Protecting America’s Life Saving Medicines Act of 2019

Protecting America's Life Saving Medicines Act of 2019

This bill directs the Food and Drug Administration (FDA) to conduct a study on drugs that are currently being tested and are unlikely to be approved, but would, if approved, address an unmet medical need for the treatment of a serious or life threatening disease or condition or a rare disease or condition (high-risk, high-reward drugs). The FDA must submit to the Department of the Treasury a list of such high-risk, high-reward drugs not later than 180 days after the completion of the study.

The bill also allows a new tax credit for 25% of the clinical testing expenses for high-risk, high-reward drugs.