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Ex-Glaxo Attorney Charged With Obstruction

From UPI Top Stories (November 9, 2010)

A former lawyer for a major pharmaceutical company was charged with obstruction and making false statements, the U.S. Department of Justice said Tuesday.

A department statement said Lauren Stevens of Durham, N.C., a former attorney for GlaxoSmithKline, was 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 US. Food and Drug Administration.

An indictment says 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 FDA, the statement said.

Data demonstrating a drug's safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved, or "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, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses, the indictment alleges.

The indictment was filed in Maryland; the FDA headquarters is in Silver Spring, Md., a Washington suburb.

The pharmaceutical company for which Stevens worked has not been charged with a crime and was not identified in the indictment, the department pointed out. But various news reports identified it as GlaxoSmithKline.

Posted: November 2010