To face the COVID-19 epidemic effects, FDA has published the “Post marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” guideline concerning adverse event management during pandemic (including COVID-19) that replaces the previous 2012 version limited to the flu syndrome.

COVID-19 -  FDA guidelines for adverse event reports during pandemics
COVID-19 – FDA guidelines for adverse event reports during pandemics

In particular, the guideline provides recommendations to companies regarding post-marketing adverse event reports for drugs, organic products, Medical Devices, combination products and food supplement.

FDA objective is to ensure a correct management of the reporting obligations assuming that during the pandemic the organization workforce could be reduced, causing some impediments to the normal adverse event reporting procedures. For this reason, FDA states that some adverse event types only can be reported, in particular:

  • reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic;
  • products answering to particular needs.

If the company is not able to satisfy the adverse event normal requirements during a pandemic, a suitable justification should be properly documented.

When the pandemic will be over, companies will have to get back to standard reporting procedures. In compliance with the Business Continuity Plan (BCP), organizations must submit the relevant reports by six months.

The Department of Health and Health Services (HHS) provides several recommendations that can be consulted on the HealthCare Emergency Preparedness Information Gateway website. In particular, see the guidelines related to Business Continuity Plan development resources, that guarantee to companies working continuity during all phases of the pandemic.