FDA's System to Reduce Mission Risk

The Food and Drug Administration took a huge step in solving one of the biggest threats to its mission to protect American health: monitoring the adverse effects of new drugs and medical devices once they hit the market. The FDA and the Centers for Medicare and Medicaid Services announced on Thursday that they will team to use the centers' Medicare claims database to track reactions from drugs and medical devices. FDA calls the new system the Sentinel Initiative.

This is what FDA needs to avoid what has happened all too often with drugs like Vioxx, an arthritis pain reliever developed by Merck. After receiving FDA approval in 1999, reports began to come in that the drug may cause fatal side effects such as a heart attack or stroke. It was not until 2004, after public pressure and a high profile lawsuit, that Merck pulled the drug off the market.