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How FDA Makes Tough Decisions

 
• By Michael McCaughan and Ramsey Baghdadi

The reapproval of Tysabri is a rare but not unprecedented event. By coincidence, litigation against FDA made public the process the agency used the last time it let a withdrawn product return to market.

When the Food & Drug Administration makes a big drug safety-related announcement, there is one point you can be sure the agency will make in discussing the decision: that it shows the system is working. FDA relies on public confidence to do its job, so the agency is careful to reassure the public whenever it address an issue involving the safety of medicines that—no matter how unexpected any development may be—there is a system of safeguards in place that is functioning to protect them.

In the case of the relaunch of Biogen Idec Inc. and Elan Corp.’s multiple sclerosis agent natalizumab (Tysabri), it...

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