S. 3325 — Expanding Access to Affordable Drugs and Medical Devices Act

This section amends Section 501 of the Internal Revenue Code of 1986 to add a new subsection (s) establishing tax-exempt status under §501(c)(3) for organizations designated by the Secretary of the Treasury, in consultation with the Secretary of Health and Human Services, as public interest drug or medical device health care organizations. Such designation applies if the organization's primary purpose is making eligible drugs or medical devices affordable; it is created and primarily operated in the United States; it is not controlled by a non-tax-exempt entity; and it meets organizational requirements limiting board and executive staff overlap with disqualified entities (i.e., taxable drug or medical device manufacturers or distributors), subject to specified exceptions. An eligible drug or medical device is one determined by the Treasury Secretary, in consultation with HHS, to be in nationwide or regional shortage (as defined in FD&C Act §§506C(h) or 506J(j)), at risk of shortage (including for over-the-counter drugs), expected to reduce patient or health system costs, address unmet health needs, or meet public health or emergency supply needs. Organizations may request designation by submitting evidence of manufacturing or distribution capability for eligible drugs or devices and an agreement to prioritize sales to the strategic national stockpile at average cost price for at least 25% of production or stock.