Stumbling Bear, concur on your posting.
Abrams speaks first. Talks about how 80% of prescriptions for kids are off label. Also mentions that in one year 50% of scripts for V are off label and another year 30% are.
Judge questions about claims AMRN wants to make, DS vs V, and why AMRN didn't go talk to FDA first. AMRN quoted from documents or expanded on those points for much of response. Judge asks if science changes for worse, people start dying, how to address that issue. Abrams responds judge can change order.
FDA's turn. First thing they state that drug has NOT been found to be safe. Judge stops right there and starts questioning about safety as he was under impression that both agreed safe. FDA says no, Anchor study only 700 vs 36 million in the Anchor indication.
Judge mentions all the off label scripts being written now. Questions if FDA has received negative feed back. FDA-no.
Judge and FDA go back and forth, but Judge tries to get FDA to admit that safety and efficacy are different issues, but FDA trying to lump them together.
Judge questions them on DS vs V. How is V not safe? Basically paraphrasing, Judge says you approved V, what's your problem?
Judge questions to FDA if V isn't safe, what is?
FDA goes to disruption and it being like pre-1962.
Judge wants them to answer how DS can make heart claim and V cannot. Judge wants FDA to quantify why not safe, which FDA has no good answer. Judge asks if safety profile was determined for DS. FDA said no. Judge questioning a lot about safety. Asks why FDA did not address any safety issue in June 5th letter.
FDA states it is not ok to make heart claim with disclaimer. Judge questions FDA about whether FDA plans on not allowing DS's to make heart claim. FDA says DS are still going to be allowed. Judge pushes as to why it's a true statement on DS, but not V. Judge having trouble with difference.
Judge questions FDA about truthful labeling and FDA says that can be a basis for prosecution. Judge talks to FDA about Caronia, which he re-read at the break and starts questioning FDA about that ruling. Big difference of opinion between FDA and Judge on the meaning of ruling. Judge asks if any other cases post Caronia, FDA says no. Questions FDA why they have not come out with new guidelines since that ruling and asks FDA if any new guidelines this year. FDA-no. Judge asks if there is a difference between a doctor starting a conversation about V vs a drug rep. starting a conversation. FDA states as long as doctor starts conversation, then speech is permitted. FDA states AMRN cannot start speech. Judge states he reads Caronia very differently from FDA. Judge asks, "If all you have is speech, how do you prosecute?" Judge reads last sentence in Caronia and tells FDA don't you have a problem? Judge pushing his view. Asks FDA if they retried Caronia. FDA-no. Judge asks why not?
Judge asks FDA if they will allow AMRN to do as they ask? Questions FDA about how they can prosecute for truthful off label claims.
Judge questions FDA about how can they allow research papers be discussed in scientific setting, but not by AMRN reps. Also asks about how come research papers can be discussed off label but cannot be distributed by reps. FDA-reprints show intent which is not allowed and can be prosecuted.
Judge questions why allow printing of study for off label use. States it's obvious the purpose of putting it on paper is to use it off label. Judge asks FDA if science changes (for worse) , how would that affect his ruling. I believe judge throws out idea about reporting back to him if changes need to be done. FDA says OK. Judge questions FDA about if V is both a drug and DS at the same time, drug for over 500, DS for 200-499 can label be the same. FDA says yes. Judge questions FDA reasoning since both would be identical. Judge talks to FDA about disclosure AMRN wants to make. FDA says misleading, science is biased. FDA asks for opportunity to counter AMRN disclosure with their own modification if judge rules against them. Judge has problem with most contested disclaimers by FDA are allowed on DS's but cannot be on V.
I would be shocked if AMRN doesn't come out with most everything they want. It seems that the most debate and push back by FDa were about heart claims.
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