Drug Safety Budgets Must Be Defended, ROI Measured

New Study Sees Drug Safety and Pharmacovigilance Team Resources Stabilize Around Emerging Benchmarks

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 19, 2010) -  Drug safety and pharmacovigilance teams play a critical role before, during and after a product launch, but are not finding themselves immune to budget and staffing challenges, according to new research.

The new report based on this research, "Benchmarking Drug Safety and Pharmacovigilance," identifies a drug safety spending standard between $300,000 and $600,000 per product covered (more information at http://www.DrugSafetyBenchmarking.com). Companies' responses differed significantly based on their portfolios, spending levels for investigational or postmarketed products, and a host of other variables. However, this optimal range applies to small, mid-size, and large pharmas as well as biotechs, according to study authors at consulting firm Cutting Edge Information.

"Companies don't usually set their budgets on a per-product basis, but we quickly found that breaking the information down this way produced more accurate comparisons across company and product sizes," said Jason Richardson, president and CEO of Cutting Edge Information. "We looked at the weight each company places on different factors in their decision-making process. As the regulatory and scientific challenges of the last decade have become clearer, companies are working out how to structure and fund Drug Safety."

These per-product comparisons are particularly useful because the data also show large discrepancies in surveyed companies' overall drug safety team budgets. Companies reported totals ranging from $100,000 up to $25 million. This spectrum reflects not only product specifications but also variations in the specific responsibilities assigned to teams at different companies. Some company cultures may consider drug safety teams as cost centers. And because drug safety is a necessity, safety teams themselves may never consider ROI a priority.

"Even though more and more organizations are flexing Drug Safety's strategic muscle, it's vital that teams communicate ROI," Richardson said. "Benchmarks provide concrete evidence for decision-making so that teams can defend and increase their resources."

The report includes more than 25 drug companies' data sets, detailing budgets, outsourcing strategies, structure, staffing and critical activities. Besides quantitative metrics, the report contains experts' recommendations for communicating best practices and making the most out of interactions with the FDA. 

For more information, visit http://www.cuttingedgeinfo.com/drug-safety/

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