FDA Rare Pediatric Disease Priority Review Rate

FDA Announces Rate for Rare Pediatric Disease Priority Review Vouchers to Increase in 2016

FDA has released the fiscal year 2016 fee rate for using a rare pediatric disease priority review voucher. The new rate for 2016 will be $2,727,000, up from 2015’s rate of $2,562,000, and will take effect starting tomorrow, October 1, 2015.

The Food and Drug Administration Safety and Innovation Act (FDASIA) contains a “sunset clause,” which states that after FDA has granted its third rare pediatric disease priority review voucher, it will have exactly one year to award any additional rare pediatric disease priority review vouchers. After the one-year time-frame is up, however, FDA may not award any additional vouchers, but any vouchers already awarded, may still be redeemed. FDA awarded its third rare pediatric disease voucher on March 17, 2015, indicating that the program would be ending after March 17, 2016 unless Congress were to take action.

However, with this announcement, it appears as though FDA does not expect that the program will be ending this coming March. One way this could be possible, is if the Advancing Hope Act of 2015, introduced in the House of Representatives on March 23, 2015 by Rep. George Kenneth “G. K.” Butterfield (D–NC–1), is signed into law. This bill is intended to provide an incentive for pediatric drug development by making the rare pediatric disease priority review program permanent.

Do you have a product that may be eligible to receive a rare pediatric disease priority review voucher? We can help determine if your product is eligible and, if so, we can help you obtain the voucher and, ultimately, receive FDA approval for your product. For more information on our services and how we can be of assistance, email us here.