By Lauren Barnett
Compliance Content Specialist, PharmaCertify
For a few years now, individuals from the Office of Inspector General and Department of Justice have been warning the pharmaceutical industry about a movement toward individual accountability in regard to fraud and abuse of healthcare laws. It seems we are starting to see the promise become a reality. Recently, a pharmaceutical executive was indicted on obstruction of an official proceeding, making false statements, and concealing and falsifying documents in relation to a FDA inquiry regarding off-label promotion of one of the company’s drugs. In the DOJ press release an FBI agent was quoted as saying, “This indictment shows that we will investigate those responsible for illegal activities done on a company’s behalf. When individual employees are identified they will be held accountable for their illegal activity.”
As a compliance professional, what is the teachable moment that can be taken from the news of this indictment? While there’s always that “orange jumpsuit” conversation, that is probably not the most constructive approach. There is certainly room to discuss that off-label promotion is still a very hot issue, or a host of issues surrounding speaker programs and advisory boards. These are all great discussion topics, however at the heart of this indictment lays an issue that applies not only to those in sales and marketing, but every employee within the company and one that echoes the sentiments of the government; personal responsibility.
Compliance does not lie in the hands of a select group of individuals with “compliance” in their title. It lies in the hands of each employee. Employees must make sure they understand the laws, policies and ethical standards of the company, and ask questions when they don’t understand. No policy or procedure can address every situation an employee may encounter in day to day activities, so it is the responsibility of the employee to ask questions when the policies in place just don’t seem to fit a particular situation. It is also the responsibility of all employees to hold their colleagues to these standards.
This indictment presents an opportunity for compliance officers and trainers to discuss what has been alleged and the impact beyond the hundred million dollar fines and CIAs. Compliance is more than a yearly check the box exercise; it is about a way of conducting business that benefits both the company and the patient. It’s time for a new conversation.