The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFDCA to subject those OTC drugs marketed without an approved NDA or ANDA to OTC drug reporting requirements, which had previously only applied to those OTC drugs with an approved NDA/ANDA. FDA has published a guidance describing relevant policies and procedures for OTC drug reporting, including (1) the minimum data elements that should be included in a serious adverse event report, (2) the label that should be included with the report, (3) reporting formats for paper and electronic submissions, and (4) how and where to submit the reports.
Who: If a company receives a report of a serious adverse event, then the responsible person (the manufacturer, packer, or distributor whose name appears on the label) must submit a report to FDA, along with a copy of the drug label. Also, for a year following the initial report, the responsible person must submit follow-up reports of any new medical information related to the submitted report.
What: To qualify as a serious adverse event, an event must either have one or more of the following patient outcomes or reasonably require medical intervention to prevent them:
- death
- a life-threatening experience
- inpatient hospitalization
- a persistent or significant disability or incapacity
- a congenital anomaly or birth defect
These outcomes are incredibly rare for OTC drugs, because (1) these products are already Generally Recognized as Safe and Effective, and (2) FDA, the healthcare community, and patients are already familiar with these drugs, their ingredients, and their effects.
When: Both the initial serious adverse event report and any follow-up reports with new medical information must be submitted within 15 days from when the company receives them.
How: These mandatory reports must be submitted using FDA Form 3500A.
Why: FDA tracks these events and uses the data collected to understand better how to protect consumers and predict problem areas.
To learn more about serious adverse event reporting or OTC drug regulations, contact us today. We have many years of experience with international drug firms and FDA and Customs import requirements.
