How are FDA Inspections and Applications impacted by COVID-19 Restrictions?

The US Food and Drug Administration FDA recently announced that the agency is starting with on-site inspections based on a COVID-19 Advisory Rating system (COVID-19 Advisory Level). This rating system "uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data".

However many question remained open with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. The FDA has now published a Questions and Answers document as Guidance for Industry called "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency". The questions and answers "are intended to provide information regarding common queries" related to the topics mentioned above.

How are FDA-Inspections impacted by COVID-19?

Because of the COVID-19 pandemic, the FDA has temporarily postponed domestic and foreign routine surveillance facility inspections. With respect to pre-approval inspections, FDA intended "to continue using other tools and approaches where possible, including requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements, requesting information from applicants, and requesting records and other information directly from facilities and other inspected entities".
In July, FDA started resuming domestic inspections with the new risk assessment system. The authority will pre-announce these inspections. FDA investigators will also be "outfitted with personal protective equipment and equipped with other necessary equipment to carry out their work".

Foreign inspections: "Foreign pre-approval and for-cause inspection assignments that are not deemed mission-critical remain temporarily postponed, while those deemed mission-critical will still be considered for inspection on a case-by-case basis."

The document further explains what FDA deems as "mission-critical" and how it will ensure the quality of imported products while inspections are limited.

How will limited inspection activities affect applications?

The FDA states that they are "using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA's ability to inspect due to COVID-19." Examples:

• FDA will continue the quality assessment of all applications per normal assessment operations (using a risk-based approach)
• Additional tools will be used wherever possible (review of the compliance history, using shared information from other foreign agencies, requesting records "in advance of or in lieu of" facility inspections).
• FDA will continue to work directly with the applicants and encourages those "to be in communication with all their facilities and sites to ensure timely responses to any inquiries".

Important! The FDA will not automatically send out a complete response letter to the applicant if an inspection cannot be conducted. "Decisions regarding applications will be based on the totality of the information available to FDA", this includes information obtained from use of the tools described above. Further details can be found in the document.

This guidance document is being implemented immediately and implemented without prior public comment. However "comments may be submitted at any time for Agency consideration".