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PBMs in the Hot Seat
The House Energy & Commerce Committee zeroed in on concentration, rebates, and pharmacy steering.

⚡️ NIMITZ HEALTH NEWS FLASH ⚡️
“Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain”
House Energy & Commerce Health Subcommittee
February 11th, 2026 (recording linked here)

WITNESS
Lori M. Reilly, Esq.: Chief Operating Officer, PhRMA
John F. Crowley: President and CEO, Biotechnology Innovation Organization
John Murphy: President and CEO, Association for Accessible Medicines
David Marin: President and CEO, Pharmaceutical Care Management Association
Angie Boliver: President and CEO, Healthcare Supply Chain Association
Chester “Chip” Davis, Jr.: President and CEO, Healthcare Distribution Alliance
James Gelfand: President and CEO, The ERISA Industry Committee
Douglas Hoey: Chief Executive Officer, National Community Pharmacists
AssociationRachel E. Sachs: Professor of Law, Washington University in St. Louis
QUICK SUMMARY
PBMs were the central villain of the hearing, with repeated bipartisan claims that market concentration, opaque fees/rebates, and vertical integration distort formularies, pharmacy reimbursement, and patient out-of-pocket costs.
“Trump RX” and “secret MFN agreements” dominated the partisan fight: Democrats framed them as opaque, misleading rebrands of existing discount programs; Republicans treated them as transparency/competition efforts but emphasized “details matter.”
FDA/NIH capacity and scientific integrity emerged as a major second track, with Democrats warning politicization and staffing losses threaten innovation; several Republicans agreed modernization/predictability is needed but focused on cutting red tape and keeping U.S. competitive with China.
Independent and rural pharmacies were a consistent pressure point, with claims that “take-it-or-leave-it” PBM contracts and steering are driving closures and “pharmacy deserts.”
Biosimilars and patents were one of the clearest policy lanes, with support for reducing barriers (e.g., interchangeability distinctions) and curbing patent/filing games to speed competition without undermining safety.
PARTY MESSAGING
🐘 Republicans
Heavy emphasis on PBM incentives (rebates/fees), offshore GPO structures, vertical integration, and the need for transaction-level transparency.
Push to reduce regulatory burden, speed trials (central IRBs, tech), and preserve strong IP to keep investment flowing—often framed against China competition.
Recurrent emphasis on transparency tools and reforms that show real prices and reduce surprise costs.
🫏 Democrats
Focus on secrecy around MFN deals, skepticism of Trump RX claims, and warnings about politicization/brain drain at NIH/FDA.
Defended IRA negotiation savings and pressed to extend negotiation/inflation rebate concepts beyond Medicare or strengthen the current framework.
Patient stories (MAT, cancer/HIV specialty drugs), denials/prior auth, and steering framed as real-world harms requiring accountability.
MEMBER OPENING STATEMENTS
Subcommittee Chair Griffith (R-VA) praised recent bipartisan health legislation and said the subcommittee was continuing its affordability series by examining the full pharmaceutical supply chain. He explained that the path from research to dispensing seemed straightforward but actually involved many layers that influenced pricing and patient access, and he described the process as operating like a “black box.” He said the witnesses would help illuminate how each entity contributed to getting drugs to patients, and he emphasized the goal of lowering costs while preserving U.S. leadership in pharmaceutical innovation. He also highlighted newly enacted PBM reforms and previewed perspectives from manufacturers, generics, PBMs, GPOs, distributors, community pharmacists, and employers.
Subcommittee Ranking Member DeGette (D-CO) said the drug supply chain had become convoluted and incentivized pricing games over effectiveness and true innovation, making high prices systemic. She credited Democrats’ Inflation Reduction Act with limiting price increases and enabling Medicare negotiations that she said had already reduced costs for certain expensive drugs, while arguing that more progress was needed. She criticized what she characterized as opaque, “backroom” drug-company dealings with the Trump administration and urged transparency. She also argued that extending ACA enhanced premium tax credits and reversing provisions in “HR 1” would lower costs, and she warned that instability and interference at biomedical agencies threatened the research pipeline that produced new treatments.
Full Committee Chair Guthrie (R-KY) thanked the subcommittee for holding the hearing and said the prescription drug supply chain was a complicated web of financial and logistical transactions from discovery to dispensing. He said the committee’s prior work had helped lead to major PBM reforms signed into law recently and argued that those reforms were a starting point for broader affordability efforts across the supply chain. He said the market had changed since 2017 through vertical integration and shifting contracting incentives that could alter behavior throughout the system. He criticized the Inflation Reduction Act for destabilizing Medicare Part D and pointed to a new “Trump RX” platform that he said was intended to help patients find low cash prices, and he said he wanted to explore further reforms to improve affordability.
Full Committee Ranking Member Pallone (D-NJ) argued Republicans were holding the hearing without a real plan to reduce costs and said they had refused to extend ACA enhanced premium tax credits that could lower premiums. He said Republicans’ “big ugly bill” would reduce coverage for millions, raise costs, and create a loophole allowing certain blockbuster drugs to avoid Medicare price negotiations, which he described as a handout to the pharmaceutical industry. He criticized the majority for excluding a patient-perspective witness and said many Americans had rationed medications due to cost. He also accused the Trump administration and RFK Jr. of undermining health agencies and public trust in vaccines, and he urged building on the Inflation Reduction Act and supporting his bill to extend negotiated Medicare prices more broadly to lower drug costs for families.
WITNESS OPENING STATEMENTS
Ms. Reilly said the United States led the world in medical discovery and that American patients generally gained access to new medicines earlier than patients in other countries. She emphasized industry investment in research and development and argued that the U.S. intellectual property system helped balance innovation with competition, noting high generic utilization and stable prescription-drug spending as a share of overall health spending. She said the supply chain was convoluted and that too much money went to intermediaries, especially PBMs, which she argued created barriers to access and harmed independent pharmacies through consolidation and opaque practices. She raised concerns about formulary exclusions, denials of coverage for new brand medicines, and the growth of the 340B program, which she said enabled large markups. She urged reforms that reduced costs without adopting price controls and warned that China was becoming a stronger competitor in clinical trials and biopharma innovation.
Mr. Crowley said he was speaking for BIO and described biotech companies as central to creating new, life-extending medicines. He shared his family’s experience with Pompe disease and said U.S.-approved innovation had given his children and others a chance at life. He argued that the U.S. system was inefficient and overly complex, with too many middlemen and some government policies that hindered progress. He said small and mid-sized biotech firms originated most new medicines but that continued U.S. leadership was not guaranteed, so reforms to FDA and clinical trials were needed to reduce cost and complexity. He warned that “most favored nation” policies risked harming U.S. innovation without solving affordability, and he called for simplifying the system so patients could reliably access “biotech miracles.”
Mr. Murphy said generics and biosimilars were the largest driver of prescription-drug affordability and reported hundreds of billions in annual savings, but he argued their full potential was being suppressed by market distortions and outdated policies. He said generics comprised most prescriptions but a small share of spending, and he warned that relentless price compression alongside rising fixed costs could drive manufacturers out and increase shortages. He said biosimilar uptake lagged other regions due to patent tactics, formulary and rebate incentives, and reimbursement policies that favored higher-priced products. He urged Congress to reduce regulatory barriers at FDA, curb patent abuse, realign incentives in Medicare/Medicaid and PBM practices so lower-net-cost drugs were favored, and strengthen reimbursement to support reliable generic supply. He concluded that protecting competition would prevent shortages, reduce costs, and improve patient access.
Mr. Marin said PBMs played a critical role in making healthcare more affordable and safe, and he said his association had not done a good enough job explaining PBMs’ value to policymakers. He argued PBMs had been misrepresented by other sectors and promised to work with the committee with better transparency and responsiveness. He said PBMs were used voluntarily because drug prices were extremely high, and he claimed PBMs delivered savings, promoted generics, and supported safety and adherence. He acknowledged Congress had recently enacted major PBM-related requirements that he said could be harmful, but he said PBMs wanted to move forward and focus on root causes of high drug prices, including limited competition and practices that blocked generics. He also urged scrutiny of wholesalers and other entities he said influenced generic pricing with limited oversight.
Mr. Davis said pharmaceutical distributors were the backbone of the supply chain and handled the vast majority of medicines dispensed in the United States. He said distributors connected manufacturers to hundreds of thousands of care sites, took physical possession and legal title of medicines, and delivered millions of products daily while operating on the lowest margins in the chain. He emphasized distributors’ role in ensuring timely availability at the point of care and in maintaining safety and security against counterfeit or contaminated drugs. He said distribution efficiencies reduced the need for manufacturers to build their own networks and saved the system significant costs annually. He supported reforms that benefited patients and reduced provider burden but cautioned against changes that could unintentionally disrupt supply chain efficiency, reliability, or security.
Ms. Boliver said traditional healthcare GPOs helped lower costs by combining providers’ purchasing volume, driving supplier competition, and securing fair terms for hospitals and other sites of care. She said GPOs delivered substantial savings and provided additional services such as analytics, emergency preparedness, and compliance support, which she said were especially valuable for small and rural providers. She emphasized that participation was voluntary for both providers and suppliers and that providers could buy outside contracts and often used multiple GPOs. She distinguished traditional provider-focused GPOs from PBM-owned “rebate aggregator” entities, arguing that the latter did not perform traditional GPO functions and operated in the retail prescription market. She said traditional GPOs negotiated point-of-sale reductions, passed post-sale rebates through to providers, did not take possession of products, and aligned their interests with provider members.
Mr. Gelfand said he represented large employers sponsoring self-insured health plans and argued that employers and patients ultimately paid prescription costs that continued rising faster than the economy. He said plan sponsors faced opacity when trying to hold vendors accountable and cited survey findings that many employers could not obtain complete claims data or were refused access. He said middlemen captured a substantial share of drug spending and argued that certain practices by PBMs, PBM-owned GPOs, wholesalers, brokers, and consultants could increase costs and create conflicts of interest. He welcomed recent PBM reforms and said more transparency and accountability were needed, including fiduciary obligations and clear pricing disclosures during vendor selection. He said the system too often incentivized self-dealing and arbitrage rather than cost-effective drugs for patients, and he urged further bipartisan reforms.
Mr. Hoey said independent community pharmacists were among the most accessible healthcare professionals and provided essential services, including during emergencies and disasters. He argued that vertically integrated insurers and their PBMs were driving independent pharmacies out of business, contributing to growing “pharmacy deserts” and thousands of closures in recent years. He praised recent federal PBM reform as progress but said consolidation had intensified, citing major acquisitions among insurers and PBMs and arguing promised efficiencies had not materialized. He described pharmacy payment as opaque and said PBMs used practices like steering, audits, and formulary manipulation that harmed independent pharmacies and patient choice. He argued specialty-drug spending drove budgets and claimed PBMs defined “specialty” to suit profits while steering spending through PBM-owned specialty pharmacies. He urged Congress to address consolidation, ban spread pricing in certain programs, require fair reimbursement, prohibit steering, and stop misclassification of specialty drugs.
Ms. Sachs said many Americans could not afford needed medications and that high costs burdened patients, payers, and ultimately households. She said manufacturers benefited from exclusive rights and guaranteed reimbursement that limited competition and allowed high prices, while intermediaries’ consolidation and vertical integration reduced competition and increased barriers to entry. She said PBMs, wholesalers, and GPOs had been criticized for practices that could raise costs or limit access, and she identified horizontal consolidation, vertical integration, and opacity as key problems. She urged reforms that made competition more effective—especially for biosimilars—along with greater transparency and oversight in concentrated markets, potentially including structural separation depending on findings. She also suggested considering approaches that addressed reimbursement directly, including strengthening Medicare negotiation, and she warned that instability at NIH and FDA threatened future innovation.
QUESTION AND ANSWER SUMMARY
Chair Griffith (R-VA) pressed on concentration and asked whether the FTC should break up the three largest PBMs. Mr. Marin opposed breakup and said the market remained competitive with many PBMs and smaller firms winning business.
Chair Griffith then asked whether PBMs had ever pressured manufacturers to raise list prices to secure formulary placement—raising costs for patients who did not benefit from rebates. Mr. Marin called it an outlier but acknowledged it had happened.
Chair Griffith challenged PBM value claims by citing West Virginia’s reported savings after creating its own PBM, and he pivoted to “deny-and-delay” by asking about treating insurers as fiduciaries and imposing liability when harmful delays occurred. Mr. Crowley supported reviewing as a patient-protection measure.
Chair Griffith then asked about fiduciary duties and the meaning of “specialty drugs,” and Mr. Gelfand said fiduciary status would better align decisions with patient and purchaser interests and that “specialty” varied widely across PBMs and often just meant “expensive.”
Ranking Member DeGette (D-CO) questioned about the administration’s alleged secret manufacturer agreements tied to tariff threats, and Ms. Reilly said the trade association did not know individual deal terms and could not provide details.
Ranking Member DeGette then focused on the research ecosystem and asked about NIH-backed science. Mr. Crowley said NIH-funded academic research was foundational to U.S. biotech leadership.
Ranking Member DeGette asked about NIH grant reductions and impacts on innovation. Ms. Sachs said NIH made about 24% fewer grants than prior averages and that reduced funding likely meant fewer future treatments because NIH underpinned most new drugs at some point.
Ranking Member DeGette also asked about politicization and staffing losses at NIH and FDA. Ms. Sachs said scientists were self-censoring and FDA had lost substantial staff, while Mr. Crowley said rebuilding FDA’s scientific workforce was critical to restoring confidence.
Rep. Guthrie (R-KY) asked why large employers could not use market power to force better PBM/insurer terms. Mr. Gelfand said employers lacked access to data and intermediaries were paid by both sides, undermining true competition. He said a major employer proposed a neutral formulary with PBM administration only, but a Big Three PBM refused and implied the others would too, which he said showed limited competitive pressure.
Rep. Guthrie asked about wholesaler vertical integration. Mr. Davis said only some top wholesalers had diversified and denied that wholesalers owned medical practices, framing diversification as responses to customer access needs.
Rep. Guthrie asked how last week’s PBM reforms helped independents, and Mr. Hoey said “reasonable and relevant” Medicare Part D contracting standards could help keep pharmacies open.
Rep. Pallone (D-NJ) asked what details were needed to evaluate savings and enforceability, and Ms. Sachs said basic terms were unknown (covered drugs, prices, eligibility, enforcement). Ms. Sachs added that “Trump RX” listings did not clearly show consumer savings because many drugs were already generic and branded prices could exceed widely available generic discount prices.
Rep. Harshbarger (R-TN) asked for contextualization of drug-price growth versus broader healthcare inflation. Ms. Reilly said drugs stayed around 14% of total healthcare spending and generic competition drove declines over time, while hospital spending rose substantially and consolidation contributed.
Rep. Harshbarger asked about patent-thicket reforms via consistent FDA/PTO disclosures. Mr. Gelfand said it could shorten litigation, accelerate biosimilar entry, and curb exclusivity-stretching tactics without harming legitimate patents.
Rep. Harshbarger asked about PBM-owned offshore “GPOs,” and Mr. Hoey alleged PBMs shifted rebates into offshore fee structures that extracted additional payments from manufacturers and employers.
Rep. Dingell (D-MI) asked why some drugs were cheaper in cash than through insurance and why PBMs discouraged that option, including in the context of “Trump RX.” Mr. Hoey blamed PBM spread pricing and said PBMs preferred prescriptions routed through them to maximize revenue, using audits and network pressure even after gag-clause reforms.
Rep. Dingell asked what Congress could do to reduce incentives toward higher-cost drugs, and Mr. Hoey urged policies that exposed and enabled transacting closer to the “net price” rather than list-based pricing.
Rep. Bilirakis (R-FL) asked how Congress could encourage investment in orphan drugs and potentially curative cell and gene therapies without shifting unsustainable costs onto the broader patient population. Mr. Crowley said Congress should reduce clinical trial complexity, modernize FDA review with more sophisticated tools, and create predictable regulatory pathways to lower development costs and attract capital, while also pursuing novel payment models to ensure access when cures emerged.
Rep. Bilirakis then asked how PBM rebate and fee incentives affected formulary coverage for low-cost generics and biosimilars and patient cost-sharing. Mr. Murphy said formularies often deprioritized generics, cited that many covered generics were not placed on generic tiers in Medicare Part D, and urged policies that prioritized FDA-approved generics once exclusivity ended and that aligned patient out-of-pocket costs with the net cost at the pharmacy counter.
Rep. Barragán (D-CA) pressed for confirmation that the three largest PBMs owned by CVS Health, Cigna, and UnitedHealth controlled nearly 80% of the PBM market, and argued that concentration undermined claims that competition lowered prices. Rep. Barragán cited reports of PBM markups on specialty generics and asked what high PBM margins meant for consumers. Mr. Gelfand said added fees and margins increased costs that consumers ultimately paid directly and through lower wages.
Rep. Barragán asked for an explanation of vertical integration and consolidation for the public. Mr. Hoey said insurer-PBM-pharmacy integration allowed a few corporate groups to control a patient’s care and pharmacy “journey,” override prescriber choices through formularies and prior authorization, steer patients to affiliated specialty pharmacies, reduce competition, and raise prices.
Rep. Carter (R-GA) challenged PCMA’s claims that PBMs lowered costs by citing FTC findings of large markups on life-saving drugs and higher reimbursement to PBM-affiliated pharmacies than unaffiliated pharmacies. Mr. Marin said PBMs saved employers money overall, said he needed to review the specific markup example, and said PBMs had been moving toward cost-plus contracts, higher reimbursement, and paying for pharmacy clinical services, while acknowledging more work was needed.
Rep. Carter asked whether PCMA would adopt key terms from an FTC settlement with Express Scripts to improve transparency and lower patient out-of-pocket costs, and Mr. Marin said many elements aligned with industry direction and noted recent legislation imposed major transparency and rebate pass-through requirements.
Rep. Carter also pressed on offshore PBM-owned “GPOs,” and Mr. Marin said those were company-level business decisions but suggested PCMA could help provide facts and implied openness to discussions about bringing activity back onshore.
Rep. Schrier (D-WA) condemned high EpiPen prices and warned manufacturers to reduce prices or face congressional action, and she asked how FDA’s refusal to review Moderna’s mRNA flu vaccine could affect innovation. Mr. Crowley said BIO supported vaccines, expressed concern about shifting regulatory standards, and emphasized the need for consistency and predictability from FDA to sustain investment.
Rep. Schrier then asked why the Vaccine Injury Compensation Program mattered and whether witnesses were concerned about threats to add autism to VICP. Mr. Crowley and Ms. Reilly said VICP had long provided compensation in rare, serious injury cases and had stabilized the vaccine market, and they said policy changes should be grounded in strong science because evidence did not support a vaccine-autism link.
Rep. Joyce (R-PA) used the Humira biosimilar rollout to argue rebate incentives distorted formularies and asked for an explanation of rebate guarantees and whether they incentivized preference for higher list-price drugs. Mr. Marin said rebates were used to lower costs and suggested plan design choices drove these dynamics, while Rep. Joyce noted higher list prices generated higher rebates.
Rep. Joyce asked whether employers used rebate guarantees and whether they reduced overall costs. Mr. Gelfand said rebate guarantees had been one of the few comparable metrics employers could use, but they resembled perpetual “discount” pricing that obscured net costs, and he said recent legislation should move the market away from that metric.
Rep. Joyce also raised concerns about PBM-owned private-label generics and biosimilars and cited a report alleging high pricing. Mr. Marin said he was not familiar with the specific report but maintained PBMs supported biosimilar competition.
Rep. Joyce asked about wholesaler acquisitions of oncology and specialty physician practices and whether vertical integration increased demand for high-cost drugs. Mr. Gelfand said promised efficiencies often failed to materialize and argued integration could raise patient out-of-pocket costs through higher deductibles, coinsurance, and out-of-pocket maximums.
Rep. Trahan (D-MA) asked what Congress should do to keep the United States competitive with China in clinical trials and biomedical innovation while maintaining safety and patient protections. Ms. Reilly urged faster and more efficient clinical trials, greater use of technology like AI, centralized IRBs, predictable and transparent regulation, stable research partnerships across academia-government-industry, and strong IP protections given the high cost of drug development.
Rep. Trahan then asked how investing in platform technologies and health data infrastructure could improve preparedness and accelerate clinical development. Mr. Crowley said platforms like mRNA resulted from decades of research, enabled rapid response in COVID, and were essential for public health and national security, including against natural outbreaks and bioterrorism threats.
Rep. Balderson (R-OH) asked how FDA could modernize and accelerate trials to lower costs and counter China’s streamlined pathways. Mr. Crowley pointed to reducing bureaucratic requirements to enter trials, updating preclinical testing expectations, and making the clinical-trial startup process more efficient through measures like centralized IRBs and streamlined contracting across academic centers.
Rep. Balderson asked how PBM contracting practices affected rural pharmacies and access. Mr. Hoey said PBMs held leverage through control of covered lives, imposed take-it-or-leave-it contracts that could reimburse below acquisition cost, and contributed to thousands of pharmacy closures and expanding pharmacy deserts in rural and underserved areas.
Rep. Balderson asked how the Inflation Reduction Act might affect generic and biosimilar market entry and competition. Mr. Murphy said competition from generics and biosimilars was the most reliable affordability tool, but he argued aspects of IRA implementation—particularly biosimilar launch-delay provisions—reduced predictability for biosimilar entrants and could discourage development unless CMS or Congress made fixes.
Rep. Veasey (D-TX) criticized “Trump RX” as a rebranding of existing manufacturer assistance and discount programs, and he argued it offered only coupons for 43 brand drugs that required cash pay and did not allow price comparison across pharmacies or include generics.
Rep. Veasey asked for confirmation of whether administration claims about “the largest reduction in prescription drug prices in history” were accurate. Ms. Reilly and Ms. Sachs said they did not have information to verify the claims.
Rep. Veasey asked whether paying out of pocket for brand drugs through Trump RX could cost more than using cheaper generics. Ms. Sachs agreed and warned consumers might not understand the difference.
Rep. Miller-Meeks (R-IA) argued drug-pricing debates had become blame-shifting across manufacturers, PBMs, and insurers while patients faced unaffordable costs. She asked whether her transparency-and-competition bill would reduce employer-plan costs and premiums. Mr. Gelfand said greater transparency and competition were essential to controlling costs for employer-sponsored plans.
Rep. Miller-Meeks asked why PBM-owned “GPOs” were based overseas and whether traditional medical GPOs operated similarly. Ms. Boliver confirmed her association’s traditional GPOs were U.S.-based and operated in the provider/Part B space rather than retaining commercial-market fees like PBM-linked entities.
Rep. Miller-Meeks pressed about overseas PBM GPOs and fee retention. Mr. Marin emphasized that recent law required rebate and GPO-related dollars to be passed through.
Rep. Miller-Meeks asked whether taxpayers should receive a return when NIH-supported research led to successful commercial products under Bayh-Dole-style licensing. Ms. Reilly said universities already received royalties when licensed inventions became medicines and that universities reinvested those funds per requirements, and she argued Bayh-Dole had been transformational in enabling the academia–government–industry innovation ecosystem.
Rep. Fletcher (D-TX) emphasized protecting scientific integrity and the research ecosystem and said trade-association witnesses could not substitute for direct testimony from member companies on sensitive issues.
Rep. Fletcher asked whether member companies had reported FDA approvals or milestones being conditioned on holding meetings at Trump properties, staying at Trump hotels, or attending private events at Mar-a-Lago. Ms. Reilly repeatedly said she had not heard of such requests and did not believe antitrust rules would bar companies from raising those concerns.
Rep. Fletcher asked whether conditioning regulatory access on such arrangements would be unethical or illegal. Ms. Reilly said it would be unethical and Mr. Crowley said he had never heard of such conduct affecting his members.
Rep. Fletcher then asked which would save consumers more—Trump RX or Medicare drug price negotiation. Ms. Sachs said Medicare negotiation had produced far larger savings and broader benefits than the limited set of products listed on Trump RX.
Rep. Bentz (R-OR) asked whether Congress could use artificial intelligence to better analyze pharmaceutical supply chain complexity and identify where reforms would be most effective. Ms. Sachs said AI was already being used across the sector and suggested it could help Congress process large volumes of contracts and data in oversight work, while warning of an “AI arms race” in which tools could also be used to deny care, including through prior authorization.
Rep. Bentz asked how to help small rural pharmacies, and Mr. Hoey said Medicare reimbursement often fell below acquisition cost and that faster CMS implementation of recent reforms, along with cost-plus approaches and limits on PBM steering incentives, could help preserve access in pharmacy deserts.
Rep. Auchincloss (D-MA) called for the committee to bring the FDA Commissioner in to answer under oath about alleged politicization and instability affecting vaccine review and agency credibility. Rep. Auchincloss said innovation and access were not mutually exclusive and asked all nine witnesses to respond in writing within 14 days to a forthcoming “request for proposal” outlining two pillars for legislation—access/affordability and innovation/manufacturing—highlighting ideas such as prior authorization reform, extending Part D-style out-of-pocket caps into commercial markets, and aligning negotiations to value rather than rebates. Rep. Auchincloss also flagged concerns that certain IRA design features could shift R&D incentives, urged clinical trial reforms such as more efficient IRBs and better EHR integration for faster enrollment, and called for proposals to strengthen drug shortage and “Made in America” manufacturing incentives through CMS pay-for-performance approaches.
Rep. Crenshaw (R-TX) pressed on whether the statutory “biosimilar interchangeability” category created an unnecessary barrier to biosimilar uptake. Mr. Murphy supported eliminating the distinction (consistent with FDA calls), arguing it would reduce regulatory complexity and expand investment, while Mr. Crowley agreed barriers should be reduced but urged a science-driven approach for biologics where additional evidence may be needed.
Rep. Crenshaw also asked about regulatory modernization for advanced therapies, and Ms. Reilly emphasized predictable, scientifically capable regulation plus strong IP and workable market incentives to sustain innovation and access.
Rep. Landsman (D-OH) questioned how pharma profits were allocated, arguing too much flowed to dividends/buybacks instead of lowering prices and expanding access. Ms. Reilly said pharma reinvested heavily in R&D (about 30% of profits), underscored high failure rates, and defended investor returns, while Ms. Sachs noted manufacturers set list prices.
Rep. Cammack (R-FL) challenged claims that consolidation and vertical integration lower prices, pointing to fast-growing revenues and asking where patients see savings. Mr. Davis said consolidation could lower prices and argued wholesalers are not “buying doctors,” but rather investing in management services organizations. Mr. Gelfand said consolidation did not appear to benefit families and suggested premiums and costs were not falling for workers.
Rep. Rulli (R-OH) praised “Trump RX” for transparency and asked how PBMs viewed it. Mr. Marin said PBMs support transparency and competition, noted new federal transparency requirements, and said the impact of Trump RX remained to be seen, though some member companies were participating.
Rep. Houchin (R-IN) asked whether independent pharmacies always see the PBM contract terms negotiated by PS(A)Os. Mr. Hoey said visibility is often limited by PBM restrictions and that contracts remain largely “take-it-or-leave-it.”
Rep. Houchin asked why independents can lose money dispensing drugs while CVS profits. Mr. Hoey blamed vertical integration and PBMs setting reimbursement that disadvantages unaffiliated pharmacies. Mr. Marin said PBM revenues would shift toward bona fide fees as rebates must be passed through. Ms. Reilly argued PBMs shifted from rebates to less-transparent fee structures, including offshore GPO arrangements and specialty-pharmacy revenue.
Rep. Langworthy (R-NY) argued Congress lacks transaction-level pricing data to pinpoint where excess costs accrue and asked how transparency would improve oversight. Mr. Gelfand said “open books” are essential and backed broader disclosure, including employer access to claims data and timely billing. Mr. Marin agreed transaction-level data would help and said new reporting is claim- and drug-specific, but urged transparency across the whole supply chain.
Rep. Mullin (D-CA) raised concerns that FDA staffing turnover could slow reviews and threaten innovation. Mr. Crowley said timely FDA interactions are critical. Mr. Murphy said companies had growing concern even if delays were not yet widespread.
Rep. Mullin asked about rare-disease development, and Mr. Crowley cited small patient populations, trial design/biomarkers, limited U.S. manufacturing capacity, regulatory predictability and staffing, IP protection, and payment certainty.
Rep. Allen (R-GA) asked about step therapy and whether reforms like the SAFE Step Act would help. Mr. Gelfand supported making step therapy electronic and timely while preserving appropriate medical management.
Rep. Allen also asked about barriers to patient access, and Ms. Reilly pointed to widespread formulary exclusions, high initial denial rates driven by prior authorization/utilization management, and high-deductible plans exposing patients to list prices before deductibles are met.
Rep. McClellan (D-VA) asked how to strengthen Medicare drug negotiation and whether international reference pricing could be incorporated. Ms. Sachs cited proposals to expand negotiation and inflation rebates into the commercial market and revisit selection/exemption rules, and said international reference pricing could be used as a negotiation factor, for drug selection, or to set ceilings/opening offers. Ms. Reilly emphasized competition and existing ACA zero-cost contraception as supporting women’s access.
Rep. Matsui (D-CA) described a constituent denied continued access to buprenorphine and asked how PBMs justify blocking lifesaving, physician-directed treatment. Mr. Marin called it a terrible case, offered to follow up, and reiterated PBMs’ cost-control mission.
Rep. Matsui argued it reflected a broader pattern of PBMs/insurers overriding clinicians.