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  • Regulatory NewsRegulatory News

    Keeping an Eye on Corporate Integrity Agreements

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Even in the world of healthcare product regulation, the initials CIA sti...
  • Feature ArticlesFeature Articles

    Evolution of Board Responsibility for Compliance Program Oversight

    Will the Pfizer Class Action be the Missing Link? This article examines how OIG's expectations of the role played by a company's Board of Directors in overseeing corporate compliance programs have changed over time in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley. In March 2015, a US district court tentatively approved the settlement of a class action lawsuit filed against Pfizer Inc., in connection with the off-label promotion of a number...
  • DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever

    The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...
  • Warning Letter Forms Partial Basis for Corporate Takeover Attempt

    • 14 August 2012
    A warning letter sent to Forest Laboratories by the US Food and Drug Administration (FDA) is fueling the latest salvo in a long-running proxy battle between activist investor Carl Icahn and the company. Icahn has for months been trying to take control of the company through its board of directors, saying the company has been underperforming to the detriment of its shareholders. On 13 August, Icahn blasted the company , saying it had failed to disclose a warning let...
  • GSK Settles Charges, Agrees to Record-Setting Fine

    British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs. In a statement released 2 July , US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupr...
  • Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

    Pharmaceutical manufacturer Abbott Laboratories has agreed to pay a near-record $1.5 billion in fines for the off-label promotion of its anti-seizure drug Depakote, with the total to be split between the federal government, states and consumers. In a lengthy statement released by the Department of Justice (DOJ), Deputy Attorney General James M. Cole called the settlement a "strong message to other companies" not to engage in fraud. DOJ explained in its statement that ...