Former Glaxo Exec Faces Federal Charges Over Wellbutrin Marketing

Federal prosecutors are pursuing criminal charges against a former GlaxoSmithKline vice president for alleged efforts to cover up illegal, off-label marketing of Wellbutrin.

On Tuesday, the U.S. Department of Justice (DOJ) issued a press release announcing that it was charging Lauren Stevens with obstructing an official proceeding, concealing and falsifying documents to influence a federal agency and four counts of making false statements to the FDA.

According to the indictment, Stevens attempted to hide the fact that Glaxo was promoting Wellbutrin for uses not approved by federal regulators. While it is legal for doctors to prescribe drugs for any uses they see fit, it is illegal for drug manufacturers to promote those medications for uses other than those approved by the FDA.

Stevens, now retired, was vice president of GlaxoSmithKline’s legal department at the time of the alleged cover up in October 2002. The indictment does not name the company or the drug involved, but Glaxo officials have confirmed that the issue is over Stevens’ handling of the FDA’s Wellbutrin investigation.

DOJ investigators say that Stevens signed and sent a series of letters to the FDA saying that Glaxo was not involved in off-label promotion of Wellbutrin, despite knowing that the company had paid physicians hundreds of times to do just that. Stevens told the FDA that the physicians had not been paid to speak on the drug’s behalf, but federal investigators later found out that one doctor had been paid to speak at 511 promotional events regarding unapproved Wellbutrin use in 2001-2002 and another had been paid to speak at 488 events.

Stevens also refused to turn over a set of slides that the FDA requested, and that she promised to provide. According to the indictment, a legal memorandum was generated inside the company that listed the pros and cons of turning over the slides, one of negatives listed was that the slides could be used as evidence that the company had been illegally promoting Wellbutrin.

When the FDA asked for the slides, Stevens did not turn them in, saying that the company’s response to the FDA inquiries and the evidence it had turned over was complete.

If convicted, Stevens faces a maximum of 20 years in prison for the obstruction charge, and five years in prison for each of the false statement charges.

Wellbutrin (bupropion HCI), which is manufactured by GlaxoSmithKline, was first approved by FDA as an antidepressant in December 1985. The drug was pulled a year later due to the high number of seizures associated with Wellbutrin side effects, but it was reintroduced in 1989 after federal reviewers determined that the seizures were dose specific and lowered the daily dosage of the drug.

Wellbutrin has come under closer scrutiny recently after a study published in May in the American Journal of Obstetrics & Gynecology suggested that there may be an increased risk of heart birth defects from Wellbutrin when the medication is taken during pregnancy.

Researchers found that mothers who were given Wellbutrin in their first trimester had double the chance of giving birth to a child with a congenital heart problem than mothers who did not take the drug. However, they were not able to establish a cause-and-effect relationship between the drug and the birth defects.

The charges against the GlaxoSmithKline executive may represent a possible shift in enforcement actions involving pharmaceutical companies, who have been fined billions of dollars in recent years over illegal marketing of drugs in violation of federal regulations. Executives at the pharmaceutical companies may increasingly find themselves facing criminal charges for their role in illegal actions taken by drug makers.