The Pharma Letter | 13 August 2010
According to a report by the UK’s Financial Times, the US Department of Justice is scrutinizing payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.
Among the drugmakers cited, the FT says that the UK’s GlaxoSmithKline and US majors Pfizer, Bristol-Myers Squibb and Eli Lilly, as well as others, have revealed they have been contacted by the DoJ and the Securities and Exchange Commission in connection with the investigation. Also, Merck & Co last week said it too had been contacted and was co-operating with the probe.
An industry lawyer familiar with the probe quoted by the newspaper said that the DoJ was looking at whether pharmaceutical companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law. The highly regulated nature of the business, and the fact that health care officials in many markets were government funded, made the industry a natural target for such a probe, the lawyer added. The investigation is at a relatively early stage, but is considered a priority for the DoJ.
The DoJ declined to comment, said the FT, but noted that, last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years.”
According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the USA. A recent report by the Department of Health and Human Services found 80% of marketing applications for drugs approved by the Food and Drug Administration in the USA had relied on at least one foreign trial.