The Regulatory Burden Of The Priority Review Voucher Program

In a recent interview, an official from the Food and Drug Administration (FDA) expressed concern about the costs to the FDA of the priority review voucher program. The director of the Office of New Drugs said he’s worried the additional priority reviews are taking resources away from other important work. Furthermore, an FDA spokesperson wrote that “These programs allow sponsors to ‘purchase’ a priority review at the expense of other important public health work in FDA’s portfolio.”
But it doesn’t have to be that way, and it’s important to tackle these concerns because the FDA is critical to the success of the voucher program in encouraging the development of drugs for neglected diseases and rare pediatric diseases.
Officials from the FDA are busy with drug reviews and the voucher program makes them busier. But the voucher program also gives the FDA more resources. Each time a voucher is redeemed, the FDA receives a user fee ($2.7 million in fiscal year 2016) from the company redeeming the voucher, in addition to the user fee ($2.4 million in fiscal year 2016) required of all new drug applications with clinical data ($5.1 million total per drug redeeming a voucher).
In anticipation of three vouchers being redeemed in 2015, Congress allocated $8 million in extra funding to the FDA so the FDA had the resources in advance. Is the user fee sufficient? If not, the FDA has the power to increase it. Indeed, the voucher user fee was $5.3 million in fiscal year 2012, a...

Source: Health Affairs Blog - October 28, 2015 Category: Health Management Authors: David B. Ridley Tags: Costs and Spending Drugs and Medical Technology Featured FDA priority review voucher program Source Type: blogs