Although Paxil was not approved in Japan until 2000, a couple years after it was approved in the US in 1992, Glaxo began looking into marketing the drug in Japan and meeting the requirements for approval by the Minister of Health and Welfare (MHW), the Japanese equivalent to the FDA.
"And the Japanese, they suspected, were not going to accept their dead rat pup studies," Tracey told the jury in his opening statement on September 15, 2009.
"And so GSK began discussions internally," he said. "Internally among themselves they said: What are we ... going to do if Japan makes us do the studies to find out why the rat pups died?"
While Healy was testifying, Tracey introduced a February 9, 1994 memo to Glaxo employee Charlie Fake, and copied to others, from Jenny Greenhorn titled, "Paroxetine Japanese reprotox requirements," and asked Healy to explain the meaning of "reprotox."
Any "agency in the world has a requirement from the pharmaceutical companies to look at the reproductive toxicities of a drug," Healy said. "This includes the impact of the drug on fertility, as well as the potential for the drug to cause birth defects."
The first sentence of the memo stated, "we have reviewed the three plans for meeting the Japanese reprotox requirements for their regulatory implications elsewhere, should a valid, significant positive i.e., adverse, result be obtained."
The next two sentences in the memo stated: "The conclusions reached within regulatory are summarized below."
"It should be noted that there is little or no regulatory information in this area, and we know of no precedents, neither have we consulted with experts outside of the company due to sensitivity of the issue," they wrote.
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