Glaxo lawyer charged with obstruction | Boston Business Journal

A GlaxoSmithKline (NYSE: GSK) associate general counsel was charged Tuesday in federal court in Boston with obstruction and false statements in connection with an investigation into the promotion of a prescription drug.

Lauren Stevens, of Durham, N.C., allegedly provided the misinformation after the federal Food and Drug Administration contacted the company in October 2002 as part of a probe into possible marketing of the drug for off-label uses. While physicians sometimes prescribe drugs for uses other than those for which they have been approved, companies selling the drugs are barred from encouraging those applications.

"The indictment alleged that, 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, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses," U.S. Attorney Carmen Ortiz's office said in a statement Tuesday.

"The indictment further 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 statement continues.

“Where the facts and law allow, the Department of Justice will pursue individuals responsible for illegal conduct just as vigorously as we pursue companies,” Tony West, assistant attorney general in the U.S. Department of Justice's Civil Division, said in a prepared statement. “False statements by a corporate lawyer to a federal regulatory agency that were this broad, repeated and emphatic demand prosecution.”

Ortiz added: “There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth.”“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.” Ortiz continued, “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.”

Attempts to reach Steven at Glaxo were unsuccessful, though an employee said she had an extension there. A Glaxo spokesman could not immediately be reached for comment.

via bizjournals.com

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