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FDA Chief to Delay Reforming Regulatory Affairs

August 24, 2007

The FDA will delay reforms to its Office of Regulatory Affairs (ORA) until a working group completes its assessment of import safety, agency Commissioner Andrew von Eschenbach recently said.

Von Eschenbach had been planning to “recast our strategy in how we address our products,” he said. However, he has suspended the ORA transformation efforts until after a working group, created July 18 by executive order from the president, submits a report.

HHS Secretary Michael Leavitt, chair of the Working Group on Import Safety, has decided to focus the group on imported drugs, medical devices and food, according to von Eschenbach. The group will issue a report with recommendations on how to ensure the safety of imported products within 60 days, von Eschenbach said, adding that Leavitt has already begun a series of meetings on the matter.

Von Eschenbach accompanied Leavitt to some of the meetings and said he has already talked with people in the field about what tools they need to inspect drugs and devices coming into the country. He said he would like to improve technology to create a more standard, unified system for inspections. The FDA will “wait and benefit” from what will come out of the working group’s investigation, he said.

The agency will need to hire more inspectors in a strategic way, focusing on where they need to go, what they should inspect and what tools they need, von Eschenbach added.