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Panel provides tips for responding to potential violations

Pharma Compliance Alert, November 12, 2008

Compliance officers need to get out of their offices and interact with employees, Liz Lewis, JD, vice president, deputy general counsel, and chief compliance officer at Millennium Pharmaceuticals said during the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C., October 27-29.

Reporting a potential violation to the compliance officer in person is one of the toughest things for employees to do. People are more comfortable talking to someone they know, Lewis said, and that may make it easier for employees to bring compliance concerns forward. Lewis also said she tries to be reasonable when people report potential violations so they will not be uncomfortable coming in again.

“It only takes one bad experience to make no one walk into your office again,” Lewis said, adding compliance officers should make sure to stay out of the gossip mill so people feel comfortable reporting concerns.

One key is to imbue everyone with the idea that compliance is a good thing, said Dan Dovdavany, JD, senior corporate counsel, investigations, at sanofi-aventis. He said companies need to create an environment where reporting potential problems is used for good and the company’s non-retaliation policy is enforced.

Companies also need to treat all employees equally and conduct all investigations in a consistent manner. Companies also need to have a transparent investigational process in place, said Wendy Goldstein, JD, MPH, a shareholder with Epstein, Becker, and Green. She also recommended compliance officers honestly explain to employees what they may encounter as a result of reporting suspected compliance investigations, including the possibility the person may not remain anonymous.

When an employee reports a potential violation, investigators must wade through a lot of information before they can find the information they need. Compliance officers can also leverage human resources, Lewis said. HR can help ensure consistency in both the investigation and any resulting disciplinary actions necessary. Sales representatives may be more comfortable hearing from their HR representative.

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