Wednesday, June 6, 2012

How many FDA auditors can you fit in a PO Box?

Ask the ICMS.

The International Cell Marketing Service Medicine Society reports that the FDA has audited its institutional review board (IRB), which the ICMS claims has been asked to review "nearly two dozen study applications over the last 3 years from nearly a half dozen countries."

The FDA has looked into a number of other IRBs in the past, including the unfortunately named Coast IRB, and a perhaps somewhat less than conscientious operator in my native NJ, Essex, which was recently busted, yet again, by Dateline NBC. Those are just the tip of the iceberg - the folks at CIRCARE have a whole catalog of IRB warning letters from the FDA chroncling oversight lapses on the part of supposed watchodgs. U Minn ethics professor Carl Elliott has been calling attention to the problems raised by fig-leaf IRBs and their porous reviews of clinical research for years now. It will be interesting to learn whether the FDA puts ICMS's review process in the same category.

Meanwhile, over at the iPS cell blog, Paul Knoepfler is reporting that the FDA has been busy down Texas way as well....