Another Psychiatric Drug, Another Potential Criminal Investigation—J&J’s Antipsychotic Risperdal

Johnson & Johnson (JNJ) said it’s in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal. In 2004, the Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena seeking documents regarding sales and marketing of Risperdal, as well as payments to physicians and clinical trials for the drug, from 1997 to 2002. The U.S. Attorney’s Office in Philadelphia sent an additional subpoena in 2005, seeking information about Risperdal marketing and adverse reactions associated with the drug. Grand jury subpoenas have been issued seeking testimony from various witnesses.

U.S. Justice Department Charges Former GlaxoSmithKline VP — A Top Lawyer—with Fraud over Illegal Marketing of Antidepressant Wellbutrin

In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss. The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments. “This is absolutely precedent-setting — this is really going to set people’s hair on fire,” said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. “This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.”

Drug-firm executives under new scrutiny in Medicare fraud

Federal inspectors want to prevent drug-company executives from doing business with the U.S. government when their companies are convicted of Medicare fraud.
Under guidelines from the Department of Health and Human Services’ Office of Inspector General, executives can be barred from contracting with federal health programs when they knew, or if the inspector general concludes they should have known, about fraud at their firms. The guidelines were posted Oct. 20 on the office’s Web site. Authorities have been spurred by large settlements, said Robert DeConti, chief of the administrative and civil remedies branch in the inspector general’s Office of Counsel. GlaxoSmithKline was ordered to pay $750 million on Oct. 26 for sale of defective drugs, and Pfizer agreed to pay $2.3 billion in September 2009 for fraudulent marketing of medicine.

Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors. Glaxo officials had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about those deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

Former GSK lawyer indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug

A former lawyer for pharmaceutical giant GlaxoSmithKline Plc has been indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug, the U.S. Justice Department said on Tuesday. The lawyer, Lauren Stevens, was indicted on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo’s promotion of the drug for weight loss, which had not been approved by the Food and Drug Administration. “Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” said Tony West, head of the Justice Department’s civil division.

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