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By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane

The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by consumers when using their products.
Documenting of adverse events has always been part of the record-keeping requirements of the Good Manufacturing Practices (GMP) regulations related to complaint files. However, until passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Actin 2006, the reporting of such events was not required for OTC drug products (unless marketed under NDA or ANDA applications). The FDA subsequently issued two guidance documents to assist firms in complying with the law, the first dealing with reporting requirements and the second addressing labeling.

The law mandates that manufacturers, packers and distributors submit reports of serious adverse events received on their OTC products to the FDA. Serious adverse events are defined as those that:

  • Result in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
  • Require, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

To facilitate the reporting of these events by consumers, the law requires that OTC drug labeling includes a domestic telephone number or complete domestic address through which a “responsible person” may receive the report. It is essential that this designated person has the necessary training and/or experience. While larger firms often employ health care professionals, this may not be feasible for smaller companies. In these cases, a standardized questionnaire should be developed to ensure that all relevant information is obtained to determine if an event is “serious” and therefore reportable.

In addition, it has become clear through recent FDA warning letters that company and/or product websites are considered an extension of labeling, so firms should monitor posts and comments received through these and other social media platforms. This presents a challenge in that these posts may lack sufficient detail to adequately complete Individual Case Safety Reports (ICSRs) required as part of the submissions – and there may be privacy concerns. However, companies should make good faith efforts to follow-up with the consumer if possible.

As of June 2015, all serious adverse event reports received on OTC drug products must be submitted to the agency through FDA’s Adverse Events Reporting System (FAERS) in electronic format using either a Database to Database Transmission or through the FDA’s Safety Reporting Portal. Additional information is available both on the FAERS website and in a draft guidance document issued in 2014.

When completing the electronic ICSRs, firms should follow good pharmacovigilance practices and include the four basic data elements: information about (1) the patient, (2) the suspected product, (3) the adverse event details and (4) the reporter (if different from patient). The format and content of such reports are completed using the Medical Dictionary for Regulatory Activities (MedDRA), a medical terminology standard developed by the International Council for Harmonization for coding the medical terminology used in the report.

The law requires that serious adverse event reports are submitted to the agency within 15 business days of receipt of the four data elements. The submission should include a copy of the product label, preferably the version associated with the product used by the consumer/patient. In addition, if any new medical information is subsequently received that relates to the initial event, this should also be submitted within 15 days.

With the widespread use of OTC drugs, the reporting of these serious adverse events is a crucial step in monitoring their safety. Manufacturers, packers and distributors should develop procedures and programs to ensure that this regulatory obligation is managed competently and efficiently to assist the FDA in its mission to protect public health.

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