Hawk...
Judge Englemayer bases his judgement in the Amarin suit on his review of Caronia which he deems relevant.
The principle in Caronia is FDA is prohibited from prosecuting a drug company for off label promotion as long as the promotion involves truthful and non misleading speech. Caronia does not protect truthful and non misleading speech if the promotion also includes illegal acts such as bribery or undisclosed financial incentives. Caronia does not protect un truthful speech. Speech can oral or written.
This gives Amarin a wide margin, but it is prudent for Amarin to submit written material they intend to use for promotion to the FDA for their scrutiny to avoid a situation where the FDA might claim the material was false or misleading. Any dispute here might be adjudicated by Judge E. Amarin however is not limited to 13 articles.
If you read the transcripts you will see there is a lot of nit picking on the part of the FDA doing everything in its power to scuttle Amarin's "end run".
The Judge also strikes down the notion that drug companies can not approach physicians pro actively, but must wait for the Doctors to request information. The judge refers to that concept..as "the FDA's preferred method of disclosing truthful information."
The picture you get is one where the FDA is clearly more focused on its authority at all times. With much less interest in its own competence, or its charge to protect the public. Why would anyone with an interest in improving the health of Americans want to stifle and censor the flow of truthful information to doctors who are charged to treat these Americans. The suppression of science and ideas puts the FDA in the company of the medieval church, Russia in the pre sixties and the Taliban.
Englemayer has already reffed a number of disclosures in the law suit..My guess is he will be called on to do that in the future.
":>) JL
News 
Market Data 
Discover 
AI
