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www.fdanews.com/articles/173160-drugmakers-to-pay-27-million-fee-for-tropical-disease-priority-review-voucher

Drugmakers to Pay $2.7 Million Fee for Tropical Disease Priority Review Voucher

September 17, 2015

Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher will pay a $2.7 million fee in fiscal year 2016 — a $165,000 increase over this year, which ends Sept. 30.

The vouchers are awarded as an incentive to invest in developing treatments for neglected tropical diseases and cut the standard 10-month review period to six months.

Drugmakers receive the voucher when a tropical disease treatment is approved, allowing them to use it with a future NDA or BLA submission or sell it to another drugmaker.

The voucher fee must be paid in addition to any other fees due under PDUFA. While the fee is increasing next year, it has dropped considerably from its high of $5.28 million in 2012, thanks to the FDA’s use of a more accurate formula.

Read the Federal Register notice at www.fdanews.com/09-14-15-tropical.pdf. — John Bechtel