Under cross-examination, Glaxo attorney, Joe O'Neil, asked Parisian to identify the FDA regulation she was referring to in stating the reports should have been submitted to the FDA. "I would specifically use (21 CFR) 314.81," she said, "FDA talks about issues with children, information about children that they are to receive that information."
"Also, as a postmarket study asked (for) by the Japanese which is the 2000 report," she stated. "That would be under (21 CFR) 314.80."
While cross-examining Parisian, O'Neil put up a power point slide listing the FDA approvals of Paxil and Paxil CR, the controlled release version, for additional indications between the initial approval for major depression disorder in 1992 through 2004, including panic disorder, obsessive compulsive disorder, general anxiety disorder, and PSTD.
Several times, Parisian noted that Paxil was not approved for use by pregnant women. O'Neil pointed out that for each new indication, FDA approved the label and Paxil was never contraindicated for use by pregnant women on the label.
Under redirect examination, Parisian testified that when Glaxo applied for approval of the new indications, the FDA was not given the internal analysis of birth defects available at the time or told about Dr Baldwin's comments on the early animal studies.
Although the 2000 report with 79 cases of birth defects was supposedly done for the Japanese government, it was never given to the Japanese, Tracey told the jury in closing arguments. "It wasn't given to the people it was prepared for," he said.
And after the report in 2000, Glaxo stopped doing the pregnancy analysis, he said. "For the next five years we have nothing," he told the jury. "We don't have any reports. We don't know how many birth defects are reported to them."
FDA Stamped Paxil Label
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