FDA Provides Guidance: Notifying FDA of a Permanent Discontinuation or Interruption in Manufacturing
Posted: April 1, 2020
FDA has published a Level 1 guidance document titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act”. The requirement for reporting was included in FDASIA in 2012 so has been in effect for several years but this final guidance was just published (in late March 2020) without the opportunity for comment as a result of COVID-19.
The following is taken from the summary contained on the FDA website:
“Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug products in the U.S. This guidance is intended to help manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs. In urging the submission of these notifications, the guidance may assist in FDA’s efforts to prevent or gate shortages of such products, including under circumstances outside of the COVID-19 public health emergency.
This information will allow FDA to better assess the specific situation and identify appropriate tools to help prevent or mitigate shortages of these products.
The guidance describes the requirement under section 506C of the FD&C Act and FDA’s implementing regulations that manufacturers notify FDA of an interruption in the manufacture of certain drugs that is likely to lead to a meaningful disruption in the supply of such products in the U.S., and the reasons for such interruption.
The products covered by the notification requirement are prescription drugs that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such product used in emergency medical care or during surgery. The guidance also recommends that manufacturers provide FDA with additional details and follow additional procedures to assist the agency in its efforts to prevent and mitigate shortages.
The guidance reiterates the requirements under section 506C of the FD&C Act and FDA’s implementing regulations concerning the timing and circumstances under which manufacturers must notify FDA regarding changes in the production of certain drugs. The guidance recommends that after initial notification of an interruption in manufacturing, manufacturers should provide updates every two weeks until the situation is resolved.
The guidance includes a list of questions for manufacturers to consider when notifying FDA that may yield information that would help FDA determine appropriate steps to help prevent or mitigate a shortage. These questions cover such issues as manufacturers’ estimated market share, their historic volume of sales, the availability of current inventory and emergency supply, and ways they think FDA can help to prevent a supply disruption.”
CGA is interacting with FDA regarding the pandemic, and because of the uniqueness of medical gases with what CGA terms “original manufacturers” and “subsequent manufacturers”, we respectfully request that members advise CGA (either Rich Craig or John Willenbrock) if you will be reporting a shortage to FDA so we are not caught by surprise should FDA contact us. All information will be kept confidential.
During discussions with FDA on March 26, CGA advised FDA that all of our members are engaged in the development of contingency plans. We impressed upon them that we have handled natural disasters in the past as an industry, working together in support of each other, however this nationwide pandemic may bring with it issues previously not experienced. We also discussed with them our interactions with DHS/FEMA and DOT.
We have also had similar conversations with Health Canada on the topic of shortages and proper notifications.
Please contact CGA’s John Willenbrock, if you have any questions, comments, or concerns.