Federal prosecutors said Tuesday they have charged a former GlaxoSmithKline executive with obstructing justice and making false statements in an effort to conceal illegal promotion of a company drug.
The Department of Justice alleges that in 2002, Lauren Stevens of Durham, N.C., signed several letters to the Food and Drug Administration denying that her company had promoted an antidepressant drug for unapproved uses. But Stevens knew that the company had paid numerous physicians to give talks touting unapproved uses of the drug, including weight loss, according to the indictment filed Monday in the U.S. District Court of Maryland.
A spokeswoman for GlaxoSmithKline PLC confirmed Stevens worked as a vice president in the company's legal department, but has since retired. The spokeswoman also confirmed that the drug — which was not named in the indictment — is Wellbutrin, a former blockbuster-selling product.
Drug companies are prohibited from promoting drugs for uses not approved by the FDA.
In recent years, federal prosecutors have reached multibillion dollar settlements with Pfizer Inc., Eli Lilly&Co. and other drug companies over their marketing practices.
But Stevens' indictment marks a rare case of the Department of Justice targeting a specific executive, rather than an entire company. Some legal experts have stressed that companies will not curb illegal marketing tactics until executives are threatened with prison time, because fines leveled against companies are often just a fraction of their total sales.
"This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," said Dara Corrigan, FDA's associate commissioner for regulatory affairs.
Stevens was charged with one count of obstructing an official proceeding, one count of falsifying documents to influence a federal agency and four counts of making false statements to the FDA. Each of the obstruction charges carries a maximum penalty of 20 years in prison. The false statements counts each carry a maximum penalty of five years in prison.
In one instance, prosecutors say Stevens withheld slides used by physicians promoting the company's drug, even though the FDA had asked specifically for the materials. Stevens claimed that the company's response to the FDA was "final" and "complete," according to the indictment.
Stevens also falsely denied that Glaxo had paid doctors to attend special sessions where medical experts discussed unapproved uses of Wellbutrin, according to the Department of Justice.
"Attendees were not paid, reimbursed or otherwise compensated to attend these events," Stevens wrote in a 2003 letter to the FDA. But prosecutors say attendees received gifts, entertainment and other compensation in return for attending the events.
During 2001 and 2002, Glaxo paid two expert physicians to speak about 500 times each about Wellbutrin, including how to use the drug to treat obesity.
A lawyer representing Stevens called her "an utterly decent and honorable woman," in a statement e-mailed to The Associated Press.
Brien O'Connor, who works with the firm Ropes&Gray, said Stevens simply followed the guidance of an outside law firm that was hired to advise Glaxo in dealing with the FDA.
"She looks forward to the day when a judge and jury can hear the true facts in this case," O'Connor said.