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As a former attorney in the U.S. Department of Justice's criminal division, Robert Litt knows plenty about what precautions companies need to take to stay on the right side of law. Now a partner at Arnold & Porter LLP (Washington, DC), his advice includes a list of six things that a company can do to help avoid problems related to compliance issues and what to do if problems occur.1. Have a real compliance program. Show your commitment to the law, don't tell it. It's not enough to just have a compliance program in place.
March 31, 2008
1 Min Read
Companies need to have serious training and supervision to ensure that companies understand and follow the rules. Make sure there are consequences when employees aren't compliant, too.2. Make sure there is separation between science and sales. There's a place for science, and there's a place for marketing.3. Be careful how hard you push the envelope. While some degree of risk-taking can be beneficial, companies also face the danger of coming too close to the line and then realize that the line isn't where they thought it was. By then, it's often too late and the government has taken enforcement action.4. Investigate and remediate. Find out what the facts really are, and if you find that something is wrong, fix things before the prosecutor tells you to fix it.5. To cooperate or not to cooperate? Litt advises, as a safe course of action, to always try to work with prosecutors but... (see #6)6. Don't say too much too soon. In addition, don't take an aggressive posture. Hear what the prosecutor to say, and then educate him or her about the situation.Litt spoke at the Medical Device Congress held at Harvard University last week.-- Maria Fontanazza
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