In late February, FDA released a draft guidance titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic,”which has yet to receive much attention. It is a revision of the draft guidance for industry of the same title published on December 16, 2008.
 
A colleague of mine recently mentioned that most businesses have a continuity of operations plan (COOP) in place should a pandemic occur that would maintain basic business functions under such a crisis—however, this plan may not take into account how you continue the business of collecting, maintaining and reporting adverse events during this time period. But as FDA points out in its draft guidance, in the event of a pandemic, a company is not freed from its AER responsibility as required under the law. True, this new guidance document is only a recommendation from FDA and not law, but this point in particular, is something responsible companies should be exploring.
 
Influenza outbreaks that paralyze an entire company are rare. But we have seen bad outbreaks, such as the H1N1 outbreak a few years ago. And for a small company, for example one with only a few employees, I can certainly envision a scenario where this may be a concern. Such an event could have a crippling effect on your business. If something like this were to happen to your company are you prepared and could you satisfy FDA that you are prepared?
 
So what should your plan look like? According to FDA “each firm’s pandemic influenza COOP plan should include instructions for reporting adverse events and provide a plan for the submission of any stored reports not submitted in the regulatory timeframes.” They further recommend that “firms should develop and prepare to implement their COOP in the event that they are not able to fulfill all adverse event reporting requirements because of pandemic-related high employee absenteeism.” What factors should you consider when you putting your plan together? FDA suggests the following:
 
• What activities are directly relevant to the processing and submission of mandatory adverse event reports to FDA?
 
• How would sites based in the United States and abroad be differentially affected by a pandemic?
 
• What are the relative amounts of resources dedicated to mandatory adverse event reporting at each site?
 
Thinking through these considerations may even help you to think about the broader COOP you may need to put in place in the event that a pandemic occurs. Additionally, while the guidance is about absenteeism related to flu pandemics, companies should also consider how it might be useful for other forms of business disruption, including other natural disasters such as earthquakes, tornadoes, and tsunamis.

This draft guidance was announced with little of the same attention that the NDI draft guidance received. CRN and many others have been critical of the Agency regarding the NDI draft guidance, but it is worthwhile to give credit to FDA for encouraging companies to be proactive with regards to managing adverse event reports.
 
In general, it’s important to stay on top of every guidance document issued by FDA because these documents reflect the Agency’s current thinking—something that should be important to every company in our industry. Being prepared is certainly not a bad thing, but being caught unprepared could have pandemic consequences for your company.


Duffy MacKay, N.D., is vice president, scientific and regulatory affairs for the Council for Responsible Nutrition, the dietary supplement industry’s leading trade association.