The Pediatric Rare Disease Voucher Program Is Set To Sunset

The Pediatric Rare Disease voucher program is set to sunset (must have Pediatric Rare Disease approval by Sep 30, 2020 and Marketing Approval by Sep 30 2022 to receive the voucher).

While I do not have a crystal ball, I can tell you this: the program has been renewed before and is one of the most popular mechanisms by which small pharma/biotech (like most of my clients) can enter the drug development space. In my experience, getting Pediatric Rare Disease designation early in development makes it much more possible to fund clinical trials.

However, the GAO report on the voucher program was not nearly as enthusiastic about the Pediatric Rare Disease voucher program as I am. You can read the report here.

If you are a stakeholder and think the government report is missing information about the small business experience, please speak with your congressional representatives to help fill in the blanks!

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