When you or a loved one gets a scary medical diagnosis, you want two things:
to cure or, at least, to prolong life with quality time.
What if the only things keeping you from that cure or that time with family were bureaucratic red tape? It doesn’t have to be this way.
Q: What is the PPA?
A: S. 1644 and H.R. 3761, the Promising Pathway Act (PPA), allows patients—advised by their doctors—to choose early access to promising therapeutic treatments.
The PPA provides:
- Access to More Treatments
- Innovative Drugs and Biologics
- Hope for the Future
Primarily, the PPA opens a safe and effective approval process for new therapeutic treatments. These could treat, prevent, or diagnose serious or life-threatening diseases or conditions.
Who It Helps:
This bill will allow patients with incurable diseases to get access to new treatments quickly.
Patients with rapidly progressing terminal illnesses
would have access to drugs that provide their only hope for treatment.
Real-world data collected from these patients
would be incorporated into the drug approval process.
would accelerate the availability of life-improving and life-saving new medical treatments.
Overall, the PPA modernizes our health care system for future generations, making it more patient focused.
HOW IT WORKS:
The PPA would require the FDA to establish a rolling, real-time, priority review pathway for promising new drugs and biologics.
PPA provides a structured way to respond to terminal patient needs for innovative treatment while still retaining the ability to balance efficacy with patient safety.
1. If needed, drug sponsors may request provisional approval status renewal for subsequent two-year periods (up to a total of six years).
2. This enables informed decision making using the most up-to-date data.
3. Availability contingent on evidence of patient benefit.