How to Keep Out of Regulatory Quicksand

Government regulators have never watched pharma sales forces as closely as they do today. On top of familiar reporting requirements, such as how many samples were given to whom, federal regulators want to know what marketers were thinking. Why, they sometimes want to know, did a sales rep give one physician more samples than another one down the hall? If they want more specifics, they can even ask for a rep's call notes. And while the reps are keeping up with federal laws, they have to learn a new set of regulations for every state in their territory. In some states, for example, nurse practitioners can sign sample receipts, but in others, doctors must sign personally for their samples.

Even the hardest charging sales reps recognize that paperwork is part of the job, but many top performers always think about selling first, and filing reports when they can. Putting off the paperwork is tempting, especially if it saves enough time for an extra office visit or two. But, neglecting the rules of state and federal agencies is dangerous. Careless mistakes can lead to big fines and deliberate shortcuts—forging the signature of a doctor who's out of the office—can land a sales rep and his company in criminal court.

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