This bill requires the Department of Health and Human Services (HHS) to provide assistance to certain nonprofit manufacturers of drugs or medical devices, establishes requirements in statute for a manufacturer to qualify as a tax-exempt nonprofit organization, and addresses related issues.

Generally, to be a tax-exempt nonprofit drug (or biological product) or device manufacturer under this bill, an organization must (1) only manufacture drugs or devices that further a public health objective, such as addressing barriers related to availability or price; (2) sell each drug or device at a public list price that is not above a certain amount as determined by various costs; (3) not compensate any employee an amount more than 40 times the compensation of the lowest-compensated employee or applicable contractor; and (4) meet various existing requirements for being a tax-exempt organization.

HHS must provide assistance to tax-exempt nonprofit organizations that meet certain requirements by awarding cooperative agreements, providing low-interest revolving loans, and waiving certain user fees. For awarding such cooperative agreements and loans, HHS shall prioritize organizations expecting to market an eligible drug or device (1) at a price lower than existing treatments, or (2) that HHS has identified as a public health priority.

The Food and Drug Administration may prioritize the review of an application for market approval of a qualifying drug or medical device from a tax-exempt nonprofit organization if the organization commits to a specific price that is significantly lower than similar treatments on the market.