RE: Application for Pediatric Rare Disease Designation8 Nov 2023 20:15
If you read the link I provided it explains clearly the process and what a priority review voucher is. It’s basically what it says it is a PRIORITY (meaning they give you priority over others) REVIEW(the part where they look/ review your rare disease drug application VOUCHER (sort of like a ticket).
That is why they’re so valuable.
Not all drugs are reviewed by FDA in the same way. Most drugs are reviewed by FDA under "standard" review times, meaning FDA has 10 months to review each product before it is supposed to render a decision.
However, for certain drugs, FDA accelerates its regulatory review in the hopes of getting products to market more quickly.
Drugs intended for use in "serious conditions," or which "demonstrate the potential to be a significant improvement in safety or effectiveness," are permitted to be reviewed under FDA's Priority Review Designation pathway. As explained in an FDA guidance document, the pathway allows FDA to review a drug in just six months instead of the standard 10.
For companies and patients alike, FDA's priority review process can be extremely beneficial. For patients with serious conditions, the expedited review means they have access to a potentially life-saving or -changing treatment. For companies, it means they can market their product more quickly and begin recouping their often considerable development costs.
What Does all This Have to do with a Priority Review Voucher?
FDA's priority review vouchers (there are three types) are incentives meant to spur the development of new treatments for diseases that would otherwise not attract development interest from companies due to the cost of development and the lack of market opportunities.
To do this, companies are given a special voucher which allows them to have any one of their drugs reviewed under FDA's priority review system.
That Sounds Interesting. What is the History of the PRV Programs?
The priority review voucher system was first proposed in a March 2006 paper published in the journal Health Affairs, and written by Duke University's David Ridley, Henry Grabowski and Jeffery Moe.
In their paper, "Developing Drugs for Developing Countries," they proposed the creation of a priority voucher system specifically targeted at neglected tropical diseases, which the authors argued lacked sufficient development incentives to produce.
This "prize," as they called it, could be used in one of two ways: Either it could be redeemed by its recipient, or it could be sold to another company, which might want to have its own drug reviewed in a six-month timeframe.
Not sure what you need the company to clarify?
https://www.raps.org/news-and-articles/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know
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