Former Glaxo lawyer accused of marketing cover-up
A federal grand jury has indicted a former GlaxoSmithKline attorney for allegedly failing to comply with an FDA request for documents in an off-label marketing probe. The indictment, some say, is a sign regulators are beginning to turn their attention to pharmaceutical executives for corporate misdeeds.
The attorney, Lauren Stevens, is accused of one count of concealing evidence and falsifying documents to influence a federal agency, four counts of making false statements to the FDA, as well as one count of obstructing an official proceeding.
GSK US media relations director Mary Anne Rhyne told MM&M that Stevens was employed by GlaxoSmithKline in the company's US legal department and is now retired.
“What it means...is that no matter who you are, even if you are lawyer for a pharmaceutical company, and I suppose particularly if you are an in-house lawyer, the government is going to scrutinize your behavior in the context of an investigation closely,” wrote Arnold Friede, a former Pfizer attorney who now runs a consultancy, in an email to MM&M. “If the government believes you have engaged in misconduct, then you are in jeopardy.”
But Porter Novelli's Peter Pitts, who is partner and director of the firm's global health practice as well as a former FDA associate commissioner, said that at this stage, “the facts of the story are extremely vague, but I don't think that...the current philosophy on whether or not higher-up individuals in companies should be held responsible for their actions has changed. That's not what this is about.”
Indeed, the facts are obscured in the indictment, with Stevens listed as a VP and associate general counsel of a corporation named “K-Corp.,” and the name of the drug shielded, too. Prosecutors use the alias “W-Drug” but say it was approved for a single use—major depressive disorder in adults. Rhyne confirmed that the drug is Wellbutrin SR.
According to the indictment, in 2002 the FDA sent the company a letter stating it had become aware that K-Corp. was promoting the drug off-label, specifically for weight loss. The agency asked for copies of promotional programs for the drug, including slides, videos, handouts and other materials, as well as for compensation provided to individuals involved in programs or activities.
Stevens, per the indictment, agreed to gather materials used by HCPs in those programs. But authorities alleged that her reply came up short. She is accused of misleading the agency and covering up documents that show the extent of K-Corp.'s promotion of the drug for unapproved uses, because she knew they were “incriminating.” Prosecutors charge that she also denied the company promoted the drug for off-label uses, even though she had determined herself that a number of doctors were discussing it for unapproved indications in sponsored programs.
The indictment was handed down by a federal grand jury in Maryland and announced by the US Attorney's Office in Boston, which led the investigation.
“Where the facts and law allow, the Department of Justice will pursue individuals responsible for illegal conduct just as vigorously as we pursue companies,” said Tony West, assistant attorney general in the Justice Department's civil division. “False statements by a corporate lawyer to a federal regulatory agency that were this broad, repeated and emphatic demand prosecution.”
Carmen Ortiz, US attorney for the District of Massachusetts, added, “Today's indictment should send a strong message to the industry that we will hold individuals accountable, and that they cannot hide behind the corporate veil.”
Stevens' lawyer offered a different take. “Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with FDA,” wrote Brien O'Connor, of the firm Ropes & Gray, in an email. O'Connor said his firm, as well as Steptoe & Johnson, will be representing Stevens.