From the Editor: Incorporating Compliance

With new guidelines and rising scrutiny, product managers need to know what to do today to anticipate a better tomorrow.
Oct 01, 2005

Patrick Clinton
Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in—and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.

The team at Polaris Management explains how to make compliance part of company culture. A company with compliance in its DNA has a better chance of anticipating change, rather than just reacting to it.

An issue that should be on everyone's radar is sampling, argues Steve Tarnoff of the Franklin Group. Devoting most of its promotional budget to sampling, industry passed out twice the dollar amount in samples as it did five years ago. Who could object? OIG for one.

Kashif Chaudry and Anne Love of Clarescent discuss ways companies might use sales force automation and other tools to bridge communication gaps among internal groups, and manage relationships with key opinion leaders. Without communication, doctors are being paid three, four, even five times by the same source for consulting in different areas—and the company doesn't even know it.

Finally, Christopher Lisanti and Pat Pesanello of BusinessEdge Solutions asked 100 high-potential primary-care physicians their greatest frustrations with pharma sales reps. That's something everyone in pharma needs to know. Do you?

Patrick Clinton is Pharmaceutical Executive's editor-in-chief and can be reached at

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