Former Glaxo In-House Lawyer Charged with Obstruction, False Statements
Updated: A former associate general counsel at GlaxoSmithKline has been charged with obstruction and making false statements during a probe into the promotion of a prescription drug.
The lawyer, Lauren Stevens, has retired from the company, a Glaxo spokeswoman told the Boston Business Journal. Stevens is accused in a federal indictment of making false statements to the Food and Drug Administration during a 2002 investigation into off-label uses of the drug, which isn’t identified in the press release announcing the charges.
National Public Radio reports that the drug was the antidepressant Wellbutrin SR, and one of its unapproved uses was weight loss.
The indictment alleges Stevens denied the company had promoted off-label uses, although she knew physicians had been paid to promote such unapproved uses. It also claims Stevens did not provide the FDA with slide sets used by the paid physicians despite a request by the agency.
According to the indictment, Stevens reviewed a legal memorandum setting forth the pros and cons of producing the slides. One of the cons was that the slides would provide incriminating evidence about off-label uses that could be used against the company.
Carmen Ortiz, U.S. Attorney for the District of Massachusetts, says in the press release that the FDA cannot protect public health if regulated entities provide false information. “There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth,” Ortiz said.
Stevens is charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the FDA.
She is represented by Ropes & Gray partners Brien O’Connor in Boston and Colleen Conroy in Washington, D.C., the Am Law Daily reports.
O’Connor gave Dow Jones Newswires a written statement that said Stevens is not guilty. “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,” he said.
Updated at 1:09 p.m. to include O’Connor’s statement.
