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To prohibit the disclosure of records by the Secretary of Housing and Urban Development of individuals for the purposes of immigration enforcement, and for other purposes.
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The U.S. should do more to enforce immigration laws and secure the border.
“Jake debates Fox News' Peter Doocy on how ICE has morphed from targeted immigration enforcement into a presidential paramilitary”
Passage votes where Jake Auchincloss broke ranks with ≥75% of Democrats. Threshold catches substantively partisan splits; unanimous-ish or close votes are excluded.
Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Securities and Exchange Commission relating to "Staff Accounting Bulletin No. 121".
Auchincloss, Griffith Introduce Faster Clinical Trials Act | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release describes a bill that would establish a Center for Clinical Trial Innovation at the FDA, create trial networks in community and rural clinics, streamline lower-risk Phase 1 trial reviews, and build a national biobank, with the stated aim of speeding clinical trials while preserving FDA safety standards.
FOR IMMEDIATE RELEASE
CONTACT: Georgina.Burros@mail.house.gov (Auchincloss)
AUCHINCLOSS, GRIFFITH INTRODUCE FASTER CLINICAL TRIALS ACT
WASHINGTON, D.C. — Today, Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA) released the Faster Clinical Trials Act. The proposal would speed the development of new treatments, invest in clinical research, and propel U.S. leadership in biomedical innovation.
For decades, the United States has led the world in biomedical research and development; the testing and approval process by which potential medicines are deemed safe and effective; and the distribution of those medicines into clinical settings. However, America’s fragmented and friction-filled clinical research enterprise has not kept pace with the speed of science nor the investment by other nations. The difficulty of integrating clinical trials into U.S. sites of care has slowed down American development, testing, and approval.
The Faster Clinical Trials Act would upgrade America’s science infrastructure—the data, research sites, and clear standards needed to develop treatments—while preserving the Food and Drug Administration’s (FDA) high standards for safety and effectiveness.
This legislation would establish a Center for Clinical Trial Innovation (CCI) within the FDA’s drug review center. The CCI would lead implementation of the Cures in Care Initiative, working with clinical sites to bring research into routine care.
Within one year of enactment, the center would establish at least three trial networks, prioritizing community health centers, rural clinics, and other sites with fewer resources. Training, shared technology, and technical support would help providers conduct trials where patients already receive care.
The proposal would direct the FDA and federal partners to connect health records and research systems, protect patient privacy, and reduce duplicate ethics reviews.
It would create a faster review process for lower-risk Phase 1 trials, including qualified third-party reviews with quality checks by the FDA. It would also advance human-based models, artificial intelligence, and alternatives to animal testing.
To prevent avoidable delays, the FDA would address common causes of clinical holds and improve support for researchers. The bill would align global trial standards, strengthen oversight of foreign research, and promote generic and biosimilar competition. It would also strengthen the FDA’s Rare Disease Innovation Hub to support flexible trial designs and help developers navigate review.
The draft would establish a legal framework for the FDA’s Oncology Center of Excellence and a process to update cancer drug labels using genomic evidence, helping identify patients who may not benefit from certain treatments.
It would also build on All of Us to establish a national biobank linking biological samples, genomic data, and health records.
Together, these changes aim to deliver better evidence and faster trials for American patients—not lower standards.
Auchincloss, Amo, Balint Conduct Unannounced Oversight Visit to Burlington ICE Facility | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release criticizes conditions at the Burlington ICE facility, where detainees have reportedly been held for days beyond the intended 12-hour limit without adequate food, beds, or showers. It calls for due process, humane treatment of detainees, and continued congressional oversight.
CONTACT: Georgina.Burros@mail.house.gov
The Burlington, Massachusetts U.S. Immigration and Customs Enforcement (ICE) facility serves as the New England regional headquarters and field office.
Burlington, MA – TODAY, Jake Auchincloss (D-MA-04), Congressman Gabe Amo (D-RI-01), and Congresswoman Becca Balint (D-VT-AL) conducted an unannounced congressional oversight visit to the Burlington Immigration and Customs Enforcement (ICE) facility. This site is a short-term facility, designed to temporarily detain individuals for no longer than 12 hours. Under the Trump administration, there have been consistent reports of ICE detainees being held there for days without proper food, beds, or showers.
Congressman Auchincloss previously conducted an oversight visit of the Burlington ICE facility in June of 2025. During this visit, the lawmakers asked detailed questions about access to legal counsel, the treatment of people in ICE custody, and whether the facility was complying with federal law.
“Today I conducted an unannounced inspection of the Burlington ICE facility. Persistent congressional oversight, in concert with public pressure, has driven modest improvements to detention operations over the past year since my previous inspection in June of 2025. I will continue oversight and accountability measures in pursuit of due process and human dignity,” said Congressman Auchincloss (D-MA).
“ICE and Border Patrol continue to negatively impact our communities and that’s why I conducted my congressional oversight with a visit to the Burlington facility unannounced,” said Congressman Gabe Amo (D-RI). “During my inspection of the Burlington facility with Congressman Auchincloss and Congresswoman Balint, we witnessed individuals held for processing, questioned ICE regarding our constituents’ concerns, and pressed for more humane treatment of those in custody. I will not stop advocating for safe communities, due process, and humane immigration reform.”
“Vermonters deserve answers about what’s happening to people from our state who are being held in ICE custody,” said Congresswoman Becca Balint (VT-AL). “This facility was designed for stays of no more than 12 hours, but people have been held for days without basic necessities. We went in unannounced because we wanted to see the conditions for ourselves and get answers. ICE has a responsibility to treat people humanely and follow the law, and we’re going to hold them to it.”
Please find below excerpts of Rep. Auchincloss’ remarks from the media briefing, lightly edited for clarity:
“We conducted a congressionally authorized, unannounced inspection of this Burlington facility, and met with leadership, as well as reviewed and inspected the facilities in which the detainees are held. We asked detailed questions regarding medical care, access to legal services, dietary procedures and nutrition, the detainee processing protocols, procedures, and timelines, as well as the nature of operations throughout the region, to target detainees and then to pass detainees along to more permanent facilities.
What we have seen is that because of sustained congressional oversight and accountability, and because of sustained public pressure, there is a trend towards more targeted enforcement operations. Yet, there is persistent broken trust between this failed agency and the community, and there remain unacceptably long detention periods for certain of these detainees.
…Speaking for myself, I think the greatest need there is also the quality and the…infrastructure for food preparation. It is still ad hoc. There has been improvement since I was here [last year] for one of my constituents in terms of the quality [and] freshness of the food.
But this is not a facility that is designed to accommodate human beings for days at a time. It's designed to accommodate human beings for hours at a time. And as Congresswoman Balint said, because of the limited number of beds available to women at Stratford, it is the women detainees who are being kept here longer, for days at a time; and that is an unacceptable scenario.”
Reps. Auchincloss, Houchin Introduce Bipartisan 16 & Up Social Media Act to Keep Kids Under 16 Off Addictive Social Media Platforms | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: Supports federal legislation establishing a national minimum age of 16 for social media platforms, citing concerns that addictive design features harm children.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
Washington, D.C. — Congressman Jake Auchincloss (D-MA) and Congresswoman Erin Houchin (R-IN), co-chairs of the bipartisan Kids Online Safety Caucus, introduced the 16 & Up Social Media Act to establish a national age standard of 16 for social media platforms.
Social media companies are the merchants and miners of digital dopamine, spending hundreds of billions of dollars annually to manipulate, monetize, and attention-frack America’s youth. Platforms built on infinite scroll, autoplay, push alerts, and personalized feeds are designed to keep users hooked. Children are the least equipped to resist these algorithms, as their prefrontal cortices — which are vital for controlling behavior — remain underdeveloped. The 16 & Up Social Media Act sets and enforces a minimum age of 16 for social media use, protecting children from these addictive platforms.
“Social media corporations addict children for profit,” said Rep. Auchincloss. “The exploitation must stop. Our kids deserve their childhoods back.”
“Every parent knows the feeling of watching a child disappear into a screen,” said Rep. Houchin. “These platforms were engineered by the smartest people in the world to hold attention, and they are winning that fight against our kids. Studies show that sixteen is the right line. This bill draws it clearly, applies it to every platform that uses these addictive features, and puts real enforcement behind it. Kids get their childhood back, and parents get a bright line they can rely on.”
“Children's wellbeing is shaped by technologies that were designed for addiction yet face almost no oversight,” said Jonathan Haidt, Social Psychologist, NYU Stern School of Business, and author of The Anxious Generation. “This is not a parenting problem. It is a structural problem, and it demands a structural response. The goal is to stop addictive design entirely. Until then, gaining access to platforms with manipulative, unsafe design needs age minimums. The 16 & Up Social Media Act delivers exactly that.”
Reps. Auchincloss, Newhouse, Moolenaar, and Khanna Reintroduce Bipartisan Legislation Targeting China’s Role in U.S. Fentanyl Crisis | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release supports reintroduction of the CCP Fentanyl Sanctions Act, which would expand U.S. sanctions and financial restrictions on China-based chemical manufacturers, online vendors, and related entities involved in fentanyl and synthetic narcotics trafficking.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
Washington, D.C. — Today, Representatives Jake Auchincloss (D-MA) and Dan Newhouse (R-WA), alongside House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party (CCP) Chairman John Moolenaar (R-MI) and Ranking Member Ro Khanna (D-CA), reintroduced the CCP Fentanyl Sanctions Act to hold the Chinese Community Party responsible for its role in the U.S. fentanyl crisis.
After its establishment in 2024, the House Select Committee on China’s Fentanyl Policy Working Group uncovered for the first time how the CCP directly subsidizes fentanyl precursors and analogues entering North America.
The CCP Fentanyl Sanctions Act strengthens sanctions on China-based and CCP-backed entities engaged in drug trafficking, by targeting the Chinese chemical manufacturers and online vendors that are profiting by poisoning the American people.
As Co-Chairman of the Policy Working Group (PWG) last Congress, Auchincloss and his colleagues focused on combating the CCP’s role in the fentanyl epidemic with legislation to curtail the threat via sanctions, trade and customs enforcement, and regulatory and enforcement measures.
The CCP Fentanyl Sanctions Act will address fentanyl exports from China by:
Targeting the “Achilles’ heel” of fentanyl and related synthetic narcotics producers—their exposure to the U.S. banking system courtesy of their licit activity;
Codifying important new authorities to address this threat while working to target those responsible for the epidemic;
Codifying and building on Executive Order 14059, which established critical new sanctions authorities against actors involved in fentanyl trafficking;
Expanding existing sanctions authorities to target PRC vessels or ports that knowingly or recklessly facilitate shipment/transportation of illicit synthetic narcotics, as well as PRC online marketplaces and other entities that knowingly or recklessly facilitate sale of illicit synthetic narcotics;
Providing authority to restrict foreign financial institution correspondent accounts and payable-through accounts if the President determines the account has knowingly facilitated transactions on behalf of individuals engaging in synthetic narcotics trafficking.
“Thousands of families in Massachusetts have been scarred by fentanyl,” said Rep. Auchincloss. “Chinese chemical manufacturers that are exporting this addictive poison to American shores should bear the full force of U.S. sanctions and anti-money-laundering measures.”
“The Chinese Communist Party must be held accountable for helping manufacture the fentanyl crisis,” said Rep. Newhouse. “For too long, they have subsidized and exported illicit narcotics, and Congress must take aggressive action to counter this epidemic that’s ruining American lives and families. This bipartisan legislation is a strong step in the right direction, as it targets CCP-backed entities, like Chinese chemical companies, who continue wreaking havoc on our communities.”
“The Chinese Communist Party has long had a role in facilitating the fentanyl crisis that has killed hundreds of thousands of Americans,” said Chairman Moolenaar. “The Select Committee’s groundbreaking report in 2024 showed how the CCP subsidized the production of fentanyl precursors sold to the Mexican cartels. The bipartisan legislation we are introducing today targets the entities and individuals who participated in this deadly and illicit practice. It is a crucial step toward holding them accountable for the pain they have caused American families.”
“Fentanyl has devastated communities across America,” said Ranking Member Khanna. “I’m proud to join Rep. Auchincloss’s bipartisan effort to hold the networks responsible accountable. We must stop the flow of fentanyl and illicit precursors into our country and protect American families.”
Reps. Auchincloss, Ciscomani Introduce the Bipartisan Alzheimer’s Early Detection Act to Expand Coverage for Pre-Symptomatic Disease Detection | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release supports legislation requiring commercial health plans and Medicaid to cover blood-based biomarker testing for early detection, diagnosis, and management of Alzheimer's disease for adults over 50.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
Washington, D.C. — Today, Representatives Jake Auchincloss (D-MA) and Juan Ciscomani (R-AZ) introduced the bipartisan Alzheimer’s Early Detection Act to allow pre-Medicare-eligible adults to access blood-based biomarker testing that detects pre-symptomatic Alzheimer’s disease before cognitive symptoms appear. Alzheimer’s disease is usually diagnosed in those over the age of 65, after symptoms appear and progressively get worse. By 2050, 13 million Americans are expected to suffer from Alzheimer’s, costing an estimated $1 trillion every year in medical and caregiver expenses.
The life expectancy after an Alzheimer’s diagnosis is four to eight years. This legislation would require commercial health plans and Medicaid to cover biomarker testing for early detection, risk stratification, diagnosis, treatment, and management of Alzheimer’s disease for adults over 50.
Biomarker testing for Alzheimer’s disease in adults over 50 is an evolving area that combines blood-based tests, brain imaging, and cerebrospinal fluid analysis to detect biological changes linked to the disease. The Alzheimer’s Early Detection Act helps advance early detection and provides access to life-altering testing to help alleviate the emotional and economic burden of Alzheimer’s on patients and families.
“Few families in America are untouched by Alzheimer's,” said Rep. Auchincloss. “My mission is to make my children's generation the first one with the medical tools to prevent this cruel and costly disease. Early detection is critical to that mission.”
“Early detection can change the way families approach Alzheimer’s disease by providing patients and their loved ones with critical information sooner,” said Rep. Juan Ciscomani. “This issue is deeply personal to me. Like most Americans, several people close to me are currently battling with this horrendous disease. I have seen firsthand the importance of ensuring families have the information, resources, and support they need before a diagnosis becomes a crisis. No family should have to navigate Alzheimer’s alone, and every American deserves the opportunity to better understand their health risks and access care as early as possible.”
“As science continues to improve early detection of Alzheimer's disease, coverage must keep pace so more Americans can benefit as soon as possible,” said Erika Sward, Chief Advocacy Officer, UsAgainstAlzheimer's. “UsAgainstAlzheimer's applauds Representatives Auchincloss and Ciscomani for introducing their bipartisan legislation to allow for pre-Medicare coverage of biomarker testing, which will help more Americans receive timely diagnoses, make informed decisions about their care, and better prepare for the future.”
“Alzheimer's disease doesn't wait, and patients shouldn't have to either,” said Casey McPherson, AfPA Executive Director, Alliance for Patient Access. “Early detection is critical, and with new tests it is possible to give patients and families more time to plan, access treatment, and participate in their own care decisions. By cutting the red tape and eliminating unnecessary hurdles, this legislation ensures patients get the biomarker testing their clinicians recommend without unnecessary delay. Thank you to Representative Auchincloss for pushing this effort forward to expand timely access to early diagnosis.”
“Currently available blood tests accurately indicate Alzheimer’s pathology in the brain at the symptomatic and even pre-symptomatic stages of the disease,” said Paul Aisen, MD, Senior Scholar, USC Schaeffer Institute. “Studies show treatment with current therapies slows the disease, delaying loss of function by months to years; the earlier treatment starts, the greater the benefit (so delays in diagnosis must be avoided). The disease typically begins in the brain when people reach their 50s or early 60s; we must enable timely, accurate diagnosis for all.”
Release: Reps. Auchincloss, Peters, Joyce Unveil Landmark Bill to Improve Discount Drug Pricing Program | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release announces introduction of the bipartisan SECURE in 340B Act to modernize the 340B Drug Pricing Program, closing eligibility loopholes, adding transparency and accountability requirements, and resolving legal uncertainty surrounding manufacturer rebate pilot programs.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
Washington, D.C. — Today, Representatives Jake Auchincloss (D-MA), Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency (SECURE) in 340B Act, the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992. This bill is also co-sponsored by Reps. Nanette Barragán (D-CA) and Dan Crenshaw (R-TX).
“Employees' health premiums are too high, and the growth of the 340B program is one driver of that inflation,” said Congressman Auchincloss. “Instead of pointing fingers, it's time to fix the problems. This bill tackles the hard issues and asks every stakeholder to compromise for the common good.”
"For nearly a decade, I’ve fought to protect the 340B program for the safety-net providers and low-income patients in San Diego who depend on it to afford their prescription drugs. I’ve also pushed to make sure those savings actually reach the people for whom they’re intended. This bill does both,” Congressman Peters said. “The SECURE 340B Act closes the loopholes that have allowed the program to drift from its mission, stops the legal chaos that plagues the program today, and puts in place the kind of transparency and accountability that will keep 340B strong for decades to come."
“Since its establishment, the 340B program has served as a critical lifeline for low-income patients to access lifesaving medications,” said Congressman John Joyce, M.D. “The statute has long needed additional clarity to reflect the way the program operates today and ensure that access to treatment remains available to patients most in need and the healthcare facilities that serve them. This bill, a bipartisan solution that I am proud to have worked on with my colleague Representative Scott Peters, seeks to close loopholes that have compromised the integrity of the program while ensuring a stable path forward for the many hospitals and patients in my district that rely on it.”
The 340B Program, the nation's second-largest federal prescription drug program, was created to help safety-net providers stretch limited resources through discounted drug prices. It allows these providers to purchase outpatient drugs at significantly reduced prices. The discounts have historically been applied upfront at the point of purchase.
However, since federal law never defined who qualifies as a 340B “patient,” the program became ambiguous, and was misused. In the absence of a legal “patient” definition, manufacturers attempted their own rebate verification systems. Courts have tried to block these rebate pilot programs, but only on procedural grounds. To this day, the federal government still has no uniform way to prevent discounted medicines from going to ineligible patients or duplicate discounts, or to validate pricing data across federal programs.
The SECURE 340B Act addresses these gaps. It pauses manufacturer rebate models for four years while a new patient definition is created and standards for contract pharmacies, data sharing, and transparency take effect. It establishes a clear, statutory definition of “patient” based on previous federal guidance. The bill also directs the Health Resources and Services Administration (HRSA) to use an independent, conflict-free clearinghouse to securely manage prescription-level data, verify claims, and protect privacy. It also strengthens HRSA's authority and provides transparency and federal guardrails.
“We support legislation that strengthens, stabilizes, and preserves this critical program for eligible hospitals and federally qualified health centers who care for our most vulnerable communities and patients. At BMC Health System, 340B savings are reinvested directly into services that expand access to care, improve health outcomes, and strengthen the healthcare safety net for underserved communities. We recognize that advancing and sustaining the 340B program, inclusive of addressing the rebate model, requires balancing the needs of patients, providers, and manufacturers. Establishing long-term regulatory certainty through durable, bipartisan solutions will help providers plan for the future and continue delivering high-quality, affordable care to those who need it most.” — David Twitchell, PharmD, MBA, SVP and Chief Innovation Officer, Boston Medical Center Health System
"The 340B program is vital to Community Health Centers (CHCs) and the 52 million people — one in seven Americans, including one in three in rural communities — who rely on CHCs for affordable, comprehensive, and high-quality care. We commend Representatives Joyce, Crenshaw, Peters, and Auchincloss for their bipartisan leadership in advancing this comprehensive legislation. Key provisions addressing contract pharmacies, providing a four-year delay of any potential rebate model, and establishing and evaluating a neutral clearinghouse are especially important. We look forward to working with these leaders and Members on both sides of the aisle to build upon the bill being introduced today and advance legislation that preserves and strengthens access to 340B for CHCs and their patients.” — Kyu Rhee, MD, MPP, President and CEO, National Association of Community Health Centers
“Recent polling shows that while most voters are unfamiliar with the 340B program, once they learn what it is, an overwhelming 91 percent say Congress should increase transparency and accountability. That tells us something important: even without getting everything they want, stakeholders and voters agree on the core reforms needed to protect patients and strengthen the program. Congressman Peters’ SECURE 340B Act reflects those areas of consensus; a clear patient definition, transparency without rigid spending mandates, and guardrails that keep the program focused on patient benefit.” — Scott Suckow, Chair of Patient Advocates United in San Diego and Executive Director of the Liver Coalition.
“Advocates for Community Health is deeply grateful for the work of Representatives Peters, Joyce, Auchincloss, and Crenshaw to advance commonsense 340B program reform. ACH is a longstanding advocate for legislation that would stabilize and clarify the 340B program, and we are encouraged that SECURE reflects many of our members' core principles for reform, including the piloting of a claims clearinghouse before we rush into a rebate model. We look forward to continuing to advance this legislation, including refinements to the patient definition that reflects current health center operating procedures, as soon as possible.” — Amanda Pears Kelly, CEO, Advocates for Community Health
“The Community Oncology Alliance (COA) appreciates the leadership of Representatives Peters, Joyce, Auchincloss, and Crenshaw for recognizing that the 340B program urgently needs bipartisan reform. The SECURE 340B Act includes important steps toward transparency, accountability, clearer patient eligibility, stronger oversight of child sites, and patient affordability protections. Those are reforms that COA has long called for to be urgently addressed. At the same time, Congress must ensure that any final legislation does not lock in the very abuses that have distorted 340B—particularly arrangements that allow PBMs from being contract pharmacies and hospital systems from capturing savings that should benefit vulnerable patients. We look forward to working with the sponsors to strengthen the legislation so that 340B discounts help patients in need, not profit PBMs and hospitals.” — Ted Okon, Executive Director, Community Oncology Alliance
Legislative Discussion Draft of Next-Generation U.S. Clinical Development to Accelerate Cures | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release presents a legislative discussion draft intended to modernize and accelerate U.S. clinical trials and clinical research, and solicits stakeholder feedback on the proposal. It states that the current clinical research enterprise is fragmented and has not kept pace with biomedical discovery.
The United States has long led the world in biomedical discovery, translation into clinical research, and approvals of new cures and life-changing treatments. However, America’s clinical research enterprise has not kept pace and is fragmented and difficult to integrate into care sites. This discussion draft aims to modernize and improve the clinical trials process for faster and more accessible clinical trials in the U.S.
For more information or to share a comment on Rep. Auchincloss' Legislative Discussion Draft of the Next-Generation U.S. Clinical Development to Accelerate Cures Proposal, please feel free to reach out to Nikita Varman, Health Policy Advisor, Congressman Auchincloss (MA-04) at nikita.varman@mail.house.gov. The deadline for feedback submission is June 30.
RELEASE: Auchincloss, Warren, Harshbarger, Hawley Reintroduce Bipartisan Legislation to Rein in Pharmacy Benefit Managers (PBMs), Cut Drug Costs | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The release advocates for legislation that prohibits pharmacy benefit managers and their parent companies from owning pharmacy chains, requires divestment of conflicting pharmacy businesses, and strengthens federal antitrust enforcement against PBM consolidation to reduce drug costs and protect independent pharmacies.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
RELEASE: Auchincloss, Warren, Harshbarger, Hawley Reintroduce Bipartisan Legislation to Rein in Pharmacy Benefit Managers (PBMs), Cut Drug Costs
WASHINGTON, D.C. – Representatives Jake Auchincloss (D-MA) and Diana Harshbarger (R-TN), alongside Senators Elizabeth Warren (D-MA) and Josh Hawley (R-MO), reintroduced the Patients Before Monopolies (PBM) Act with expanded bipartisan support to rein in drug pricing middlemen, known as pharmacy benefit managers (PBMs), from enriching themselves and crushing competition at the expense of patients and independent pharmacies.
In the 119th Congress, new original cosponsors include Senators John Fetterman (D-PA) and Roger Marshall (R-KS), alongside Representatives Greg Landsman (D-OH) and Buddy Carter (R-GA) of the Committee on Energy and Commerce, and Jerry Nadler (D-NY) and Troy Nehls (R-TX) of the Judiciary Committee.
Since the PBM Act was first introduced in 2024, states across the country have sought to break up these giant conglomerates. In early 2025, Arkansas passed a law to prevent the joint ownership of PBMs and pharmacies. Later that year, 39 state attorneys general wrote a letter urging Congress to “pass[] an act prohibiting PBMs, their parent companies, or affiliates from owning or operating pharmacies.” In April, Tennessee lawmakers passed a law to ban joint ownership of PBMs and pharmacies, and the Tennessee Governor is expected to sign the bill into law as soon as this week. This growing bipartisan momentum in support of the goals of the PBM Act from across the nation sends an important signal to Congress that the work to rein in PBMs is not yet finished.
Over the past decade, PBMs have morphed into large health care conglomerates that exercise control over nearly every link of the prescription drug delivery chain. Today, the largest health care conglomerates each own a PBM — which pays for pharmacy services — as well as the pharmacy chains that provide those services. This inherent conflict of interest results in higher drug costs for patients and fewer independent pharmacies, but bigger profits for the corporate health care giants.
The Patients Before Monopolies (PBM) Act will address this by:
Prohibiting a parent company of a PBM or an insurer from owning a pharmacy business;
Requiring that a parent company in violation of the PBM Act divest its pharmacy business within one year of the bill’s enactment;
Creating automatic penalties if a company fails to divest in a timely manner, including disgorgement of profits and forced sales of assets in the event of noncompliance;
Enabling the Federal Trade Commission (FTC), Department of Health and Human Services (HHS), Antitrust Division of the Department of Justice (DOJ), and state attorneys general to bring lawsuits requiring violators of the PBM Act to divest their pharmacy business and disgorge any revenue received during the period of such violation;
Enabling private parties, including independent pharmacists, to bring lawsuits against violators of the bill, and secure treble damages in successful lawsuits;
Directing the FTC to distribute any revenue raised by penalties to harmed communities, including consumers overcharged at vertically integrated pharmacies; and
Allowing the FTC and DOJ to review and block future actions that would recreate the anticompetitive conditions addressed by the bill or harm the public interest.
“Like so many small business owners in America, independent pharmacists are working hard and playing by the rules but getting ripped off by monopolies,” said Rep. Auchincloss. “The PBM industry is rife with self-dealing and price gouging. Congress made modest but meaningful reforms earlier this year, and now the next step is banning PBMs from owning pharmacies. It's an unacceptable conflict of interest and yet another example of the vertical integration in health care that is raising prices for patients.”
“Our PBM Act is gaining momentum because people are realizing that you can’t lower health care costs without tackling corporate greed in the health care system,” said Senator Warren. “It’s time we finally rein in the health care middlemen that are jacking up drug costs and driving small pharmacies out of business.”
“Americans are paying more and more for healthcare while seeing less in return. PBMs are at the center of a broken system that rewards middlemen while driving up costs for patients and pushing out independent pharmacies,” said Senator Hawley. “Working Americans deserve better. This legislation is a major step toward restoring transparency and making healthcare more affordable for every American.”
“As a lifelong pharmacist, I’ve seen firsthand how PBMs game the system. When the same corporate giant that sets reimbursement rates also owns the pharmacy collecting them, that’s not a free market—it’s a rigged one,” said Rep. Diana Harshbarger. “We have antitrust laws for a reason. When monopolies squeeze out independent pharmacies, raise costs for patients, and reduce consumer choice, Congress has a duty to restore fair competition. The Patients Before Monopolies Act ends this blatant conflict of interest once and for all.”
"Pharmacy Benefit Managers drive prices up for patients and run independent pharmacies out of business,” said Rep. Jerry Nadler. “These greedy corporations have dodged regulation at the cost of American patients and small businesses for far too long. For my entire career, I have fought to make healthcare accessible for all Americans, and I am proud to support this bill reining in PBMs and enforcing fair business practices.”
“We’re taking on these giant healthcare companies to get prescription drug prices down, and to protect our family-owned pharmacies,” said Rep. Greg Landsman. “These companies make billions in part because they control so much of the market, but our bill will change that and put patients first.”
“Pharmacy Benefit Managers (PBMs) have been stealing hope and health from the American people for decades, inflating prescription drug costs, forcing pharmacy closures, and blocking access to medications.” As a pharmacist from coastal Georgia, I came to Congress with the goal of building a health care system that puts patients before profits,” said Congressman Buddy Carter. “I proudly support the Patients Before Monopolies Act, which builds on my previous PBM legislation signed into law last January, to continue cracking down on PBMs’ anti-competitive practices.”
“Americans are sick and tired of giant corporations putting profits over patients,” said Congressman Troy Nehls. “For too long, the largest Pharmacy Benefit Managers (PBMs) have manipulated the prescription drug market supply chain, crushed independent pharmacies, and have driven up costs for patients. I’m proud to be an original cosponsor on this bipartisan legislation to restore accountability, protect local pharmacies, and lower costs for American families.”
“PBM vertical integration with retail, mail-order, and specialty pharmacies has led to reduced patient choice and higher drug prices for patients and payers. The Patients Before Monopolies Act cuts out PBM conflicts of interest at their root by breaking up PBM ownership of and affiliation with pharmacies. APCI commends Senators Warren and Hawley, and Representatives Harshbarger and Auchincloss on fighting against PBM anticompetitive practices and advancing policies that will restore competition to the prescription drug marketplace,” said Greg Reybold, Vice President of Public Policy, American Pharmacy Cooperative, Inc.
“With the reintroduction of the Patients Before Monopolies Act (PBM Act), we are grateful to Senators Warren and Hawley and Representatives Harshbarger and Auchincloss for standing up for patients and pharmacies. For too long, the largest health insurers have resorted to fear and intimidation tactics, expending substantial resources in order to scare and confuse the public into thinking PBM reform will be bad for them. With this new legislation, PBMs will finally be held accountable for years of abusing their role as ‘benefits administrators’ to undercut pharmacy providers while also profiteering off the backs of unsuspecting employers, patients and taxpayers,” said Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency.
“Divesting PBMs from owning pharmacies will stop the conflict of interest that drives patients into PBM-owned specialty pharmacies where specialty generic drug prices are kept artificially high. The Patients Before Monopolies Act levels the playing field for community pharmacists and finally puts patients ahead of PBM profits,” said Madelaine Feldman, MD, FACR; Rheumatologist; Vice President, Advocacy & Government Affairs; Coalition of State Rheumatology Organizations; New Orleans, Louisiana.
“Giant PBMs and insurers owning their own pharmacies has driven independent pharmacies out of business and reduced patient access to quality care. The Patients Before Monopolies Act addresses the root cause of this problem — consolidated market power — by eliminating the inherent conflicts of interest within the 'Big Three' PBM business model,” said Morgan Harper, Director of Policy and Advocacy, American Economic Liberties Project. “We are thrilled to see Sen. Warren and Sen. Hawley and Reps. Harshbarger and Auchincloss lead this bipartisan effort to lower drug costs, protect independent retail pharmacies, improve patient access to care, and break up Big Medicine.”
“The Patients Before Monopolies Act takes an important step toward restoring integrity and competition in healthcare by ending the deeply flawed model where PBMs and insurers can own the very providers they oversee and reimburse,” said Robert Levin, MD, President, Alliance for Transparent & Affordable Prescriptions. “When the same corporations control the financing, administration, and delivery of care, patients and independent providers are put at a disadvantage. Healthcare decisions should be driven by what is best for patients, not by vertically integrated corporations maximizing profits through self-preferencing and consolidation.”
“American Pharmacies strongly supports the Patients Before Monopolies Act. When PBMs own pharmacies, the resulting self-dealing and conflicts of interest distort the marketplace and too often undermine affordable, accessible, patient-centered care. American Pharmacies and our 700 independent pharmacy members across the country thank the bill’s sponsors for their leadership in confronting one of the root causes of rising costs and barriers to care,” said Steve Hoffart, R.Ph., Chairman, American Pharmacies.
“PBMs have a choice — operate as a PBM or operate as a pharmacy, but you can’t have it both ways,” said B. Douglas Hoey, pharmacist, MBA, CEO, National Community Pharmacists Association. “Having both functions under one roof is a huge conflict of interest and drives up prescription drug prices. The Patients Before Monopolies Act is critical in supporting patients and independent pharmacies and restoring a free market. NCPA is proud to support it and thanks Reps. Harshbarger, Auchincloss, Carter, Nadler, and Nehls, and Sens. Warren, Hawley, Marshall and Fetterman for their leadership.”
RELEASE: Congressman Auchincloss questions Secretary Kennedy on FDA whistleblower disclosures, White House fast-tracking of psychedelics | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: Congressman Auchincloss questions FDA Commissioner Makary's use of the Commissioner's National Priority Voucher program to fast-track psychedelic drug approvals based on political influence rather than scientific merit, and raises concerns about compromised scientific standards and political pressure within the agency.
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
WASHINGTON, D.C. – Today, Congressman Jake Auchincloss (D, MA-04) questioned Health and Human Services Secretary Robert F. Kennedy Jr. at a House Energy and Commerce Health Subcommittee hearing about the recent decision by the Food and Drug Administration (FDA) to fast track three approvals for psychedelics under the Commissioner’s National Priority Voucher (CNPV) program, based on a text Joe Rogan sent to President Trump. One of these psychedelics was previously denied by the FDA in 2024.
Representative Auchincloss has dialed up the pressure on Commissioner Makary for months regarding his CNPV program, which has allowed for accelerated drug and biologic approvals not for the most promising scientific discoveries, but for companies with ties to MAGA.
Please find below the full disclosures from current and former FDA staff Rep. Auchincloss shared today, as well as a portion of Rep. Auchincloss’ exchange with Secretary Kennedy.
These disclosures from current and former FDA staff shared with the congressman’s office support public reporting of political pressure at the FDA:
1. “Over the past year, FDA career staff have been alarmed and demoralized by the reckless changes at our Agency. This administration has approached FDA with a fundamental suspicion of career staff and with an appalling focus on ‘media wins.’ These ‘media wins’ have been anything but wins for our Nation’s public health. Rather than the purported ‘gold standard science’ FDA staff have been subject to a steady, unrelenting compromise of our scientific standards to support ideologically driven policy goals, and to promote the careers of short-sighted political appointees, who are more focused on media sound-bites and their own self-promotion than our Nation’s health.”
2. “Dr. Makary began his FDA tenure with the promise of upholding principles of gold standard science, radical transparency, and common sense. In addition, based on his public positions regarding inappropriate influence of the pharmaceutical industry on the Agency, he had the promise of upholding the independence of FDA scientific decision making and keeping the Agency free of corruption.
In practice, Dr. Makary's tenure has been essentially Orwellian in nature, going directly against his stated principles every day while obsessively focusing on his external image. Rather than pursuing gold standard science, his appointees in senior leadership roles start with the conclusion and search for evidence to support it. Rather than convening panels of external scientific experts with a range of perspectives, he convenes so-called "expert panels" with cherry-picked panelists who share his opinion. In contrast to radical transparency, he works in siloed and secretive groups with very limited input from staff scientists, and career staff learn about new policies after they are announced in press releases or journal articles. In contrast to common sense, he appoints people to senior scientific leadership positions based more on loyalty to him and being a good soldier, regardless of their qualifications or competence to do the job. And rather than reducing potential corruption from industry, his approach has made direct lobbying to the Commissioner's Office a smart and productive business practice for companies to get what they want, favoring companies that are more politically connected.
The end result of his disastrous leadership is a chaotic and unpredictable FDA that makes decisions based on politics and is bleeding leaders with principles and scientific neutrality. This is completely unacceptable for a premier public health agency that is expected by the American public to ensure safe and effective medical products and other products under its regulatory purview.”
3. “I recently left FDA due to the political pressure I was receiving to withhold my recommendation for approval for a drug that was intended for a rare disease. I was part of a review division that was constantly under pressure. Specifically for this recent example, we met frequently with Prasad and other FDA leadership who emphasized the drug should not be approved. However, from the review document and my experience, it would have been approved had it not been for the political pressure.”
Please find the full video of Rep Auchincloss’s exchange with Secretary Kennedy here.
Secretary Kennedy: I can tell you that all the decisions that have been made at that agency are made with the approvals of panels of career scientists.
Auchincloss: That's just not true. So let me reclaim my time. That is categorically false, because there is, in fact, a program called the Commissioner's National Priority Voucher Program. I've been investigating that as well for the last six months. This program expressly allows political leaders to short-circuit science and pick and choose politically favored treatments. Now, White House and FDA leadership have pressed staff to award vouchers to certain companies as part of White House pressure campaigns. Most recently—and egregiously—the FDA just issued three of those vouchers for psychedelics based on a text from Joe Rogan. And one of those psychedelics was denied by the FDA in 2024.
So let's just go through what happened here. Joe Rogan had a guest on his podcast, and the guest was talking about psychedelics. Joe Rogan texted the President of the United States, and the President texted back: “Sounds great. Do you want FDA approval? Let's do it.” That was from the President of the United States.
So just to be clear, is the President of the United States allowed to grant FDA approval?
Secretary Kennedy: The career staff—
Auchincloss: Is the President of the United States allowed to grant FDA approval?
Secretary Kennedy: Career staff at FDA have all supported that decision.
Auchincloss: Is the President of the United States allowed to grant FDA approval? Because he thinks he is. Is he wrong?
Secretary Kennedy: He doesn't do it.
Auchincloss: He doesn't do it. So—and yet the FDA, within hours—
Secretary Kennedy: There's been no FDA approval—
Auchincloss: Issued three priority vouchers from this illegal, unauthorized program to respond to political pressure from the White House. Secretary, this flies in the face of your stated commitment to putting science over politics.
RELEASE: Joint statement from bipartisan Kids Online Safety Caucus co-chairs Reps. Jake Auchincloss and Erin Houchin on the Meta, YouTube social media trial verdict | U.S. Congressman Jake Auchincloss Of Massachusetts 4th District
Position: The representatives support federal legislation requiring age assurance for online platforms and holding them liable for protecting children, arguing that litigation alone is insufficient to address social media companies' exploitation of minors.
“Today is a good day in the overdue effort to hold social media corporations accountable. Meta and YouTube tried to deny, deflect, and delay – but a jury heard the evidence and found them negligent in how they designed their apps for children. However, Congress must be clear-eyed about the limits of litigation. Going forward, the platforms will change their terms of service language and continue to hide their exploitation of children behind bad-faith Section 230 defenses. Lawmakers must come together in a bipartisan effort to pass a federal age assurance law that raises the age of Internet adulthood to at least 16 years old and holds apps liable for adhering to it. We have the bills, we’re on the committee of jurisdiction, and we’re committed to working together to make it happen.”
Representatives Jake Auchincloss (D-MA) and Erin Houchin (R-IN)
Contact:
Georgina.Burros@mail.house.gov (Auchincloss)
Parker.Armstrong@mail.house.gov (Houchin)
Source: open-data mirrors of the Senate eFD and House Clerk financial-disclosure systems. Disclosure within 30 days of trade is required by law (45 for spouse/dependent trades).
Top PAC donors · 2026 cycle
Political action committees that gave the most to this rep's principal campaign committee this cycle. PAC giving is direct organizational support — industry, ideological, or leadership.
1.MANUFACTURED HOUSING INSTITUTE PAC2 contributions$10,000
2.LABORERS INT'L UNION OF NORTH AMERICA PAC (LIUNA PAC)3 contributions$10,000
3.AIPAC2 contributions$10,000
4.SMITH & NEPHEW, INC. PAC (S+N PAC)2 contributions$10,000
5.NATIONAL COMMUNITY PHARMACISTS ASSOCIATION - PAC4 contributions$10,000
6.CONQUERING CANCER PAC2 contributions$10,000
7.CAREFIRST BLUECROSS BLUESHIELD ASSOCIATES FEDERAL PAC2 contributions$10,000
9.AMERICAN INSTITUTE OF CERTIFIED PUBLIC ACCOUNTANTS POLITICAL ACTION COMMITTEE4 contributions$10,000
10.JOHNSON & JOHNSON POLITICAL ACTION COMMITTEE4 contributions$9,500
Source: OpenFEC (api.open.fec.gov) Schedule A receipts where contributor type is “committee.” Aggregated by contributing committee. Self-transfers from joint-fundraising / victory committees are excluded.
Top individual contributors · 2026 cycle
Itemized individual contributions over $200 to this rep's campaign committee, aggregated by donor employer. PAC giving is shown above; this section is people, not organizations.
1.BAIN CAPITAL$62,000
2.KKR$20,500
3.LIBERTY MUTUAL INSURANCE$20,050
4.MASSACHUSETTS GENERAL HOSPITAL$19,250
5.KECHES LAW GROUP$18,800
6.PALANTIR TECHNOLOGIES$18,350
7.FLAGSHIP PIONEERING$17,110
8.BLACKSTONE$16,500
9.WCAS$14,700
10.ANDREESSEN HOROWITZ$14,000
Source: OpenFEC Schedule A receipts where contributor type is “individual,” aggregated by the donor's self-reported employer. This is a geographic / industry correlation, not a corporate endorsement.
