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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2025 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.
DATES:
This rate is effective on October 1, 2024, and will remain in effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., 6th Floor, Beltsville, MD 20705-4304, 240-402-4989; or the User Fees Support Staff at OO-OFBAP-OFM-UFSS-Government@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Establishment of the Tropical Disease Priority Review Voucher
Section 1102 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) added section 524 to the FD&C Act (21 U.S.C. 360n). In section 524 of the FD&C Act, Congress encouraged development of new human drug and biological products for prevention and treatment of tropical diseases by offering additional incentives for obtaining FDA approval of such products. Under section 524 of the FD&C Act, the sponsor of an eligible human drug application for a tropical disease (as defined in section 524(a)(3) of the FD&C Act) shall receive a priority review voucher upon approval of the tropical disease product application (as defined in section 524(a)(4) of the FD&C Act).
B. Establishment of the Rare Pediatric Disease Priority Review Voucher
Section 908 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) added section 529 of the FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress encouraged development of new human drugs and biological products for prevention and treatment of certain rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products. Under section 529 of the FD&C Act, the sponsor of an eligible human drug for a rare pediatric disease (as defined in section 529(a)(3)) shall receive a priority review voucher upon approval of the rare pediatric disease product application (as defined in section 529(a)(4) of the FD&C Act).
The FD&C Act includes a sunset of authority to award rare pediatric disease priority review vouchers. Section 529(b)(5) of the FD&C Act provides that after September 30, 2024, FDA may not award any rare pediatric disease priority review vouchers unless a rare pediatric disease product application: (1) is for a drug that, not later than September 30, 2024, is designated under section 529(d) of the Act as a drug for a rare pediatric disease, and (2) is, not later than September 30, 2026, approved under section 505(b)(1) of the FD&C Act or section 351(a) of the PHS Act. This limit of FDA's authority to award rare pediatric disease vouchers does not affect the ability to use rare pediatric disease priority review vouchers issued by FDA.
C. Establishment of the Material Threat MCM Priority Review Voucher
Section 3086 of the 21st Century Cures Act (Pub. L. 114-255) added section 565A to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act, Congress encouraged development of material threat MCMs by offering additional incentives for obtaining FDA approval of such products. Under section 565A of the FD&C Act, the sponsor of an eligible material threat MCM application (as defined in section 565A(a)(4)) shall receive a priority review voucher upon approval of the material threat MCM application.
Although under section 565A(g) of the FD&C Act, material threat MCM priority review vouchers may not be awarded after October 1, 2023, this “sunset” of authority to award vouchers does not affect the ability to use material threat MCM priority review vouchers that have already been issued.
D. Transferability of the Priority Review Voucher
The recipient of a priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) (or section 351(a)) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party. The voucher may be transferred repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the PHS Act. As further described below, a priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding review goals for FY 2025 is available at: https://www.fda.gov/media/151712/download.
The sponsor that uses a priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a priority review user fee in addition to any other fee required by PDUFA. FDA published information on its website about how the priority review voucher program operates.
Information regarding the tropical disease priority review voucher program is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers.
Information regarding the rare pediatric disease priority review voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
Information regarding the material threat MCM priority review voucher program is available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions.
This notice establishes the FY 2025 priority review fee rate for use of tropical disease, rare pediatric disease, and material threat MCM priority review vouchers at $2,482,446 and outlines FDA's process for implementing the collection of priority review user fees. This rate is effective on October 1, 2024, and will remain in effect through September 30, 2025.
II. Priority Review User Fee Rate for FY 2025
FDA interprets section 524(c)(2) (tropical disease priority review user fee), section 529(c)(2) (rare pediatric disease priority review user fee), and section 565A(c)(2) (material threat MCM priority review user fee) of the FD&C Act as requiring that FDA determine the amount of each priority review user fee for each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year.
A priority review is a review conducted within a timeframe prescribed in FDA commitments for such reviews made in connection with PDUFA reauthorization for FYs 2023—2027, known as PDUFA VII. For the FYs 2023 through 2027, FDA has committed to a goal date to review and act on 90 percent of the applications granted priority review status within the expedited timeframe of 6 months after receipt or filing date (filing date for new molecular entity (NME) new drug application (NDA) and original biologics license application (BLA) submissions; receipt date for priority non-NME original NDA submissions). Normally, an application for a human drug or biological product will qualify for priority review if the product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. An application that does not receive a priority designation receives a standard review. A priority review involves a more intensive level of effort and a higher level of resources than a standard review.
FDA is setting a fee for FY 2025, which is to be based on standard cost data from the previous fiscal year, FY 2024. However, the FY 2024 submission cohort has not been closed out yet, thus the cost data for FY 2024 are not complete. The latest year for which FDA has complete cost data is FY 2023. Furthermore, because FDA has never tracked the cost of reviewing applications that get priority review as a separate cost subset, FDA estimated this cost based on other data that the Agency has tracked. The Agency expects all applications that received priority review would contain clinical data. The application categories with clinical data for which FDA tracks the cost of review are (1) NDAs for an NME with clinical data and (2) BLAs.
The total cost for FDA to review NME NDAs with clinical data and BLAs in FY 2023 was $305,296,115. There was a total of 61 applications in these 2 categories (34 NME NDAs with clinical data and 27 BLAs). (Note: These numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no investigational new drug review costs are included in this amount.) Of these applications, 37 (19 NDAs and 18 BLAs) received priority review and the remaining 24 (15 NDAs and 9 BLAs) received standard reviews. Because a priority review compresses a review that ordinarily takes 10 months into 6 months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to nonpriority review costs in estimating the effort and cost of a priority review as compared to a standard review. This multiplier is consistent with published research on this subject, which supports a priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using FY 2023 figures, the costs of a priority and standard review are estimated using the following formula:
(37 α × 1.67) + (24 α) = $305,296,115
where “α” is the cost of a standard review and “α times 1.67” is the cost of a priority review. Using this formula, the cost of a standard review for NME NDAs and BLAs is calculated to be $3,558,645 (rounded to the nearest dollar) and the cost of a priority review for NME NDAs and BLAs is 1.67 times that amount, or $5,942,937 (rounded to the nearest dollar). The difference between these two cost estimates, or $2,384,292, represents the incremental cost of conducting a priority review rather than a standard review.
For the FY 2025 fee, FDA will need to adjust the FY 2023 incremental cost by the average amount by which FDA's average costs increased in the 3 years prior to FY 2024, to adjust the FY 2023 amount for cost increases in FY 2024. That adjustment, published in the Federal Register setting the FY 2025 PDUFA fees, is 4.1167 percent for the most recent year, not compounded. Increasing the FY 2023 incremental priority review cost of $2,384,292 by 4.1167 percent (or 0.041167) results in an estimated cost of $2,482,446 (rounded to the nearest dollar). This is the priority review user fee amount for FY 2025 that must be submitted with a priority review voucher for a human drug application in FY 2025, in addition to any PDUFA fee that is required for such an application.
III. Fee Rate Schedule for FY 2025
The fee rate for FY 2025 is set in table 1:
Table 1—Priority Review Fee Schedule for FY 2025
| Fee category | Priority review fee rate for FY 2025 |
|---|---|
| Application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee | $2,482,446 |
| Application submitted with a rare pediatric disease priority review voucher in addition to the normal PDUFA fee | 2,482,446 |
| Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee | 2,482,446 |