FDA Responds to Coronavirus Outbreak

On Feb. 14, 2020, FDA detailed the agency’s efforts to address the Novel Coronavirus (COVID-19) situation in the United States and abroad. FDA is taking steps to proactively ensure the health of the drug supply chain as well as working with drug manufacturers and industry partners to develop medicines to treat the virus.

FDA is dedicating resources to identify potential vulnerabilities to the supply chain that may be caused by the COVID-19 outbreak. The agency has been in contact with drug companies and international regulators in order to monitor the supply chain for interruptions. Specifically, the agency is keeping an eye on raw materials manufactured in China. If a disruption in any part of the supply chain occurs, the agency has plans to expedite the review of alternative supplies.

Impact on facility inspections

According to a statement by FDA Commissioner Stephen M. Hahn M.D., FDA inspections of facilities in China are impacted by the State Department travel warning. Travel to China is being evaluated on a case-by-case basis, according to Hahn; therefore, inspections of Chinese facilities may be put on hold. FDA has postponed China facility inspections for the month of February after determining that 90% of the scheduled inspections were for routine surveillance. For-cause inspections have been postponed until FDA can determine which facilities must be inspected. A risk-based model is being used to prioritize these facilities. “…a manufacturing facility that makes sterile injectable drug products will have a higher inherent product risk than a facility that makes oral capsules. As part of our risk-based model, we also consider patient exposure, as the more products a facility manufactures, the more likely a patient is to encounter products made at the facility,” Hahn said in the statement. The agency is also considering factors such as inspection history, product recalls, or quality problems associated with the facility.

Treatment development

As part of the agency’s efforts to expedite potential treatments for the virus, FDA issued an emergency use authorization (EUA) for the use of a diagnostic test that the Centers for Disease Control and Prevention (CDC) developed. An EUA review template was also developed by FDA for tests to detect COVID-19. The EUA template has been shared with more than 50 developers.

“Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers,” said Hahn in a press statement.

Source: FDA