Artice by David Voreacos. Bloomberg News
Nov. 9 (Bloomberg) -- A former attorney for GlaxoSmithKline Plc was charged with obstruction and making false statements during an investigation into unapproved uses of a drug, the U.S. Justice Department said today.Lauren Stevens, of Durham, North Carolina, was accused yesterday in an indictment of impeding an inquiry in 2002 by the U.S. Food and Drug Administration into the marketing of a drug for uses not approved by the FDA. Stevens was a vice president and associate general counsel for London-based Glaxo.
Stevens signed letters to the FDA making false statements and hid the extent of the company’s promotion of a drug for unapproved uses, including weight loss, according to the indictment. She knew a Vermont physician had spoken at 511 promotional events in 2001 and 2002 to discuss off-label uses and a Michigan doctor had spoken 488 times, prosecutors said.
“There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth,” Carmen Ortiz, U.S. attorney for Massachusetts, said in a statement. “Federal agencies such as the FDA cannot protect the public health if entities and individuals they regulate provide false information.”
The indictment doesn’t identify the company by name. A Glaxo spokeswoman, Mary Anne Rhyne, confirmed in an e-mail that Stevens worked in the legal department and is now retired.
An attorney for Stevens, Colleen A. Conry, didn’t immediately return a call seeking comment.
Charged in Maryland
Stevens, who was investigated by Ortiz’s office, was indicted in Maryland, where the FDA is based.
A spokeswoman for Ortiz, Christina Sterling, said that Stevens will be summoned to appear at a later date for an initial appearance.
Stevens is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements. The first two charges carry maximum terms of 20 years, and the false-statements counts carry terms of five years.
Sterling said that the drug in question, which is not identified in the indictment, hasn’t been the subject of a settlement.
The case is U.S. v. Stevens, 10-cr-694, U.S. District Court, District of Maryland (Greenbelt).


