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This bill aims to protect patients’ access to lower-cost drugs under the 340B program. It makes clear that drug makers must honor 340B discount prices no matter how or where a medicine is dispensed—at a hospital or clinic, through a local contract pharmacy, by mail, or at a specialty pharmacy. It also says manufacturers cannot add new hurdles, like limiting where drugs can be delivered or demanding extra claims data, unless those conditions are standard business practice and approved in advance by federal health officials .
Hospitals, clinics, and health centers in 340B can keep using one or more contract pharmacies to get medicines to their patients, and all 340B protections still apply in those cases. If a manufacturer intentionally breaks these rules (other than overcharging), the government can fine them up to $2,000,000 per day until they fix the problem. The health department must set detailed rules for these penalties and create a way for 340B providers to file claims within 180 days of the bill becoming law .
Key points
Revises paragraph (1) of section 340B(a) to replace certain text and to add requirements that manufacturers not place conditions on covered entities' ability to purchase and use covered outpatient drugs at or below the applicable ceiling price, lists categories of prohibited conditions (i)-(iv), and adds a new paragraph (11) applying the requirements and prohibitions in paragraph (1) to covered entities that contract with pharmacies (contract pharmacies).
Adds a new clause (vii) authorizing the imposition of civil monetary penalties for violations of subsection (a)(1)(C) or (a)(11) (other than an overcharge), requires assessment standards to be established in regulations promulgated by the Secretary within 180 days of enactment, applies to manufacturers that intentionally violate the requirements, caps the penalty at $2,000,000 for each day of violation, requires the Secretary to consider specified factors in setting the amount, and provides that penalties continue each day until the violation ends.
Adds paragraph (D) requiring the Secretary to promulgate regulations, not later than 180 days after enactment, to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process established under subparagraph (A).
Referred to the House Committee on Energy and Commerce.
Introduced July 22, 2025 by Doris Matsui · Last progress July 22, 2025