Policy & Systemic Advocacy
In developmentWe track and explain the legislation that shapes patient access, including expanded access, the 21st Century Cures Act, and Right to Try.
What we do today
- Track and explain laws and rules that affect patient access
- Publish plain-language summaries patients and families can actually use
What we don't do yet
- Lobby lawmakers, file regulatory comments, or run legislative campaigns
The Current Landscape
Understanding where we are helps us see where we need to go. Here's the legislative foundation that shapes patient access today.
1987+
Compassionate Use (Expanded Access)
FDA program allowing patients with serious conditions to access investigational drugs outside clinical trials when no comparable alternatives exist.
2016
21st Century Cures Act
Landmark legislation streamlining drug approval, enhancing patient access, and promoting medical innovation through regulatory modernization.
2018
Right to Try Act
Federal law allowing terminally ill patients to access investigational treatments that have completed Phase I trials without FDA approval.