Tag Archives: FDA

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.”

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.

Big Pharma executives facing legal threat; including potential fines and prison time

Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds. Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties. Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

Big Pharma executives facing legal threat; including potential fines and prison time

Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds. Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties. Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.