On November 9, the Department of Justice ("DOJ") announced that a former vice president and associate general counsel at GlaxoSmithKline ("GSK"), Lauren Stevens, had been indicted on charges stemming from an FDA investigation into GSK's drug marketing practices. The indictment charges Ms. Stevens with a total of six counts: one count of obstructing an official proceeding, one count of concealing and falsifying documents, and four counts of making false statements to FDA. The first two counts carry a maximum penalty of 20 years in prison, and the latter two five years for each false statement.
FDA's investigation began in 2002, when FDA became aware of GSK's marketing of Wellbutrin SR® (buproprion) for unapproved uses. Wellbutrin SR® had only been approved for the treatment of depression in patients over the age of 18, but GSK had allegedly been marketing the drug for, among other unapproved uses, weight loss and obesity. Ms. Stevens was in charge of cooperating with the FDA in its investigation and was less-than-forthcoming in her responses.
For instance, FDA requested presentation materials from a number of GSK-sponsored promotional events from 2001-2002. In response, Ms. Stevens contacted approximately 550 of the 2,700 speakers from these events. She received presentation materials from around 40 speakers, and informed 28 of them that their presentations were in violation of FDA policy, as they promoted off-label uses. Rather than forward the presentation materials to FDA, however, Ms. Stevens allegedly acted on the advice of a "nationally prominent law firm retained by her employer" (according to a statement by Ms. Stevens' lawyer) and failed to disclose the materials.
GSK recently agreed to a $750 million settlement to absolve itself of liability arising from claims of defectively-manufactured drugs. The present lawsuit against Ms. Stevens does not implicate GSK, and illustrates different approach taken by federal prosecutors in holding large pharmaceutical companies accountable for non-compliance with FDA standards: targeting high-ranking officials and holding them personally liable for their actions within the company.
As Richard DesLauriers, Special Agent in Charge of the FBI's Boston Division, stated in the DOJ announcement, "[t]his indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf. When individual employees are identified, they will be held accountable for their illegal activity. Individual employees now know that concealing information from the government, obstructing investigative activity and making false statements to federal investigators will be investigated and prosecuted."