Expanding Access to Affordable Drugs and Medical Devices Act

Sponsor: Jacky Rosen (Democratic-NV)December 3, 2025

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Introduced

In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

Read twice and referred to the Committee on Finance.

Lets non-profit groups make affordable drugs and medical devices without losing their tax-exempt status.

This bill would create a new type of tax-exempt organization focused on making drugs and medical devices more affordable and available. These groups could manufacture and distribute needed medical products without losing their non-profit status. This aims to help patients get access to cheaper medicines, especially those in short supply or addressing unmet health needs.

What Would Change

Today, there are no clear rules in the tax code for non-profit organizations that make and distribute drugs and medical devices, which can make it difficult for them to get or keep their tax-exempt status. This bill would create a new type of tax-exempt organization specifically for groups that manufacture and distribute drugs and medical devices to meet public health needs. These organizations would be able to operate without losing their non-profit status, as long as they focus on affordability and meet other specific requirements.

Key Provisions

Creates a new tax-exempt status for organizations that make or distribute drugs and medical devices to meet public health needs.
Lets these organizations keep their non-profit status even if they make or sell medical products, as long as they follow specific rules.
Requires eligible drugs or devices to meet specific criteria: they must either be in shortage or lower costs, AND they must address an unmet health need or public health emergencies.
Requires these organizations to give the government priority access to at least 25 percent of their products for the Strategic National Stockpile during emergencies.
Sets rules for what kind of funding these organizations can accept without their funders facing tax penalties.

View on Congress.gov

S 3325 · 119th Congress · December 3, 2025 · AI Summary by gemini-2.5-flash · 5/10

Expanding Access to Affordable Drugs and Medical Devices Act

What Would Change

Key Provisions

Lobbying Activity