Archive for July, 2013

Managing Integrity in Deed by Clarity of Word

This article was first published at Pharmaceutical Compliance Monitor on July 17, 2013.

The world is full of obvious things which nobody by any chance ever observes.”

–Sir Arthur Conan Doyle

As the field of modern American healthcare continues to flex its newly grown muscles under the Affordable Care Act, the need for commitment to corporate integrity becomes ever more apparent. In a perfect world, the question of whether such leadership should come through an edict from the Federal Government or be provided as a matter of course within each individual company should not be a subject of debate, and yet recent failures on the part of of certain corporate giants within the health care community have forced the issue to the forefront, making those tasked with compliance ask the question “where does compliance begin?” The unnerving truth is that in today’s age of regulatory enforcement, the existence of an integrity agreement is little more than a necessary prerequisite, and its effectiveness suffers greatly as a result.

Most compliance officers agree that pharmaceutical companies should have a robust compliance program, yet at the same time, these same individuals may hold vastly different viewpoints about the infrastructure necessary to allow such programs to function in a corporate environment. With an eye on company revenues and private sector profits, pharmaceutical companies should never see a thoughtful and effective compliance program as simple counterbalance, though this is often the case.  To do so may lead a company into the path of wary and watchful government regulators equipped with newfound investigative strengths. While not always a foregone conclusion, a pharmaceutical or biotechnological company would be wise to fear the impact of a mandated corporate integrity agreement (“CIA”), especially when it comes at the heels of a state or federal investigation. Continue reading →


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