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But I think that there are a couple of things to think about if we want to place our face our faith in the FDA doing things in an expeditious way the recent controversy over the EpiPencosting six hundred dollars well their×39;been a generic out there that applied in2009 so seven years later we haven't×39;gotten an approval, and it's over I think frivolous sort of complaints basically it injects the drug it injects the right dose it works and yet the FDA saying well it×39’s not identical to the EpiPendevice and so for technical reasons it×39;being held up at least that's what IN×39;veered in the press seven years so Think we shouldn't place a lot of faith in some sort of expeditious process in fact I think the whole FDA process needs to be overhauled not just for people whore terminally ill but for everything wed a miserable job at the length of term of trying to approve drugs in our country so if we×39’re going to wait backhand say oh well everything×39’s just swimmingly well just be patient I thinkthat'’s a big mistake I think the biggest part rt of the debate here though is over whether the compassionate use program works and I think that needs to continue to be driven home whether it works doesn't×39’t work and I've learned a lot today about whether it works or doesn't×39;work I think the fact that we have patients calling drug companies, and they are not eligible but not showing up inane statistic it×39’s not measurable maybe how large the number of patients that are ineligible my political director sister has pulmonary fibrosis her drugs not approved here she actually is getting clinical trial because she live sin New York but if she lived in Bowling Green Kentucky my guess is it×39’s got little harder to get into one of these trials because we don't have major university but the drug she×39;using in her trial has been on the market for ten years in Japan why in the world do we not use drugs that have Beeton the market to the public, so phase 3 trial might have a thousand patients how many people live in Japan100 million people it×39’s a rare disease, but maybe there are 10,000 people in Japan using the drug why are we not using that data we give the FDA the option to use the data, but they choose not to so and this is the problem become to this legislation it comesforwardand IN×39’ll try to put a word in that the FDA should or shall do this and everybody says well let's just give them the option of using it let×39’s trust the FDA to do the right thing one of the Dadoes what they've always done and Thais slow ball and slow roll things and some have instance entrance we don't wavelike thousands of instances of the FDA saying you know we got it done we have thousands of instances of it taking five and ten years, but we also have to look at the whole FDA process EpiPen got a38 year patent on the world would we Dothan they tweak their patent on the device okay it delivers it slightly faster quicker different the needles slightly longer we...
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