around the globe and serving at the highest echelons of military and civilian leadership. Esteemed graduates include the Honorable Carlos Del Toro, the current Secretary of the Navy; General Randy George, the Chief of Staff of the Army; former Chairmen of the Joint Chiefs of Staff; and many others from every branch of our Armed Forces.
Throughout its 140-year history, the Naval War College has been a forward-looking institution and has consistently worked to break the mold of traditional military strategy and thinking. As the Naval War College celebrates this impressive milestone, Senator Whitehouse and I know that the faculty, staff, and students will continue this tradition of excellence and innovation.
We are proud of the talented men and women who have made the Naval War College the strong and well-respected institution it is today. Along with Senator Whitehouse, I would like to congratulate the entire Naval War College community on this important milestone.
- Senate Floor·July 31, 2024·p. S5684-S5686
Statements On Introduced Bills And Joint Resolutions
Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children. Children are not just small adults. Drugs affect their developing…
Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children.
Children are not just small adults. Drugs affect their developing bodies differently, so new treatments need to be studied carefully to ensure that they are appropriately prescribed and that dosages are properly adjusted. Additionally, drugs that are designed to treat a specific condition in adults may have enormous benefits in treating completely different illnesses in kids, but research is needed to unlock these potentially lifesaving possibilities.
Unfortunately, drug development still leaves children behind. The legislation we are introducing today would help speed therapies to children who need them by making needed changes to the Best Pharmaceuticals for Children Act BPCA, and the Pediatric Research Equity Act, PREA--two laws that encourage and require the study of drugs in children.
Data resulting from BPCA and PREA studies are added to drug labels to give parents and providers essential information on the safety and efficacy of drugs used in children. I was proud to have helped author these laws when I
was a member of the Health, Education, Labor, and Pensions Committee. While we have made tremendous progress in advancing treatments for children because of these laws, there are gaps. For example, there is a loophole in PREA that exempts drug companies from pediatric study requirements when the treatment would only be used for a rare pediatric condition.
There are close to 7,000 rare diseases without appropriate treatments, and the vast majority of these diseases affect children as well as adults. But in developing new drugs also known as orphan drugs to treat rare diseases, pharmaceutical developers focus their research on adult patients only since they are not required study their impact on children.
And since the majority of new drugs approved by the Food and Drug Administration, FDA are orphan drugs, this means that the majority of newly approved drugs have not been studied for their impacts on kids. This leaves doctors, parents, and sick kids in the dark about the best possible treatments. Our bill closes this loophole to require studies for children so that they, too, can benefit from new and innovative treatments for rare diseases.
In addition to this change, the Innovation in Pediatric Drugs Act would invest in pediatric studies of older, off-patent drugs. The FDA incentives and requirements under BPCA and PREA work for many newer drugs but unfortunately cannot help encourage studies of older drugs. For this reason, in 2002, Congress authorized a program which funds the National Institutes of Health to conduct studies of off-patent drugs used in children that would never be completed otherwise. Drug studies are expensive, and costs have only increased since then, but the program has been flat-funded at $25 million since it was created more than 20 years ago. Our legislation would increase the authorization for the BPCA NIH program to ensure we have better data about older drugs to treat diseases in children.
Lastly, the Innovation in Pediatric Drugs Act would give FDA the authority it needs to ensure that legally required pediatric studies are completed in a timely manner. Due dates for studies required by PREA are typically deferred by FDA until after the approval of the drug for adults, but, FDA has no effective enforcement tools to ensure that these studies are completed on time--or at all.
I am pleased to be working with my colleague Senator Capito on pediatric health issues. We have worked closely for many years on pediatric cancer, first authoring the Childhood Cancer Survivorship, Treatment, Access, and Research, STAR Act in 2015. That bill was signed into law in 2018, and we worked to fully fund the law every year since.
I look forward to working with her as well as the sponsors of the House companion legislation, Representatives Anna Eshoo and Michael McCaul to move the Innovation in Pediatric Drugs Act forward, to give children and their families more options for treatments.
- Senate Floor·July 31, 2024·p. S5685-S5686
Introductory Statement on S. 4905
Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children. Children are not just small adults. Drugs affect their developing…
Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children.
Children are not just small adults. Drugs affect their developing bodies differently, so new treatments need to be studied carefully to ensure that they are appropriately prescribed and that dosages are properly adjusted. Additionally, drugs that are designed to treat a specific condition in adults may have enormous benefits in treating completely different illnesses in kids, but research is needed to unlock these potentially lifesaving possibilities.
Unfortunately, drug development still leaves children behind. The legislation we are introducing today would help speed therapies to children who need them by making needed changes to the Best Pharmaceuticals for Children Act BPCA, and the Pediatric Research Equity Act, PREA--two laws that encourage and require the study of drugs in children.
Data resulting from BPCA and PREA studies are added to drug labels to give parents and providers essential information on the safety and efficacy of drugs used in children. I was proud to have helped author these laws when I
was a member of the Health, Education, Labor, and Pensions Committee. While we have made tremendous progress in advancing treatments for children because of these laws, there are gaps. For example, there is a loophole in PREA that exempts drug companies from pediatric study requirements when the treatment would only be used for a rare pediatric condition.
There are close to 7,000 rare diseases without appropriate treatments, and the vast majority of these diseases affect children as well as adults. But in developing new drugs also known as orphan drugs to treat rare diseases, pharmaceutical developers focus their research on adult patients only since they are not required study their impact on children.
And since the majority of new drugs approved by the Food and Drug Administration, FDA are orphan drugs, this means that the majority of newly approved drugs have not been studied for their impacts on kids. This leaves doctors, parents, and sick kids in the dark about the best possible treatments. Our bill closes this loophole to require studies for children so that they, too, can benefit from new and innovative treatments for rare diseases.
In addition to this change, the Innovation in Pediatric Drugs Act would invest in pediatric studies of older, off-patent drugs. The FDA incentives and requirements under BPCA and PREA work for many newer drugs but unfortunately cannot help encourage studies of older drugs. For this reason, in 2002, Congress authorized a program which funds the National Institutes of Health to conduct studies of off-patent drugs used in children that would never be completed otherwise. Drug studies are expensive, and costs have only increased since then, but the program has been flat-funded at $25 million since it was created more than 20 years ago. Our legislation would increase the authorization for the BPCA NIH program to ensure we have better data about older drugs to treat diseases in children.
Lastly, the Innovation in Pediatric Drugs Act would give FDA the authority it needs to ensure that legally required pediatric studies are completed in a timely manner. Due dates for studies required by PREA are typically deferred by FDA until after the approval of the drug for adults, but, FDA has no effective enforcement tools to ensure that these studies are completed on time--or at all.
I am pleased to be working with my colleague Senator Capito on pediatric health issues. We have worked closely for many years on pediatric cancer, first authoring the Childhood Cancer Survivorship, Treatment, Access, and Research, STAR Act in 2015. That bill was signed into law in 2018, and we worked to fully fund the law every year since.
I look forward to working with her as well as the sponsors of the House companion legislation, Representatives Anna Eshoo and Michael McCaul to move the Innovation in Pediatric Drugs Act forward, to give children and their families more options for treatments.