Drug Development Regulations, New Guidance on Postmarketing Adverse Event Reporting.

Drug Regulators FDA publish New Guidance – Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.

Introduction

This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. In particular, this document gives guidance on (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.

Minimum Elements for an Individual Case Safety Report (ICSR)

The person who first notifies the responsible person about an adverse drug event is the reporter. Reporters can include patients, relatives of patients, consumers, doctors, pharmacists, other health care practitioners, or other individuals.

Reporters convey information on adverse events to the responsible person by various means, including phone, the Internet, fax, e-mail, or regular mail. Based on the information from the reporter and any other information received or obtained on the adverse event, the responsible person completes an ICSR in one of the formats described in section V of this document and submits it to FDA.

The quality of reports of serious adverse events submitted to FDA is critical for appropriate evaluation of the relationship between the product and adverse event(s).

In order for FDA to avoid duplication, interpret significance, facilitate follow-up, and detect fraud, at a minimum, the four data elements listed in the bullets below should be included in any serious adverse event report for an OTC drug product that is marketed without an approved application:

• an identifiable patient
• an identifiable reporter
• a suspect drug
• a serious adverse event or fatal outcome

The responsible person should actively seek information on any minimum data element not initially provided by the reporter. The responsible person should not submit a report on the incident to FDA unless and until each minimum data element is obtained. FDA does not intend to take enforcement action for failure to submit a report for a serious adverse event where, after due diligence, the responsible person is unable to obtain one or more of the four minimum data elements. The responsible person should maintain records of the event information and its efforts to obtain the basic elements for an individual report in its files.

Serious Adverse Event

A serious adverse event, as defined in section 760(a)(3) of the Act, must have one or more of the following patient outcomes or, based on reasonable medical judgment, require a medical or surgical intervention to prevent one of the following patient outcomes:

• death
• a life-threatening experience
• inpatient hospitalization
• a persistent or significant disability or incapacity
• a congenital anomaly or birth defect

The ICSR must be submitted within 15 business days of receipt of the report of the serious adverse event received through the address or phone number on the label (section 760(c)(1) of the Act). The date the responsible person receives the four basic elements (i.e., identifiable patient, identifiable reporter, suspect drug, serious adverse event) is Day 0 of the 15-business-day time clock and should be entered into item G.4 of FDA Form 3500A or its electronic equivalent.

Submitting the Label

Each ICSR of a serious adverse event associated with an OTC drug marketed in the United States without an approved application must be accompanied by a copy of the label on or within the retail package of the drug (see section 760(b)(1) of the Act).

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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