The Pediatric Rare Disease Voucher Program was just reinstated by an act of Congress. This gives us until September 2024 to gain Pediatric Rare Disease Designation (PRD). While this program is not as important to large drug development companies, who can simply purchase a voucher if they think it will improve their balance sheet, it is mission critical for smaller companies in the rare disease space.
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.