Tag Archives: FDA

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.

Public ‘misled’ by drug trial claims

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned. Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings. The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light. Pfizer maintains its drug is effective. Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK. But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data. This is not the first time a large drug company has come under fire about its published drug trial data.