
This act introduced the pediatric rare disease priority review voucher program back in 2012 and was more recently permanently reauthorized in 2019. The voucher program provides incentives for research companies to study rare diseases which include all childhood cancers. Because clinical trials are fiscally expensive, time consuming, and often difficult, companies rarely take the time to focus on lesser known diseases such as childhood cancer.
To provide an incentive for companies to conduct such research, the priority review voucher follows these steps:
1. A drug or pharmaceutical company will present a childhood cancer treatment for FDA approval and file for a rare disease voucher request.
2. If the FDA approves the treatment and the request, an official voucher will be issued to the company.
3. When the company wants to request FDA approval for another drug later on, they can utilize the voucher, reducing the FDA review time from 10 months to 6 months. This is beneficial because it saves the company valuable time and allows them to enter the market earlier!
Comments