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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 and annual performance reports 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), 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

As a result of utilizing these alternative approaches, CDER completed facility assessments to meet UFA dates by reducing the need to conduct PAIs 58% of the time in FY2020 Q3, 64% of the time in FY2020 Q4, 56% of the time in FY2021 Q1, and 48% of the time in FY2021 Q2. FDA has also enhanced use of sampling and testing drugs being marketed.

In addition to this inspection data, the tables below show:

  1. Percentage of applications acted on during the fiscal year by quarter, on or before their user fee goal date
  2. Number of ANDA originals and supplements, as well as NDA/BLA manufacturing supplements, approved for drugs used in the treatment of patients with COVID-19

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

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)
Prescription Drug User Fee Act (PDUFA)
Original Applications2 98% 94% 93% 93%
Efficacy Supplements2 100% 94% 95% 97%
Manufacturing Supplements 99% 97% 98% 97%
   
Generic Drug User Fee Amendments (GDUFA)
Original Applications 94% 93% 91% 89%3
Original Applications with Imminent Approval 98% 96% 94% Will be provided during the next quarterly update4
Prior Approval Supplements 99% 96% 99% 95%
PAS with Imminent Approval 99% 97% 99% Will be provided during the next quarterly update4
   
Biosimilar User Fee Act (BsUFA)
Original Biosimilar Product Applications2 100% 75% 67% No actions taken this quarter
Supplements with Clinical Data2 100% 100% 100% 100%
Manufacturing Supplements 100% 95% 94% 93%

Number of ANDA originals and supplements, as well as NDA/BLA manufacturing supplements, approved for drugs used in the treatment of patients with COVID-195

Fiscal Year 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)
ANDA Originals 17 14 18 8
Supplements 314 277 149 176

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. Imminent Approval data will be incorporated into the Q2 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.
  4. 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.
  5. 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. Please visit COVID-19 Frequently Asked Questions for Information about medical products approved for the treatment of COVID-19.
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