S. 2983 · 117th Congress
Accelerated Drug Approval for Prescription Therapies for Coronavirus Act
- Stage
- In committee
- Sponsor
- Mike Braun
- Introduced
- 2021-10-07
- Latest action
- 2021-10-07 · Introduced in Senate
Summary
Accelerated Drug Approval for Prescription Therapies for Coronavirus Act or the ADAPT for COVID Act
This bill authorizes the Food and Drug Administration (FDA)to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the drug is intended to treat or prevent COVID-19 or another disease of epidemic potential.
The FDA must process and review an application under this bill within 180 days of submission.