Import Safety Pilot Casts Global Net For Inspecting Drug Manufacturers
This article was originally published in The Tan Sheet
Executive Summary
The U.S. is launching a pilot program with Australia and the European Union to "spread our inspection net wider" for drug manufacturing facilities, according to Health and Human Services Secretary Michael Leavitt
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The U.S. is launching a pilot program with Australia and the European Union to "spread our inspection net wider" for drug manufacturing facilities, according to Health and Human Services Secretary Michael Leavitt. FDA will "work more closely with foreign regulators who have systems of inspection and regulation that we trust" to "jointly plan, jointly allocate and jointly conduct international pharmaceutical inspections," Leavitt said at an import safety summit July 9 in Washington (1 (Also see "Import Safety Summit Has Room At The Table For Many Stakeholders" - Pink Sheet, 7 Jul, 2008.), p. 11). The initiative will begin with inspections of active drug ingredients, because "these are the starting points of the problems with many medications that we all use," he explained. HHS also announced a third-party certification program concerning farm-raised shrimp as a pilot project in an FDA program (see story this page). If successful, the inspection pilot could expand to include other types of manufacturing facilities, according to HHS. The department did not say when it will evaluate the pilot. Australia, the EU and the U.S. will split inspection responsibilities and share their results, but each will make independent policy decisions based on the information gathered. The current system results in "great redundancy as several countries inspect the same plants for essentially the same things," Leavitt said. In the collaboration, however, FDA, EU and Australia will each inspect some of the facilities. "Facilities will be inspected more often and [FDA] can focus more resources on those products that present particularly high risks," Leavitt said. FDA says it does not have the resources to inspect all facilities that manufacture foods and drugs imported to the U.S. Instead, under its Food Protection Plan, FDA will inspect facilities based on risk (2 (Also see "FDA Right On Risk Approach, Slow On Food Protection Progress – GAO" - Pink Sheet, 16 Jun, 2008.), p. 14). The pilot is a fundamental shift in how FDA and regulators ensure product safety in an industry that increasingly relies on imported goods, Leavitt said. The initiative moves the agency closer to implementing the Bush administration's Interagency Import Safety 3 Action Plan finalized last November (4 (Also see "Mandatory Food Recall Power For FDA Better Than Using Existing Authorities?" - Pink Sheet, 12 Nov, 2007.), p. 6). It also moves FDA away from traditional border inspections, which are more expensive, less effective and slow the process of making products available to consumers, Leavitt explained. - Elizabeth Crawford ([email protected]) |