Adverse events reports generated in DTC campaigns require "minimal information" collection -- PhRMA.

Executive Summary

ADVERSE EVENT REPORTS FROM DTC CAMPAIGNS REQUIRE "MINIMAL INFORMATION" to be collected from consumers by sponsors, the Pharmaceutical Research & Manufacturers of America suggests in a proposed approach to processing adverse event reports from consumers that are medically unconfirmed. When patients report adverse events in response to contacts made as part of a direct-to-consumer campaign, sponsors should collect "patient identification, the product, the adverse experience(s) and the reporter information," the PhRMA proposal states. The proposal was submitted in response to the International Conference on Harmonization draft guidance on periodic safety update reports for marketed products.