U.S. Congress
U.S. House of Representatives and U.S. Senate
News releases, reports, statements and associated documents from all members of the U.S. House and the U.S. Senate as well as the House and Senate leadership and House and Senate committees.
Featured Stories
U.S. Reps. Auchincloss, Boyle, Lawler Introduce Bipartisan Resolution to Designate November 2024 as Lung Cancer Awareness Month
WASHINGTON, Nov. 23 -- Rep. Jake Auchincloss, D-Massachusetts, issued the following news release on Nov. 22, 2024:U.S. Representatives Jake Auchincloss (D-MA), Brendan F. Boyle (D-PA), and Mike Lawler (R-NY) introduced a bipartisan resolution in the U.S. House of Representatives to designate November 2024 as Lung Cancer Awareness Month. The initiative aims to draw attention to the importance of prevention, early detection, and research to curb lung cancer, which remains the leading cause of cancer-related deaths in the United States. In the United States Senate, the resolution is led by Senator ... Show Full Article WASHINGTON, Nov. 23 -- Rep. Jake Auchincloss, D-Massachusetts, issued the following news release on Nov. 22, 2024: U.S. Representatives Jake Auchincloss (D-MA), Brendan F. Boyle (D-PA), and Mike Lawler (R-NY) introduced a bipartisan resolution in the U.S. House of Representatives to designate November 2024 as Lung Cancer Awareness Month. The initiative aims to draw attention to the importance of prevention, early detection, and research to curb lung cancer, which remains the leading cause of cancer-related deaths in the United States. In the United States Senate, the resolution is led by SenatorTina Smith (D-MN).
"Lung-cancer screening saves lives. The difference between early and late detection of a tumor is often a matter of life and death," said Rep. Auchincloss. "Washington needs to do more to advance awareness of screening and to support research and clinical care."
"Lung cancer impacts families and communities across the country. This resolution is an important step in raising awareness, encouraging preventative measures, and supporting groundbreaking research to save lives," said Rep. Boyle. "By coming together, we can ensure more Americans have access to the tools and resources needed to combat this devastating disease."
"Lung cancer is the deadliest and one of the most common forms of cancer," said Rep. Lawler. "We simply must do more to raise awareness and combat this deadly disease. That's why I'm joining Congressman Brendan Boyle in introducing a bipartisan resolution recognizing November as National Lung Cancer Awareness Month. One life lost to lung cancer is too many. Together, we can build a future where the devastation of lung cancer is no more."
The resolution highlights the need to increase public awareness campaigns, expand access to screening programs, and invest in life-saving research through federal agencies like the National Institutes of Health (NIH).
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Original text here: https://auchincloss.house.gov/media/press-releases/us-reps-auchincloss-boyle-and-lawler-introduce-bipartisan-resolution-to-designate-november-2024-as-lung-cancer-awareness-month
Sens. Cornyn, Cruz Bill to Rename Border Patrol Checkpoint After Fallen Agent James Dominguez Passes Senate
WASHINGTON, Nov. 23 -- Sen. John Cornyn, R-Texas, issued the following news on Nov. 22, 2024:AUSTIN - U.S. Senators John Cornyn (R-TX) and Ted Cruz (R-TX) today released the following statements after the Senate passed their James R. Dominguez Memorial Act, a bill that would rename the U.S. Border Patrol checkpoint on U.S. Highway 90 West in Uvalde County after James Ray Dominguez, a Border Patrol agent who tragically lost his life on July 19, 2012, while clearing debris from the side of Highway 90 near Cline, Texas:
"Agent Dominguez was a courageous officer, loving father, and devoted public ... Show Full Article WASHINGTON, Nov. 23 -- Sen. John Cornyn, R-Texas, issued the following news on Nov. 22, 2024: AUSTIN - U.S. Senators John Cornyn (R-TX) and Ted Cruz (R-TX) today released the following statements after the Senate passed their James R. Dominguez Memorial Act, a bill that would rename the U.S. Border Patrol checkpoint on U.S. Highway 90 West in Uvalde County after James Ray Dominguez, a Border Patrol agent who tragically lost his life on July 19, 2012, while clearing debris from the side of Highway 90 near Cline, Texas: "Agent Dominguez was a courageous officer, loving father, and devoted publicservant who tragically died while working to protect his fellow Texans," said Sen. Cornyn. "I'm grateful to my Senate colleagues for their support of this legislation to rename a Border Patrol checkpoint in Agent Dominguez's honor as a reminder of his impressive legacy as not only a respected agent but also a good Texan, who served his community selflessly and humbly."
"Agent Dominguez was a patriot, a dedicated public servant, and a devoted husband and father," said Sen. Cruz. "His legacy will continue to inspire the men and women of our Border Patrol to serve with the same selflessness. I am proud to join my colleagues in memorializing his memory by naming the Border Patrol checkpoint in Uvalde in his honor."
Senators Kyrsten Sinema (I-AZ) and and Joe Manchin (I-WV) also cosponsored the bill. This legislation was led in the U.S. House of Representatives by Congressman Tony Gonzales (TX-23) and passed on May 21, 2024. The bill now heads to the President's desk to be signed into law.
Background:
Agent James Ray Dominguez served with the U.S. Border Patrol from 2000 to 2012. On July 19, 2012, he stopped to assist a stranded motorist with a flat tire, was struck by a passing vehicle while helping clear debris along U.S. Highway 90 West near Cline, Texas, and tragically passed away. He was assigned to the U.S. Border Patrol's Uvalde Station in the Del Rio Sector and is survived by his wife and four children.
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Original text here: https://www.cornyn.senate.gov/news/cornyn-cruz-bill-to-rename-border-patrol-checkpoint-after-fallen-agent-james-dominguez-passes-senate/
Sens. Carper, Graham, Reps. Kiggans, Blunt Rochester Applaud Unanimous Senate Passage of Legislation to Protect Coastal Ecosystems
WASHINGTON, Nov. 23 -- Sen. Thomas Carper, D-Delaware, issued the following news release on Nov. 22, 2024:Today, U.S. Senator Tom Carper (D-Del.), Chairman of the Senate Environment and Public Works (EPW) Committee, Senator Lindsey Graham (R-S.C.), Congresswoman Lisa Blunt Rochester (D-Del.) and Congresswoman Jen Kiggans (R-Va.) celebrated final unanimous Senate passage of their legislation to amend and reauthorize the Coastal Barrier Resources Act (CBRA) and codify maps to update and add units to the Coastal Barrier Resources System (CBRS). The legislation is known as the Strengthening Coastal ... Show Full Article WASHINGTON, Nov. 23 -- Sen. Thomas Carper, D-Delaware, issued the following news release on Nov. 22, 2024: Today, U.S. Senator Tom Carper (D-Del.), Chairman of the Senate Environment and Public Works (EPW) Committee, Senator Lindsey Graham (R-S.C.), Congresswoman Lisa Blunt Rochester (D-Del.) and Congresswoman Jen Kiggans (R-Va.) celebrated final unanimous Senate passage of their legislation to amend and reauthorize the Coastal Barrier Resources Act (CBRA) and codify maps to update and add units to the Coastal Barrier Resources System (CBRS). The legislation is known as the Strengthening CoastalCommunities Act in the U.S. Senate and the Bolstering Ecosystems Against Coastal Harm Act in the U.S. House of Representatives. The House passed the legislation unanimously in September.
The CBRA, which was originally authored by Delaware Congressman Tom Evans in 1981, protects 3.5 million acres of our nation's coastal barrier islands and wetlands by prohibiting most federal financial assistance and development on designated coastal areas. By preventing taxpayer funds from being used to develop these pristine areas, CBRA has saved the taxpayer $9.5 billion, protected coastal communities from deadly storms, and protected habitats that support important economies and wildlife.
This legislation will enlarge the CBRA System by adding more than 290,000 acres to it. This will further save taxpayers money, expand flood protections for today's coastal communities, and conserve important habitat. This bill also adopts comprehensive revised maps prepared through the U.S. Fish & Wildlife Service Hurricane Sandy Remapping Project to right size the program. Specifically, it will codify 195 updated or new maps that the United States Fish and Wildlife Service has transmitted to Congress for the CBRS.
The bill includes a provision to support sustainable aquaculture operations and authorizes $1.9 million in annual appropriations to implement CBRA through fiscal year 2031. This legislation is slated to go to the President's desk next.
"Low-lying states, like my home state of Delaware, are particularly vulnerable to the devastation wreaked by extreme weather and storms. As climate change continues to fuel stronger hurricanes and other extreme weather events, we must do more to protect our coastal communities from its costly impacts," said Senate Environment and Public Works Committee Chairman Carper. "These updates to the Coastal Barrier Resources Act will save taxpayers money by curbing new development in low-lying areas, while also preserving critical wildlife habitat and protecting our coastal communities. I'm thankful to each of my colleagues - on both sides of the aisle and on both sides of the Capitol - who helped write, pass and deliver this bill to the President's desk."
"I am glad this legislation is headed to the President's desk. It makes important updates to Coastal Barrier Resources Act maps impacting South Carolina and allows for increased local input as additional maps are considered," said Senator Graham. "I was proud to work with my colleagues and Chairman Carper to pass this legislation in the Senate and protect vulnerable land from coastal hazards such as flooding and storm surge."
"I am incredibly proud to see the BEACH Act become law," said Congresswoman Kiggans. "We owe it to ourselves and the generations after us to take care of the world we live in, and my bipartisan legislation does exactly that. For 40 years, the Coastal Barrier Resources Act has not only protected millions of acres of beaches and wetlands, but also prevented billions of dollars in property damage from natural disasters and undoubtedly saved lives. With the BEACH Act as law of the land, I am confident Americans can continue to be good stewards of both our environment and taxpayer dollars."
"Since my first term in Congress, I have been a steadfast champion for Delaware's coastal communities, leading and securing passage of legislation like the Strengthening Coastal Communities Act," said Congresswoman Blunt Rochester, a member of the House Energy and Commerce Committee. "I am so pleased to have been able to build on that work with the bipartisan BEACH Act and I wholeheartedly celebrate its passage in the Senate. As extreme weather becomes more frequent due to the climate crisis, this legislation will protect Delawareans and our natural resources from hazards including flooding, storm surge, wind erosion, and sea level rise. It also includes policies I authored to extend disaster loan eligibility to aquaculture businesses and improve our understanding of how extreme weather is affecting our coastal barrier areas. I am proud that the BEACH Act now heads to President Biden's desk for his signature and grateful for the across-the-aisle collaboration it took to get it there."
You can view the U.S. Fish and Wildlife Service's proposed changes to the CBRA System in Delaware here (https://fwsprimary.wim.usgs.gov/cbrs-projects-mapper/).
You can read the full text of the BEACH Act here (https://www.congress.gov/118/bills/hr5490/BILLS-118hr5490ih.pdf) and a one pager on the bill here (https://bluntrochester.house.gov/UploadedFiles/240924_One_Pager_BEACH_Act.pdf).
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Original text here: https://www.carper.senate.gov/newsroom/press-releases/carper-graham-kiggans-blunt-rochester-applaud-unanimous-senate-passage-of-legislation-to-protect-coastal-ecosystems/
Senate Health Committee Ranking Member Cassidy, Colleagues Introduce Legislation to Strengthen Cybersecurity in Health Care Sector as Part of Bipartisan Working Group
WASHINGTON, Nov. 23 -- Sen. Bill Cassidy, R-Louisiana, ranking member of the Senate Health, Education, Labor and Pensions Committee, issued the following news release on Nov. 22, 2024:Today, U.S. Senators Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (D-NH) introduced legislation to strengthen cybersecurity in the health care sector and protect Americans' health data. This legislation is a product of the senators' health care cybersecurity working group launched last year. ... Show Full Article WASHINGTON, Nov. 23 -- Sen. Bill Cassidy, R-Louisiana, ranking member of the Senate Health, Education, Labor and Pensions Committee, issued the following news release on Nov. 22, 2024: Today, U.S. Senators Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (D-NH) introduced legislation to strengthen cybersecurity in the health care sector and protect Americans' health data. This legislation is a product of the senators' health care cybersecurity working group launched last year.
"Cyberattacks on our health care sector not only put patients' sensitive health data at risk but can delay life-saving care," said Dr. Cassidy. "This bipartisan legislation ensures health institutions can safeguard Americans' health data against increasing cyber threats."
"Cyberattacks on our health care systems and organizations not only threaten personal and sensitive information, but can have life-and-death consequences with even the briefest period of interruption. I'm proud to introduce this bipartisan legislation that strengthens our cybersecurity and better protects patients," said Senator Warner.
"In an increasingly digital world, it is essential that Americans' health care data is protected," said Senator Cornyn. "This commonsense legislation would modernize our health care institutions' cybersecurity practices, increase agency coordination, and provide tools for rural providers to prevent and respond to cyberattacks."
"Cyberattacks in the health care sector can have a wide range of devastating consequences, from exposing private medical information to disrupting care in ERs - and it can be particularly difficult for medical providers in rural communities with fewer resources to prevent and respond to these attacks," said Senator Hassan. "Our bipartisan working group came together to develop this legislation based on the most pressing needs for medical providers and patients, and I urge my colleagues to support it."
The Health Care Cybersecurity and Resiliency Act of 2024:
* Strengthens cybersecurity in the health care sector by providing grants to health entities to improve cyberattack prevention and response.
* * Provides training to health entities on cybersecurity best practices.
* Supports rural communities by providing best practices to rural health clinics and other providers on cybersecurity breach prevention, resilience, and coordination with federal agencies.
* Improves coordination between the Department of Health and Human Services (HHS) and Cybersecurity and Infrastructure Security Agency (CISA) to better respond to cyberattacks in the health care sector.
* Modernizes current regulations so entities covered under the Health Insurance Portability and Accountability Act (HIPAA) use the best cybersecurity practices.
* Requires the HHS Secretary to develop and implement a cybersecurity incident response plan.
Click here (https://www.help.senate.gov/cyber-wg-bill-textpdf) for full bill text.
Click here (https://www.help.senate.gov/cyber-wg-sbspdf) for the section-by-section.
BACKGROUND
Health records, unlike other personal records like credit card numbers, are more valuable on the black market since health conditions are permanent and cannot be reissued.*
According to HHS, a record 89 million Americans had their health information breached in 2023, more than double since 2022. These cyberattacks severely impact health care operations, costing an average of $10 million per breach and leading to an interruption or long-term delay in care. In 2022, Louisiana, hackers compromised almost 270,000 personal records, including health information.
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Original text here: https://www.help.senate.gov/ranking/newsroom/press/ranking-member-cassidy-colleagues-introduce-legislation-to-strengthen-cybersecurity-in-health-care-sector-as-part-of-bipartisan-working-group
Senate Energy Committee Chairman Manchin, Sen. Capito Announce Progress Empowering West Virginia to Permit Carbon Storage Projects
WASHINGTON, Nov. 23 -- Sen. Joe Manchin, D-West Virginia, chairman of the Senate Energy and Natural Resources Committee, issued the following news release on Nov. 22, 2024:Charleston, WV - Today, Senator Joe Manchin III (I-WV), Chairman of the Senate Committee on Energy and Natural Resources, and Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Committee on Environment and Public Works, announced that the Environmental Protection Agency (EPA) has proposed granting West Virginia the authority to oversee and administer the Class VI well program in the state, which is more commonly ... Show Full Article WASHINGTON, Nov. 23 -- Sen. Joe Manchin, D-West Virginia, chairman of the Senate Energy and Natural Resources Committee, issued the following news release on Nov. 22, 2024: Charleston, WV - Today, Senator Joe Manchin III (I-WV), Chairman of the Senate Committee on Energy and Natural Resources, and Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Committee on Environment and Public Works, announced that the Environmental Protection Agency (EPA) has proposed granting West Virginia the authority to oversee and administer the Class VI well program in the state, which is more commonlyknown as Class VI "primacy". These wells are designed to inject carbon dioxide (CO2) into deep rock formations and serve as critical infrastructure for deploying carbon capture and storage (CCS) projects. Once finalized, primacy will allow a CCS project developer in West Virginia to apply directly for permits from the West Virginia Department of Environmental Protection (WVDEP), accelerating the process, which currently requires a permit from EPA, while still upholding strict safety standards.
"West Virginia has always been at the forefront of deploying cutting-edge energy technologies," said Chairman Manchin. "CCS will strengthen our energy security, create high-paying jobs, and reduce emissions. Ensuring these wells can be approved quickly and safely by WVDEP experts who know our state best is key to realizing this goal, and I'm glad the state and the EPA have collaborated on this important initiative and look forward to seeing it finalized as quickly as possible."
"After too long of a delay, it is welcome news that EPA has taken this step towards granting West Virginia the authority we need to properly implement carbon capture technology. I have frequently said that the states are better suited than Washington to carry out this authority and get these projects up and running. Carbon capture, use, and storage is essential to protecting our ability to provide reliable, baseload power in West Virginia through coal and natural gas, while reducing our power and manufacturing sector emissions. I look forward to the swift finalization of this authority and its enactment in our state," Ranking Member Capito said.
Senator Manchin has long advocated for carbon capture technology, including expanding the 45Q tax credit in the Inflation Reduction Act and increasing research and demonstration programs for carbon capture in both the Bipartisan Infrastructure Law and the Energy Act of 2020. He has also led the initiative to streamline the Class VI well approval process and delegate permitting primacy to states, securing additional funding through the Bipartisan Infrastructure Law to help states pursue primacy and bolstering EPA resources to hire staff for processing well and primacy applications more efficiently.
Senator Capito has continuously advocated for West Virginia to be granted Class VI well primacy. In May 2023, Senator Capito introduced legislation to streamline state primacy applications for Class VI wells. In November 2023, Senator Capito urged the EPA to more quickly grant state primacy for Class VI storage wells and disburse funding from the Infrastructure Investment and Jobs Act, which she fought to include for future CCUS projects in the state. Senator Capito's remarks are available here.
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Original text here: https://www.energy.senate.gov/2024/11/manchin-capito-announce-progress-empowering-west-virginia-to-permit-carbon-storage-projects
Reps. Lizzie Fletcher & Morgan Luttrell Lead Bipartisan Effort To Allow Members of Congress To Share Lifesaving Resources With Constituents During Natural Disasters
WASHINGTON, Nov. 23 -- Rep. Lizzie Fletcher, D-Texas, issued the following news release:Congresswoman Lizzie Fletcher (TX-07) and Congressman Morgan Luttrell (TX-08), joined by six of their colleagues, sent a letter to the House Committee on Administration requesting a change to the current House Rules to allow members of Congress to share information about non-profit resources during natural disasters. Under the current rules of the House of Representatives, Members of Congress are prohibited from referring constituents to or sharing information from resources unaffiliated with the government, ... Show Full Article WASHINGTON, Nov. 23 -- Rep. Lizzie Fletcher, D-Texas, issued the following news release: Congresswoman Lizzie Fletcher (TX-07) and Congressman Morgan Luttrell (TX-08), joined by six of their colleagues, sent a letter to the House Committee on Administration requesting a change to the current House Rules to allow members of Congress to share information about non-profit resources during natural disasters. Under the current rules of the House of Representatives, Members of Congress are prohibited from referring constituents to or sharing information from resources unaffiliated with the government,even during natural disasters.
"Following a natural disaster, local and national non-profit entities, like shelters or food banks, are often first on the scene and have the infrastructure to help disaster victims, often before the Federal Emergency Management Agency (FEMA) can even set up operations," the members wrote. "While FEMA plays a crucial role in recovery efforts, its efforts are supported by other organizations, including non-profit entities that provide services that FEMA cannot, including addressing medication shortages and long-term food assistance. These non-profit groups fill the gap in local communities where FEMA is unable to help because of lack of resources or lack of ability. But, because of current House rules, we are unable to refer constituents to these entities for assistance, even when their work may be lifesaving.
"In the aftermath of Hurricane Beryl, Congresswoman Fletcher's office received a call about a constituent's elderly, disabled parents," the members continued. "They had lost power, their food had spoiled, and they were unable to leave their house to receive aid. In this instance, it would have been helpful to connect the constituent to a non-profit entity, like the Houston Food Bank, to receive help. Staff were unable to provide a helpful referral because of current House Administration rules that prohibit congressional offices from referring constituents to any non-governmental groups, including non-profits. This is just one of the many examples of how this rule blocks critical aid."
Congressmembers Troy Carter (LA-02), Henry Cuellar (TX-28), Sylvia R. Garcia (TX-29), Garret Graves (LA-06), Al Green (TX-09), and Marc A. Veasey (TX-33) joined Representatives Fletcher and Luttrell in this request and signed the letter.
To read the full letter, click here (https://fletcher.house.gov/UploadedFiles/Letter_to_House_Admin_on_Referrals_to_Non_Profit_Groups_FINAL1.pdf).
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Original text here: https://fletcher.house.gov/news/documentsingle.aspx?DocumentID=5548
House Oversight & Accountability Subcommittee Issues Testimony From FDA Chief Medical Officer Marston
WASHINGTON, Nov. 23 -- The House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic released the following testimony by Hilary Marston, chief medical officer of the Food and Drug Administration, from a Nov. 14, 2024, hearing entitled "Preparing for the Next Pandemic: Lessons Learned and The Path Forward":* * *
Chair Wenstrup, Ranking Member Ruiz, and members of the Subcommittee, thank you for the opportunity to testify before you to discuss the Food and Drug Administration's (FDA or Agency) efforts regarding pandemic preparedness.
The COVID-19 pandemic, the response ... Show Full Article WASHINGTON, Nov. 23 -- The House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic released the following testimony by Hilary Marston, chief medical officer of the Food and Drug Administration, from a Nov. 14, 2024, hearing entitled "Preparing for the Next Pandemic: Lessons Learned and The Path Forward": * * * Chair Wenstrup, Ranking Member Ruiz, and members of the Subcommittee, thank you for the opportunity to testify before you to discuss the Food and Drug Administration's (FDA or Agency) efforts regarding pandemic preparedness. The COVID-19 pandemic, the responseto Highly Pathogenic Avian Influenza (HPAI) in dairy cattle, as well as emergency-induced supply chain disruptions causing shortages of medical products have underscored the need to continue to optimize our nation's preparedness and response capabilities. These public health emergencies and threats also make clear the value and importance of vaccines, therapeutics, and diagnostics to address pandemic threats, and the role these products serve in saving lives. FDA works in close coordination and collaboration with our partners across all levels of government, to help facilitate the development, authorization, licensure, approval, clearance, and availability of critical, high-quality, safe, and effective medical products and ensure the continuity of the food supply to address current and future public health threats.
Additional authorities and funding as requested in the Fiscal Year (FY) 2025 President's Budget for federal agencies are necessary to address future challenges most effectively. The lessons learned and proposals I will discuss today will help bridge key gaps and barriers to enable a robust and timely response to future emergencies--by enhancing early detection; providing safe, effective, and accessible medical countermeasures (MCMs), such as personal protective equipment (PPE); maintaining health system capacity; and fortifying continuity of access to food and medical products. We look forward to continuing work with Congress to ensure future readiness.
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FDA's Public Health Emergency Preparedness and Response Mission
FDA plays a key role in pandemic and public health emergency response. Preparation for future public health emergencies depends on diverse strategies--often decades in the making--as well as the establishment and refinement of authorities and flexibilities that allow the Agency to identify and mitigate risks while promoting innovation.
FDA used every tool in its toolbox during the COVID-19 public health emergency. We promptly issued guidance to industry to provide clear recommendations regarding data to satisfy applicable requirements and helped developers to advance the most promising candidate MCMs as quickly as possible. The Agency helped make COVID-19 vaccines available swiftly while upholding our rigorous scientific and regulatory standards by prioritizing and streamlining reviews. During the COVID-19 pandemic, FDA scientists and employees worked tirelessly, cooperatively, intensively, and efficiently alongside researchers and manufacturers to minimize the time between the clinical development process, manufacturing scale-up, and the regulatory review process. As the virus evolved, FDA leveraged what was known about the vaccines and their underlying technologies to streamline the authorization and approval of updated COVID-19 vaccines, as appropriate, that more closely targeted circulating variants. COVID-19 vaccines are one of the most significant and important public health interventions in our history, and the available data continue to demonstrate that the benefits of the authorized and approved COVID-19 vaccines outweigh their risks, producing a substantial reduction in the most serious outcomes of COVID-19, including severe illness, hospitalization, and death.
FDA's unprecedented efforts during the COVID-19 pandemic were also instrumental in making in vitro diagnostic tests available to the public. The Agency authorized emergency use of over 500 COVID-19 tests, including point-of-care (POC) tests; rapid at-home tests; multi-analyte tests that can detect both COVID-19 and flu; and tests using various sample types, including saliva and breath samples. FDA encouraged development of at-home and over-the-counter (OTC) tests for COVID-19 early in the pandemic. FDA worked interactively with test developers and provided resources, including templates to help facilitate Emergency Use Authorization (EUA) requests, a recurring townhall series to provide information for test developers, guidance documents, and FAQs. Notably, the Agency granted marketing authorization under traditional premarket authorities for tests for COVID-19 and other conditions. This includes granting traditional marketing authorization of the first OTC test to detect both flu and COVID, paving the way for this type of device to be available for future respiratory virus seasons. FDA also authorized emergency use of numerous other devices, including ventilators, personal protective equipment such as respirators, and many others.
The lessons learned from the COVID-19 pandemic help the Agency better respond to current emergencies. For example, FDA continues to facilitate availability of diagnostic tests as the United States experiences other outbreaks. Currently, FDA is working with other government agencies like the Centers for Disease Control and Prevention, and with test developers who may be interested in developing additional HPAI-specific tests. In addition, FDA's early engagement with stakeholders and work with private and public entities on mpox text development and availability led to the issuance of prompt guidance and templates building on the lessons learned from COVID.
FDA also approved and authorized several treatment options for COVID-19--including Paxlovid, and remdesivir--which reduce the risk of severe illness, hospitalization, and death. The COVID-19 pandemic highlighted the need to be able to stand up well-designed and powered clinical trials that could answer important therapeutic questions. The Agency has and will continue to support efforts to meet future COVID-19 vaccine and treatment needs, including pivoting as the virus adapts and continuing to help advance medical products to protect the most vulnerable populations. For example, FDA is working closely with sponsors to facilitate the development of monoclonal antibodies (mAbs) that target the virus and retain activity against currently circulating variants to address immediate unmet needs, such as pre-exposure prophylaxis for immunosuppressed patients, and to facilitate development of new products with conserved targets that are less susceptible to changes in SARS-CoV-2 (e.g., Pemgarda (pemivibart)). We are also leveraging lessons learned from the COVID-19 response in our everyday reviews, including review of rare disease therapies where ongoing and informal communication with the Agency can be especially beneficial.
Additionally, when tackling a public health crisis, accurate, science-based communication is of paramount importance. Improving trust in science-based organizations requires a collaborative effort. FDA is continuing to build effective relationships with the public, front-line clinicians (doctors, nurses, pharmacists, etc.), biomedical scientists, and educators. We are also working to improve how we can continue to provide accurate and reliable information about FDA-regulated products to trusted messengers in communities to better inform the public about their choices about health and healthcare.
As we reflect on the devastating losses and lasting impacts the COVID-19 pandemic and more recent outbreaks have had worldwide, we are using the lessons learned and knowledge gained to be thoughtful about preparing for future public health emergencies and to inform our future response efforts both in times of crisis and in everyday best practices. This includes continuing to leverage existing relationships with entities outside FDA in emergency response situations. The Agency's capacity to drive future emergency responses depends on developing shared goals and maintaining open communication channels and continued collaborations with regulatory, academic, state, Tribal, local, territorial, and industry partners even in the absence of a crisis.
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Facilitating Access to Safe and Effective Medical Products
As FDA prepares to combat future threats, ensuring access to safe and effective medical products continues to be of utmost importance. FDA provides support to this mission through its work in several preparedness areas.
Public health emergencies--whether the COVID-19 pandemic or more recently Hurricanes Helene and Milton--continue to expose supply chain vulnerabilities, including a lack of resiliency, the capability to withstand or mitigate disruptions, and redundancy, impacting the availability of multiple medical products. There is a need for greater transparency into medical product supply chains to improve resiliency in manufacturing, which will help to ensure continued access to critical products, including drug products, during emergencies when supply chains might be disrupted.
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Drug Product Supply Chain
FDA works within its authorities to find ways to help prevent and mitigate drug shortages, and in Calendar Year (CY) 2023, we worked with manufacturers to successfully prevent 236 drug and biologic shortages. The COVID-19 pandemic served as a reminder that the drug supply chain is extremely vulnerable to supply disruptions and surges in demand. Prior to this pandemic, most shortages were seen in generic sterile injectables, a historically low margin business, where investment in buffer stocks and manufacturing upgrades have been difficult to achieve. When manufacturing issues disrupt supply, manufacturers of certain drugs are required to notify FDA. This notification requirement provides FDA more time to mitigate or prevent a shortage, and the Agency has relied on these notifications to help prevent supply disruptions. However, during the pandemic and since, we also saw unprecedented demand for drugs. Similar notifications of increases in demand from manufacturers would allow the Agency more lead time in mitigating supply impacts.
Looking to future preparedness, and in accordance with the National Strategy for a Resilient Public Health Supply Chain, it is critical for the U.S. government to have visibility into the end-to-end supply chain data. The authorities provided under the Federal Food, Drug, and Cosmetic (FD&C) Act provisions, including those added by section 3112 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136), enhanced FDA's visibility into drug and medical product supply chains and the tools available to the Agency to help identify, prevent, and mitigate drug shortages. To increase patient access to critically needed medications in shortage or to prevent potential shortages, FDA leveraged these available tools by expediting reviews of submissions, prioritizing certain establishment inspections to address drug shortages, expediting reviews of submissions (including for COVID-19 therapeutic biologics), and exercising regulatory discretion where appropriate to help increase supplies of critically needed medications, including via temporary importation.
FDA is working within its authorities to help mitigate supply chain issues, but FDA's authorities were not designed with a complex 21st Century supply chain in mind, including consumer and provider expectations for the availability of essential products. Efforts are underway across government to address these challenges. However, the Agency has identified numerous gaps in its authorities to protect consumers, patients, and the supply chain generally. Providing greater transparency into supply chains is needed to improve resiliency in manufacturing and prevent and mitigate shortages of medical products and the food supply. These priorities will enhance national security and improve public health preparedness. The FY 2025 President's Budget includes several critical legislative proposals intended to promote FDA's efforts to bolster supply chains and address current vulnerabilities. For drug products, this includes proposals to enhance FDA's insight into the human and animal drug supply chain to more effectively prevent or mitigate a shortage, including to understand supplier reliance on the sources of API, and to close a loophole that does not require manufacturers to notify FDA if a likely human drug shortage is caused by a spike in demand.
Additionally, in the FY 2025 President's Budget proposal FDA is seeking authority to require facilities at which drugs are manufactured to create, submit, and maintain Site Master Files (SMFs). This would improve the Agency's understanding of manufacturing activities and provide critical information that could assist FDA when conducting risk identification for sites for surveillance and for-cause based inspections. SMFs are internationally harmonized documents that typically contain specific information about the firm's manufacturing and product activities and quality management and quality control activities at the named site. SMFs also identify any closely integrated operations at adjacent and nearby buildings. For example, FDA could look to the SMF in cases of inadvertent cross-contamination of human drugs, animal drugs, and biologics by substances present at a manufacturing facility, but not referenced in an approved application or license or reflected in a supplement or other such report. Another FY 2025 President's Budget proposal seeks authority to provide FDA with a formal, designated opportunity for a facility inspection and evaluation before distribution of certain non-application drug products and certain APIs in the United States for the first time. Under current law, for drugs that are not subject to premarket approval requirements, such as many over-the-counter drugs like hand sanitizers and certain eyedrops, and APIs for compounded drugs, FDA typically does not have such a formal, designated opportunity to inspect the manufacturing facilities before such products are first shipped to or distributed in the United States. Having such an opportunity for facility inspection would help enable FDA to identify potential safety issues related to manufacturing before a non-application drug product is first distributed.
Relatedly, as more manufacturers enter the vaccine and biotherapeutics industries, the ability of FDA's Office of Inspections and Investigations to respond robustly to future pandemics will depend on operational readiness and surge capacity. Critical investments are needed, such as increasing the inspectorate's workforce capacity for oversight of medical products, including MCMs, and funding training and continuing education. A strong inspectorate is especially critical to provide oversight where products face potential shortages because inspections allow FDA to identify quality problems early and to work with firms to correct such problems before they threaten supply or patient safety. Additionally, FDA could achieve more effective and efficient oversight if it had improved authorities for conducting remote regulatory assessments. This could include extending FDA's authority to request records or other information in advance of or in lieu of inspections, to cover all FDA-regulated products. In the Food and Drug Administration Omnibus Reform Act of 2022 (FDORA), Congress recognized that remote records request authority was key to future preparedness by expanding this authority beyond drugs to include devices and to sites or facilities subject to bioresearch monitoring inspections. New authorities for mandatory remote interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing) would additionally provide a tool for the Agency's oversight of the regulated industry to ensure a safe, reliable supply chain.
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Medical Device Supply Chain and Safety
U.S. preparedness and our national security depend on a strong domestic supply chain for medical devices. The COVID-19 pandemic demonstrated that by the time there is an emergency, it is often too late to prevent shortages. Supply chain disruptions were already beginning to occur even before COVID-19 cases were identified in the United States, as other nations had outbreaks and needed PPE, testing supplies, and other devices in excess of available supply. For example, the United States and other countries saw a shortage of gowns caused by a recall prior to the pandemic. FDA received information about supply chain challenges with gowns after there was already a shortage. If FDA had device shortage authorities in place prior to the COVID-19 pandemic, mitigation efforts for N-95 respirators, surgical masks and other PPE, testing supplies, ventilators and other essential devices could have begun much earlier in the United States.
The CARES Act added manufacturer notification requirements to help FDA identify and address device shortages (section 506J of the FD&C Act) before they occur. However, these authorities are temporally tied to a public health emergency (PHE). Since manufacturing disruptions that may lead to shortages occur outside a PHE, the temporal limit hurts FDA's ability to mitigate and prevent device shortages. This contrasts with other product shortage authorities, such as drugs and critical foods, that require notifications for certain discontinuances and interruptions in manufacturing whether there is a PHE or not. By the end of CY 2022, FDA's Center for Devices and Radiological Health had taken or informed mitigation actions on more than 350 potential and actual shortages of critical devices, ranging from pediatric tracheostomy tubes to tests and testing supplies. FDA also used information gathered under these authorities to perform assessments that enabled us to:
* Expedite premarket reviews and inspections;
* Issue guidance documents, letters to healthcare providers, and enforcement discretion;
* Publish communications, including conservation strategies to provide end users with information on device shortages; and
* Work with the Administration for Strategic Preparedness and Response (ASPR) on Defense Production Act priority ratings and other actions by U.S. government entities, such as the Department of Defense and the Department of Transportation. Each of these departments depend on the information from FDA when implementing mitigations.
Regardless of whether they occur during a formally declared PHE or other major crisis, we know that medical device shortages most often impact our most vulnerable and underserved populations--such as children and rural populations. As an example, rural hospitals often do not have the funding to purchase multiple types of critical equipment, such as X-ray machines and washers and sterilizers to clean and sterilize reusable medical devices. When these devices and equipment cannot be serviced or replaced because of a lack of parts or materials, patients may have to drive hours to seek the care they need or forego care altogether. It is therefore critical to ensure FDA receives information as early as possible so the Agency can intervene before harm comes to patients. The Agency continues to see supply chain disruptions--including those for neonatal/pediatric hemodialysis catheters, blood culture vials, and infant duodenoscopes--but FDA did not receive notification from manufacturers. FDA receives some information about supply chain interruptions from patients, health care providers, and professional associations, but these typically come only after patients are already being impacted. The United States remains vulnerable while it does not have the device shortages authorities it needs.
To protect patients, build a more resilient domestic supply chain, and help reduce dependence on foreign sources, it is critical that Congress remove the temporal limitation that requires manufacturers to notify FDA about interruptions or discontinuances in the manufacture of certain devices only during or in advance of a PHE, as outlined in the FY 2025 President's Budget request.
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Diversifying the Medical Device Supply Chain
The COVID-19 pandemic magnified the problem of substandard and fraudulent products from international firms, largely from China. While this issue is not new, it has become more pervasive and widespread.1 In addition, based on our extensive investigations, including a review of device premarket submissions, facility inspections, and data analysis, FDA has observed a troubling increase in issues such as data falsification, violation of quality system regulations, and marketing of products without FDA authorization among a range of products. This situation makes the United States vulnerable to having ineffective or unsafe products enter the supply chain, which compromises our nation's response PHEs and routine patient care. Further, we are not always able to understand the relationships between different Chinese firms, including intermediaries in the supply chain, which complicates FDA's ability to ensure that import controls comprehensively prevent exposure to the public.
FDA will continue to take steps to address these issues within our current authorities, including through inspections, warning letters, import alerts, recalls, and safety-related communications. Despite extensive efforts using FDA's existing authorities, the entities responsible for developing, manufacturing, importing, and distributing these products into the United States have demonstrated the ability to evade the Agency's oversight.
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1 See e.g., http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication
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Overseeing and Monitoring Products Critical to Public Health
FDA has also seen that supply disruptions for other critical products can have an immense impact on families. Preventing food shortages is vital to public health, and we are grateful that Congress included a provision in FDORA to require manufacturers of infant formulas and medical foods, which are critical foods, to notify FDA of potential shortages. Looking forward, as outlined in the FY 2025 President's Budget request, parallel authority to require notifications during a declared PHE of anticipated interruptions in the supply chain of additional categories of foods designated by FDA would help the Agency better ensure the continuity of the food supply and avoid shortages of nutritionally important food products.
Finally, across all these areas, FDA's partnerships with state, local, and U.S. territorial governments continue to play an important role in the protection of public health, particularly as FDA partners with them in the regulation of products, helping to ensure the safety and integrity of supply chains, and assisting in enforcement against products that are being unlawfully sold. As outlined in the FY 2025 President's Budget, FDA is proposing to amend the FD&C Act to allow for disclosure of non-public information to state, local, and U.S. territorial government agencies with counterpart functions related to FDA-regulated products while ensuring confidentiality of non-public information (such as confidential commercial information) provided by FDA. New provisions for the disclosure of non-public information to these agencies with complementary functions related to FDA-regulated products, and a federally consistent expectation for disclosure, could achieve faster and more effective action to protect the public health during national PHEs, other state/local disaster declarations, outbreaks, or other public health events, and for routine regulatory oversight.
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Vaccine Surveillance and Monitoring
Over 270 million people received more than 676 million doses of COVID-19 vaccines in the United States. Vaccine safety is a top priority for the federal government, and we take reports of health problems following COVID-19 vaccination very seriously. FDA and its federal and state partners cooperate to conduct intensive monitoring of U.S. COVID-19 vaccine safety using a variety of overlapping approaches. FDA also collaborates with international partners to understand the safety of these vaccines globally. Through the Biologics Effectiveness and Safety Initiative, part of the FDA Sentinel Initiative, FDA can analyze information occurring in millions of health insurance claim submissions or electronic health records (EHR) recorded in large data systems. FDA's ability to analyze claims information is limited by the fact that some vaccinations are not recorded in health insurance claims data. Additionally, FDA needs to quickly verify information or access additional information to evaluate the adverse events of interest. A coordinated federal public health data reporting authority, as outlined in the FY 2025 President's Budget request, would help the Agency to more swiftly identify adverse event patterns and trends associated with the use of vaccines or other MCMs, and swiftly be able to communicate with health care providers and patients about safety signals.
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Fostering Medical Countermeasure Development
As part of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act, Congress required FDA to establish a platform technology designation program to support the development and review of certain platform technologies that can be incorporated or used in more than one drug or biological product. In May 2024, FDA issued draft guidance entitled, Platform Technology Designation Program for Drug Development./2
This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug and selected biologics product development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies, which will be particularly valuable during a pandemic. Of note, the guidance includes platforms in mRNA vaccines as one example of a potential platform technology that could be eligible for the designation program.
Given the potential use of platform technologies in products incorporating human genome editing technology, such as CRISPR, in its July 2024 guidance agenda,/3 FDA's Center for Biologics Evaluation and Research (CBER) announced its intent to issue draft guidance on the Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing. The guidance is intended to provide additional clarity specific to these types of products. Even outside of the platform technology designation program (for those platforms that do not qualify for the designation, e.g., because they are not yet part of an approved product), FDA is evaluating how we can implement the spirit of the provision by leveraging data and information about platform technologies across related products during the development process.
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2 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/platform-technology-designation-program-drug-development
3 http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2024
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Further, enhancing FDA's regulatory capabilities and readiness to respond to emerging pathogens; helping ensure blood safety and availability; and expeditiously reviewing new vaccines, updates of existing vaccines and other medical products are all vital to the Agency's continued success in preparation and response to public health threats. During the COVID-19 pandemic the Agency saw that FDA staff need to be prepared to continue to address the current pandemic needs while also preparing for potential future pandemics and staying on top of our daily work to help ensure blood safety and availability and regulate vaccines and other medical products. With additional resources, as requested in the FY 2025 Budget, the creation of a specialized program to defend against emerging pathogens and other threats, would position the Agency to respond to emerging and identified threats of concern and focus experienced resources to work quickly on MCM development to address these concerns. In consultation with our federal government partners, the program could: further accelerate the review of critical MCM product applications; provide recommendations and guidance to developers of vaccines and other medical products and to relevant federal partners; use real-world data to study the safety and effectiveness of products for addressing biological incidents and identify which products may be best suited for specific pathogens or for use in different populations; and facilitate product development including advances in manufacturing. It could also support applied scientific research within CBER that contributes to development and review of biological products to counter biological incidents and emerging pathogens.
Animal Health and Pandemic Preparedness The COVID-19 pandemic and the emergence of HPAI in dairy cattle also highlighted the importance of the connection between animal health and pandemic preparedness. National preparedness efforts need to include reducing the spread of diseases between animals and humans, maintaining a secure food supply from animal agriculture, and strengthening supply chains for animal drugs along with animal health and welfare. FDA's Animal and Veterinary Innovation Agenda supports the development of innovative, safe and effective products and streamlined and clarified regulatory processes so industries we regulate can have access to an array of modern technologies to monitor, prevent, control, and treat increasing animal health challenges, such as zoonotic and animal infectious disease threats, leading to healthier animals and communities.
Similarly, as on the human side, the Agency has identified areas where current authorities for animal health do not meet preparedness needs. For example, FY25 legislative proposals seek to require manufacturers to notify FDA of a shortage of animal drugs caused by either a decrease in production or an increase in demand.
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Conclusion
FDA continues to advance its mission to protect and promote public health by helping to ensure the safety of human and animal food, and the safety and effectiveness of medical products. The Agency is continuing to monitor its policies, the marketplace, and national needs, and will continue to adapt as the circumstances and needs of the nation evolve to be ready for the next 18
emergency. The Agency takes our public health mandate very seriously and works each day to be prepared for future pandemics and emergencies. FDA looks forward to continuing to work with Congress on the Agency's public health emergency preparedness and response mission and strengthening FDA's authorities to continue building a resilient supply chain for critical medical products, foods, and medical countermeasures. Thank you again for the opportunity to testify.
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Original text here: https://oversight.house.gov/wp-content/uploads/2024/11/FDA-SSCP-Written-Testimony-11.14.24_Final.pdf