Drug Industry Daily

FDA Investigates Global Recall System as Part of International Pivot

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SEATTLE — The FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls.

The move toward a global system, currently in its early stages, would help address fast-growing gaps in global oversight of international product recalls, Mark Roh, regional food and drug director for the FDA’s Pacific Region, said.

The agency can no longer be “the quality control unit at the border that we have been for so long,” he said. Under the global approach being considered, the FDA and its foreign counterparts would jointly determine which country will take the lead in working with a company on a given recall, and the recall would extend to all countries.

The evolution is critical to the safety of the supply of medicines in the U.S., Roh said, since U.S. imports of FDA-regulated products could triple by 2015. Roh spoke at the Regulatory Affairs Professionals Society’s 2012 conference.

The effort is also intended to bolster the FDA’s transformation into an explicitly international organization; it grew out of the agency’s 2011 supply chain initiative, designed to foster partnerships with key foreign counterparts (DID, June 21, 2011).

Establishing the new system will likely require revoking or rescinding existing recall procedures and replacing them with new guidance documents. New legislative authorities would also be required to enable use of third-party assistance in global recalls. As a first step, Roh said the OIP is assessing the agency’s own ability to manage the transformation of the recall system and whether all parts of the agency support the change. After that, the FDA would begin evaluating the mechanisms needed to begin working with foreign partners.

The FDA’s charge to OIP to explore these possibilities comes as the Office of Regulatory Affairs (ORA) is being restructured to keep up with increasingly global operations (DID, Sept. 20). OIP and ORA together make up the larger Office of Global Regulatory Operations and Policy. — Johnathan Rickman