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Pharmaceuticals

HHS Beefs Up Import Safety Strategy

July 14, 2008 | APPEARED IN VOLUME 86, ISSUE 28

In the wake of contaminated heparin blood-thinner drugs and the biggest salmonella outbreak in years, the Department of Health & Human Services has announced two new initiatives to improve the safety of imported medical products and food. The first will focus on active pharmaceutical ingredients. In that pilot project, FDA will collaborate with its counterparts in Australia and the European Union to inspect drug manufacturing facilities. "Scaling up our current inspection strategy won't work. We need a fundamental change in strategy," HHS Secretary Michael Leavitt said at an Import Safety Summit in Washington, D.C., on July 9, where he announced the initiatives. The new collaboration will allow FDA to take advantage of trusted inspection systems in other parts of the world. The second initiative involves the farm-raised shrimp industry. In that program, FDA will assess the use of third-party programs that certify whether foreign processors are in compliance with FDA's seafood regulations. The agency wants to extend third-party certification programs to other areas. "We intend to offer expedited access to those products shown to meet our standards and to focus more of our resources on those products that present higher risks," Leavitt said.

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