The U.S. Food and Drug Administration updated its guidance for reporting during the coronavirus pandemic in regards to reporting adverse effects of various products. The announcement addressed how companies should proceed throughout the crisis.
According to the announcement, “This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.”
Companies will have more wiggle room when dealing with “certain required adverse event reports are not submitted to the FDA within the timeframes required by statute and regulation, provided that any delayed reports are submitted within 6 months of the restoration of adverse event reporting processes to their pre-pandemic state.”
The FDA emphasized that while companies may have more leniency in certain areas it is important to remember that, “During a pandemic, normal adverse event reporting processes should be maintained to the maximum extent possible. All adverse event data should be handled using each firm’s usual standard operating procedures, and regulatory and statutory requirements for adverse event reporting should be met to the maximum extent possible.”
Companies that run into problems related to the pandemic such as high rates of employee absenteeism, they should focus their efforts on the following types of reports:
- reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic
- other reports indicated in the guidance
- reports on products presenting special concerns as specified by FDA
While CBD products are not officially listed as health supplements, and may not fall under these rules, many companies are still choosing to follow the guidelines laid out by the FDA. As CBD legislation catches up to the industry, this practice will most likely flow from an appreciated practice to a federal requirement.
