Bill > S3325

This bill amends the Internal Revenue Code to create a new category of tax-exempt organizations called "public interest drug or medical device health care organizations" that can manufacture and distribute drugs and medical devices while maintaining their nonprofit status. To qualify, an organization must primarily aim to make drugs or medical devices more affordable, be created and primarily operated in the United States, and meet specific organizational requirements, such as limiting board membership from for-profit medical companies. The bill defines "eligible drugs or medical devices" as those addressing drug shortages, expected to significantly reduce patient costs, meet unmet health needs, or address public health emergencies. Organizations seeking this designation must submit evidence of their manufacturing capabilities and agree to provide priority access to their products for the strategic national stockpile if needed. The bill also establishes rules about permissible funding sources for these organizations, allowing funding from governmental entities, other tax-exempt organizations, and limited amounts from other sources, while preventing excessive financial contributions from for-profit medical companies. The provisions would take effect one year after the bill's enactment, giving organizations time to adapt to the new regulatory framework.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/3325/all-info