Course shows companies what NOT to put in writing
By Bill Berkrot
NEW YORK (Reuters) - Want to avoid those embarrassing internal emails containing concerns that an important product may be harmful, or documents that could attract the attention of an ambitious prosecutor?
The Medical Technology Learning Institute and Compliance- Alliance is offering: “Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails” — a course tailor-made for the drug industry and medical device company executive anxious to cut down on pesky multimillion-dollar legal settlements.
Dangerous Documents offers such helpful tips as: Instead of writing, “We’ll meet on Thursday to destroy the documents,” it’s better to say, “We’ll meet on Thursday to implement our document retention policy.”
The course is the brainchild of Compliance-Alliance founder Nancy Singer, a former U.S. prosecutor who did litigation for the Food and Drug Administration.
Singer is using her expertise to educate company officials on how to write internal and external communications that do not contain potential “land mines,” which she describes as anything that “if it’s uncovered, it explodes.”
“Documents are like diamonds,” she is fond of saying. “They are very precious and they last forever.”
The Compliance-Alliance mission statement says the course will present “the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements.”
But there appears to be more here than instruction on how to be an upstanding corporate citizen and keep government agencies happy. The course agenda reads more like a primer on how to avoid raising red flags with the regulatory police or the suspicion of prosecutors and product liability lawyers.
Some of the more eye catching topics listed in the program for the $995 course include:
* Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act
* 18 words that will attract the attention of prosecutors or plaintiffs’ lawyers
* 8 common practices that are sure to get you in trouble
* The dangers in not monitoring employee emails
Singer insists this is not about how to bury negative data or avoid getting caught for nefarious practices.
“I want to educate all employees on the ramifications of how inappropriate statements can be used,” Singer said. Continued…
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