Mechanisms to improve safety would include post-market surveillance that would report directly to the commissioner of the FDA, and be separate from the officeofnewdrugs.
The document, written by John Jenkins, the director of the OfficeofNewDrugs, and Paul Seligman, director of the office that handles statistical science and epidemiology, clearly spells out the reasons for the Bextra recall and what Pfizer (nyse: PFE - news - people ) would have to do to get that drug back on the market.