This name will be very familiar to Rog, as I've been telling him to read this for years. I actually reread it this month, so I can discuss with a lawyer friend, the topic of FDA jurisdiction and preemption for medical devices vs. drugs/biologics. [What do you discuss on vacation????]
David Kessler is former FDA commissioner under George HW Bush and Bill Clinton. He is known for many things, the most notable of which was his fight to have nicotine fall under FDA jursidiction, as a drug delivery device. The question he said, hinges on the intent of the tobacco companies: is the intent to deliver an addictive substance. Kessler feels (and proves) the answer is an unequivocal "Yes". He also felt the conversation and laws should turn, so that smoking is recognized as a pediatric disease. If you do not start smoking by the time you are 18, odds are extremely high that you will not ever start. Kids, never intending to become addicted, take a single cigarette and try it, and before they have time to think about the consequences, are hooked for life. Kessler wants to regulate cigarette availability to minors. He ultimately took his battle to the Supreme Court, and lost in a 5-4 opinion during the Rehnquist court. I believe the case is FDA v. Brown & Williamson.
The book is fascinating, thought-provoking and certainly controversial. It will make you angry beyond belief.
And it's a "must read". I've read it a half dozen times, and have given it as a gift a few times. For years it was my "best book ever" until finally Shilts' book superceded it (clears throat to Roger).
Next time-- a light offerring. Really!!!
Lisa
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