Pfizer Corporation has agreed to pay $491 million to resolve allegations stemming from a whistleblower suit which alleged that its subsidiary Wyeth illegally marketed the transplant drug Rapamune for uses not approved by the FDA including for patients getting liver, lung heart and other transplants--dangerous uses. Rapamune was approved in 1999 only for ise...
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Category: Pharmaceutical
Uncle Sam Charges Sage Pharmaceuticals and Management for Distributing Unapproved drugs
The Department of Justice, on behalf of the Food and Drug Administration has filed a case against Sage Pharmaceuticals Inc, it's President and Director of Corporate Quality for manufacturing and distributing unapproved drugs. The required FDA approval process is to make sure that drugs manufactured and distributed to consumers are safe and effective for...
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18 fired at Novartis for fabricating sales data of diabetes drug Galvus
The Swiss drug manufacturer Novartis has dismissed 18 sales executives for fabricating and inflating sales numbers of its diabetes drug Galvus. The sales executives reportedly used sales incentives provided by the company to buy stocks from wholesalers and show an increase in sales of the drug in order to meet their target quota....
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Glaxo research chief fired following GSK probe into data fabrication in multiple sclerosis paper regarding interleukin-7
The head of GlaxoSmithKline's (GSK) Research & Development operations in China has been fired and another researcher has resigned following a GSK probe into data fabrication on interleukin-7 research published in Nature Magazine. Nature reported that Jingwu Zhang of GSK had found data suggesting that the signaling molecule interleukin-7 caused a subset of T...
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Foreign drug manufacturing plants target of FDA and Dept. of Justice Inspections
Following the revelations concerning the massive fraudulent data submissions by India's generic drug manufacturer Ranbaxy which agreed to pay $500 million to settle a False Claims Act case, the Department of Justice has publicly said that it will be taking an especially hard look at drug manufacturers abroad. The DOJ wants to make sure...
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Even after paying $500 million to settle whistleblower suit for fraud in testing, Indian generic drug maker Ranbaxy’s sales skyrocket in US
Despite the fact that India's largest drug maker, Ranbaxy, which manufactures generic drugs was caught lying to the FDA about test results and about quality control, the company's sales appear strong here. According to analysts Ranbaxy has a solid plan to cut costs by 15 percent once it starts selling the products made in...
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Toxic generic drugs flooding the U.S. — Ranbaxy just the tip of the iceberg
Last week, the Indian generic drug manufacturer Ranbaxy pleaded guilty to seven felony counts involving manufacturing and selling its pharmaceuticals and agreed to pay $500 million, the largest fine of its kind against a generic drug maker. The evidence mounted by the government included forging and falsifying data submitted to the Food and Drug...
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CEO of J&J unit Janssen in Korea faces criminal charges over defective Children’s Tylenol Sales
The CEO of Johnson & Johnson's subsidiary Janssen, which manufactures over the counter drugs in Korea may face criminal charges for continuing to sell Children's Tylenol after discovering it might contain more than the labeled amounts of acetaminophen. Too much of this drug can lead to liver damage. During the period of time...
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Whistleblower in generic drug maker Ranbaxy case to receive $48.6 million reward one of the largest to date
The whistleblower in one of the largest settled False Claims Act cases against a pharmaceutical company, Ranbaxy will receive $48.6 million from what the government recovered, which will exceed $500 million. Dinesh Thakur, former Ranbaxy executive first tried to report the company wrongdoing to Ranbaxy management but they would not listen to him. Ranbaxy...
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U.S. Sues Novartis for pharmacy kickbacks
The Department of Justice has filed a case against Pharmaceutical manufacturer Novartis, asserting that it provided illegal kickbacks to pharmacies in the form of discounts and rebates to promote its drug Myfortic. This, says the feds, lures the pharmacists to become salespeople for its drugs and that is illegal. The numbers are not minor....
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