In the wake of a large settlement (for more, see here), GlaxoSmithKline attorney Lauren Stevens was indicted for obstruction and making false statements to the FDA. Allegedly, the attorney withheld incriminating documents and made misrepresentations in letters sent to the FDA. In addition to actions related to poor manufacturing, charges also relate to GSK programs to promote off-label uses of Wellbutrin. At the time, the antidepressant was promoted off-label for weight loss.
In 2002, the FDA requested all promotional materials regarding Wellbutrin incuding all those from GSK-sponsored speaking programs. Stevens drafted an internal memorandum to highlight the “pros and cons” of producing the requested materials to the FDA. While “pros” included credibility with the FDA, “cons” included providing “incriminating evidence about potential off-label promotion.” In the end, the attorney failed to provide the requested materials, yet assured the FDA that GSK had fulfilled its document production duties.