Brain Cancer Advocacy

UPDATE: the house has introduced a true promising pathways bill(HR. 7269).You can help gbm warriors and warriors and warriors of other diseases by adding your name to this letter that would get us faster access to new treatments: https://virtualtrials.com/activism.cfm#/1/

Many Thanks to virtual trials.com for bringing this opportunity to our attention.

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Overview of the bill: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.

What does this mean for Brain Cancer Warriors? 

• The bill will speed up the regulatory process for getting drugs showing benefits to the patients who need them.
• It ​requires the FDA to establish a real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions.
• Under this pathway, provisional approval would be granted by the FDA to treatments demonstrating substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).
•  Moreover, the bill would require the Centers for Medicare and medicaid Services (CMS) to cover therapies provisionally approved through this pathway and prohibit private insurance from denying coverage to therapies that are made available under this pathway on the basis that they are investigational therapies.
• Finally, it would require the creation of registries for those using a provisionally approved drug and the sharing of data from these registries to help speed the overall fight.