Measuring Drug Safety ROI Is Difficult, but Feasible

Drug Safety and Pharmacovigilance Teams Rarely, If Ever, Fully Communicate Their Value to the Larger Organization, Finds Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - June 17, 2010) -  Communicating return on investment (ROI) is a low priority for many drug safety and pharmacovigilance teams, says life sciences consulting firm Cutting Edge Information.

Drug safety teams are necessary to ensure that products are safe and side effects are known and monitored. Nevertheless, drug safety and pharmacovigilance teams are not immune to the budget and staff cuts that drug manufacturers have experienced recently.

"When companies cut drug safety resources, they increase their exposure to risk, and that's a dangerous game to play," said Jason Richardson, president of Cutting Edge Information ( "While proving hard ROI may not be easy in terms of traditional calculations, it is critical for these teams to establish a process for communicating their value internally and externally."

Cutting Edge Information's study "Benchmarking Drug Safety and Pharmacovigilance" ( stems from surveys and interviews with life science executives from more than 40 companies. The report contains best practices, strategies and benchmarks for drug safety, pharmacovigilance and risk management teams.

One executive said he is aware that his team's efforts "appear primarily as an expense" and that no income is generated directly from drug safety activities. But the team believes in its role to the company and communicates its value as much as possible.

An effective way to present the drug safety team's value is to draw upon other companies' missteps. Citing examples of competitors' drugs that have been pulled from the market due to missed risk can go a long way in convincing drug safety stakeholders of the function's value.

Companies can also draw on their own drug safety management successes. Showing how drug safety efforts allow the company to continue marketing drugs that hold a documented level of risk can be a powerful economic argument. These teams use sound risk mitigation strategies that satisfy the needs of regulatory authorities and reduce the risk to the public. At the same time, these products continue to generate revenue because of the drug safety plans put in place.

For more information on best practices in drug safety and pharmacovigilance, visit

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Stephanie Swanson