FDA Takes Calculated Approach to Auditing during COVID-19

Although inspections are critical, according to US Food and Drug Administration Commissioner Stephen M. Hahn, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products. “Safety and quality must be part of the daily routine at a firm for their products to be high quality and reliably suitable for the US consumer,” he explained in previous press statements from the FDA press office.

Under normal circumstances, the agency uses risk-based models to identify firms for inspection. FDA prioritizes for inspection facilities deemed as higher-risk based on specific, defined criteria. For drug and device inspections, these criteria can include inherent product risk. To supplement inspections, FDA also uses a number of other tools, including denying entry of unsafe products into the United States; physical examinations and/or product sampling at US borders; reviewing a firm’s previous compliance history; using information sharing from foreign governments as part of mutual recognition and confidentiality agreements; and requesting records “in advance of or in lieu of” on-site drug inspections.

Furthermore, FDA will conduct inspections when a potential risk to public health is detected, and the agency has remained in contact with domestic and foreign regulatory counterparts to identify emerging risks in the medical products and food supply systems, according to an FDA spokesperson. “When we suspended routine operations, mission critical inspections were conducted for products deemed as mission critical drugs because of reasons including medical necessity, drugs for which there is a shortage, and pre-approval inspections for novel drugs or drugs related to the potential treatment of COVID-19,” says the spokesperson.

Both for-cause and pre-approval inspections can be deemed mission critical. They are identified on a case-by-case basis by the agency and conducted with appropriate safety measures in place.

Where routine domestic and foreign surveillance inspections have been postponed during the COVID-19 pandemic, FDA has used and implemented additional alternative approaches and records reviews, including, among other things, when appropriate evaluating records in lieu of conducting certain onsite inspections on an interim basis when travel is not permissible, according to an FDA spokesperson. The agency’s labs also continue to analyze high-priority samples.

“The resumption of prioritized domestic surveillance inspections has been an important area of focus for us,” the FDA spokesperson observes. As of July 10, 2020, FDA was working toward the goal of restarting routine on-site domestic inspections during the week of July 20. Resuming prioritized domestic inspections is, however, dependent on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments, according to whom. “In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area,” noted Hahn in an FDA statement.

Preparation for restarting on-site prioritized domestic inspections involves using the tools available while considering other factors including the operational status of the facility, the ability for the appropriate investigator to travel, evolving local, state, and federal requirements, and updates to Centers for Disease Control (CDC) guidance. “We are using a newly developed risk assessment system to help it, and individual states make informed risk-based decisions on when and where to resume prioritized domestic surveillance inspections,” says the FDA spokesperson.

In addition, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses to help assure the safety of the investigator and the firm’s employees. This approach will provide for the “safest possible environment to accomplish our regulatory activities while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities,” Hahn says.