This bill, titled the Medicines for the People Act, would create a new National Institute for Biomedical Research and Development within the Public Health Service Act. The new institute would conduct full-cycle research and development of drugs, devices, and biological products using federal laboratories, contracts with public and private entities, and acquisitions of existing technologies. Key provisions include government ownership of patents and trade secrets from institute-funded research, mandatory sharing of clinical trial data with the public, and licensing agreements that prioritize nonprofit and public entities while allowing some for-profit licensing under public interest terms. The institute would be overseen by a 15-member governing board with restrictions on members from the pharmaceutical industry, and it would receive an initial authorization of $90 billion for fiscal year 2027.
HR 1244, the "Reducing Drug Prices for Seniors Act," requires Medicare Part D plans to calculate coinsurance for covered drugs based on the plan's actual acquisition cost (the negotiated net price paid by the plan) rather than the drug's wholesale price, starting in 2026. This change directly affects Medicare Part D beneficiaries who pay coinsurance after meeting their deductible but before reaching the out-of-pocket threshold. The bill mandates that plans use the actual cost reported in the Detailed DIR Report, excluding certain drugs covered under specific exceptions. This policy aims to lower out-of-pocket costs for seniors by aligning coinsurance with the price the plan actually pays for medications.
Alternatives to Prevent Addiction In the Nation Act or the Alternatives to PAIN Act This bill reduces cost-sharing and prohibits the imposition of certain utilization requirements under the Medicare prescription drug benefit for certain non-opioid pain management drugs. Specifically, the bill requires such drugs to be covered without a deductible and to be placed on the lowest cost-sharing tier (if any). The bill also prohibits the imposition of prior authorization requirements (i.e., requiring prior approval from a plan) or step therapy requirements (i.e., requiring the use of alternative drugs before a drug is covered under a plan) with respect to such drugs.
HR 1492 amends the Social Security Act to extend the negotiation period for standard drug manufacturers under the federal drug pricing program. Specifically, it changes the timeframe from 7 years to 11 years for small-molecule drugs (like traditional pills) to negotiate prices with the government, aligning it with the existing 12-year period for complex biologic drugs (like insulin or monoclonal antibodies). This adjustment directly affects pharmaceutical companies that produce small-molecule drugs, giving them a longer window to negotiate pricing terms. The bill makes this change effective as if it had been part of the 2022 law that established the program.
This bill automatically qualifies certain Medicaid beneficiaries for Medicare Part D prescription drug subsidies when they turn 65. Specifically, it treats individuals enrolled in Medicaid under specific state plan provisions (as defined in Section 1902(a)(10)(A)) with income below 200% of the poverty line as "subsidy eligible" for Part D, without requiring additional application. The provision applies to those who were enrolled in Medicaid the day before turning 65, and the subsidy period is limited as determined by the Secretary. It takes effect for Medicare plan years beginning January 1, 2027. The bill does not change drug pricing but streamlines access to existing subsidy programs for this group.
HR 3493, the Global Fairness in Drug Pricing Act, requires the U.S. Health and Human Services Secretary to establish price targets for pharmaceutical manufacturers, ensuring U.S. drug prices align with those in comparable developed countries. It directs the HHS Secretary to certify safe importation of drugs from low-cost countries and facilitate direct-to-consumer purchasing programs at the set prices. The bill also authorizes antitrust enforcement against drug companies for anticompetitive practices and mandates a study on whether manufacturers engage in unfair pricing that forces U.S. patients to subsidize global drug research. This legislation directly affects pharmaceutical manufacturers and American patients seeking affordable prescription drugs.
HR 1476, the PLASMA Act, adjusts discount rates for plasma-derived drugs under Medicare Part D starting in 2026. It sets gradually decreasing discount percentages (from 99% down to 90% by 2030) for these specific drugs when beneficiaries reach their annual out-of-pocket spending threshold. The bill directly affects Medicare Part D beneficiaries using plasma-derived biological products (drugs made from human blood or plasma) and the manufacturers of those drugs. Certain drugs for low-income subsidy beneficiaries and small manufacturers are excluded from these discount provisions. The law phases in these changes over several years to align with existing Medicare Part D cost-sharing rules.
The RAPID Reserve Act creates a federal program requiring drug manufacturers to maintain 6-month reserves of critical medicines with vulnerable supply chains - such as those concentrated in single regions or with few producers. Eligible manufacturers (with FDA-registered facilities and strong quality records) must store these reserves domestically or in OECD countries and share them during emergencies, like shortages or public health crises. The program prioritizes domestic production, allocates $500 million for fiscal year 2026, and mandates HHS to publish a list of covered drugs and report on the program’s effectiveness. It directly affects drug manufacturers and distributors selected to participate in the reserve system.
The Old Drugs, New Cures Act creates a new "priority research drug" designation for older medications being studied for new medical uses. It directly affects drug manufacturers who want to investigate existing drugs (approved over 10 years ago) for new indications addressing significant unmet medical needs, particularly for diseases affecting 33%+ of beneficiaries in federal health programs like Medicare, Medicaid, or VA care. Key provisions require the Secretary to designate such drugs within 60 days of a request, then exclude them from Medicaid and Medicare pricing rules that typically treat minor drug modifications as "line extensions." This exclusion allows manufacturers to potentially secure better reimbursement for these repurposed drugs under current program rules. The bill changes how these specific drugs are classified in federal healthcare programs, not the drugs' medical use.
The Prescription Drug Transparency and Affordability Act (HR 2450) requires pharmacy benefit managers (PBMs) to provide detailed, regular reports to group health plans and health insurance issuers about prescription drug pricing and spending. These reports, to be submitted every six months (or quarterly if requested), must include specific information about drug costs, rebates, out-of-pocket spending by participants, and other financial details in plain language and machine-readable format. The law specifically applies to "specified large employers" (employers with 100+ employees) and "specified large plans" (plans with 100+ participants), aiming to increase transparency about drug pricing and help health plans make more informed coverage decisions. The bill includes enforcement provisions, with potential civil penalties for non-compliance, and requires reports to be provided in accessible formats while maintaining privacy protections.
