On Thursday, September 30th, FDA announced its user fee rates for fiscal year 2022 for Sponsors using the priority review vouchers (PRVs) for the following:
- Tropical diseases
- Material threat medical countermeasures (MCM)
- Rare pediatric diseases
What is a Priority Review Voucher?
FDA developed its PRV program to incentivize and encourage Sponsors to develop products for the treatment of diseases that would not otherwise be attractive to drug developers due to the extreme cost associated with their development. These include drugs for the treatment of tropical diseases, rare pediatric diseases, or to be used as medical countermeasures.
To encourage the development of these products, FDA offers Sponsors of these products a voucher that allows any one of their products to be reviewed by FDA under the priority review system. Sponsors have the option to either sell the PRV to another Sponsor or use it for another one of their products to reduce FDA’s review time to six months rather than the Agency’s standard ten-month review.
In order to enable FDA to review these products at an expedited rate, FDA collects user fees from companies seeking approval of certain products. Priority Review Vouchers are no exception and have associated user fees that are collected upon application submission.
FDA User Fee Rates for Fiscal Year 2022
Last week, FDA announced the user fee rates that will be collected in 2022 for using a priority review voucher will be $1,266,651. That is for all three types of priority review vouchers and is even lower than the previous all-time low rates of $1,360,879 in 2021 and $2,167,116 in 2020. It is important to note that these fees are in addition to the required prescription drug user fee amendments (PDUFA) fees set for 2022. The additional fee for using a PRV represents the additional cost FDA estimates it will incur to achieve the compressed 6-month review timeline.
Are you in the process of developing an FDA application and want to use a PRV to expedite FDA’s review of your submission? Regardless of what your regulatory needs are, we have the expertise and experience to help you achieve successful interactions with the regulatory agencies across the globe. Contact us today to learn more about our comprehensive suite of global regulatory services.
