US Congress is concerned about FDA Inspection Backlog

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

In a letter sent directly to Janet Woodcock, Acting Commissioner, US Food and Drug Administration (FDA), the Congress of the United States, House of Representatives (Committee on Energy and Commerce) expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.

For the authors, "the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear". Furthermore, it is not clear how delayed inspections will impact drug applications and approvals.

Given these concerns, the authors ask some inspection related questions and expect responses within a timeframe of two weeks. These questions also attempt to collect concrete data that has not yet been published. These include for example:

• Number of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) with response letters citing a "deficiency in the application related to FDA's inability to conduct a preapproval inspection, a surveillance inspection, or a requested re-inspection of a facility following a notice of Official Action Indicated (OAI)".
• For how many pending NDAs, ANDAs, or BLAs, FDA needs to inspect a facility before the application can be approved?
• Has FDA conducted an analysis to determine how delayed inspections may impact the agency's ability to make drug approval decisions in the future?
• To what extent does FDA use inspection reports and additional  information from other inspectorates, especially from states with which an MRA exists?

Overall the authors want to know how long it will take, "after a return to standard operations for both domestic and foreign inspections, to resolve the inspections backlog caused by the pause in inspections during the COVID-19 pandemic?"