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Re: Biobillionair post# 208453

Tuesday, 08/13/2019 12:06:57 PM

Tuesday, August 13, 2019 12:06:57 PM

Post# of 425847
How about United States v. Caronia (https://www.reuters.com/article/us-offlabel-conviction/u-s-court-voids-drug-reps-conviction-cites-free-speech-idUSBRE8B21DC20121204)? Isn't that the preceding case that Amarin used as the foundation for their argument? What about United States v. Pacira (https://www.reuters.com/article/us-pacirapharma-fda-lawsuit/pacira-fda-reach-agreement-on-pain-drug-marketing-restrictions-idUSKBN0TY0E820151215), which shortly followed Amarin's settlement? They seem to be doing pretty well.

In any case, arguing that something is a "unicorn event" and therefore the rules don't apply is exactly the kind of speculation that I was talking about in my first post. The FDA is like any other regulatory body with strict rules that are enforced by normal people. If you don't believe me, feel free to talk to anybody with a public sector job that deals with the FDA or USDA about how overbearing those departments are.
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