FDA pediatric voucher application, page-2

The US Congress created the priority review voucher program in 2007 based on a 2006 Health Affairs paper (Ridley et al. 2006). Under the law, following approval by the Food and Drug Administration (FDA) of a treatment for a neglected or rare pediatric disease, the developer receives a voucher for priority review for a different drug. Two drugs receive priority review for each voucher: the drug winning a voucher for a neglected or rare pediatric disease, and the drug using a voucher for another indication.

The voucher may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease, and sell the voucher to a large company for use on a commercial disease.

Priority review means that the FDA aims to render a decision in 6 months. In contrast, the FDA aims to complete a standard review in about 10 months.

The voucher program is intended to reduce two types of inefficiency. First, the voucher program motivates more treatments for neglected and rare diseases. Second, the voucher program speeds approval of potential blockbuster therapies in the US, getting US patients access to these treatments more quickly.

GW Pharmaceuticals is selling its rare paediatric disease priority review voucher (PRV) for $105 million to Biohaven Pharmaceutical.

The voucher, which entitles the holder to a six-month speedy review of a marketing application, was issued under a US Food and Drug Administration (FDA) programme designed to incentivise the development of treatments for rare paediatric diseases.

I am starting to see why PYC would apply for this..............

( I hereby admit that I love google....)