Less than a year ago, Amgen Inc. had a major compliance problem. The biotech juggernaut was selling three different drugs for “off-label” uses and at doses not approved by the Food and Drug Administration—all while paying doctors to prescribe them. Someone blew the whistle, and the resulting U.S. Department of Justice lawsuit squeezed Amgen for a guilty plea and $762 million, the largest settlement any biotechnology company has ever had to pay.
The case became a symbol of what Ernst and Young attorney Ted Acosta calls “extraordinary change” in compliance for the pharmaceutical industry. In the last decade, Acosta said in a recent report, “Life Sciences Compliance: The Last Decade” [PDF], the areas that big pharma are accountable for have expanded rapidly—particularly in compliance with federal regulations like those at the FDA.
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