Former Glaxo lawyer charged with making false statements to FDA

A Durham attorney who once worked in GlaxoSmithKline's legal department has been charged with obstructing an official proceeding, concealing and falsifying documents and five counts of making false statements to the Food and Drug Administration.

Lauren Stevens was indicted this week by the U.S. Justice Department for impeding an FDA inquiry in 2002.

The indictment doesn't name the company Stevens worked for other than to say it was a major pharmaceutical company. The company has not been charged with a crime.

Mary Anne Rhyne, a GSK spokesperson, confirmed that Stevens worked in the company's U.S. legal department and is now retired.

London-based GSK has its U.S. headquarters in Research Triangle Park.

In an e-mail statement, Stevens attorney, Brien T. O'Connor of Ropes & Gray LLC, said his client is innocent of the charges:

"Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. 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. She looks forward to the day when a judge and jury can hear the true facts in this case, which will show that she has done absolutely nothing wrong."

The indictment states that in October 2002 the FDA asked for information about the company’s promotion of a prescription drug as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the agency, also known as "off-label" uses.

In response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, according to the indictment.

The indictment also alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug.

The company paid one such physician to speak at 511 promotional events in 2001 and 2002 and another physician to speak at 488 such events during that time period, according to the indictment.

"There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth," said Carmen Ortiz, U.S. Attorney for the District of Massachusetts, in a release. "Federal agencies such as the FDA cannot protect the public health if the entities and individuals they regulate provide false information and conceal the true facts."

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. Charges contained in the indictment are simply accusations, and not evidence of guilt.