In view of potential drug supply interruptions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) recently issued a guidance on procedures drug manufacturers should take to notify the FDA of changes in manufacturing facility operation that could lead to disruptions in drug supplies.
The guidance document, entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, addresses a number of issues, including the following:
When to Notify the FDA: Manufacturers must inform the FDA at least 6 months in advance of a permanent discontinuance, or an interruption in manufacturing that is likely to lead to “meaningful disruption” in supply of a product. If 6-months’ notice is not possible due to unforeseen circumstances, the notification must be submitted as soon as practicable, and no later than 5 business days after the discontinuance or manufacturing interruption.
What Information to Include: Manufacturers should identify the name of the product, as well as the estimated duration of the manufacturing interruption, the name of the distributor, and identify a reason for the shortage.
How to Notify the FDA: Notifications must be submitted electronically in a format that the FDA “can process, review and archive.” The notifications can be submitted by email or to the CDER Direct NextGen Portal. Manufacturers should submit separate notifications for each discontinuance or manufacturing interruption.
Failure to Notify the FDA: If a manufacturer fails to notify the FDA of a discontinuance or shortage, the FDA will issue a noncompliance letter. The manufacturer would be required to respond to such a letter in 30 days, providing a reason for the noncompliance, and submit the required information about the discontinuance or manufacturing interruption.
The FDA notes that it has been closely monitoring the medical supply chain “with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biologic products in the US,” and adds that notifying the FDA according to this guidance will help the agency to prevent or mitigate shortages.
The FDA added that it maintains public lists of drugs and biologics that are subject to shortages. The list includes the name of the product, the reason for the shortage, and the estimated shortage duration, based on information submitted by the manufacturer. This posted information may also include information that the manufacturer makes available to stakeholders and patients about the shortage. The drug shortage information can be found here.