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 brain child 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 "landmines," 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."
However, 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. Continued...