'I Don't Think That's An Accurate Portrayal': Erin Hawley Fires Back At Ketanji Brown Jackson

Justice Jackson so um what difference if any uh do courts owe the opinion of the expert agency concerning the safety and efficacy of drugs so under this Court's administrative procedure precedence your honor apaa review of course is not Toothless um instead um in this case uh we're not asking that the court second guess the agency determinations at all but rather look at what FDA said again in 2021 when FDA took away the in person visit it did So based on fairs data it says elsewhere cannot be used to calculate the incidence of an adverse event as well as studies that says that ja 407 are quote not adequate I guess I don't understand how that scope of review is not second guessing the agency I mean they're looking at studies and you're saying that the court can look at studies maybe different studies maybe the same studies and critique their conclusions about them so what what difference do we owe them at all with respect to their assessment that these studies establish what it is that they say uh they do about safety and efficacy I don't think that's an accurate portrayal of the the APA claimant issue here your honor and the reason being again is we're just asking this court to look at what FDA said um the fdca says you have to have adequate tests and test results as well as sufficient information understand but didn't the lower courts go beyond that I mean representations were made here today that the lower courts actually relied on on studies that have since been found discredited and removed so they were obviously looking at not just what the FDA was looking at in order to make their assessment so are you asking us to just look at the FDA and not anything else so so yes that claim is not even before this court um but with respect to the two claims that are before the court the 2016 and the 2021 we think the fda's own statements here are are arbitrary um in 2016 what the da said was we're going to look at uh individual studies um and then even though we say they're interrelated at J 298 uh we're going to take all of the protections away uh at once that was arbitrary in State Farm it would be arbitrary here as well thank you