Pharmaceutical Compliance Monitor
The help to keep in Compliance
GlaxoSmithKline’s $3 billion settlement with the government earlier this month – exceeding Pfizer’s $2.3 billion and Eli Lilly’s $1.4 billion settlements in 2009 and AstraZeneca’s and Novartis’ settlements in 2010 – marked the latest of several cases brought against major pharmaceutical companies, in part, for illegally marketing prescription drugs.
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Every compliance officer knows that regulatory oversight and enforcement will continue unabated in 2012. However, here are five factors that could make the risk management challenge even greater in the New Year:
• External Forces
o Responsible Corporate Officer Liability
o Increased collaboration between FDA and OIG
• Internal Forces
o Regulatory knowledge gaps
o Disconnect between marketing and medical/regulatory/legal/compliance functions
o Untrained promotional agency vendors
By actively addressing internal forces within their control, drug and device companies can create a less vulnerable organization in the face of external regulatory compliance pressures.
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