dr. throckmorton, but ask dr. crosse for comment. one of the explanations i have heard for shortage was that f.d.a. was forcing manufacturers to come up with the state-of-the-art manufacturing practices, even though the old tried and true were completely adequate to ensure safety and effectiveness. the argument went that to meet the new standards, manufacturers had to shut down. i heard something that's almost the opposite the argument that f.d.a. had been telling some companies for years that their facilities were in decline and needed to be upgraded to avoid problems in the future even though they were meeting inspection standards and eventually those warnings unfortunately came through. so dr. throckmorton, can you comment on these two different perspectives? you mentioned in your testimony that f.d.a. is trying to encourage industry to adopt new technologies but at the same time f.d.a. is not raising the bar, not raising the bar in standards for existing appropriate technologies. that seems a very nuanced point. can you just elab

dr. throckmorton, you're saying success has been made in the new shortages, right? we see that on that chart. dr. crosse, you have concluded there has been progress made as we see from that pending chart, correct? and that's both in the testimony? >> that's correct. >> so that's kind of my sumation. this chart is very illustrated in the report and kind of highlighted what most people talked about. i guess a couple years ago when we've been having this debate, i always wondered why the market itself doesn't respond to alleviate the shortages based upon a price signal. now, dr. burgess kind of mentioned, which dr. throckmorton, you may dismiss there was a tamaflu signal sent. i don't know that. you said you didn't know that. why, in my minute left, is there something structurally about how we -- either the government in its coding or its spending through medicare and edicaid or the insurance applications of purchasing drugs, is there something that distorts the market signals for shortages? >> i'm not sure. >> maybe that's something, mr. chairman, to follow-up in anoth

dr. throckmorton, the inspection of a.p.i. can remain a barrier and anda can market the generic drug. how has the agency tried to improve its record on this issue to ensure that the anda holders can market a drug and potentially address a drug shortage? >> so two parts to that answer. the first part would be some of the actions we already talked about, the expedited reviews and expedited inspections. there is a second longer term and that relates to the passage of kadufa, an opportunity to sort of balance the playing field, if you will, so we're able to devote the resources we need to to the generics market which 85% of the u.s. drug market is generic now. we're able to allocate to it to make sure they're getting the attention they need, the reviews from our reviewers that they need to. that's an important addition to us. >> thank you so much. i see my time has expired. i thank you, mr. chairman. >> the chair thanks the gentlelady. that concludes the questions of the members who are present. we'll have additional questions we'll send to you in writing. if you'll please respond promptl

dr. throckmorton the fda inspection of api candy a barrier how has the agency tried to improve the record of this issue to ensure that the anda can market the drug and address the shortage? >> the first part is the expedited reduced the fda can do but there is a second longer term with the generic drug user free act provides additional opportunities did resources to balance the playing field so we can devote their resources to the generics market which 85 percent of the drug market is you generics. and how to make certain with the compliance history in the review that they need is the important admission. >> my time is expired. >> that concludes the questions we have additional ones we will send in writing if you will respond promptly remind members they have 10 business days to submit for the record and members should submit by close of business tuesday, a february 25. thank you very much. the testimony we look forward to continue to work with you. without objection we are adjourned. [inaudible >> we do expect to have a series of votes later this morning so we want to make sure we have a