Prior to the COVID-19 pandemic, FDA was struggling to inspect all of the assets in their portfolio and had gotten a lot of pressure from the GAO as a result of the number of “never inspected” facilities in their purview. With the COVID-19 pandemic and the grounding of the inspectorate, FDA needed to resort to different methodologies and alternative tools to provide oversight, including inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing at borders. However, these alternative tools are not foolproof: many foreign establishments that supply the US market are located where foreign regulator reports many not be available, and from March 1 to December 1, 2020, FDA placed 9 foreign establishments on import alert for refusing FDA record requests. There is concern in industry about the long-term consequences of pauses in pre-approval inspections and the subsequent backlog of marketing authorizations as well as the effect of the pause of surveillance inspections. In fact, it has been reported that for OGD, FY 2021 ANDA approvals are on pace for the lowest full year total during the generic drug user fee program’s second 5 year cycle. In addition, from March 2020-March 2021, FDA had 48 application decisions delayed because a facility inspection could not be performed. This situation is obviously not sustainable and has a great impact on all applications at the FDA, and the speed of drugs to market. In this webinar, we will discuss the affect that the COVID 19 pandemic had on FDA inspections, the downstream effects of the pause, and the likely scenarios for recovery.
- Overview of actions during pause in onsite inspections by FDA
- Long term consequences of pause
- Effects on applications that we have seen to date
- Pre-pandemic inspectional initiatives and current status