a morning morning before he began i would like to make clear on the record that all of the parties to this case agree that anything that is in their briefing in administrative prakriti in this case can be discussed on the public for that use is only seven point five milligrams marker some there is about one dose for a fairly rare use of the drug that is mentioned on the label that does require seventy five milligrams to be administered and f d a pointed that out in the citizen petition even seventy five milligrams though your honor is significantly less than one hundred seventy five or two hundred fifty the question for the court is whether these where it is more than fifty that's correct your honor the question for the court however is whether f d a was permitted promise of a factual promise behind that question drug has to be intended for a specific indication otherwise from this branding statute and all of the requirements to have adequate instructions for intended uses would make no sense at f d a for its part i think page twenty nine where it says combination with everything else in the administrative record which includes f d a is medical review at page six ninety seven of the administrative record where the medical review team at f e i estatic that the larger vial sizes were to support the is charged with looking at the labeling the report that they issued said again that the larger vial strengths were to support colorectal cancer and in fact they proposed amendments to the labeling to clarify how it should be used in colorectal cancer treatment again spectrums application itself i j h seven twenty five makes the same point it lists the proposed indication for the larger bio strength to be colorectal cancer  a from approving an application for such drug for such disease or condition so the question really is what is an application and how does that determine what an application is really for and i'm like the fourth circuit case here of the application itself contained an inherent mismatch standards and f d a would like you to focus solely on the use listed on the proposed labeling they submitted but of course f d a does not out review an application based solely on the proposed labeling it has to look at what that liebling will be attached to and here that labeling is proposed by sandoz to be attached only to these large strength vials those large strength vials of course are the ones that spectrum and f d a have recognized it's a part colorectal cancer treatment it's in fact when sanders submitted its application when it initially applied for before it realized there was an orphan drug exclusivity problem with getting that approval so  unlike the fourth circuit in the in the sigma tab case which of course is that case from a different circuit and thus not binding the question that was presented to the court was when there was a disconnect between a proposed label and x the confusion comes in because if they had submitted this application for methotrexate rescue and they had proposed to put that label on a fifty milligrams pile we wouldn't be here today we wouldn't have any objection to that because it is a plausible down in some respects to a factual question of whether what you just said is so corrupt that it would be on reasonable for f d a to conclude otherwise they during the course of any process but you come to a final conclusion that may be different from statements made in the course of the process of that final conclusion was inconsistent with what you just said that the larger vial sizes were else would show that there are unreasonable in concluding what they concluded so i think there are a number of things that answer your honor's question one of them is that we think the language of the statute focuses on the application as a whole there is no indication in the statute that congress intended drug that was the core holding ink in sigma talent and we don't disagree with that when a specific use though has a specific formulation that is really intended objectively intended only for that use and already taken upon itself when it interpreted and promulgated regulations to implement the orphan drug act this same the same analysis that we are saying it should have performed in this i guess what i'm getting at is when they say that a drug meets that standard how are we to the source whether f d a is wrong that that's the heartburn one thing that's interesting your honor i would i would suggest you read if you read the ascii a brief and you read standards this brief there is no statement in that brief in which a says we believe that this hundred seventy five and two hundred fifty milligrams vial are intended for methotrexate rescue they don't say that in fact it would be very difficult for them to say that given everything else they said  point five milligrams could be withdrawn from i want to determine for both and it's primarily intended for the one that they can't be intended for but it's still secondarily intended for one that is promise for how are we supposed to parse that is i think the situation that was the case in sigma tao there and there was a plausibly intended use that was on the label and the pioneer company was arguing there was actually if you looked outside of f d a as record there was other material that showed there was another intended use in our case you don't get past that threshold question because the labeling is simply not plausibly intended to be applied in the mathematics to the rescue use and that's really our this is a case where the agency is asking the court to allow it to indulge in this willful blindness so they doesn't need to look at material in its own files that suggest that there is an inconsistency that mismatch between the label the use and the the product on which it is placed makes this case different from the other ones the c r c that the colon rectal cancer indication also explains f d a is lack of concern with the with the overfill that would be in this drug product f d a has guidance documents that direct parties as to its view on how much extra drugs there should be and f d a brushes that guidance document aside here the park or a foreseeable use test and again that is dr makes this case quite different from state mentality a foreseeable use test would depend on things that f d a can't actually analyze in a pre approval contacts like the marketing data that was at issue in cigarette towers like how insurance companies will reimburse the strug the things that we are pointing to and say saying that f d a can't choose to disregard are things that f d a already knows that are already part of the review process f has to undertake in order to approve the application for sandoz this drug and the application is what is the focus of the statute the intended use comes in three three sixteen point three b fourteen in  indication intended for the methotrexate indication likely also intended for color rectal cancer but at least plausibly intended for one indication that would be on its label and so this is not an attempt as n p r mass of a pioneer company to block competition this is an attempt to ensure that any competition that f d a authorizes to come on the market is lawful competition i can reserve the remainder of my time for abo this as the refuse website probably states the f d a is responsible for for for for protecting the public health by sharing the safety if you see it security of among other things human drugs in sexually abuse efforts to protect the treatment of methotrexate indications but aren't we supposed to look at the real world in the real world we all know what's happening or will happen at this the at the pre the free suggest that it's being marketed for another or being approved for another use yes technically that file size can be for the other indication but we all know that it's going to be prescribed  that's only if there's marketing right i think i mean that says and get to the doctors find the correct the the post  the post market or the other words the cartwheel wrong doctors are allowed to prescribe the higher vial size for the uses to which they have excellent seventy that's correct and the f d a is wants to be careful not to infringe upon that it's it's well established that the f d a does not regulate there are least two medications which go beyond fifty milligrams one i believe that's a seventy five milligram medication another which ranges from eighty five ninety milligrams in addition that's far short of one seventy five to or did f d a rely upon in determining that they won seventy five to fifty size vials are appropriate and safe and effective for the methotrexate indications and the primary thing that f d a relied upon the spectrum submitted for the drug included the methotrexate indications on the one seventy five to fifty as we pointed out in our brief when the f d a was finalizing the draft labeling they sent the labeling that included the matter tractate indications to spectrum and spectrum did not respond with any objections wait a minute you're not supposed to include the methotrexate in patients so even if you were  indications as well as the as well as the cole rectal indications the other thing that i wanted to address the judge capitalist question about don't you look at don't we need to be concerned but the real world what's going to happen in the real world that's not what congress intended the plain language of the statute says it cannot be approved for such drug for such use or such a disease or condition which f translated in its regulation to force such use or indication basically the same language and commentary about three sixteen point thirty six i'm sorry three sixteen point three b fourteen in the definition the intended use is in that definition but it's the definition of what is the same drug it's not the definition of what is the use or condition or disease or indication it's the same drug there's no question this is the same drug are drugs of the same drug as their drug but what congress says is you cannot approve the same use of disease indication condition for the second and that's the exclusivity that spectrum has gotten and has received and has not been violated and for the same reason because that restriction has not been excluded or exempted or waived there was no need additional difference between the fifty milligram vial and the one seventy five milligram vial and besides just the size of the vial as the record makes clear the one seventy five to fifty vial is a ready to use vial in other words there's no mixing that's required by the clinic in order to administer the drug the fifty milligram on the other hand is  reconstituted so it could well be that the reason that the market is interested in the larger size vial is not because of the size of the vial but because of the convenience of being able to administer a ready to use drug and that would support people wanting to use the larger size vial for the methotrexate indication as well as the fact the fifty milligram under some circumstances may be too small does your reading of the statute allow  for the f d a ever to consider the intended use not under the orphan drug act as your honor found in the us against regenerative science case intended use is important for required to do extra research into what foreseeable uses might be out there what it can't do is put its head in the sea and ignore things that are in it's and records here in particular among other things there was a drug shortage that was affecting treatment for colorectal cancer and f d a was very concerned with remedying that shortage that's why it improperly expedited review of standards this product it's why f d a here could ignore the overfill issue the overfill guidance that it's always f d a burden to offer a reasoned decision making that accounts for all of the evidence in the record that's what they have not done here that's where they fell short in response to mr parker's point about the proposed lastly i'd like to reiterate that all statutes must be read in the context of the broader statutory scheme here three sixty c c is part of that f t c essay and the f t c is premised on the notion that when manufacturers come to a and seek approval for a product that approval that they're seeking is for the use they intend to put the product to when that is not met what you have is a label that is a mismatch for a product and that's where there's simply no way that congress could have intended on ambiguously for f d a to approve labels that are not reflective of an intended use of a product thank you very much ro