Drugs

Priority Vouchers Do Little for Development: GAO

A new Government Accountability Office (GAO) report on FDA’s priority review voucher (PRV) program shows that after a decade of experience, the vouchers have had little or no effecet on drug development. However, GAO says that the seven drug sponsors GAO interviewed said PRVs were a factor in drug development decisions, with six saying they were one of a number of factors, while one said the voucher was pivotal in its development of a drug. “Some academic researchers and stakeholders expressed concerns about the PRVs as incentives for drug development, including the potential for the expected revenue from the sale of a PRV to decline as more are awarded and available for sale,” the report says.

Mandated by the 21st Century Cures Act, the report says that as of 9/30/2019 FDA had awarded 31 PRVs across the three PRV programs (tropical diseases, rare pediatric diseases and medical countermeasures. The majority have been awarded through the rare pediatric disease PRV program. Seventeen of the 31 PRVs were subsequently sold to another drug sponsor for a low of $67.5 million to $350 million, it says. “However, the available sales prices of the PRVs sold since 2/2017 have varied less than those sold previously, ranging from $80 to $130 million,” according to GAO.

So far, GAO says that drug sponsors have redeemed 16 of the 31 vouchers to obtain a priority review for a submission to FDA. The drugs for which the PRVs were redeemed treat or prevent a variety of conditions and diseases, including human immunodeficiency virus, Type 2 diabetes, and different forms of arthritis.

Those surveyed in the study suggested areas for improvement, including:

Requiring innovation for PRV-eligible drugs new to the global market. Currently, drug sponsors can get a voucher for a drug already approved outside the U.S.
Requiring drug sponsors to guarantee access to PRV-eligible Some criticized drug sponsors awarded a PRV because they have no obligation to make the approved drug available at an affordable price.
Limiting PRVs to drug sponsors with financial need. One drug sponsor and one researcher suggested awarding a PRV only to drug sponsors that financially require it to develop their drug.
Making administrative changes to FDA’s process for determining the list of tropical diseases eligible for a PRV to make it more transparent.

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