US SB3325

Creates a new "public interest drug or medical device health care organization" designation allowing nonprofits that manufacture or distribute drugs and medical devices to qualify for 501(c)(3) tax-exempt status

Eligible drugs/devices must address drug shortages, significantly reduce costs for patients or health systems, meet unmet health needs, or address public health emergencies

Designated organizations must agree to provide HHS priority access to at least 25% of their production for the strategic national stockpile at average cost pricing when needed

Organizations must be U.S.-based, not controlled by for-profit entities, and meet board independence requirements limiting overlap with for-profit drug/device manufacturers

Applies to taxable years beginning one year after enactment; Treasury Secretary must issue affordability guidelines and cost transparency regulations in consultation with HHS