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The general approach is pretty simple.

#1  Be competent.  Making regulatory and compliance decisions and giving direction requires in-depth knowledge of FDA laws and regulations that apply to drug marketing and promotion.  But it doesn't stop there.  It also requires extensive knowledge (and homework) to understand specific products, their labeling, their development and regulatory history as well as the entire regulatory background for the product's class. Competence comes from experience.  I have a lot of that, but experience isn't everything. Competence also comes from continued research and study of historic and current interpretations of the regulations and enforcement.  Whatever knowledge is necessary to make good decisions, you have to pursue it. Know a lot.  Know what you don't know.  Continue to know more.

#1  Be ethical.  Yeah, that's two number 1's.  I know.  But in this line of work, you can't make decisions to ensure truthful, non-misleading, fair, balanced, and useful medical messaging and communications unless you're competent.  If you make bad decisions resulting in false or misleading advertising, promotion, or medical communications, then the result is that (intended or not) the company is thought to have acted unethically.  The ability to have effective marketing of a medical product requires a good story, a good plan, and a steady compass for the truth regardless of the business tensions.  At the complex intersection of patients, doctors, marketing teams, sales teams, review committees, investors, lawsuits, government enforcers, payers, the media, and the fragile uncertainties of science and medicine--there lies an exceptional need for the competence to act ethically and to make ethical decisions.

#2  Be reasonable.  This one is a no brainer, but it's vital to understand each person's role in any decision making process.  On a personal level, whether its a marketing person, a regulatory or legal person, medical, the government, etc.; there are no enemies.  There are just goals.  Interpersonal conflicts can make even the most competent people entirely ineffective.  It's important to be reasonable and sympathetic, in addition to being right.  

#3  Be creative and open to new ideas.  As the regulatory or compliance person in the room, no one is going to mistake me for the "creative" guy.  But who doesn't like a creative campaign or program?  Its often difficult, but if a message or program is a good idea...its truthful...and helpful to patients and healthcare providers, then who does't like trying to find a way?

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