Expanding Access to Affordable Prescription Drugs and Medical Devices Act

Expanding Access to Affordable Prescription Drugs and Medical Devices Act

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.