FDA outlines strategy for global regulation

FDA highlighted the importance of partnerships with its foreign counterparts as a key element in a plan announced this week to address regulating products created by an increasingly global supply chain. The strategy, which came in a report published on Monday, highlights the need for a "global coalitions of regulators" to establish international systems in order to share information and resources. Additionally, the agency said it will focus on risk analytics and modernization of its IT capabilities, as well as allocating agency resources based on risk.

The report notes that FDA doesn't have the resources to keep pace with the pressures of globalization -- at current funding and staffing levels, it would take the agency nine years to inspect every high-priority pharmaceutical facility once. The agency did not define what constitutes a high-priority facility. Instead, FDA Commissioner Margaret Hamburg said the agency must collaborate and develop private and public partnerships to close the gap between the agency's regulatory resources and import levels. In a conference call to discuss the pathway, Hamburg added that the agency's strategy will require upfront investments but in the long run would enable FDA to use fewer resources to regulate the supply chain for drugs. ...