The US Department of Justice has charged Lauren Stevens, former vice president and associate general counsel of British drug manufacturer GlaxoSmithKline (GSK), with obstruction and making false statements during a USFDA investigation into unapproved uses of its antidepressant Wellbutrin for weight loss.
GSK has not been charged with a crime and was not identified in the indictment.
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 FDA.
The indictment alleges 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.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials.
The charges were filed in the District of Maryland, where the FDA is located. The case is being prosecuted by the Civil Division's Office of Consumer Litigation and US Attorney's Office for the District of Massachusetts.
The case is being investigated by agents from the Office of Inspector General of the Department of Health and Human Services, the FBI, the FDA's Office of Criminal Investigations and the Defense Criminal Investigative Service (DCIS).