Ranbaxy pays $500m to settle FDA fraud charges

by JoelLane 31. May 2013 16:40

Ranbaxy Indian generics giant Ranbaxy has agreed to pay a $500m fine to settle FDA charges of fraud – covering unsafe practices – at two of its factories.

The fine, the largest ever paid by a generic drug manufacturer in the US, comprises $150m for criminal charges and $350m for civil claims.

The offences relate to documents submitted to the Medicare and Medicaid programmes between 2003 and 2010, which Ranbaxy acknowledges made false claims regarding certain products.

FDA inspectors found that drugs manufactured at two Ranbaxy factories in India did not meet safety requirements.

The generic drugs in question included an acne drug (isotretinoin), an epilepsy and nerve pain drug (gabapentin) and antibiotics including amoxicillin.

Ranbaxy manufactured, distributed and sold these drugs when their strength, purity or quality was not that specified by the product literature or the FDA’s approved formulation.

The company acknowledged that inspections of its factories had found evidence of inadequate product testing and record-keeping, as well as deviations from good manufacturing practice.

It also admitted making “false, fictitious and fraudulent” statements to the FDA in annual reports filed in 2006 and 2007 regarding the dates of stability tests conducted on antibiotics.

In 2008, the FDA banned Ranbaxy from selling about 30 drugs in the US. In 2009, it halted reviews of certain Ranbaxy products.

Ranbaxy’s former owners, the family who founded it, have repudiated what it claims are implicit accusations of corruption levelled at it by the company’s present management.

Dinesh Thakur, Ranbaxy’s former Global Head of Research Information and Portfolio Management, will receive $48.6m of the settlement as a whistleblower.

GSK fined over Dong-A deal

by emma 24. October 2011 12:49

Zofran

GSK has been fined three billion South Korean won ($2.6 million) for conspiring with Dong-A Pharmaceutical over drugs sales, a Fair Trade Commission (FTC) official has said.

The FTC claims that GSK offered Dong-A the exclusive rights to sell the products Zofran (pictured)and Valtrex in 2000.

But in return, the FTC says, if the Seoul-based pharmaceutical company pulled a generic version of Zofran it introduced in 1998 or ever produce or sell medication that could compete against Zofran and Valtrex.

Kim Jun-Ha, a FTC official involved in the case, says the two “shared benefits” which should have gone to consumers after GSK made wrongful gains of around 16 billion won.

“With the cheaper generics made by Dong-A taken off the market, the financial burden on patients and on the government's health insurance budget has increased,” Kim said.

GSK's South Korean unit says the decision is “very regrettable” and “inappropriate” and will appeal against the decision.

“We simply exercised our legitimate patent rights,” a statement said.

The anti-trust agency also fined Dong-A Pharmaceutical $2.1 billion won for its part in the collusion, it added.

Google fined $500m for illegal drug ads

by emma 26. August 2011 11:34

Pf industry news

Google has been fined $500 million by the US government for allowing Canadian pharmacies to advertise unlicensed drugs to American patients.

The charges outlined that the company sold millions of dollars’ worth of Google AdWords to Canadian pharmacies importing drugs from other parts of the world not licensed for use in the US, and could be dangerous.

US Attorney Neronha said the fine was “about taking a significant step forward in limiting the ability of rogue online pharmacies from reaching US consumers”.

The $500 million penalty, said to be one of the largest such fines in American history, was reached by combining Google’s profits made from the AdWords used by the pharmacies, plus gross revenue made in these sales to US consumers.

The fine allows Google to avoid criminal prosecution, but the settlement also details that steps must be taken by Google to avoid such an event in the future.

“It is about holding Google responsible for its conduct by imposing a $500 million forfeiture, the kind of forfeiture that will not only get Google’s attention, but the attention of all those who contribute to America’s pill problem,” Attorney Neronha added.

The US Department of Justice stated that while Canada has its own laws for prescription drugs, these drugs being imported into the US are not always subject to Canadian regulatory authority and could come from anywhere.

The Department of Justice said that Google was aware “as early as 2003” that it was illegal for pharmacies to ship unlicensed prescription drugs into the US from Canada, but had failed to take action.

The Department also stated that from 2003 to 2009, Google provided customer support to some of the advertisers, assisting them in optimising their advertisements.

But in a statement, Google claimed to have previously banned the advertising: “It’s obvious with hindsight that we should not have allowed these ads on Google in the first place”.

Acting Director Martin-Weis of the FDA, who was involved in securing the fine, said: “The result of this investigation has been a fundamental transformation of internet pharmacy advertising practices, significantly limiting promotion to US consumers by rogue online pharmacies”.

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