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  1. FDA User Fee Programs

CDER’s Work to Meet User Fee Goals During the Pandemic

On January 31, 2020, the Secretary of Health and Human Services declared a public health emergency related to COVID-19, effective as of January 27, 2020. One of the challenges facing FDA during the public health emergency is how to ensure timely reviews of applications for drugs and biological products despite a surge in work volume and practical constraints, such as travel limitations, quarantine and social distancing requirements or lockdowns. Americans depend on the agency to review and, when they meet our high scientific standards, approve medical products that are important to patients and health care professionals.

A key way FDA meets its mandate is through user fee programs. These statutory programs authorize FDA to assess and collect fees from companies that produce certain medical products, including drugs and biological products. FDA has generally committed to reviewing 90% of applications for specified drug and biological products within the timeframes we have agreed to in user fee negotiations with industry. As we focus on fighting the pandemic on multiple fronts, we still prioritize meeting our user fee commitments while maintaining our high standards and responsibility to the public health and the safety of our staff.

Additional information on the user fee commitments is available below:

The purpose of this webpage is to provide periodic updates on key metrics related to application review and the pre-approval process throughout the pandemic. The data presented below only reflects CDER data and includes all actions due during the specified timeframe, regardless of receipt date. This differs from FDA’s annual Congressional performance reports where performance is based on the fiscal year of receipt, and includes CDER and Center for Biologics Evaluation and Research (CBER) data.

CDER Inspections during COVID-19

As we evaluate and inspect manufacturing facilities, we maintain our rigorous review standards, while ensuring the health, safety and well-being of our investigators. We continue to use a risk-based approach to identify the need for pre-approval inspections (PAIs) and pre-license inspections (PLIs), as described in the Preapproval Inspections Compliance Program, since only a subset of application reviews (historically around 20%) warrant pre-approval inspections. We also continue to conduct mission-critical inspections of domestic and foreign manufacturing facilities to help assure compliance with our high standards for quality. Similarly, for the Bioresearch Monitoring program, pre-approval and for-cause assignments deemed mission-critical are being considered for on-site inspection on a case-by-case basis.

While continuing to conduct mission-critical and prioritized inspections, due to practical constraints, such as travel limitations, quarantine and social distancing requirements or lockdowns, we have been increasingly relying on alternative approaches to inspections including:

  • Reviewing the inspection history of facilities to assess feasibility of relying on records or trusted partner inspections
  • Using information shared by trusted foreign regulatory partners
  • Requesting records directly from facilities in lieu of drug and biological product inspections
  • Performing remote interactive evaluations in which we remotely evaluate livestreamed video of facility operations and engage in other remote, live interactions with facility operators

FDA has also enhanced use of sampling and testing of drugs being marketed. As a result of utilizing alternative approaches to facility assessment and oversight, CDER continues to complete application assessments to meet UFA dates without compromising the high standards for quality. 

The tables below show the following:

  1. Reduction of facilities needing pre-approval inspections (PAIs) and pre-license inspections (PLIs) by utilizing alternative approaches
  2. Percentage of applications acted on during the fiscal year by quarter, on or before their user fee goal date
  3. Number of abbreviated new drug application (ANDA) originals and ANDA, new drug application (NDA), and biologics license application (BLA) manufacturing supplements, approved for drugs and biologics used in the treatment of patients with COVID-19

Reduction of facilities needing pre-approval inspections (PAIs) and pre-license inspections (PLIs) by utilizing alternative approaches

Fiscal Year (FY) Quarter FY20 Q3
(4/1/2020 – 6/30/2020)
FY20 Q4
(7/1/2020 – 9/30/2020)
FY21 Q1
(10/1/2020 – 12/31/2020)
FY21 Q2
(1/1/2021 – 3/31/2021)
FY21 Q3
(4/1/2021 – 6/30/2021)
FY21 Q4
(7/1/2021 – 9/30/2021)
FY22 Q1
(10/1/2021 – 12/31/2021)
FY22 Q2
(1/1/2022 – 3/31/2022)
FY22 Q3
(4/1/2022 – 6/30/2022)

Reduction in Facilities Needing PAIs/PLIs

59%

64%

56%

51%

56%

53%

40%

43%

32%

Percentage of applications acted on during the fiscal year by quarter, on or before their user fee goal date1

Prescription Drug User Fee Act (PDUFA)
Fiscal Year (FY) Quarter FY20 Q3
(4/1/2020 – 6/30/2020)
FY20 Q4
(7/1/2020 – 9/30/2020)
FY21 Q1
(10/1/2020 – 12/31/2020)
FY21 Q2
(1/1/2021 – 3/31/2021)
FY21 Q3
(4/1/2021 – 6/30/2021)
FY21 Q4
(7/1/2021 – 9/30/2021)
FY22 Q1
(10/1/2021 – 12/31/2021)
FY22 Q2
(1/1/2022 – 3/31/2022)
FY22 Q3
(4/1/2022 – 6/30/2022)
Original Applications2 98% 94% 93% 93% 91% 92% 95% 93% 96%
Efficacy Supplements2 100% 94% 95% 97% 92% 90% 90% 91% 98%
Manufacturing Supplements 99% 97% 98% 97% 99% 97% 96% 97% 97%
Generic Drug User Fee Amendments (GDUFA)
Fiscal Year (FY) Quarter FY20 Q3
(4/1/2020 – 6/30/2020)
FY20 Q4
(7/1/2020 – 9/30/2020)
FY21 Q1
(10/1/2020 – 12/31/2020)
FY21 Q2
(1/1/2021 – 3/31/2021)
FY21 Q3
(4/1/2021 – 6/30/2021)
FY21 Q4
(7/1/2021 – 9/30/2021)
FY22 Q1
(10/1/2021 – 12/31/2021)
FY22 Q2
(1/1/2022 – 3/31/2022)
FY22 Q3
(4/1/2022 – 6/30/2022)
Original Applications 94% 93% 91% 89% 90% 94% 88% 90% 88%*
Original Applications with Imminent Approval3 98% 96% 94% 92% 94% 96% 93% 93% Will be provided during the next quarterly update3
Prior Approval Supplements (PAS) 99% 96% 99% 95% 97% 93% 94% 97% 96%
PAS with Imminent Approval 99% 97% 99% 96% 97% 93% 95% 98% Will be provided during the next quarterly update3
Biosimilar User Fee Act (BsUFA)
Fiscal Year (FY) Quarter FY20 Q3
(4/1/2020 – 6/30/2020)
FY20 Q4
(7/1/2020 – 9/30/2020)
FY21 Q1
(10/1/2020 – 12/31/2020)
FY21 Q2
(1/1/2021 – 3/31/2021)
FY21 Q3
(4/1/2021 – 6/30/2021)
FY21 Q4
(7/1/2021 – 9/30/2021)
FY22 Q1
(10/1/2021 – 12/31/2021)
FY22 Q2
(1/1/2022 – 3/31/2022)
FY22 Q3
(4/1/2022 – 6/30/2022)
Original Biosimilar Product Applications2 100% 75% 67% No actions taken this quarter 100% 67% 100% 100% 67%
Supplements with Clinical Data2 100% 100% 100% 100% No actions taken this quarter 100% 100% 100% 100%
Manufacturing Supplements 100% 95% 94% 93% 100% 100% 96% 100% 83%

Number of ANDA originals and supplements, as well as NDA/BLA manufacturing supplements, approved for drugs used in the treatment of patients with COVID-194

Fiscal Year (FY) Quarter FY20 Q3
(4/1/2020 – 6/30/2020)
FY20 Q4
(7/1/2020 – 9/30/2020)
FY21 Q1
(10/1/2020 – 12/31/2020)
FY21 Q2
(1/1/2021 – 3/31/2021)
FY21 Q3
(4/1/2021 – 6/30/2021)
FY21 Q4
(7/1/2021 – 9/30/2021)
FY22 Q1
(10/1/2021 – 12/31/2021)
FY22 Q2
(1/1/2022 – 3/31/2022)
FY22 Q3
(4/1/2022 – 6/30/2022)
ANDA Originals 17 14 18 8 7 4 9 7 10
Supplements 314 277 149 176 215 135 144 167 140

Resources


1 This metric only contains CDER data and will not match the FDA Annual Performance Reports, which also include CBER data, and uses different methodology for data calculations.
2 Includes applications that were resubmitted.
3 Performance adjusted for imminent approval or tentative approval. Under the Generic Drug User Fee Amendments, FDA classifies an action as an imminent approval or tentative approval action if it is taken within 60 days of the original goal date.
4 Drugs and biologics determined by the FDA to be regularly used in the treatment of patients with COVID-19, not necessarily treatments for COVID-19. 
* Imminent approval data will be incorporated into this metric with next quarter’s webpage updates, and the preliminary results indicate this metric will exceed the 90% metric for original applications when imminent approvals are included.

 
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