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4 Lessons Learned from Corporate Integrity Agreements: A Roadmap to Effective Compliance
Not so long ago, headline news from the Life Science industry celebrated new medical treatments and discoveries. But in the past few years, and notably in more recent times, these headlines have focused on fraud and abuse. Swirling round them all were acronyms (most notably FDA, SEC, DOJ, CPA and FCA) and allegations that stretched from off-label marketing and kickbacks to defrauding government-run health plans.
There is zero likelihood that enforcement agencies will lose their appetite for investigating the Life Science industry. Those attending a recent Pharma Congress heard Assistant US Attorney General Lanny Breuer promise a laser focus on the industry. He pointed out that the United States and international enforcement agencies were building a united front against bribery and corruption through shared information and investigations. He didn’t stop there. The US Department of Justice’s (DOJ) interest in the Pharmaceutical industry, according to Breuer, extended beyond its early target areas of illegal payments to regulators for approvals, to government employed doctors and hospital committees or drug/device purchases, and to sales agents for illegal sales. The DOJ will continue to investigate and prosecute those old standbys, but the newest, and potentially greatest trigger for DOJ attention centers on payments by the industry to foreign doctors conducting clinical trials abroad.
To outside observers, the fines and penalties represent the most significant feature of settlement agreements. From inside the industry, the accompanying Corporate Integrity Agreement (CIA) or Deferred Prosecution Agreement (DPA) presents as much, or more, of a challenge. A typical five-year CIA imposes high costs, oftentimes the presence of an outside monitor, compliance demands that permeate every aspect of a company’s operation and 24/7 vigilance.
Key provisions of recent CIAs create a road map to compliance before violations or enforcement actions occur. In this paper, we look at four of the most frequent provisions – and what companies should implement as core elements of a robust compliance program.