S. 3387 · 114th Congress
Safely Advancing Valuable and Inexpensive New Generic Solutions Act
- Stage
- In committee
- Sponsor
- Tom Cotton
- Introduced
- 2016-09-22
- Latest action
- 2016-09-22 · Introduced in Senate
Summary
Safely Advancing Valuable and Inexpensive New Generic Solutions Act or the SAVINGS Act
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of certain generic drug applications and act on them within 150 days. This generic fast track review applies to applications for drugs: (1) that are not under patent or for which patents will expire soon, (2) for which there is no marketing exclusivity in effect, and (3) for which a generic has not recently been introduced to the market by more than one manufacturer.
The FDA must report on applications subject to generic fast track review and provide an annual accounting of how it has spent generic drug user fees.