Pdufa Calendar 2023

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Pdufa Calendar 2023

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The Food and Drug Administration (FDA) has released consumer prescription drug rates for fiscal year (FY) 2023. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (PDUFA VII), as amended by the Prescription Drug Fee Amendment of 2022, FDA will charge a fee for certain applications for inspections of human drugs, biological products, and drugs subject to certain approved products may be subject to prescription fees. This announcement sets rates for fiscal year 2023. This tax applies to the period from October 1, 2022 to September 30, 2023.

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Robert Marcorelli, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 61075, Beltsville, MD, 301-796-7223; and support staff for utility costs

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h) establish two types of user fees. The fee is calculated as follows: (1) an application fee is charged for certain types of human drug and biological product applications; and (2) a prescription drug program fee is charged for certain approved products (section 736(a) FD&C). action). The statute also specifies the conditions under which such fees may be waived or reduced (Section 736(d) of the FD&C Act) or under which exceptions, refunds, or exemptions from the fees apply (Sections 736(a)(1) (C) through (G) )., 736(a)(2)(B) through (C), and 736(k) of the FD&C Act.

The default revenue amount for total revenue from all PDUFA fees from fiscal years 2023 through 2027 is established by PDUFA VII. FY 2023 base income amounts are $1,151,522,958. FY 2023 base income amounts are adjusted for inflation, strategic hiring, and capacity retention and resources required for the human drug application process (Capacity Planning Adjustment (CPA )). This amount is further adjusted for the additional dollar amount set forth in the statute (see Section 736(b)(1)(F) of the FD&C Act) to provide additional full-time positions (FTE) in support of PDUFA VII. initiative. Where applicable, operating reserve adjustments are added to ensure sufficient operating reserve of the deferred user fees. The previous adjustment amount is adjusted to provide additional direct costs to fund the PDUFA VII initiative. Fee amounts are set annually so that enrollment fee receipts are 20% of gross revenue and prescription drug program fee receipts are 80% of gross revenue (see Section 736(b)(2) of the FD&C Act ).

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($3,242,026), for applications that do not require relevant clinical data ($1,621,013), and the prescription drug program fee ($393,933). This fee is effective as of October 1, 2022 and is valid through September 30, 2023. Applications submitted after October 1, 2022 must use the new fee schedule.

The base income amount for FY 2023 is $1,151,522,958 (see sections 736(b)(1)(A) and (b)(3) of the FD&C Act). This amount excludes inflation adjustments, strategic assumption and retention adjustments, CPA, additional dollar amounts, operating reserve adjustments (if applicable), and additional direct costs (see Section 736(b)(1) of the FD&C Act). ).

PDUFA VII specifies that $1,151,522,958 will be adjusted for inflation in FY 2023 through two separate adjustments. (1) FD&C Act).

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The inflation-adjusted personnel cost component is the average annual percentage change in all PC&B costs paid per FDA FTE position multiplied by the ratio of PC&B costs to total FDA costs for the first three of the four preceding fiscal years. Human drug application review process for the first three of the four preceding taxable years (see Section 736(c)(1)(A) and (B)(i) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified fiscal years and shows the percentage change from the previous fiscal year and the average percentage change for the first three of the four fiscal years through FY 2023. The average value for three years is: 1.3918 %.

The statute specifies that this 1.3918% must be multiplied by the ratio of PC&B costs to FDA's total costs in the human drug application review process. Table 2 shows the total commitments for PC&B and the human drug review process for the first three of the four previous fiscal years.

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The statute provides that the inflation-adjusted portion of non-wage spending is the population of urban consumers (Washington-Arlington-Alexandria, DC-Virginia-Maryland-West Virginia; not seasonally adjusted; all goods, annual index) for the first three of the previous four years of available data All costs, excluding reimbursement and disbursement costs, multiplied by a percentage of the total costs of the human drug application process (as defined in Section 735(6)) for the first three years of the previous four tax years years (Sec. 736(c)(1) See (A) and (B)(ii)). Table 3 provides summary data for CPI rates of change reported for the Washington-Arlington-Alexandria region.

The statute specifies that this 2.0434% must be multiplied by all costs other than PC&B multiplied by a percentage of the total costs of the drug application process applicable to individuals. Since 61.8539% was charged to PC&B (see Table 2), 38.1461% is the non-PC&B portion of the cost (100% – 61.8539% is 38.1461%). The non-salary adjustment is 2.0434% x 38.1461% or 0.7795%.

Next, we add the salary adjustment (0.8609%) to the non-salary adjustment (0.7795%) to arrive at a total inflation adjustment of 1.6404% (rounded up) for FY 2023.

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Therefore, multiplying the base income amount for FY 2023 ($1,151,522,958) by 1.6404% gives an inflation-adjusted amount of 18,889,582. Adding this amount to the base yield gives the inflation-adjusted base yield. The amounts are 1,170,412,541 dollars.

For each fiscal year, after the annual revenue base set forth in Title II has been adjusted for inflation in accordance with Title II.A above, the statute directs FDA to further increase revenues and fees to support strategic recruitment and retention. For taxable year 2023, this amount is $9,000,000 (see Section 736(c)(2)(A) of the FD&C Act).

The statute specifies that the FY 2023 revenue base of $1,151,522,958 shall be adjusted as described in sections II.A and II.B above, and then further adjusted for changes in resource capacity requirements. On the human drug application review process (see section 736(c)(3) FD&C). In accordance with the statutory process, FDA developed a new CPA methodology and applied it for the first time in setting rates for FY 2021. The implementation of this methodology is described in the Federal Register dated August 3, 2020 (85 FR 46651). ). This methodology involves an iterative, continuous improvement approach in which the agency seeks to refine key audit data and estimates to improve accuracy over time.

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For FY 2023, updated to improve time reporting categories included in CPA. Therefore, the baseline time and capacity reporting data has been adjusted to reflect the improvements. Further updates are expected in the coming years.

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