The FDA and Drug Safety

The Archives of Internal Medicine contained an article today that called for far-reaching reforms at the Food and Drug Administration. Several of its authors are people with whom I've worked over the years. I do not have a subscription to the Archives, but someone kindly sent me a pre-embargo copy (it is now released). After reading it, I thought its contents were, from start to finish, a significant contribution to the current public debate over the state of the U.S. drug safety system. The editors should have made this article open to the public. Even though this is often done with significant articles in other medical journals, the editors of the Archives chose not to in this case. So, as a public service, I am republishing it here in its entirety.