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ms. ellsworth: yes. and there are two amicus briefs from the pharmaceutical industry that expands on why exactly that is so concerning for pharmaceutical coanies who depend on fda's gold standard review proce t approve their drugs and be able to sell their prodtsn line with that considered judgment. justice jackson: can you say what they y? ms. lsrth: i am happy to. i think the reality is and this decision allow is a good example of. you haveieonne study that was an analysis of anonymous blog pts you have another set of studies that he reli othat were not in the administrative record and would not be bau they postdateheecisions. they have been retracted for a lack of scientific rigor and misleading presentations of data. those sorts of errors can in fact judicial analyses precisely because judges are not experts in statistics or the methodology used for scientific studies and clinical trials. that is why the fda has many hundreds of pages of analysis in the record of what the scientific data showed and c
ms. ellsworth: yes. and there are two amicus briefs from the pharmaceutical industry that expands on why exactly that is so concerning for pharmaceutical coanies who depend on fda's gold standard review proce t approve their drugs and be able to sell their prodtsn line with that considered judgment. justice jackson: can you say what they y? ms. lsrth: i am happy to. i think the reality is and this decision allow is a good example of. you haveieonne study that was an analysis of anonymous blog...
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Mar 31, 2024
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ms. ellsworth: yes. i think he significant concerns and there are two amicus briefs from the pharmaceutical industry that expands on why exact tt is so concerning for pharmaceutical companies who depend on fda's gold standard vi process to approve their drugs and be able to selthr products in line with that considered judgment. justice jackson: can you say wh they say? ms. ellsworth: i am happy to. i think the reality is and this decision allow is a good example of a. you have a district court that among other in relied on one study that was an analysis of anonoublog posts. you have another set of studies ate relied on that were not in the administrative record and wod t be because they stdate the decisions. they have been retracted for a lack of scientificig and misleading presentations of data. those sorts of errors can in fact judicial analyses precisely because judges are not experts in statistics or the methodogy used for scientific studies and clinical trials. that is why the fda has many hundreds
ms. ellsworth: yes. i think he significant concerns and there are two amicus briefs from the pharmaceutical industry that expands on why exact tt is so concerning for pharmaceutical companies who depend on fda's gold standard vi process to approve their drugs and be able to selthr products in line with that considered judgment. justice jackson: can you say wh they say? ms. ellsworth: i am happy to. i think the reality is and this decision allow is a good example of a. you have a district court...
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Mar 27, 2024
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ms. ellsworth: that is correct.ury is that you think you will sell more if the restrictions that previously were in place were lifted. so you will make more money. ms. ellsworth: the injury is that we are prevend om selling our product in line with fda's scientific judgmt out■k the safe use of the drug. justice alito and you will be harmed because he will sell ability to market its product is how it considers the relory scheme that governs it product. justice alito: during th questioning of the solicitor general statement was made that no course has ever previously second-guessed the fda's judgment about access to a drug, correct? it has never second-guesd that. ms. ellsworth: that is correct. stice alito: do you think the fda is infallible? ms. lsrth: we do not and we do not think that is t-ed up in any way. justice alito has the fda ever created a drug and then pulled it after experience showed it had adverse consequences? ms. ellsworth: it has done that and i think that underscores why the adrsevent reporting and
ms. ellsworth: that is correct.ury is that you think you will sell more if the restrictions that previously were in place were lifted. so you will make more money. ms. ellsworth: the injury is that we are prevend om selling our product in line with fda's scientific judgmt out■k the safe use of the drug. justice alito and you will be harmed because he will sell ability to market its product is how it considers the relory scheme that governs it product. justice alito: during th questioning of...
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Mar 27, 2024
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and as ms. ellsworth said, retracted studies.ly behave. and so it was dismaying and i think the most important worry about a case like this is that if it did go forward, then it is, if it is mifepristone today, it could be who knows what drug tomorrow. that is not a way to run the government or a society. >> we didn't cherry pick those quotes that we showed you at the beginning of the segment. there did seem to be broad skepticism across the political spectrum from a number of the justices about both the merits of the case and the process. by which it was brought to the supreme court. and the standing. >> that is exactly right. i have seen more than 500 cases there at the court. normally, it is difficult to tell what the justices are going to do. sometimes it is pretty easy. obviously anything could happen. there was a wide consensus on both sides of the court and the middle of the court that this challenge had to fail. that it just didn't have merit and that the people trying to raise it just didn't have a claim to walk in to fe
and as ms. ellsworth said, retracted studies.ly behave. and so it was dismaying and i think the most important worry about a case like this is that if it did go forward, then it is, if it is mifepristone today, it could be who knows what drug tomorrow. that is not a way to run the government or a society. >> we didn't cherry pick those quotes that we showed you at the beginning of the segment. there did seem to be broad skepticism across the political spectrum from a number of the...
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ms. towels were, which are very difficult to intercept. but nevertheless, damage has done by folding debris. abilities were set on fire. more than a dozen people were injured, entire streets were covered in the shards of glass from from the windows blow. now it's by the explosion and even for people who were not impacted by us directly by last night's attacks and waking up in the middle of life with due to error, it serves going off to explosions. is a very hard thing to live. and so is the presumption that this is retaliation for yesterday's attacks on brushes belgrade bridge. right, so you crane has been stepping up its attacks across the border into rushes builder at the region. they have been attacking the drones with rockets. and in addition to that, there has been an incursion into russian territory that already started on march 12th, 3 russian voluntary fighting units that are fighting on behalf of ukraine crossed into the russian territory and were fighting with uh, refreshing troops there on the ground. this is something that the
ms. towels were, which are very difficult to intercept. but nevertheless, damage has done by folding debris. abilities were set on fire. more than a dozen people were injured, entire streets were covered in the shards of glass from from the windows blow. now it's by the explosion and even for people who were not impacted by us directly by last night's attacks and waking up in the middle of life with due to error, it serves going off to explosions. is a very hard thing to live. and so is the...
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Mar 27, 2024
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ms. ellsworth: we do not have a wthretee ouun rereapvebts then applied to mifepristone. it is only one of seven that with respect to pharmaceuticals and as a company that has thfrom the pharmaceutical industry that endtot. ality is and this decision allow is a good example of a. you have a disicot ntcitsetre >> thank you counsel. apotwea anc teeur50 imnd w rre a coseesr rt nk me io metaem sth impairmen'f ous resources from advocatinglyatuie fda took away the requirement that eaggressiveocuracer dd. nor h the line you quohac wn tene.e on wasted resources, their resources. oar injury t aboveng bs with more accurate information. nc take dr. francis. she is on the labor and delivery floor. on orouceec nwh cathey called the - o deal wi ca process - a atin whi possible given the emergencyrrs reanef de e ri e ues,thal and think the agency can't do this dar -o they relied first onthere are y60 uesunef run with this. e nn wan - o y theory standing. when yououenin aeyth women who has an adverse event. y?al sal adoit pt t ncl a g entitled to francis t of aounl echoes this decoratio
ms. ellsworth: we do not have a wthretee ouun rereapvebts then applied to mifepristone. it is only one of seven that with respect to pharmaceuticals and as a company that has thfrom the pharmaceutical industry that endtot. ality is and this decision allow is a good example of a. you have a disicot ntcitsetre >> thank you counsel. apotwea anc teeur50 imnd w rre a coseesr rt nk me io metaem sth impairmen'f ous resources from advocatinglyatuie fda took away the requirement that...