Former Glaxo Lawyer Charged With Obstruction of Probe
The Wall Street Journal
November 2010
By THOMAS CATAN And PETER LOFTUS
Federal prosecutors charged a former GlaxoSmithKline PLC attorney with lying to obstruct a U.S. investigation into whether the pharmaceutical company illegally marketed an antidepressant as a weight-loss drug.
The Department of Justice on Tuesday indicted Lauren Stevens, a former vice president at the drug company, with four counts of making false statements to the Food and Drug Administration, as well as obstructing its investigation and withholding documents.
The indictment reflects a new U.S. effort to hold company executives legally accountable for criminal wrongdoing, rather than simply fining the companies for violations.
"This indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf," said Richard DesLauriers, a special agent at the Federal Bureau of Investigation.
Ms. Stevens's lawyer said she did nothing wrong.
"Lauren Stevens is an utterly decent and honorable woman," Brien O'Connor said. "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."
The indictment didn't identify the company or drug involved, but Glaxo confirmed that Ms Stevens formerly worked in its U.S. legal department and that the investigation involved its antidepressant Wellbutrin SR. It declined to comment further.
In its 2009 annual report, Glaxo disclosed that the government was inquiring about the company's response to an October 2002 letter from the FDA. The letter asked for information on the company's "alleged promotion of Wellbutrin SR for off-label use," meaning a use for which the drug didn't have FDA approval. Antidepressants have at times been associated with weight loss, though also with weight gain.
The U.S. attorney's office in Massachusetts has been leading a long-running investigation into Glaxo's marketing of several products between 1997 and 2004, including Wellbutrin SR, Glaxo has disclosed.
Glaxo first disclosed the existence of the investigation in 2004, and last year said it was taking a $400 million charge in relation to the probe, in a possible sign that it was approaching a settlement.
The Justice Department, acting on behalf of the FDA, has recently reached a slew of recent legal settlements with pharmaceutical companies for various violations, many of them prompted by information from whistleblowers.
Last month, GSK pleaded guilty to charges that it knowingly sold adulterated drugs made at its factory in Puerto Rico, paying $750 million in fines. The previous month, Allergan Inc. pleaded guilty to charges that the company actively promoted its top-selling product, the wrinkle-smoothing drug Botox, for unapproved medical uses such as treating headaches and pain. It paid $600 million to resolved the charges.
No individuals were indicted in those cases. To have an effective deterrent effect, the Justice Department has emphasized that it wishes to prosecute individual executives involved in corporate wrongdoing, so that the fines aren't simply seen as a cost of doing business.
The Wall Street Journal reported in March that the Food and Drug Administration planned to increase prosecutions of industry executives and corporate counsel.
Tuesday's indictment alleged that Ms. Stevens made a series of false statements and deliberately withheld potentially incriminating evidence from investigators. For example, she allegedly decided not to submit presentations made on the company's behalf by doctors who promoted the drug for unapproved purposes, prosecutors said.
A memorandum she requested to help decide whether she should hand over the slide sets warned that such a move would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation," the indictment said.
Instead of providing the slides, Ms. Stevens wrote that the company's responses to the FDA's requests were "final" and "complete." The indictment says a company employee reported the alleged off-label promotion of the drug and sent the FDA some of the missing slides.
—Jeanne Whalen and Alicia Mundy contributed to this article.
Write to Thomas Catan at thomas.catan@wsj.com and Peter Loftus at peter.loftus@dowjones.com
November 2010
By THOMAS CATAN And PETER LOFTUS
Federal prosecutors charged a former GlaxoSmithKline PLC attorney with lying to obstruct a U.S. investigation into whether the pharmaceutical company illegally marketed an antidepressant as a weight-loss drug.
The Department of Justice on Tuesday indicted Lauren Stevens, a former vice president at the drug company, with four counts of making false statements to the Food and Drug Administration, as well as obstructing its investigation and withholding documents.
The indictment reflects a new U.S. effort to hold company executives legally accountable for criminal wrongdoing, rather than simply fining the companies for violations.
"This indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf," said Richard DesLauriers, a special agent at the Federal Bureau of Investigation.
Ms. Stevens's lawyer said she did nothing wrong.
"Lauren Stevens is an utterly decent and honorable woman," Brien O'Connor said. "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."
The indictment didn't identify the company or drug involved, but Glaxo confirmed that Ms Stevens formerly worked in its U.S. legal department and that the investigation involved its antidepressant Wellbutrin SR. It declined to comment further.
In its 2009 annual report, Glaxo disclosed that the government was inquiring about the company's response to an October 2002 letter from the FDA. The letter asked for information on the company's "alleged promotion of Wellbutrin SR for off-label use," meaning a use for which the drug didn't have FDA approval. Antidepressants have at times been associated with weight loss, though also with weight gain.
The U.S. attorney's office in Massachusetts has been leading a long-running investigation into Glaxo's marketing of several products between 1997 and 2004, including Wellbutrin SR, Glaxo has disclosed.
Glaxo first disclosed the existence of the investigation in 2004, and last year said it was taking a $400 million charge in relation to the probe, in a possible sign that it was approaching a settlement.
The Justice Department, acting on behalf of the FDA, has recently reached a slew of recent legal settlements with pharmaceutical companies for various violations, many of them prompted by information from whistleblowers.
Last month, GSK pleaded guilty to charges that it knowingly sold adulterated drugs made at its factory in Puerto Rico, paying $750 million in fines. The previous month, Allergan Inc. pleaded guilty to charges that the company actively promoted its top-selling product, the wrinkle-smoothing drug Botox, for unapproved medical uses such as treating headaches and pain. It paid $600 million to resolved the charges.
No individuals were indicted in those cases. To have an effective deterrent effect, the Justice Department has emphasized that it wishes to prosecute individual executives involved in corporate wrongdoing, so that the fines aren't simply seen as a cost of doing business.
The Wall Street Journal reported in March that the Food and Drug Administration planned to increase prosecutions of industry executives and corporate counsel.
Tuesday's indictment alleged that Ms. Stevens made a series of false statements and deliberately withheld potentially incriminating evidence from investigators. For example, she allegedly decided not to submit presentations made on the company's behalf by doctors who promoted the drug for unapproved purposes, prosecutors said.
A memorandum she requested to help decide whether she should hand over the slide sets warned that such a move would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation," the indictment said.
Instead of providing the slides, Ms. Stevens wrote that the company's responses to the FDA's requests were "final" and "complete." The indictment says a company employee reported the alleged off-label promotion of the drug and sent the FDA some of the missing slides.
—Jeanne Whalen and Alicia Mundy contributed to this article.
Write to Thomas Catan at thomas.catan@wsj.com and Peter Loftus at peter.loftus@dowjones.com
Labels: fda, glaxo, GlaxoSmithKline, GSK, Lauren Stevens, paxil, pharma, pharmaceutical, wellbutrin
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