FDA is slashing the fee for using a tropical disease priority review voucher to $3.6 million in fiscal year 2013, a 32.6% reduction from the previous year’s rate of $5.3 million, but whether a price cut drums up interest in the regulatory product remains an open question.

The agency announced the new rate, effective Oct. 1, in a Sept. 13 Federal Register notice. “After reviewing more recent data and experience with the program, FDA has revised the formula to better approximate the current and ongoing incremental FDA resource costs for a priority review,” the agency said.

The previous year, FDA had included IND review costs as part of the calculation, but for FY 2013 they were dropped from the formula. Also, instead of charging applicants the full cost that the agency incurs for a priority review, FDA will now only charge “the incremental cost of conducting a priority review rather than a standard review.”

Those changes, along with the decision to calculate FDA’s salary and benefit cost using a three-year instead of a five-year average, produced the significant reduction in the fee.

The fee to redeem the voucher is on top of other application fees under the Prescription Drug User Fee Act. For FY 2013, the fee for applications requiring clinical data is $1,958,800 and the fee for applications that do not require clinical data is $979,400.

Sponsors Will Not Redeem Any Vouchers In FY 2013

Despite the bargain rate for FY 2013, the agency does not expect any sponsors to redeem the vouchers this coming fiscal year. FDA reported in its budget documents for FY 2013 that it has not been notified of any sponsor’s intent to submit a voucher for 2012 or 2013; the program requires 365-day notice of intent to submit Also see "FDA's Projected $20 Mil. In 2013 Biosimilar User Fees Translates Into 68 More Staffers" - Pink Sheet, 13 February, 2012..

To date, Novartis AG is the only company to redeem a priority review voucher issued by the agency. The company received the voucher in 2009 following the approval of its antimalarial Coartem (artemether/lumefantrine) and used it to obtain a six-month review of Ilaris (canakinumab) for treatment of gouty arthritis. Last year FDA issued a “complete response” letter to Novartis requesting more clinical data to evaluate Ilaris’ benefit-risk profile in refractory patients Also see "Novartis Takes Stock Of Ilaris For Gout Following FDA's Complete Response Letter" - Pink Sheet, 29 August, 2011..

Paul Herrling, chair of the Novartis Institute for Tropical Diseases, said earlier this year that it is too early to know if the voucher program will be a success, which will depend on whether there is a market for them Also see "R&D For Diseases Of Developing Countries Could Be Driven By Pooled Funds" - Pink Sheet, 21 May, 2012..

However, there has been no consensus on the voucher’s value. A survey conducted last year by the BIO Ventures for Global Health found that drug companies were willing to invest about $100 million on average to gain a voucher but individual respondents cited potential investments ranging from zero to $300 million Also see "Priority Review Voucher Value Still Confounds, But Remains An Incentive For Sponsors" - Pink Sheet, 21 September, 2011..

FDA Cuts Priority Review Voucher Fee By 32%; No Takers For FY 2013

More from United States

More from North America