The Creating Hope Act

The Creating Hope Act pediatric priority review voucher program has been wildly successful. It is critical that Congress reauthorize the program permanently so that children with serious illnesses can have hope for new therapies, better health and even possibly cures.

The Creating Hope Act establishes an incentive for drugs to be developed expressly for children with rare diseases. The incentive is a priority review voucher that can be earned by a company that develops a rare pediatric disease drug.

Since the passage of the Creating Hope Act pediatric priority review voucher program, the FDA has approved 19 new therapies for children with serious illnesses, two of which are for children with cancer.

Vouchers have traded for as much as $350 million and are now trading for $100 million, providing a significant incentive for drug development for seriously ill children. $2 billion in vouchers have been traded.

The Creating Hope Act has helped children like Emma Whitehead, who was treated with the first FDA approved drug for a gene therapy, Novartis’ Kymriah, for B-cell precursor ALL. Kyrmiah earned a voucher.

Now is the time for the Creating Hope Act to be permanently reauthorized. There is clear evidence of its impact.

The Creating Hope Act sunsets on September 30, 2020.

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