To amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedited approval of drugs for serious or life-threatening diseases or conditions.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Faster Access to Specialized Treatments Act'' or ``FAST Act''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress finds the following: (1) The Food and Drug Administration (FDA) serves a critical role in helping to assure that new medicines are safe and effective. Regulatory innovation is one element of the Nation's strategy to address serious and life-threatening diseases or conditions by promoting investment in and development of innovative treatments for unmet medical needs. (2) Over the previous two decades, since the accelerated approval mechanism was established, advances in medical sciences, including genomics, molecular biology, and bioinformatics, have provided an unprecedented understanding of the underlying biological mechanism and pathogenesis of disease. A new generation of modern, targeted medicines is currently under development to treat serious and life- threatening diseases, some applying drug development strategies based on biomarkers or pharmacogenomics, predictive toxicology, clinical trial enrichment techniques, and novel clinical trial designs, such as adaptive clinical trials. (3) As a result of these remarkable scientific and medical advances, FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases...