Merck pays $950 million to settle Vioxx charges
pharmafile | November 23, 2011 | News story | Sales and Marketing | Department of Justice, Merck, Vioxx, marketing violations, off label marketing
Merck will pay out $950 million and admit that it illegally marketed its painkiller Vioxx in the US.
It will pay $321.6 million in criminal charges after pleading guilty to promoting Vioxx as a treatment for drug rheumatoid arthritis treatment before it was licensed for the use.
The FDA approved Vioxx for three indications in May 1999, but did not approve its use for rheumatoid arthritis until April 2002. Nevertheless Merck promoted the drug for rheumatoid arthritis for nearly three years, and received an FDA warning letter about the ‘off label’ marketing in September 2001.
In a parallel settlement, Merck will also pay $628.4 million to settle civil charges that it made false statements about the drug’s safety.
The charges are the latest controversy around the notorious drug. Vioxx (rofecoxib) was withdrawn in 2004 after the drug was found to significantly increase the risk of heart attacks and stroke. In 2007 the firm paid $4.85 billion to settle the tens of thousands of litigation claims surrounding the use of Vioxx.
Tony West, assistant attorney-general for the civil division of the US Department of Justice, said: “When a pharmaceutical company ignores FDA rules aimed at keeping our medicines safe and effective, that company undermines the ability of healthcare providers to make the best medical decisions on behalf of their patients.”
The US government will get $426.4 million from the settlement, and $202 million will be distributed to state Medicaid health insurance programmes for 43 states, and the District of Columbia.
As part of this week’s settlement, Merck also entered into an agreement about its sales, marketing, publication and government pricing activities.
The Department of Justice said that agreement strengthens oversight of the company and will require top officials to complete annual compliance certifications, and the company will post information about payments to doctors on its website.
As part of the plea agreement, the Department acknowledged that there was no basis for a finding of high-level management participation in the violation, according to Merck.
The massive fines imposed on Merck are just the latest in a string of cases brought by the US government against pharma companies for marketing violations.
In 2009 the US government imposed a $2.3 billion fine on Pfizer for a string of offences including illegal off-label prescribing of Bextra – its rival to Vioxx – and bribery of officials.
Earlier this month GlaxoSmithKline agreed to pay $3 billion to settle US government investigations into the sales and marketing of diabetes drug Avandia.
Ben Adams
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