thing courage is roughly a million patients a month a million patients a month to be treated for a longer use of a laxative with the benefit of the doctor's supervision and this is everyone's agree whether differences in duration of use can be a meaningful safety based distinction short the argument that we make which i think very straightforward is undisputed is that there is a serious risk during this the second week of use that there would be safety problems that's the definition of a prescription drug notices on a small bottle if that were true we would need prescriptions at all because if you want your hypothetical assumes that everyone after a week is going to terminate you see a doctor  don't know i don't agree with that if we with one distinction here is that there's a unique circumstance idiosyncratic to this particular situation of i think the premise is that everybody no matter how infirm i do this fact pattern can be presumed conclusively to be adhering to what the label states and i don't understand you are you have to assume that there are look there  hearing the o t c label otherwise what's the point of your argument the o t c argument labels as use no more than seven days if they're actually using it as long as they want that they wouldn't have any need for the prescription except that we know that's counter factual because we have a million patients roughly we don't know much so so are you telling me that they are reading the o t c where i'm saying that doctors are advising people that stop at the end of seven days that's what i mean i think in some situations they will in some social situations they won't it's been studied i think there's there's so many questions here that are worthy of study because i don't believe that is rigid is saying let's assume everybody here right and so that is been stated that fourteen days is not a safe period that's the definition of descript so everybody agrees that but the what what what's the overall look here is that is the rule that's being applied the meaningful difference cast states that the prescription products safe only under the supervision of a licensed practitioner a safety concern assuming that people are using it for a week which generally you hope they are but that doesn't mean that in the in the context of people going to a doctor that say i am a user that will argue that your stand of the argument  population and the only thing is labeling and they explain that the labeling actually is just an artifact of the way in which they want all in the past they wanted all g c s to be labeled the same it wasn't because this particular drug had to be in a certain way it was because for confusion purposes they wanted them to be the same that's their explanation now you may not like the explanation and you can simply challenge that actually shows arbitrary and capricious but it doesn't seem like that side that's a reasonable claim that's not the same drug and i think that's a i think it's important for me to address that which is it's an internally inconsistent position at times they clearly say that safety based which i thought we'd agreed to earlier and it kind of they say that his consistency and the question of whether or not the standard is the meaningful difference test all the evidence that we submitted is that hospitalizations tripled that's doubled after it went over the counter so the question isn't whether the overpower should be withdrawn it's whether we want to remove a system where a million prescriptions are a month are being are being given by doctors and we have doctor write that's the evidence you're well let's look at it i mean i understand i mean i'm curious skepticism none of this is been looked at before we turn this massive system on its head and throw it out the door let's have some look at these questions presumptively suman that there's no problem because it's a seven days and stop is inconsistent with the fact that doctors are giving a million prescriptions a month to because they believe that's the right way that people should be under doctor's supervision and the only the only what i'm hearing is that even though it's a meaningful difference because it's safety based which everyone agrees the seven verse fourteen safety base that's why the f d a refused to give fourteen days to the over counter right everybody agrees that the safety base thinks it meets the standard that this isn't something all i'm hearing is that we're assuming that after seven days everyone's going to stop so what's the difference right that that's the argument and i just do not think in  complex a system like this with the infirm people addicted people that are going to doctors and being under doctor's supervision and saying ok that you need to be an opioid detox rather than taking this week after week throwing out all out just because we assume as a matter per se that people stop after we just seems to me to be totally improper when everyone agrees that there's a safety base distinction which meets exactly their standard and the one point i available at a different dosing regimen or duration of use does not require physician involvement it's right in their own notice so by the standard of everybody follows what the look the put the print on the person on the bottle you never have duration of use being a problem because you can always just say and use this way go see a doctor but let's not let's get out of that order fishel world and deal with the people that are getting doctors help at a million a month so that people that much please the court sarah caroline we have the government f d a reasonably with through the approvals of petitioners products which as judge garland noted are identical to over the counter me relax in every meaningful respect they have the same approved indication for more than a week it's not that the paying fifty or whatever it is itself miramax itself becomes more dangerous to use it as an addictive it doesn't build up toxicity it's that after a week we don't trust the patient self diagnosis anymore is that the safety risk that's how i understood it i think that's basically right judge millette i think the concern the public health determination f d a has made is that essentially if people have these symptoms for seven days  and haven't gotten relief from the over the counter product there might be some underlying serious condition and the persians should see a doctor to see if you know it is something like that there's nothing in apart from th but then there's that footnote and surely there are certain drugs if used for a short time are perfectly fine but over a longer period of time can build up either addictive qualities just based on the duration of use or a buildup of  the reason i don't know that is because none of the examples that f d a cited in that footnote or elsewhere relied on either duration of use or driessen of therapy standing alone to find a meaningful difference so i frankly don't know exactly what that reference in the footnote meant but it doesn't matter because even if the duration of use or grecian therapy whether they're the same or the different or different could hypothetically somewhere be enough standing alone to create a meaningful difference it certainly doesn't here right that's right and in view especially of f d a is determination that that near lax is effective within less than a week you know perhaps three or four days to treat vacation constipation which is the only indication that either the prescription or the over the counter product is indicated for it made perfect sense to adhere to f d a its longstanding policy suggesting that people see a doctor after seven days and happy to answer any other questions that the except for the one of the last case duration of use is not an absolute bar and you have to evaluate particular circumstances we're going to light handle got hammered on the nose there needs to be an evaluation as to whether or not people are following the label and whether there's safety issues if it really is a case by case is that was just established in that last questioning then there should be an examination at a four to four and four to six is the adverse event documentation that shows that the hospitalizations have doubled tripled and the that's it doubled and there's a load of information about who's following what which populations are doing what and there's so much to consider to at least look at it since it's case by case and duration of use thank you you've been prevented what was just one minor not minor actually portable one and that before i leave first of all we appreciate very much the court expediting the oral argument we know you're busy in the busy day manifestly and then also if there's any question about whether or not this is going to this that it's going to be upheld or not we would ask for a stay pending a november second date so that we don't turn this whole big system upside down and then have to clean it up but it's not be a one size fits all it's of should be evaluated based on a hearing thank you very much thank you cards in this the insertion to swear in one more new member of the