FDA Suspends ORA Reforms and Field Laboratory Closures

August 9, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Commissioner Andrew von Eschenbach announced that the US Food and Drug Administration will not reform its Office of Regulatory Affairs until the Working Group on Import Safety finalizes its report evaluating import safety, according to the FDA News Drug Daily Bulletin.

Rockville, MD (Aug. 3)-Commissioner Andrew von Eschenbach announced that the US Food and Drug Administration will not reform its Office of Regulatory Affairs until the Working Group on Import Safety finalizes its report evaluating import safety, according to the FDA News Drug Daily Bulletin.

Secretary Michael Leavitt of the US Department of Health and Human Services heads the working group, which was established on July 18, 2007 by executive order from the President. Von Eschenbach says the group will focus its attention on imported drugs, medical devices, and food. Within 60 days, the group is supposed to issue a set of recommendations to ensure the safety of imported products.

Leavitt has begun to hold meetings to prepare the report, and von Eschenbach attended some of the meetings. In addition, von Eschenbach has met with field agents to discuss what tools they need to inspect imported drugs and devices. He stated that FDA will need to hire more inspectors for certain locations. Von Eschenbach also aims to improve technology and standardize the agency’s system for inspections.

Reflecting von Eschenbach’s desire to re-evaluate FDA’s advisory committee process, the agency’s Office of Integrity and Accountability is examining when the agency decides to schedule advisory committee meetings, who serves on the committees, how FDA manages the committees, and how the committees can reflect diverse opinions.

In related news, von Eschenbach is also waiting for the working group report to be completed before he moves forward with plans to close more than half of FDA’s field laboratories.