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S. 3325

BillFederalSenateIn Committee
Expanding Access to Affordable Drugs and Medical Devices Act
About This Bill
Committee
Latest Action · December 3, 2025
Read twice and referred to the Committee on Finance.
Congress
119th (2025–2027)
Introduced
December 3, 2025
Cosponsors (1)
0D 1R
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Summary

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This bill amends federal tax law to create a new category of tax-exempt organizations that manufacture and distribute drugs and medical devices to address public health needs. Organizations can request designation as "public interest drug or medical device health care organizations" if they primarily focus on making eligible drugs or devices affordable, are U.S.-based, and meet strict governance requirements—including limits on board members and executives who can also serve competitors in the private pharmaceutical industry. Eligible drugs and devices must address drug shortages, reduce patient costs significantly, meet unmet health needs, or address public health emergencies, and designated organizations must give the federal government priority access to purchase up to 25 percent of their production for the national stockpile at competitive prices. The bill also establishes funding rules allowing these organizations to accept grants from government and tax-exempt entities and revenue from drug sales, but limits private commercial funding to no more than 1 percent of annual receipts. The law takes effect one year after enactment.

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