Thanks. I think both parties recognize that the injunction basically decides the case. The Judge asked some questions about what the FDA intended to do if he decided against them, in terms of seeking a stay of his order pending appeal to the Second Circuit, but the FDA was non-committal.
No mention whatsoever of anti-trust, nor would I have expected it. No mention of FDA "poor treatment" of Amarin or bad science behind recession of SPA, etc. Stuck strictly to the Complaint.
There are lots of tidbits in my notes which I hope to post when I get a chance. For example, FDA started their entire argument disagreeing with Amarin's claim that the drug is "safe" and is not an issue. She argued that safety is still an issue because the drug can only be "safe" if there is an actual benefit that was established. Since no benefit demonstrated for that population, then safety remains an issue. The Judge looked somewhat perplexed at this line of argument, stating, "I thought that "effectiveness" is separate from safety. Is there a safety problem? Have you heard any complaints from the field from all the people taking Vascepa?" FDA: No. But the Anchor population is much bigger -- 36 million -- and there is no data on whether there would be safety issues in that population. Judge: But you have approved Marine -- if there was a safety issue, why would you have done that? FDA: Because it was safe in that context; a drug is not safe if it is not effective.
The Judge did not buy any of this and it was exactly the wrong way to start the FDA's argument.
Another nugget: Judge: So if doctor calls Amarin and says I have questions about what are FDA approved uses for Vascepa vs off-label uses, and if Amarin answers truthfully, its not misleading, but if Amarin calls up the doctor and has the exact same conversation, the speech is misleading because there is an intention to promote off label? FDA: Yes. Judge then points out that everyone knows that the intention is always to promote the drug.
Judge also asked why the FDA didn't appeal or re-try Caronia -- no good answer.
Judge delved into whether there were mechanisms to change course if he issued an injunction and new science came out disputing the claims. All basically agreed there were mechanisms in place including consulting with Amarin, asking the Court to overturn its order, or withdrawing the drug from the market.
Court also asked how long it would take to finalize their "guidance" as expressed in the letter to Amarin. The FDA attorneys looked at each other blankly. The Judge: Two months? By Labor Day? 2015? Can you give me something to give me an idea whether the FDA might issue something to narrow the focus of this? FDA: No response. Silence. "We really cannot say how long it might take. Public comment could take a year."
I don't want to imply that the Judge was ever critical of the FDA or torpedoed them or expressed obvious dismay with their arguments. The Judge was completely impartial. He just peppered them with hypotheticals that they simply couldn't answer and pointed out the inconsistency of their positions and the fact that they have not successfully distinguished this case from Caronia.
And now back to work!
