The feds said it was coming, and now it has: The Justice Department has charged a pharmaceuticals executive--albeit a former one--in connection with off-label marketing allegations. In this case, it's an erstwhile in-house counsel for GlaxoSmithKline ($GSK), Lauren Stevens; she's charged with obstruction and making false statements during a probe of Wellburtin SR marketing.
According to the indictment, Stevens signed letters to FDA that hid the company's promotion of Wellbutrin SR for off-label use, including weight loss (the indictment didn't name the company or the drug, but a GSK spokeswoman confirmed their identity). Charged by the agency with gathering information on Wellbutrin marketing, Stevens found two doctors had "repeatedly promoted" the drug for off-label use, but didn't hand over that evidence, the indictment states. Moreover, Stevens asserted that the company had, apart from "isolated deficiencies," only promoted Wellbutrin for approved uses, the indictment alleges.
"There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth," U.S. Attorney Carmen Ortiz said in a statement. "Federal agencies such as the FDA cannot protect the public health if entities and individuals they regulate provide false information." Stevens faces up to 20 years in prison for two of the charges, and up to five years for the remaining four counts.
Stevens' attorney said his client isn't guilty of obstruction or false statements. "Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm," Brien O'Connor of Ropes & Gray told Bloomberg.
The specifics of Stevens' case aside, that the government has filed actual charges against a drug-company executive is precedent-setting, legal experts say. "[T]his is really going to set people's hair on fire," Washington lawyer Douglas Farquhar told the New York Times. And there's every indication that Stevens won't be alone. "[T]he Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations," Assistant AG Tony West vowed.