Recent surveys by Cutting Edge Information found that the majority of drug safety budgets grew between 2012 and 2013, and are projected to continue growth for 2014.
The research for the study, "Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting," found that among surveyed Top 20 pharmaceutical companies, only 14% project a decrease in budgets while 57% project an increase. Surveyed Top 50 companies are more optimistic, with 67% predicting an increase in budgets and the remaining 33% expecting no funding changes going into 2014. Among small companies, 18% project a decrease in drug safety budgets and 45% expect budgets to increase; the remaining 36% expect no change.
The data revealed an average percentage of budget change expected among surveyed company types between 2013 and 2014. Top 20 and small companies project a 5% increase and Top 20 affiliates and Top 50 companies expect an 8% increase on average, reflecting the growth of drug safety functions across the board.
A number of factors are driving drug safety's growing profile. One interviewed biopharmaceutical company manager cites the increased legislation for high-risk drugs as a major factor in driving up drug safety costs and budgets. As an interviewed small company's senior vice president explained, "If you had the same company with the same products five years ago, your costs would be much lower than today. Safety regulation laws have changed tremendously." Other companies are focused on developing a successful drug safety team, which requires a substantial investment. Once a successful team has been established, then the operation is able to scale well to accommodate more products, according to another director. Once the pharmacovigilance group's processes and SOPs are in place, expansion within the company is easier to handle.
The data in "Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting" (http://www.cuttingedgeinfo.com/research/regulatory/drug-safety/) are designed to assist in companies' drug safety efforts and elevate pharmacovigilance teams' strategic impact through well-defined standard operating procedures and social media tools. Pharmacovigilance teams can use this report to:
Optimize drug safety budgets and outsourced spending.
Build a strong team and cultivate a drug safety culture companywide.
Improve efficiency and implement best-in-class practices.