A new approach, making better use of limited resources, is being taken as the US Food and Drug Administration (FDA) attempts to deal with rapid globalisation that has seen regulated imports quadruple since 2000.
“There has been a perfect storm – more products, more manufacturers, more countries and more access”, said Margaret Hamburg, commissioner at the FDA. Also, use of excipients and active pharmaceutical ingredients from overseas in US-made drugs “is making the distinction between domestic and imported products obsolete”.
In response the FDA has written a report, Pathway to Global Product Safety and Quality, that says the agency must act globally. To achieve this goal the FDA must implement four strategies:
- Partner with other regulators to form global coalitions
- Work with coalition to develop international data systems and share information
- Leverage the efforts of third-parties and industry to allocate FDA resources based on risk
- Focus on risk analytics by building tools to gather and look at information
As a whole, the strategy aims to combine international coalitions with new investigative tools. Using these tools the FDA will “aggregate and utilise multiple sources of information as inputs to intelligence and regulatory analysis”, said the agency in its report.
“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety. We can no longer rely on historical tools, activities and approaches”, said John Taylor, acting principal deputy commissioner at the FDA.