Report Finds Drug Safety Budgets on the Rise in 2014

Recent surveys conducted by pharmaceutical business research firm Cutting Edge Information point to a continued rise in pharma companies’ drug safety budgets in 2014.

Cutting Edge says that 57 percent of Top 20 pharmaceutical companies are seeing an increase their pharmacovigilance budgets  of approximately 5 percent: from $12.5 million in 2013 to $13.1 million this year. At the same time, 67 percent of Top 50 companies expect their safety budgets to grow by 8 percent. Among small drugmakers, 18 percent said their spending on safety will go up 5 percent.

The report cites recent drug safety legislation as having been a primary factor in the budget boosts. An EU pharmacovigilance law passed in 2011, for example, mandates increased monitoring of drugs’ benefits and risks and allows the European Medicines Agency to require postmarketing safety and efficacy studies that some in industry claim will cost companies up to US $33,000. And under a pilot program launched this month to promote transparency, the EU is publishing drugmakers’ risk-management plans for approved drugs.

Meanwhile, the FDA has recently begun implementing track-and-trace legislation, requiring serial numbers on every lot of every drug distributed in the U.S. The FDA and EMA also are working to better coordinate their responses to drug safety problems.

The heightened regulatory oversight is driving some companies to acquire new technology and develop drug safety teams, complete with pharmacovigilance processes and standard operating procedures, Cutting Edge says. — Lena Freund

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