S3325-119

In Committee

Expanding Access to Affordable Drugs and Medical Devices Act

119th Congress Introduced Dec 3, 2025

Summary

What This Bill Does

Allows certain nonprofit organizations that manufacture or distribute affordable drugs or medical devices to keep section 501(c)(3) status if Treasury and HHS designate them as public interest organizations.

Who Benefits and How

Nonprofit organizations focused on affordable drugs or medical devices gain a path to tax-exempt treatment while producing or distributing products that address shortages, unmet health needs, or high costs.

Who Bears the Burden and How

Treasury and HHS must administer a new designation regime, monitor compliance, and issue guidance, while designated nonprofits must meet governance, affordability, and stockpile-access conditions.

Key Provisions

  • Creates a public-interest designation that protects eligible nonprofits from losing 501(c)(3) status for manufacturing or distributing drugs or medical devices.
  • Requires Treasury, in consultation with HHS, to apply eligibility, governance, affordability, shortage, and unmet-need criteria.
  • Directs Treasury and HHS to issue guidance and monitor ongoing compliance.

Evidence Chain:

This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.

At a Glance

What This Bill Does

Allows certain nonprofit organizations that manufacture or distribute affordable drugs or medical devices to keep section 501(c)(3) status if Treasury and HHS designate them as public interest organizations.

Key Policy Areas

Healthcare, Finance, Government Operations

Primary Purpose

Allows certain nonprofit organizations that manufacture or distribute affordable drugs or medical devices to keep section 501(c)(3) status if Treasury and HHS designate them as public interest organizations.

Policy Domains

Healthcare Finance Government Operations

Main Provisions

Identified Gains
Contextual inference, no direct clause citation
  • Public-interest nonprofit drug and medical device organizations
  • Patients facing shortages or unaffordable products
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is

Contextual inference, no direct clause citation

Identified Costs
Contextual inference, no direct clause citation
  • Treasury and HHS designation administrators
  • Designated nonprofits subject to new conditions
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is

Contextual inference, no direct clause citation

Legislative Progress

In Committee
Introduced Committee Passed
Dec 3, 2025

Ms. Rosen (for herself and Mr. Curtis) introduced the following …

Dec 3, 2025

Read twice and referred to the Committee on Finance.

Dec 3, 2025

Introduced in Senate

Stakeholder Effects

cui bono?

How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.

Healthcare
1 mention across 1 clause
+1 positive

Public-interest nonprofit drug and medical device organizations

Government
1 mention across 1 clause
-1 negative

Treasury and HHS designation administrators

1/2
sections analyzed
Full impact breakdown

Bill Structure & Actor Mappings

Who is "The Secretary" in each section?

Domains
Healthcare Finance Government Operations
Actor Mappings
"the secretary"
→ Secretary of the Treasury
"the secretary of health and human services"
→ Secretary of Health and Human Services

We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.

Learn more about our methodology