Pharmacovigilance benchmarking report highlights pharma’s drug safety efforts

Per-product spending can top $2.5 million, finds Cutting Edge Information


With Risk Evaluation and Mitigation Strategies (REMS) and other regulatory requirements taking effect, drug safety is becoming an expensive undertaking for pharma companies. A new study by Cutting Edge Information finds the largest pharma companies spend an average of $16 million per year on pharmacovigilance, with the vast majority of that spending taking place in the United States. Mid-size companies spend an average of $2.9 million a year, while small companies and biotechs spend $1.6 million and $1.1 million respectively.

The report, “Benchmarking Drug Safety and Pharmacovigilance,” combines quantitative data and qualitative research from drug safety employees at 30 pharma companies of various sizes. Analysts divided participating firms into four categories—large, mid-size, small, biotech.

Case management, including adverse event reporting, takes up the largest chunk of the budget in mid-size companies (48%) and small companies (40%). In large companies, case management and risk mitigation strategy (REMS) have an equal budget allocation (16%). In biotechs, filing regulatory documents takes the biggest chunk of the budget at 23%.

Not all companies surveyed operate an in-house drug safety department. About 14% (mostly small and biotech companies without a marketed drug) rely solely on drug safety vendors. On average, nearly two-thirds of responding companies choose to outsource some portion of their drug safety budgets, with 100% of small, 83% of mid-size, 44% of large and 77% of biotech companies outsourcing some portion.

Eighty percent of companies ask vendors to work with post-marketed products, and case management is the activity outsourced the most, at 57%. Outsourcing this activity “added a layer of objectivity to the drug safety process,” noted one company participating in the Cutting Edge Information survey.

As for REMS, the majority of that work is performed in-house across all company sizes, with 78% of large, 100% of mid-size and 50% of small and 33% of biotech companies performing REMS activities internally.