their crl? the answer was that in about 18% of cases, 11 of the 61 crls, there is no press release whatsoever and really no way for anybody to know that the product had been rejected. in an additional 13, the company put out a press release that said that a complete response letter had been released but provided no details whatsoever what that reason was. and then the rest of this or the fraction of the statements that were matched. so we have 61 crls. they're maybe about ten pages long apiece. 61 crls had an average of 10 to 11 statements. the question is what fraction of the statements were actually there? and you can see that in those that had a press release that actually gave reasons, you can see that typically only one to 25% of the statements were matched and only occasionally were higher fractions of the statements actually disclosed. okay, so now we're changing the frame to instead of looking at the crls, now the unit of analysis is the statement themselves of which i mentioned there we

there were 61 crls as i mentioned, and this is the number of the crls that made mention of a reason for disapproval in these seven domains to which i referred. you can see first of all, they were an array of different reasons they were turned down. you can tell by the numbers here that many had much more than one reason, right, since there were 61 and many of them have in the 40s. and you can see efficacy, safety, and clinical manufacturing and controls were the primary reasons. but most importantly about two-thirds of the crls had an efficacy reason for turning down a product and it was similar numbers to safety. at the bottom, 87% had either safety or efficacy reason included in the crl and 48% had both. we drew the conclusion from this that in fact the fda does not turn down products for trivial reasons and hopefully that has helped to counter the misinformation on that point in a general way. of course, that doesn't answer the question of what might be happening for any particular crl because that is not yet being released. okay. so in here we're looking again at crls as the unit of

>> crls related to already marketed drugs. yeah, i would make two points. in terms of making a cut around that, that's a pretty small subset. so we might be trying to loo lo little farther than that. and that information generally is made public. now, that said, there could be a lot of value doing that. so i'm not by any means saying i don't think that's a good idea. i think we're trying to look a little more broadly than that, a little bit of a broader subset. and that could be certainly scoped into what we do. but a subset also where the information might not diffuse as readily but for our ability to release the crls. that could certainly be part of a policy. >> one of your predecessors, he really lights up on the issue of transparency is the agency correcting on this information out there. and you just alluded to this possibility. and i think he was incredibly frustrated when people would say things he knew not to be true and he felt sort of policies and procedures at the agency made it really hard for him to just go out there, was not it case. do you fe