Legislative Tracker

Prescription Drug Transparency and Affordability Act

This bill requires pharmacy benefit managers (PBMs) to report, at least once every six months, prescription drug pricing, payment, and utilization data to the health insurance plans for which the PBM provides services.

Specifically, a PBM contracted to provide services to an employer or sponsor offering a large group health insurance plan (i.e., a plan with at least 100 employees or participants) must report to the plan certain information for prescription drug claims under the plan. This includes, for each drug, the difference between the compensation paid by the plan to the PBM and the compensation paid by the PBM to the pharmacy.

Further, for each therapeutic class of drugs under the plan, a PBM must report (1) the total amount it received in rebates, fees, and discounts; and (2) the net spending for each class after such rebates, fees, and discounts.

Each PBM also must report certain information about (1) drugs for which total spending exceeded $10,000; and (2) drugs dispensed through pharmacies affiliated with the plan or PBM, such as the percentage of prescriptions dispensed by such affiliates.

Finally, a PBM providing services to any group health insurance plan must provide the plan with a summary document that includes similar information for prescription drug claims under the plan, as determined by the Department of Health and Human Services. Plans must also make certain aggregate summary information available to plan participants.

PBMs and plans that violate these requirements are subject to civil penalties.

Prescription Drug Price Relief Act of 2025

This bill requires the Department of Health and Human Services (HHS) to review brand-name drugs annually for excessive pricing and, if a drug is found to be priced excessively, to void any exclusivity granted to its sponsor.

Specifically, HHS must review all brand-name drug prices at least annually and upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.

An entity accepting an open, nonexclusive license under these provisions must pay a reasonable royalty to the holder of the relevant patent or approved new drug application, and must price the generic drug or biosimilar below the excessive rate.

Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of these countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including development cost, revenue, and the size of the affected patient population.

The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.