FDA Plans to Extend Its Global Regulatory Reach

June 20, 2011 — The US Food and Drug Administration (FDA) plans to take a more global approach to ensure the safety and quality of regulated drugs and medical devices, the agency's commissioner announced during a media briefing today.

One prong of the new 4-pronged approach will involve partnering with counterparts worldwide and creating global coalitions of regulators intent on ensuring and improving global product safety and quality, said FDA Commissioner Margaret Hamburg, MD.

"This is a long-term strategy," Dr. Hamburg said. "It cannot be accomplished immediately and will probably take many years to implement, depending upon resources."

One part of the new approach will mean regulators no longer regard borders the same way. "The border can no longer be the nation's primary line of defense against unsafe imported products," she said. "Instead, the border must serve as a final checkpoint on preventive controls throughout the supply chain."

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