Merck & Co will pay $950 million, which has already been set aside, to settle criminal and civil charges with the US government regarding off-label promotion of its now-withdrawn painkiller Vioxx.
Merck will pay two-thirds of the reserved charge to resolve civil allegations related to Vioxx, which the firm says does not constitute any admission of liability or wrongdoing. However the company has agreed to plead guilty to a misdemeanour of marketing Vioxx (rofecoxib) by sales reps in the USA for the treatment of rheumatoid arthritis before the FDA’s approval of that indication in April 2002.
Bruce Kuhlik, the firm’s general counsel, said “we believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx”. The company also has entered into a new corporate integrity agreement, and Merck “recognises the importance of robust compliance programs and is committed to adhering to the law”, he added. Mr Kuhlik concluded by saying that the settlement of this lengthy investigation is in the best interests of our stakeholders”.
Settlement of the investigation, which began seven years ago, is signed with the USA and individually with 43 states, plus the District of Columbia, Previously disclosed litigation with seven states remains outstanding.
Tony West, assistant attorney general for the civil division of the US Department of Justice, said that “when a pharmaceutical company ignores Food and Drug Administration rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients”. He added that “as this plea agreement and civil settlement make clear, we will not hesitate to pursue those who skirt the proper drug approval process and make misleading statements about the safety and efficacy of their products”.
