Speeding Therapy Access Today (STAT) Act of 2021
The Speeding Therapy Access Today (STAT) Act of 2021, H.R. 1730 / S. 670 was introduced In March, 2021.
This bipartisan legislation is a result of more than a year of collaborative effort by rare disease community partners and congressional leaders, working to identify opportunities to ensure that all rare disease communities receive access to safe and effective treatments and cures at the earliest moment possible.
The STAT Act establishes a Rare Disease Center of Excellence at the FDA that will improve the development of and access to therapies for the rare disease community by:
- Optimizing interagency coordination of rare disease expertise.
- Advancing science based regulatory policies.
- Targeting development for ultra-rare diseases, and
- Ensuring the intended patient populations ultimately receive access to approved therapies.