Warner-Lambert submitted a new drug application for Rezulin. Dr. John Gueriguian was assigned as the FDA's chief medical reviewer of Rezulin.
Fall of 1996
Gueriguian recommended the drug was not safe to be put on the market.
The FDA removed him from the case and replaced him with Dr. Robert Misbin, who recommended approval.
The FDA approved Rezulin.
March of 1997
Warner-Lambert began selling Rezulin.
Fall of 1997
Evidence of the first patient deaths began surfacing.
December of 1997
Rezulin was pulled off the market in Great Britain due to safety concerns.
July 27, 1998
The consumer group Public Citizen petitioned the FDA to withdraw Rezulin in the United States.
March of 1999
At public hearings, the FDA's Misbin supports keeping Rezulin on the market, saying the benefits still outweigh the risks, but that patients should be carefully monitored.
Summer of 1999
As adverse event report continue to mount, and new drugs become available, Misbin reverses himself and decides Rezulin should no longer be on the market. His FDA superiors disagree.
March 2, 2000
After meetings between FDA and Warner-Lambert fail to produce a withdrawal of Rezulin, Misbin writes letters to Congress, asking for an investigation into why the drug remains on the market.