stack of one hundred dollars notes

New Fees Announced for Use of Priority-Review Vouchers

In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).  Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for a specific drug or biologic that meets the regulatory and statutory provisions of the relevant acts, authorizing the issuance of such vouchers.

The fee for using any of the three types of vouchers for FY 2020 is $2,167.166.  Remember that is in addition to the PUDFA fee associated with the NDA or BLA filing, which is $2,588,478.

The voucher can be used by the applicant that obtained approval for the drug for which the voucher was awarded, or it can be sold to another firm to use to garner a six-month priority review of any 505(b)(1) NDA application or BLA under Section 351(a) of the Act.  In addition, the voucher can be resold any number of times until it is used for submission of any application as outlined above.

Firms that use the voucher are thus into the Agency for a total of $4,755,644 upon submission of an eligible application when using a priority-review voucher.  And we wonder why prescription drugs are so costly!  Apparently, firms that have their eyes set on a potential blockbuster drug would jump at the chance for a six-month review and that is why priority review vouchers sell in some instances for as much as $350 million.  That is a big boost to the bottom line for some companies, and you don’t have to have a sales force to market the product.

A 2017 article (here) published in Locust Walk titled “What happened to the value of priority review vouchers (PRV)?” discusses the price paid for five vouchers (ranging from $67.5 million to $350 million), but also notes that at the time there were nine outstanding unused priority review vouchers.  Other authors believe that the high number of unused vouchers will have a tendency to bring down their sale value.  We will see.