What are the Steps to Reporting an Adverse Event to FDA?

By Robert Fish

Each month EAS independent consultants answer one question sent in by readers of EASeNews. This month’s question on adverse events reporting for both OTCs and dietary supplements is answered by Independent Advisor for Quality and Compliance, Robert Fish. Mr. Fish spent 33 years with FDA, including time as the Director, Division of Field Investigations where was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He has expertise in compliance matters and cGMPs as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

Question: What are the steps to reporting an Adverse Event to FDA? 

Fish: In December 2007 the Dietary Supplement and Non-prescription Drug Consumer Protection Act (The Act) became effective. That law required that all over the counter drug and dietary supplement manufacturers and distributors investigate and report to FDA any serious adverse event reports concerning any of their marketed products.

The Act defines an adverse event as any undesirable experience associated with the use of a medical product in a patient. The event is considered serious when the patent outcome is:

  • Death
  • Life-threatening
  • Hospitalization (initial or prolonged)
  • Disability or Permanent Damage
  • Congenital anomaly/birth defect

Other serious (example-required medical or surgical intervention, allergic bronchospasm)

The Act requires that reports of serious adverse events be reported to FDA within 15 business days of receiving the information. The reports are required to submitted using Med Watch Form 3500A.

FDA issued Guidance for Industry concerning this adverse event reporting as well as guidance for completion of the Med Watch 3500A form.

Companies must have procedures in place to screen all complaints for any possible indications of adverse events with the marketed products. Those that meet the definition of serious must be investigated and reported on the Med Watch Form 3500A within 15 business days. Screening of the complaints may require the assistance of medically trained staff.

Once a 3500A has been submitted, update reports can and should be submitted as more information becomes available. 

EAS offers assistance with the completion of 3500A reports as well as assessments of consumer comments and complaints for applicability to this regulation. Contact EAS for more information.

Posted in 2019, 2019 June, Ask the Expert, EASeNews.