applications have received some review by the f.d.a. at this point. 90% of the 6,000. they have received some kind of communication also. and over 1,700 have been approved or tentatively approved. we tentatively approve when we can't approve yet because patent is still blocking full approval. last month alone, we approved or tentatively approved 99 generic drug applications. how this was accomplished is detailed in my written testimony. it's a very complicated picture required us to rebuild the entire program from the ground up. but none of this could have been done without the incredible dedication and passion of a lot of people at the f.d.a. i will tell you, mr. chairman, ranking member, that the people at f.d.a. share your passion for ensuring that the families and communities in this country have

access to affordable drugs where all possible. i really like to publicly thank all the people who work so hard and so long over the past three years to make this program work. it has been an incredible effort. the staff in the office of eneric drugs who have worked extensively long hours over time, continued, got the job done, the staff in the newly formed office of pharmaceutical quality that has totally revamped how we do the quality review. the staff in the office of regulatory affairs, which is our field organization, that not only has ramped up and hired and done more inspections, but actually volunteered and helped do some of the review work so we could get these applications reviewed. and all the other people who pitched in. we had people in our laboratories who put aside their

experiments. they put their experiments on hold so they could review parts of generic drug applications that they were qualified to review. the heroic staff who really launched our new info matics platform, we all know the story about government i.t., huge i.t. implementation. it is never pretty. we had multiple legacy systems at all the data had to be transformed and leaned up and put into a single system. and we were in the depths of despair a few times, but we have gotten through that. we are running off a new i.t. system. it has already proven its worth and i thank them because they really went through a lot. the financial staff, who had to set up a fee collection system from scratch and collect all these fees and allocate them appropriately. and our h.r. and add min -- admin staff who helped hire more people to get this job done.

we would not have done it without all of them. i think we owe them a great deal of thanks for making this program work. now, discussions about the backlog and so forth i'd like to have in our back and forth conversation because this is a complicated issue. but i think the news is good news. it's not bad news. i recognize that there remain a number of challenges that we all need to address collectively, but i am really sure because we have gotten through the worst of this that we can deal with the challenges we have ahead. and i look forward to your questions. thank you. senator alexander: thank you, dr. woodcock. we'll now begin a series of round of five-miment questions. dr. woodcock, i think all of us on the panel, mib every senator, are interested in drug prices as throw lowe as is reasonable, the statutory mission of the f.d.a. is safe and effective drugs. it's not to set drug prices, am i correct?

is it also correct that one of the effects of the -- you just said in your testimony, over the last 30 years of the hatch-waxman amendments and the generic movement that's gone from zero to 88% has been a massive reduction or avoidance of higher drug prices. did you say $1.7 trillion in savings? senator alexander: dr. woodcock: 1.7 trillion. senator alexander: it would make sense then that we should focus our attention on ways to continue to make generic drugs available to as many people as possible. two ways we have sought to do that in the committee are to avoid unnecessary regulatory burdens and to make sure we have a competitive marketplace where prices are low. i want to ask you, and you invited this really, about the backlog. 30 years ago the hope was that

generic approvals could be 180 days. there is a backlog of 4,700 applications waiting to be reviewed in 2012. then there have been a lot more applications since then. you described those. the median approval time to get review of a generic drug was 30 months four years ago. today the approval time seems to months, and you are approving about the same number of new drugs. yet over that period of time you have collected $1 billion and hired 1,000 new people. what can we do about the backlog and the approval time? help us understand what the facts are. dr. woodcock: let me walk you through this. it's complicated. the backlog applications that

were sitting there in 2012 when we put the program in place, ok, have been there for 40 months. we have approved a lot of them. we have taken action on 82% of these. some type of action. we have gone back to the manufacturer. they have withdrawn some, so forth. but they have been there since 2012. so even if we approved all of them tomorrow, their approval time would be 40 months because that was 40 months ago. the longer it takes, just like the rest of us, they are not getting any younger. so those applications that were sitting there in 2012 are going to at minimum have approval time, total time to approval of 40 months because they started 40 months ago. the ones that were -- we are getting in now have a due date

for complete response of 15 months. we have already approved some in the previous cohort last year that had 15 months' time frame. we approved a drug in nine months. senator alexander: you're saying the new application vs. a different median time. dr. woodcock: they were the first ones that had goals. none of these others, the 2012 pending, and then the first two years of the program, had no goals assigned to them. senator alexander: what about the number of approvals today as compared with a few years ago? dr. woodcock: if you look at the senator in my testimony, you'll see that we didn't do, in the first two years of gadufa, we didn't jump up approvals. it was pretty much up and down. in april of last year, approvals went up and they have stayed up. as i said last month we approved or t.a.ed 99 generic drugs. so we are on a path to get these efficiently out the door now.

we had to build the program. we had to get this i.t. system. we had to hire and train these people. senator alexander: if i may, one more question. i don't want to go over my time. i want to make sure that you're making the distinction between what a guidance requires and regulation requires. i know the office of management and budget is interested in that. i have heard some concerns about one proposed guidance on quality for generic manufacturers that would impose new obligations to submit reports. are you making a distinction between guidances which are -- don't have the rule of law and regulations which may have the rule of law but do require certain amount of public comment? dr. woodcock: we certainly do. we have as part of implementing this program, we have put a policy office in the office of generic drugs, and established a new policy office in the office of pharmaceutical quality, which does the quality regulation. and both of those offices, part

of their function, their staffed partly by lawyers, is to make sure we follow good guidance practices and follow the appropriate practice force regulations. senator alexander: thank you very much. senator murray. senator murray: dr. woodcock, as i mentioned in my opening statement hatch-waxman has been an incredible success and provided patients and families with access to quality, high quality, lower cost drugs. and building on that success this committee's bipartisan work to pass the generic drug user fee amendments provided f.d.a. with the resources to tackle existing backlog. some are now saying that the backlog of generic applications remaining at f.d.a. is part of the reason patients and families are experiencing high drug costs. how do you respond to those claims? dr. woodcock: the high drug costs are driven by multiple factors, but one would be -- might be lack of competition. is there a generic competitor

for the innovator product? those we call the first generic, the first generic to get on the market, which begins to lower the price. we have looked at all these backlogs. and there is nothing in that backlog that would be a first generic potentially. even if it's one or two applications, either of those could be the first generic. but we haven't looked at. we can't approve applications even as a first generic if they don't meet our standards, if they are substandard in some way, or if they are incomplete. we may not always approve every am quation that comes before us -- application that comes before us that's first generic. but we expedite those products. senator murray: the first generics? dr. woodcock: we absolutely do. they get a fast track through the process and we make sure we pay atonings it those. i can assure you in the backlog sitting there in 2012 and that we are working on now, that we have largely worked on, that

there's nothing that hasn't been looked at and given attention. and certainly that would provide a first generic. senator murray: when f.d.a. does approve those potential first generic applications, do companies usually market those generic drugs right away? dr. woodcock: we don't understand the behavior of companies. of course sometimes difficult to ascertain what they are doing in the market, as senator collins' hearing with the committee demonstrated, but we have noticed that often companies will not market a product. sometimes for a significant amount of time after they received an approval for first generic. senator murray: ok. yesterday the h.h.s. assistant secretary for planning and evaluation came out with a report about the generic drug market he concluding that generic drug prices are not the primary driver of the high drug costs facing many patients and families across the country. report found that the generic drug market as a whole is quite competitive, although some

statements have experienced large pricing increases. what tiche competition exists for innovator drugs currently on the market? what does that mean for patients? dr. woodcock: with your permission i'd like to bring up a slide if i could. this one would be good. this shows -- it's a simple bar chart, it shows the 99 on the left is the number of innovator drugs that only have one generic competitor. there are 66 that have two generic competitors. all the rest have three to 10 generic competitors, which has been shown to really bring the price down when there is that much competition in the market. in addition, could i have the pie chart, if you look at this pie chart, this is all -- picture of all the drugs that would be out there, if you look at the silver slice, that's innovator drugs that could have a generic competitor but don't. and many of those are orphans or

very small market drugs. so there is a remaining group of products, it's small, but that's where we see a lot of the action as far as price changes when generic competition is possible. senator murray: i'm told it typically takes three approved generics before we see real pricing competition kick in and prices go down. how many innovator drugs have reached the level of having three generic competitors? is that your number -- dr. woodcock: you can see the vast majority have large enough sales, i imagine, multiple competitors get in the market. senator murray: that's what drives the price. dr. woodcock: yes. senator murray: you mentioned how the f.d.a. generics program is on its way to being a real success story because of the resources congress provided. i wanted to just ask you, can you describe the current status of f.d.a.'s generics workload? dr. woodcock: yes. could i have another chart. there we go.

this chart shows the entire workload at almost the current time. at the top the number -- this is too complicated, but at the top the 6218 is all the applications we have had to deal with since the program started. the bottom number, 600, those are the one that is haven't entered review yet. that's only 10% that haven't entered review. some of those were submitted very recently. 2,400, we are in the stage of back and forth with the companies. so we are going back and forth. we are trying not to have these multiple cycles like we had in the past that get the issues resolved during the review process and try to get to a first cycle approval. senator murray: when people say backlog, it's not like the drug is sitting there, nothing is happening to t it's part of the backlog even if it's been withdrawn by the company or you're going back and forth with

the company? dr. woodcock: well, this is simply the overall workload. the backlog was something that existed at 2012, bingo. there it was. in the future, we are not going to have any backlogs. but we are going to have -- if we get 1,000 drugs submitted a year, applications, we are going to have a bunch in process. they won't be in backlog. they'll simply be moving down the process. but because we have a lot of them that don't have goal dates now, although we have assigned them action dates, this is a better description of where they all are, i think. even though it's overly complicated. you see that almost 600 have been withdrawn by the firms. and we have approved 1,500 tentatively approved 268. and we are working on these 2,400. that's 4,000 that have either been approved, tentatively approved, or talking to the companies. senator murray: thank you very much.

7 senator alexander: thank you, senator murray. the next senator collins and casey then cassidy then franken. senator collins. senator collins: thank you, mr. chairman. dr. woodcock, first let me thank you for your many years of public service and all that you're doing to expedite generic drug applications in order to make prescription drugs more affordable for consumers. i know that you're familiar with the investigation, the aging committee is doing into the sudden, very aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades. one is 63 years old. 5,000% there's been a increase in its price bye buy a company that invested not one

dime -- price by a company that invested not one dime in the research and development that led to this drug. i'm concerned that our current regulatory structure doesn't take into account situations where there is essentially a market failure, because the population of patients may be small. there's no generic application. whether it's pending or not. it just hasn't happened. now, i know that the f.d.a. currently provides an express lane review for certain generic drug applications, including first generics and those that would help solve medical drug shortages. could you give us some idea of what the timeline is for the expedited review for drugs for the first generics or those that are in the medical shortages

category? dr. woodcock: well, they get to the front of the queue. of course with so many applications coming through, we can expedite different things. we have to treat them fairly. all would get expedited in the same way. so they get extra attention. they get moved to the review queue front. so they get reviewed first. and people shepherd them through. but if they are substandard in any way, under our new process, of course, we'll call the manufacturer and try to get that application repaired. say we go inspect a facility and it is substandard, we are still not going to approve that drug. but we do move them along as fast as possible. for the cohort that comes in after september of this year, there's going to be a 10-month review clock. that's the goal. so all -- that's for all generic drugs. so somebody who smits a generic

drug october 1 of this year, can expect a 10-month review. and if we are successful, they will get an approval at the end, not a lot of questions about their application. that's pretty expedited as it is. especially since they have facilities often in china and india and different places around the country may have to check senator collins: let me ask you about a situation of the two of the drugs that we are looking at, iso prell and nitropres, these two drugs once had f.d.a. approved -- f.d.a.-approved generic competitors, but over time those competitors left the market. and now there's only one manufacturer left. so if a new manufacturer were to come in now, would that patient be expedited?

dr. woodcock: that's a good quefment we will take it back and try to figure out what our policy should be on that because it would be akin to a first generic although technically not a first generic. senator collins: that's why i ask it. dr. woodcock: part of our problem is knowing whose market and when. these people come and in out of the market. if they don't withdraw their applications hard for us to say whether they are marketing unless we get notified of a shortage. which case it becomes clear. senator collins: the other issue, related issue, that i ask you to work with us on as we try to come up with solutions to these market failures is figuring out what the length of time for an expedited approval should be that would discourage the company from buying up a decade's old drug and increasing the cost of t if it's a short enough time, it's not going to be worth the amount of money

that the manufacturer -- they are not manufacturers, they are more like what i call hedge fund pharmaceutical companies. would pay to get the right -- rights to that drug. one of the ideas that i'd like to work with you on is whether there's a way to take away the incentive by having this expedited approval that would encourage the generic to come in and discourage the company from buying up the decade's old drug thinking it's going to have a monopoly long enough to make a great deal of money. dr. woodcock: we would be happy to work wufment we also have to consider there is development work the company has to do. they can't just turn a switch and start manufacturing a drug tomorrow. so there is not time it has to go in as well. senator collins: what we are finding is a lot of these

companies are not doing the manufacturing. so it's a very new and interesting business model. i'm convinced that it's one that is really negative tore -- negative for patients, providers, hospitals, and for federal and state health care programs. dr. woodcock: mr. chairman, may i make an editorial comment. senator alexander: yes. dr. woodcock: thank you. we have talked to some members in house and some of you-all about advanced manufacturing and our efforts on this. why we like advanced manufacturing, we are trying to push it with the industry, that allows them to turn very quickly and really ramp up very fast. senator alexander: you want to define advanced manufacturing. what you mean by that. dr. woodcock: certainly. potato chips and m&m's and all sorts of foods in this country and fine chemicals are made in continues manufacturing lines, or computer controlled, automobiles, even with robots, pharmaceuticals are not made

that way. they are made almost like cooking. or pharmacy compounding steps. and we are really trying to push to move to modernize computer controlled continuous manufacturing. 's much more efficient and effective. senator alexander: like 3-d printing? dr. woodcock: we did approve this year, a 3-d printed product. first one. that's one of the aspects that enables doing things like that, yes. that's an aspect i think we should explore to provide agillity into the system. senator collins: thank you. i apologize. senator alexander: senator collins, we know that in the committee on aging you and senator mccaskill have done a lot of work on this subject. we know also you don't have legislative authority so we welcome the work product from your committee over here as we

work on our legislation. senator casey. senator franken. senator franken: thank you. i appreciate senator collins' questions and part of your answer on -- it seemed to suggest that the data that you have on the market is not totally complete. dr. woodcock: that's correct. senator franken: is there anything you can do -- is an aspiration of yours to make that data complete? more complete? dr. woodcock: it's very difficult to figure these things out because -- senator franken: who would do that? dr. woodcock: i believe senator collins' hearing they talked about the contracts and the

rebates and the -- all the different things in the u.s. distribution chain that nobody really knows the answer to. the insurers, i think, would really like to know how these drugs are moving and what is actually being paid for them at different steps that they don't know. that is what i took from the testimony. we can find out sort of ex-post facto by looking at what has been dispensed at the end of the day and putting the picture together. but it's very difficult to say -- senator franken: trying to figure that out would inform what you're approving -- what you're taking up to approve. because you want to make the market more efficient. i want to ask you about an article in the "wall street journal" this wyche. i'm sure you have read it -- this week. i'm sure you read t it was by the c.e.o. of a drug compounding company and he suggested that

basically he pointed to a drug that his company did and we took up compounding in this mmittee, and a number of us, including the chairman and senator roberts, but he was basically saying that he -- he did, compound a drug, generic, that had been one of these drugs that they exploded the price on and he got the market by compounding this. we saw the risks associated with compounding, but then we also ve the f.d.a. authority to regulate compounding. you read this piece. did you -- do you think that there are risks to this?

or are there -- is the up side -- what's the upside and what are the risks? dr. woodcock: i believe there are very great risks. the congress established outsourcing facilities as part of the it re-establishment of compounding several years ago. but those are for sterile injectables. the tablets would be compounded -- could be compounded by any compounding facility under this it -- what is being proposed. in the last two months we have dealt with two outbreaks, all right. one was vitamins where they compounded vitamins way excess i have, way excessive vitamins were put into tablets. people were hospitalized with kidney failure. the second one -- senator franken: those are vitamins considered supplements

which you don't -- dr. woodcock: we regulated those. we intervened. we were able to track people down. the second one was a hormone. it was 1,000 times more potent than it was supposed to be. eople ended up in the hospital very sick. and these were small outbreaks that the pharmacy and us together were able to track these people down. the people who were still not in the hospital. make sure they were -- the drug was recalled. but a mass production of drugs such as to substitute for a generic or an innovator drug that's out there, under noncontrolled conditions, i know everybody talks about regulatory burdens, but we ask them to do is make sure they do the right thing each time. and this is what happened. they put in too much. they used the wrong source. and used ultraconcentrated source. and they put people in the hospital. and if they had been making thousands of these tablets, they could have put thousands of

people in the hospital. if hat's what we face alternative sources that don't have good manufacturing practices are going to go into mass production. senator franken: i'm out of time. i'm out of time. senator alexander: that's a very helpful question about two important pieces of legislation before this committee. that's very interesting discussion. senator robert -- senator cassidy. senator cassidy: i ecosenator collins' compliments of your work and also i appreciate your straightforwardness. a couple things. first, to play off i think i forget who it was, someone asked regarding back lock applications, you said at least 85% of those were prethis legislation had some action. that means 15% have not. i could imagine if you are one of that 15% you're just like,

oh, my gosh. secondly, 85% have had some action. that action might have been to kick them back. any comments on why that 15% still kind of in perfectingtory and the 85%? dr. woodcock: when we negotiated this agreement with industry, they were realistic that we weren't going to be able to review 6,000 applications in three years. and hire 1,000 people and rebuild our entire generic drug system and totally reorganize. all of which we have done. so the goal was that we -- clear out 90% of the backlog applications by the end of the program. five years. that was the agreed upon goal. with industry. with another other intermediate goals. what we have done, we have already goten back to them or worked on 82% of them. senator cassidy: i have a short time and so many questions. i'm also told by industry, and learned to say what i have been

told not what i know. that when you mention the incomplete or low quality applications, sometimes they are low quality because in the interval between when it's submitted and when it's reviewed, the standards have changed. it's now low quality not because it was low quality at the time of submission, but because it's low quality at time of review. are those applicants notified when standards change and the implications that have changing standard upon the quality of their initial application? dr. woodcock: absolutely. we try to do that. that's our policy offices. we are issuing many more guidances. those often are product specific guidances. like a cookbook or recipe. senator cassidy: the follow-up question, you-all of there implied -- it is not the case, it has been made public the guidance as to what is a good quality application? dr. woodcock: we try. there are things such as we have gotten applications where they have cut and pasted portions from another application.

totally the wrong application in there. it's hard to think of every single thing that people can do that isn't right. but we do try to give guidance. having a policy offices we definitely aspire putting out much more guidance on what -- and training on what is acceptable. i have a slide in the -- senator cassidy can i move to something else. i'll accept your explanation. next, following up on what senator collins said, also relating become back you gave to energy and commerce committee a couple years ago when i was there, one of the reasons for drug shortages is there has been a concentration of drug manufacturers. there's a quality problem with that one concentrated facility, my gosh, it ripples through. now, what i'm told is that gadufa actually has a facility fee and therefore if you only have one facility, or if you contract out to a c.m.o., a contract manufacturering organization, that somehow you lower the facility fee.

it would require us to change that. but because of this we have had a concentration of manufacturing units. is that a fair assessment? dr. woodcock: i doesn't know whether that's driven concentration or not. i think there are many factors. but that could have been one. and we are certainly considering that in the discussions for the next program. senator cassidy: we should consider that because it requires say a substitution of a product fee as opposed to a if silt fee, fair statement? dr. woodcock: there are many different ways this could be -- we are trying to maket fee structure as fair as possible. the burden is shared appropriately among the people who benefit from the program. senator cassidy: do you have a list of how many manufacturing units if you will, there wrrks or c.m.o.s, were active before gadfua and the number of facilities now? dr. woodcock: one of the innovations was self-identification. so we have one, 2012, where

everybody had to put up their hand and say we are making a generic drug or we are making an active ingredient. we have it for those for three years. not before. that was one of the defects. senator cassidy: if you had it when you started and now. do you have that number? dr. woodcock: we can get back to you. i don't have t senator cassidy: could you remember the drug manufacturers or publish or could you require, we are making these drugs and contracting out the c.m.o.s for this and kind of have that as a real time database? we need to know if we are concentrating manufacturers. if so, because you have told us that that is a major cause of drug shortages, and some of the them are bad actors you also told us that. some have a loft problems. some not f that were made public we would know how many there were, and two if they were good or bad actors s that possible to make that public? dr. woodcock: i think that -- we can give you the overall numbers. we could try.

but i think making the actual people public would probably require regulation change or something -- there is registration enlisting that is done now, but it is -- we have different problems with that. which we could get back to you on. senator cassidy: thank you. senator alexander: thank you, senator cassidy. senator warren. senator warren: thank you, mr. chairman. everyone is here looking for ways to bring down the cost of drugs. both brand name and generic drugs. but can't do that if we don't correctly identify why the prices are so high. some people want to blame the f.d.a. for high prices saying if the agency would approve generic drugs faster, the drug pricing problem would go away. i just want to dig into that claim a little bit. let's begin with generics competing with brand name drugs. according to an analysis by harvard researchers, it takes an average of 12 1/2 years for a

brand name drug to face competition by generics. and no doubt if those brand name drugs had compete with the generic drugs they would be cheaper. the law is clear, the f.d.a. can't bring a generic drug to market while the brand name drug is still protected by any form of exclusivity or patent. is that right? dr. woodcock: that's correct. senator warren: ok. let's look at the time after generics are legally allowed on the market. how long does it take the f.d.a. to approve a new application for a generic drug? dr. woodcock: that's something that's in flux. but this year it will take us 15 months on average to get back to the firm, if they have sent in a complete application, we could probably approve t new applications. ones submitted this year. senator warren: what commitment time are you looking at going forward?

dr. woodcock: in september -- october of this year, if you submit a generic drug application, you could expect to get an answer back in 10 months. senator warren: 10 months. we are going from 15 months to 10 months. you feel like you're on target getting the pieces in place. dr. woodcock: that is doable. senator warren: i want to measure that against the claim that the average time for f.d.a. approval has increased. you talked about the backlog and the difficulty of dealing with applications that date back years. but the average time for new applications, is it going up or down? dr. woodcock: the new applications haven't reached their sort of time to get approved yet. so can't really say. the goal's only kicked in last year. that was a 15-month goal. as i said we already approved one at nine months. we have approved a number of them that's been shorter than the 15-month goal.

senator warren: you are committing to a shorter time period. dr. woodcock: we are committed to meeting the goals. senator warren: let me ask you another question about this. when a company suddenly raises the price of a generic drug, obviously approval of a competing generic drug would probably bring the price back down. dr. woodcock, does the f.d.a. expedite applications in situations when there's been a price spike? dr. woodcock: no. senator warren: why not? dr. woodcock: we don't really know. we have to be fair. there's a lot of lawsuits around generic drugs and so forth. we have to be fair to all. we don't know what a price spike is. a pill costs 10 cents and now it's 30 cents? 10 cents and now costs $875? senator warren: that spounds spikey neefment dr. woodcock: we also don't, i think, have the expertise to determine. we aren't economists or finance people.

we are doctors and lawyers and scientists. what we -- senator warren: could you use that as a criteria for deciding to expedite on a particular drug? or is there some legal ambiguity about that? dr. woodcock: there might be ambiguity, if congress directed us to prioritize -- senator warren: i asked where you are right now. dr. woodcock: i don't know the answer to that specifically. i imagine it might be possible if there were some bulletproof definition of what a price -- what if you doubled from a dime to 20 cents? senator warren: this may be something we want to look at. that's helpful. look at the proposal on the table today. yes, congress could make sure that the f.d.a. has the funding and personnel it needs. yes, there's room to improve generic drug approval processes as the new user fee program is fully implemented. yes, there could be limited situations where the f.d.a. might be able to expedite review of the generic drug to help

lower prices. we are already heading toward 10-month approval. that should help. but let's not kid ourselves. making those tweaks won't solve the drug pricing problem. the market for prescription drugs has little transparency. it has broken price elasticity, and has very long legal monopolies. and, sure, we can make some changes, small changes, to have the f.d.a. approve generics, but real change will require us to face the fact that the market for prescription drugs is not working and rethink the overall structure of drug pricing. . >> thank you, senator warren. now, i got senator roberts, senator casey, senator burr and senator murphy. so senator roberts. mr. chairman,

thank you. and thanks, also, to the ranking member for holding this hearing. everybody knows about the cost of prescription drugs. they continue to make headlines, and i truly appreciate dr. woodcock. you are an excellent witness, and thank you for your clarity and your comments. in addition to new user fees in 2012, as has been said, and the f.d.a. has proposed a gulation in 2013 regarding generic labeling that according to one estimate could increase spending on generic drugs by billions of dollars. in 2015, a proposed equality metrics program to draft guidance -- draft guidance that would require manufacturers to collect new information and also to collect and report .nformation from the c.m.o.'s

the generic drug manufacturers have raised significant concerns, i think to everybody here, regarding reporting complexity, the confidentiality of data, increased information technology pending all of which would increase burdens on manufacturers and require significant efforts to resolve. now, if these quality reports were to be required and obviously are necessary to ensure high-quality drugs, generic drugs, shouldn't this be done through rulemaking? i would pause here and say this is the first time my house or senate career that i've ever proposed more rulemaking. [laughter] but rulemaking rather than a guidance where there is no responsibility to look at the impact on small business and those who are involved can't respond to comments which to me seems to be very important. dr. woodcock: well, both of those, the regulation you mentioned, first, and then the

draft guidance that we issued some time ago on quality metrics, we're -- we request for comments. the draft guidance is not actionable. it's simply request for comments. so we did receive a great deal of comments on both of these, and we are in the time of digesting these comments. and we will take appropriate steps after we've gotten feedback, but we have gotten a great deal of feedback on the quality metrics draft proposal both from the innovator industry and the generic industry and it's actually one of the few times where they appear to be united in their opinions. so we will certainly -- are taking that into consideration in what we do next. senator roberts: i appreciate that. i think most of the questions that i have here have already been asked by members. the definition question i think

was raise bid senator murray, your testimony you highlighted the ongoing challenge of submission quality and the question was, have you made public guidance or otherwise what the standard for good quality submissions is? when was that released or have you released that? dr. woodcock: well, it's a whole series of different guidances. for example, the -- we issued products specific guidance that tells you for this -- if you're going to copy this innovator product, here's how you should do your bioequivalence studies and so forth. we've issued -- we've really ramped up their issuances of those because they're extremely helpful to industry. senator roberts: how many people do you got doing it this? dr. woodcock: the guidance development? senator roberts: we're interested in 2015 and everybody left behind and those in the future, how many people

people -- what, 1,000 doing this or what? dr. woodcock: there's about maybe 1,000 people in the office of generic drugs. senator roberts: right. dr. woodcock: there's 800, 900 people working on pharmaceutical quality. and then our inspectors, we added 70 new inspectors to do some of these foreign inspections and stuff. so the program is probably perhaps 3,000 people overall. senator roberts: 3,000 people. i reesht that i have 30 seconds left which i'll yield back to senator franken who needed more time. senator franken: it's going to take me about 25 seconds to recall. [laughter] i'll yield the time. mr. alexander: thank you for this outburst of bipartisanship. senator casey. senator casey: thank you, mr. chairman, very much. thank you for your testimony and your service. wanted to focus on an area

that i know you've spoken to but i'm not sure the specific question was asked about the so-called -- we have to be careful with acronyms here. rems, the risk evaluation mitigation strategy. and the other acronym, the elements to ensure safe use. the basic question i have was, when you testified about some you have llenges that in implementing shared risk evaluation system, can you outline for us the challenges you face and then if any, and i'm assuming there are, what you propose as solutions? dr. woodcock: well, when congress in the f.d.a. elements it's t in place the rems,

supposed to be risky drugs is supposed to mitigate some of the risks and we approved drugs with recommends if they're particularly risky. when they go generic, the generics also need to have this risk system around them. and congress, in order to decrease the burden on health care said if at all possible there would be a single shared rems amongst the innovator and the competitors. well, this has proven get competitors to work together so that the competitors can get a market share from the innovator has proven very challenging for the f.d.a. to get that done. and that has delayed access. in addition, the rems programs may restrict who gets the drug and that may be an excuse not give the drug to the generic so they can compare it to their

drug. so all of these have caused barriers and delays in getting generics on the market. more broadly, companies on their own behalf have restricted programs that we don't really understand but they're not related to rems. we'd had hundreds of inquiries from companies who can't get hold of the innovator drug to compare their drug to. we've done everything we can to -- we've written a letter saying that rems doesn't require this, you can give it out for this purpose and so forth and we also refer these get t.c., ok, but we still complaints from generic companies not getting the comparisons they need to. senator casey: i want to make sure i understand the problem you face. why has it not worked, in your

judgment? dr. woodcock: well, i think the innovator companies feel it's their duty to their stockholders to delay competition as much as possible. that's the kind of the citizen petitions we get and all sorts of things that attempt to delay generic competition and this is yet another opportunity. senator casey: what would you hope we'd do, if anything? dr. woodcock: part of the rems provision is a practical matter, we have to try and try and try and then finally we declare defeat and we go ahead and let the generics have their own system that's separate but equal. if that provision were removed from statute then potentially we could just go to that and not have a delay involved. however, that won't fix the instance where the innovator company is not providing outside of recommends. they just have a way -- outside of rems. they just have a way of not

providing the drug to the generic company and i think that would require discussions. very casey: thanks much. senator alexander: thanks, senator casey. senator hatch is next but i wouldn't remind me saying it's not often that a united states senator has a chance to introduce a significant piece of legs and 30 years later see it as successful as this has been, taking the number of generic drugs prescribed from 0% to 88% of all the prescription drugs so we welcome you to a hearing on your bill. senator casey: thank you, mr. chairman. happy to do that. it was a real battle in my office between the generic industry and the farm suit -- senator hatch: thank you, mr. chairman. happy to do that. it was a real battle in my office between the generic industry and the pharmaceutical industry. they decided to ram out of the office and two of them, they got to the door and two of them got at the same time got stuck in the door. [laughter]

hatch hatch we all started -- senator hatch: we all started to lafment i said, come back. i wanted to kill them. i got really irritated. i had a bad tooth at the time and that aggravated it as well. to make a long story short, we're pleased with hatch-waxman and henry deserved a lot of credit at that time for cooperating on this. at the inception of the drug user fee program in 2012 there were approximately 2,800 generic applications awaiting approval and the average approval time for an application is -- if i got it right -- 30 months. going into its fourth year and $1.2 billion later, the backlog has increased to 4,000-plus applications and the average approval time for an application has steadily risen from 30 months in fiscal year

48 40 months in 2013 and times in 2015. this is more than the statutory six-month review time directed by the hatch-waxman act, which s one of the bills that i feel very pleased with. since 2013, the number of approvals show a declining trend in approvals. both tentative and final. f.d.a. approved 619 generics in 2012. 535 in 2013. 500 in 2014 and 346 in fiscal year 2015. now, a critical is up sub-set of approvals are first generics -- first generics offer the first opportunity for consumers to benefit from the savings provided by generic drugs over brand drugs but only if they're approved on the first earliest

day. as i understand it. it's staggering to think of the savings that were lost in the u.s. health care system in 2015 alone due to first generic approval delays. so having said all that, i want to personally thank you for the work that you do. you do a terrific job. and i recognize it. would you agree this backlog keeps safe, low-cost generic drugs off the market and reduces competition, just yes or no? dr. woodcock: yes. senator hatch: i thought you would well, let me go a little bit further. will the backlog be eliminated gadufa 2? start of dr. woodcock: absolutely. we have already acted on 82% of -- at least communicated with companies on 82% of those. senator hatch: how many applications have the agency received since it was

implemented? wroip -- dr. woodcock: that i don't know. senator hatch: would you provide that? dr. woodcock: it's about 15% of the workload and we expedite all of those. senator hatch: how many first generic applications have missed approval in the last, say, three years, if you have that knowledge? dr. woodcock: i have to get back to you. it's a small number, though. senator hatch: we submit for the record that the target actions before the agency -- without naming the applicant and the associated reference products, that would help us out here. dr. woodcock: we can do that. senator hatch: how does f.d.a. track prior applications such as those associated with public health needs, drug shortages or first generics, and what is the average approval time for these critical applications? dr. woodcock: we track them through our new i.t. system where -- and we have project management over all these

applications now. so we have a project manager aware of each one of them and hope making sure it moves properly through the system. senator hatch: mr. chairman, can i make a statement at the end? senator alexander: yes. senator hatch: the reason hatch-waxman was essential, there was only about 18% of generics on the marketplace back when we did it. today it's approaching 90% and that has been a very, very good thing. however, some people played the market too. and have distorted that. even with regard to generics. we want to get to the bottom of this. i personally want to thank the chairman and ranking member of this committee for getting into this and i sdend to help them every step of the way. i want to personally thank the people at f.d.a. it's a hard job. you've got all kinds of pressure on you. there's -- all kinds of

irritations and comments and screaming and shouting about these things. and we don't give you enough help to do it. i also was the author of the f.d.a. revitalization act, giving you the huge facility you have out there where there have been 30-plus offices all over this area. so all i can say is i hope you keep going because the generics are absolutely critical to this country. actually critical to our federal budget. absolutely critical to the success -- successful reputation of the f.d.a. so hopefully if you see any changes in hatch-waxman or other bills that you're subject to that you think would help, we sure would like to hear from you. dr. woodcock: absolutely. senator hatch: thank you, mr. chairman. senator alexander: thanks, senator hatch. before we go to senator murray,

dr. woodcock, i said that there were no generic drugs 30 years ago. there were some, right, but they had to go through the whole process. what would be the accurate way to describe the percent of generic drugs 30 years ago? dr. woodcock: i believe there were some. they had quality problems as well. so the program that was put into place improved the quality and acceptability of them as well, but there were some generic drugs out there. at that time. senator alexander: ok. senator murphy. senator murphy: thank you very much, mr. chairman. welcome, dr. woodcock. thank you for your service. a comment and one question. comment is just an extension on the point that senator warren was making. i am hopeful we are going to spend some serious time and attention to this question of spiraling drug costs. it's important for consumers.

it's certainly important for the federal budget. i agree with senator warren that we won't place good share of the blame on the regulatory process. there are certainly efficiencies we can gain, but i agree with her. i think it's worth restating that what is exceptional about the united states is the way in which we have structured other market for drugs, the way in which prices are set. we are virtually the only country in the world that doesn't have a process for capping and controlling drug costs. the result of that is that american consumers and the u.s. government bear the lion's share of r&d costs for the entire industry globally and the rest of the world consumers are free riders. second, and more difficult to talk about, is the fact if you take a look at the 16 publicly traded companies that sell the best-selling drugs in this

country, half of them are taking in a greater profit at the end of the year than they are spending on research and development. and that's 2014 numbers. we certainly have discovered and dispensed life-changing drugs because of the product mobility in our system. those are stunning numbers. my question is a very specific one. you, i think, ended your testimony with a set of challenges and barriers. one of those that you outlined was this problem in which we don't have convincing bioequivalence test method available. and i think that's worth just exploring a little bit. you got money to try to develop those pathways, and so you also caution us that it takes time. so can you tell us a little bit more about the timing of that research, how we should judge

its effectiveness? and then to the extend 10th we've been successful in getting another $2 billion over in n.i.h., what's the degree of cooperation with n.i.h., what more can they be doing to try to solve this problem? dr. woodcock: thank you. well, n.i.h. doesn't typically do this type of research. this is very applied research, and what we're talking about here is that drugs that aren't systemically absorbed and go through the blood are hard to determine whether they're bioequivalent to the innovator drug. so that would be all the creams and lotions and different topical agents as well as inhalation drugs. and then we have a new category, very complicated drug out there that also are going to pose problems in characterizing them and making the they are the same as innovator. kind of similar to the biosimilar problem.

the research we're doing, i think you can judge if it's going to bear fruit because we would issue draft guidance and the draft guidance would have a new bioequivalence test in it and we might do workshops and other things to try to get the scientific community onboard. we would say instead of having to do clinical trial and all that entails, comparative clinical trial, you can use this bioequivalence test and, you know, you put the cream on these people and you put the other cream on maybe their other arm and then you measure something or whatever you do, whatever we say and then that would stand in for the bioequivalence results. and that would really improve uptake in generic competition in these areas where they aren't systemically absorbed drugs. senator murphy: just forgive my ignorance, but these guidances would be for classes of drugs, types of treatments or for

specific drugs or treatments? dr. woodcock: it would probably be nor drug classes sometimes and for specific drugs other times. senator murphy: do you have enough funding to get to where you think we should be five years from now, 10 years from now in terms of guidance in order to keep up with the pace of technological change in these drugs? dr. woodcock: we have to get back to you on that. we invested a substantial amount, but compared to n.i.h., we invested like $24 million. and we are having a lot of research done, but it takes time, as i said in my testimony, to get that research finished, to understand the implications, transfer it into policy and guidance and educate the world in how to do these studies. but it's a key to some of the silver gap there of drugs that don't have generic competition at all because it's too expensive or almost impossible or infeasible for them to figure out how to show they're the same.

senator murphy: thank you very much, mr. chairman. thank you, dr. woodcock. senator alexander: senator whitehouse. senator whitehouse: thank you, dr. woodcock, for being here. i will continue on the same theme. it strikes me -- i'm not an advocate for government price controls. but it does seem to me there are circumstances in which very clever people have either observed or created a monopoly r themselves and then used that monopoly power to extort the marketplace would not support if it were not operating correctly and it seems to me there are some pretty obvious signals of when that might be taking place. to me it's not a determinative factor but it's a red flag factor. if the people involved aren't in the business of creating pharmaceuticals, they're in the business of speculation, that ought to put up a red flag, to

me. if the price hike is beyond a certain amount, let's say 1,000%, you know, again, not fully determinative but that may send up a little red flag. if there are no alternatives to which a certain set of customers or patients can readily turn, that would seem to be part of the monopoly posture. and i'm wondering if your organization is looking in any way at trying to define where the market failure is taking place and saying, ok, these are red flags or if you see that as somebody else's job? dr. woodcock: well, the report issued yesterday by h.h.s. on some of the pricing issues around pharmaceuticals gets to those issues. for the economic ones, i believe they're better suited than the f.d.a. because as i said, we're doctors -- senator alexander: the f.d.a.

is not looking at that. dr. woodcock: we look at sole source because that's a red flag that there could be a shortage because there's only one manufacturer and if something goes wrong that's a big problem. senator whitehouse: you're looking at it as a shortage point of view than a price manipulative point of view? dr. woodcock: yes. if you show the bar chart. you look at those who have few competitors, ok. so the ones in that chart there where they only have one generic, that might be the only drug on the market, actually. the innovator may be off or they're only two or there's two. those are areas where there isn't a lot of competition and where there could be a shortage or a loss of product. but we -- senator whitehouse: it strikes me if we could define the characteristics of bad behavior that everybody on this committee sees and acknowledges exist than trying to go a long

way around in trying to figure out how your drug approval process can resolve that problem is a very inefficient way to do it. you should go right at where the problem is speculators buy drugs that don't have competition and create massive price increases. if you simply say we are not going to allow that any longer, people go away and find more productive ways to spend their time. let me ask you a different question entirely. we had questions about the device regulating side of the f.d.a. and about the drug regulating side of the f.d.a. and about the need for there to be a new track in the f.d.a. for drug-device combinations and this committee is obviously looking at that. what can you tell me about where the f.d.a. is in terms of making a recommendation to us on what the drug-device combination would look like, what is your recommendation to us for that? dr. woodcock: well, i believe

that the f.d.a.'s ready to work with the committee on this and we're very interested in looking at some solutions to this problem. senator whitehouse: have you proposed any? dr. woodcock: i don't know if we proposed significant legislation and i don't know where the administration is on that. however, i would say from my own technical point of view it is a problem. we need more clarity, and we probably need a different path that they -- senator whitehouse: both you in charge of the drug side and device side have said the same thing to me. you can't do drug-device combination using our process. there has to be a new process that emerges. so do you think it would be wise for you when the device side to sit down and spend a little time making a recommendation to us as to how you think those drug-device combinations may be best regulated? dr. woodcock: certainly. we've had numerous conversations about this with our colleagues at devices and

the office of combination products and going through multiple scenarios. so i think we would be very eager to discuss it with the committee. senator whitehouse: a proposal from the agency would actually be obliged to implement it i think would be helpful to the committee. thank you, chairman. senator alexander: thank you, senator whitehouse. senator murray, do you have any further comment? senator murry: i don't have any further questions. i want to thank dr. woodcock for her really important expertise and answer to the questions. i think it's been an excellent hearing. we got a lot of work ahead of us and look forward to working with you in a bipartisan fashion to move forward. thank you. senator alexander: thank you, senator murray. let me add my thanks to you, dr. woodcock. that is a -- you've been there for 30 years in one position or another, but it's hard to imagine there be a more exciting time than right now given the rate of innovation. you have a -- we have the

logical tension that exists etween prices, safety, effectiveness and then incentivizing and encouraging a supply of new treatments and cures and devices that will save lives. i mean, we're talking about the next generation of cancer treatments and innovative therapies for a.l.s. and alzheimer's, infectious diseases. we've seen what's happened with hepatitis c. we've seen what's happened with cystic fibrosis. you've had a role in all of that. we're told in alzheimer's that if we simply delayed onset for five years that could save our health care system $367 billion by 2015 and the grief and the anguish is is incalculable and there has been 123 unsuccessful attempts of developing drugs

for alzheimer's, i'm told, while only four are successful. so my hope at least is that while we're working on safe and effective and keeping the market competitive so prices are as low as possible that we don't do anything to discourage or disincent the development of these new life-saving treatments. the hearing record will remain open for 10 days. member may submit additional information if they would like. the next session in our committee will be an executive session on february 9 to begin the step-by-step process to produce legislation. there will be several bills considered with amendments. these are all bipartisan bills in that sense they've been sponsored by members of our committee on both sides of the aisle. and perhaps they can grow into companion legislation to the work that 21st century cures package that the house has already passed.

the president is vitally interested in what we're doing with precision medicine and also now with his cancer initiatives, we welcome the administration's input on that. so we look forward to february 9, and we thank you, dr. woodcock, for coming today. the committee will stand adjourned. [captions copyright national cable satellite corp. 2016] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org]

under that broad strategy we're going to take a lot of action. >> about this testimony today, do you believe you have all the resources you need to maximize competition, do you feel there are other steps you could take in dr. woodcock: the congress hasn't vested in f.d.a. -- have anything to do in prying prices. we have no authority in that area but we are charged with making sure that products that could get on the market get on, are developed and then reviewed as efficiently as possible. and we have a huge strategy in that. i believe we have sufficient resources on the review side now and hopefully on the infection side, we're still

working on our inventory. senator roberts or -- was asking me about that. but the research side, we're going to get back to them. i mean, it is a question. there could be a very large research agenda. not only do we have the nonsystemically absorbed products, ok, and we need a different equivalence method, often a different one for each one, but we also have complex drugs and we're seeing more and more of those. approved a generic to propaxone. and it took a tremendous amount of effort. that was a benefit to the consumers. i think that's a good question. do you have enough resources to carry forward the anticipated workload of research and efforts we are going to have going forward to approve these? >> when you talk about clearing

the backlog, you said absolutely, to senator hatch, this will be cleared out. why so certain? dr. woodcock: well, we have to take, first, action. that's a commitment under gdufa. >> at the end of fiscal year 2017. we're at 86%. dr. woodcock: we're at 86% now. two more years. that's why we will never have a 100% goal. there will be some stray here and there. there will be a policy reason. we're blocked by some dispute or different things like that we can't help that. but we know because of our performance so far that we're going to achieve that goal. >> i'm sorry. you say 86% right now. in the hearing i thought you were talking about 8 %. dr. woodcock: it depends what you count. it's 84% if you count just the original applications. it's 86 if prs if you include

the pre-approval supplements. you're also -- it's all in the testimony. if you want to look at the actual numbers but those numbers change every day because we're just really cranking up. i understand the senators' frustration because of the performance of the program in the last several years hasn't been, you know, like we gave all this money, why didn't we -- we redid everything, we redid everything about the program and built it to mood earn review process and we're just going to crank the next two years, no doubt. >> do you think the f.d.a. should -- you were talking about there's a bright line here, we should be thinking about price. as price becomes a bigger and bigger issue nationwide, do you think the f.d.a. needs to expand its approval? dr. woodcock: no regulator similar to the f.d.a. around the world involved in that way, ok. they have separate entities that -- they're tech assessors,

national health care system that has drug pricing. the regulators -- what i told one of the senators, if they give us direction to prioritize in a certain way based on certain criteria somebody else develops, we could do that. but we can't -- it's a slippery slope to get us involved in that part of it. we need to stick to the science, i think, and safety and effectiveness and a level playing field and the fairness. you know, the other part of the review process, we didn't talk very much and sh -- and other legal maneuvers to keep us from approving generic and that's a very massive workload. f you ever read any -- all the science, all through the -- that's a great deal of work, too, that has to be done. so any further elements that

are introduced, we prioritize this over that, it's another just like the rem, things delaying us like suing us and saying it's not fair. there's a balance there. i think it's better if the f.d.a. does not get involved in pricing issues. that doesn't mean we couldn't respond to direction from some ther body. >> [inaudible] dr. woodcock: most of generics are still decreasing in price. this is a problem for a small area, of course. through medicaid, pricing went down for 64% of the drugs. >> that silver slice you were talking about, that's what? dr. woodcock: it's the innovator drugs that doesn't ave any generic competition. >> [inaudible] dr. woodcock: nobody waiting. they're orphans, complex drugs.

there might be ones that don't have a bioequivalence test. the marketplace may be too small. if you have four or five other entrants in that space then they might not make money. >> do you think the guys need to think about that, to think about that silver slice? dr. woodcock: we just wanted to present the reality to the committee about where the vulnerabilities are. it's people we think in the press -- so you guys can correct this, ok -- are presenting this as a giant problem across and it isn't. i go to the drugstore. i bought a generic the other day. it was 23 cents. of course, that was my co-pay. but still my insurance company i'm sure didn't pay very much, right? so in general, the generic drugs are affordable but there is a small segment. that's what we wanted to present where they don't have a lot of competition. there's only one generic, that little bar we showed, they may

have the -- there might be only one in that space. and the silver part, there's no competition whatsoever. even though there could be. so why is that? so those are the areas where without competition they have a lot of freedom to change things around. >> do you have thoughts about -- when you say why is that, what do you think, why is that? dr. woodcock: i think it's generally driven by the opportunity -- business opportunity. and people don't see business opportunities in these small markets. or if there's a barrier because it's hard to do -- you have to do a clinical trial, that is a barrier. that's why we're doing this research, spending millions of dollars on research, and the industry gave us that money because they see if they can get a bioequivalence test instead then there would be a generic entry. >> we need to wrap it up.

you need to go. dr. woodcock: the small markets, the orphans and others, i think what senator collins is talking about, some of these old, small volume perennials, they're hard to make. all right. they have to be sterile, right? everybody's learned that, right? they have to be sterile. it's hard. they aren't big. nobody picks them -- takes them chroniclely. they stock the emergency room carts for them. it's not a big market. so how many, you know, players -- where is the business opportunity to enter that market? and that's where we're working on advanced manufacturing. so if we can make more manufacturing more agile and flexibility and so forth, then we think that would help people enter -- lower a barrier to entry as well. thank you. > thank you very much.

>> if you missed any of this generic drug hearing or any of congressional coverage today you'll find it at c-span.org. it is four days until the iowa caucus. our coverage continues this afternoon with former senator and candidate rick santorum who won it in 2012. he's holding a town hall meeting in indianola this afternoon. we'll have live coverage beginning at 1:00 p.m. eastern here on c-span. rand paul is also in iowa. the kentucky senator campaigning in des moines. we'll have live coverage of his voters there. after that we're going to take

your phone calls and your twitter questions and that all begins at 4:00 p.m. eastern. meanwhile, back in washington, president obama will head north, traveling to baltimore today to speak to the house democratic caucus meeting. congressional democrats are talking about their legislative strategy for the next year. c-span2 will have the president's comments just a bit after 7:10 eastern this evening. and donald trump, meanwhile, is skipping tonight's fox news debate. instead will hold a rally at drake university in des moines. we'll have live coverage of what's being called a special event for veterans at 9:00 p.m. astern here on c-span. >> c-span's campaign 2016 is taking you on the road to the white house for the iowa caucuses. monday, february 1, our live coverage begins at 7:00 p.m. eastern on both c-span and c-span2. we'll bring you live precaucus coverage, taking your phone calls, tweets and texts. and then at 8:00 p.m. eastern, we'll take you to our republican caucus on c-span, and a democratic caucus on c-span2. see it in its entirety and join in on the conversation on -span radio and at c-span.org. >> "the new york times" has put

together this map on where mainstream republicans are most popular in the u.s. as you can see, supporters for carley bio, jeb bush, fiorina are in florida. candidates don't do well in the south. the data being provided by a democratic data firm. and based on interviews on republican leading respondents. you may notice in iowa where the nation's caucus takes place monday, establishment candidates do well in the northwest part of that state. and here's a bit more about the iowa caucuses. on february 1. joining us from des moines this redlawsk, theid author of why iowa? so, let's begin with the history of the iowa caucus. who decided that i was should go first and why? guest: good morning.

accident,e or less an not so much that it was decided to go first but after the disasters democratic national convention of 1968, the democrats revised their rules, they made it so that caucuses and primaries tend to be more open and available. and one of the effects of that in a caucus state like iowa was to require that the party publicly advertised and provide information about upcoming party events like caucuses. it is important to recognize that iowa is a caucus convention state. it is followed by county conventions in everyone of the 99 counties and send the congressional district conventions and finally he state convention. 1972,the rule changes in

it turned out that the iowa -- itatic party couldn't got pushed into my. you have to backtrack those steps and once you get back tracking, you find that you have to hold the caucuses in late january 1972. new hampshire had been first in the nation pretty much for as long as primaries existed. no one paid careful attention to that. it was rather an oddity rather than anything that happened on purpose. host: how do the caucuses work? guest: it works differently for the two parties. basic aspects are the same. voters go to a location in their precinct, not the place they usually vote in general elections -- a location in a

school or church or public opening of some kind. will call a chair caucus to order. at that point, if you are not signed in, you cannot participate. the doors effectively close. state, the chair will call the caucus to order, and do party business and then the parties diverge. if you are a republican, you will sit down and listen to other members of your caucus who are lucky and who are in a lucky spot -- you might get a candidate. you hear them talk for just a moment and with 11 candidates this year it will take longer than usual. following that, publicans will vote. the chair passes out a ballot. people will mark their

preference and drop it on a box. it will be counted as reported to a caucus and said reported using a brand-new mobile app in des moines. at that point, republicans will move on to collecting delegate and they will elect some large. they also do party business with electing precinct people and voting on potential platforms to send to the county convention. democrats do much of the same stuff but the thing and that is different is how they vote. when the chair says that it is time, what he or she will do is tell people to go to a particular part of the room. to physically stand up and move. have a publicts vote. everyone can see who use of art. they moved to different parts of the room, they are counted and

if any of the groups and candidates do not have 15%, they have to do a real line. and in the real line process, anyone can move but usually people who move will be those in groups of less than 15%. they can try to get people over to them or they can go somewhere else. finished, everyone will be counted again. if there still remains a group of less than 15%, just the people in that group must then realign or they can go home. at that stage, the chair will do caucus count and they will count the number of delegates that each group is entitled to elect based on the size of the group. the group's elect the delegate. so the hillary clinton group

will elect hillary clinton. the chair will report that delegate count to the democratic headquarters in des moines and then they move forward and do business. how will we know the winner of the iowa caucuses? probably relatively quickly this year. by relatively quickly i mean within a couple of hours after the 7:00 start time. republicans take about an hour to do this process. the expectation this year is app,because of the mobile the results will come in electronically at the party will begin to approach the results online as they come in. so we will see the trend almost immediately. we will begin to see the big picture soon after that. for the democrats, it takes longer.

that process can run as long as two hours depending on the need .o do the final realignment and they will report the results as a covenant that but i would expect the republican numbers before the democrat. host: this used to be referred to as a beauty contest. how has that changed? guest: the beauty contest aspect was on the public inside. that was because the votes had no connection to the delegate counts. could win most of as the ron paul folks did in 2012. the reason they could do that is because they stayed when everyone went home and they did the party business and elected themselves and they got county committees and so on. are year, the republicans

binding the reports for the national convention. that means the island republicans will report the iowa at thein national convention if there is a contested first ballot. if there is an uncontested ballot than the chair will work on hundred percent of iowa's vote for that person. unlikeat means is that 2012 when the ron paul delegates go to the floor of the convention, they refused to vote. and that cannot happen. either the vote will be proportional or it will be hundred percent to the winner. becomes -- then the delegates are free to vote. on the democratic side, they are

not bound. but because they are elected by their preference group, hillary clinton people are elected by delegates, and in they are less likely to shift their allegiance unless their candidate asked them to. host: we are talking about the role and history of the iowa caucuses. we have a line for the iowa voters. we have david breslau skier -- we have david redlawsk here. are on the line. caller: i am deeply offended by the two ugly that has existed since 1976. i never agreed to have iowa and new hampshire go first. we have 50 states here and your guest seems like a nice this is outrageous

that these two small haveresentative state subverted our process. .e need to start from scratch i would like to see a national referendum of the 50 states and see if the other 48 states agree that iowa and new hampshire second forirst and the remainder of our democratic form of government because i don't think it is right. has said, it was an accident of history. host: why is it right? guest: well, the interesting thing is -- this argument is made all the time. otherrly every cycle states try to go first since this started in 1972, they haven't been successful. there are a lot of things to

argue on both sides but the basic idea of iowa and new hampshire is that it is an opportunity for candidates to get out and talk to voters. one of the biggest values of this process is that candidates have to talk to real people on the ground. they cannot win these events by dropping a massive amount of money on advertising. if we started in a large state ,ike new york or california neither of those states are anymore presented of the country to iowa or new hampshire. he would not have the same kinds of grassroots policies that make candidates better. it helps them learn what is on people's minds. -- i have listened to hundreds of questions.

we have the same kinds of questions that people around the country are asking. people are forced to actually respond to voters. could that be done somewhere else? intentionally. that youok, we argue could start a process like this in any small state but the key idea it -- key idea is that candidates can get out and meet virtually everyone who will vote for them when the time comes and i think that is incredibly powerful. host: so are the candidates hearing what is on the minds of a variety of people? -- i was hijacked our democracy and it is hearing just the voices of a certain part of our country. how can that be reflective of how this election will turn out? , most obvious is that

it is demographic. is one of the five white to states in the nation. it is also before the union. this is one reason by a victory by bernie sanders in iowa and then in new hampshire may signal much less about the state of the democratic already raised their first appears. jeff greenfield has made these arguments before. these are old arguments. yes, iowa doest not look like california. it does look like new york and neither does new hampshire. about it wehink have a sequential system. somebody has to go first. there isn't a way to get around that unless we have a national primary. think of it broadly. by, hampshire, south carolina and nevada.

when combined, these four states will go before super and they are a good reflection of -- iowa, economically is a good representation. financial services are huge as our wind energy and alternatives. new hampshire has a different kind of republican party in iowa does. and in south carolina, the democrats, half of the voters are african-american and then in nevada, the latino population is significant. when you put them all together you get something that begins to approximate the country as a whole and i think that is the way to think about it. argument is that someone has to go first and it on theo be a place where ground operations and building a

campaign is like building a business. realng real people with concerns and i once have the same concerns that the nation has. and needing to be able to respond to them -- that is critically important. redlawsk is our guest and he is taking your comments and questions about the iowa caucuses. we are five days away. here are the phone lines. democrats, (202) 748-8000. .epublicans, (202) 748-8001 , (202) 748-8002. and i will voters, (202) 748-8003. caller: i am still having a hard time understanding how the candidates are picked.

how many candidates as a having candidatesthe total -- how do super delegates into play? is it a undertake all? -- a winner take all? guest: iowa has about 1% of the country's population and it has roughly 1% of the delegates for the two conventions plus or minus a bit because there are bonuses depending on the republican party. but a good rule of thumb is that it is roughly proportional to population. iowa is an evenly balanced state politically despite recent successes for republicans. a voter registration is evenly balanced. it is an even state and that is true with the delegate count. the superdelegates for the

democrats are usually people who are in various party offices and political offices, members of congress and they are not process at all. the delegates are selected proportionally. this is true for the democrats and has always been true for the democrats because the delegates are assigned based on the strength of the candidate in that precinct. precinct -- if -- it sanders gets 45% will probably round to 50% in the precinct. for the republicans, the actual physical human beings who get to go do not have to reflect with the voting in the caucus was. harshly because it was a secret ballot so you don't -- it will probably round to 50% in

the precinct. know area earlier, thisoned year, at the national convention, he will not get to vote whatever way they would like to vote. their votes are recorded based on what happens in the caucuses. no national delegates are being picked on monday night. it will reflect the state parties equivalents. national convention delegates will not be picked until the congressional elections in april. joey in nebraska, you are next. caller: i'm just going to throw out a brief comment quickly and listen. i took part in the first congress -- first caucus in barack obama and

hillary clinton first ran. for us it was historic for nebraska. we've never had a caucus of until that point and of course, we elected barack obama as president later on. it was in the lancaster county for me. and you guys are right when the experts say that when you caucuses, it is not the same as showing up in rallies. you have to be disciplined. you have to corral people i do to decide which side wins. it in my case, we went back and forth between hillary clinton and barack obama. it has been several years so i don't remember the exact outcome but i think it was a win for obama. personally speaking as a citizen, i prefer a straight vote to the caucus because it is too much horse training in my

opinion. i went to university and i took sociology and you get into a lot of groupthink. i prefer a straight vote. how can we encourage everyone to do this? that's all i wanted to say. because the c-span cameras will be there to show you how the caucus unfolds. and look at that when it gets underway. , onell be at 8:00 eastern hour behind. what did you hear there? guest: primaries are easier. there is no question about it. the polls might be open for 12-14 hours and you show up where you always show up and if there is no line you are in and out in a few minutes.

one of the things the democrats caucus does is allow people to express a second choice. it is the case that in the delegate selection process across the country whether in primaries or caucuses, there is a threshold applied differently in different places. the bottom line is if a candidate does not get 15% at the state level or the district level, that candidate gets no delegates from those voters. so the voters that but it for those candidates are unrepresented. process, if you are below 15% and supporting a candidate not doing so well, two things can happen. you can convince people to join you and your candidate gets you can sayrt, or my second choice is a different candidate and i will go register

my second choice. in american politics we rarely get to do that. we either win or lose. in the caucus process you don't win or lose, you win but even if you lose you have the opportunity perhaps to express your second choice. i think that's a pretty good set up. host: let's show viewers who won in the past in iowa caucuses. 2008, barack obama. 2004, john kerry. 2000, al gore. in 1988, richard gephardt. the caucus winners on the republicans, you have rick santorum. 2008, i got to be. 2000, george w. bush. 1996 and 19 88, bob dole. what percentage of the iowa population shows up? it varies tremendously.

republican on the side is usually a little bit less than on democrats. in 2012 and 2008, republicans had approximately 125,000. this is about 600,000 republicans, rounding here. number in the the state. basically 2012 was a record turnout and so had 2008. prior to that, turnout was more in the realm of 60,000 voters. democrats, 2008 turnout blew through the roof and through the walls of a lot of places the democrats were having caucuses. about0 democrats also 600,000, showed up. 2004 roughlyle the

125,000 and in 2000 it had been in the 60,000 or so range as best we know. obviously then it varies a lot. right now we are all wondering what it will look like. democrats do not expect to hit the 239,000 number again but i think they expect to be higher than 125,000 that came before. republicans are preparing for an increase anywhere from 10 to 20 in some counties. in some counties that might have a 50% increase. regardless, it's a nomination contest so a lot of people do not vote. that is true in primaries as well. host: matthew is an independent. go to thendents caucus and participate? they can. i'll has same-day registration web you are independent or not an eligible -- not a registered

voter. just go to the precinct, register to vote right there, and pick your party. it is technically true that if you are a democrat and you want to caucus for republicans, you can do that. we registered to vote as a republican and walk right in. anyone can come and caucus as long as you are eligible. you just have to, i think you can do it online but you absolutely can. host: matthew, an independent in green bay, wisconsin. enjoyed thei really washington journal and wish there were more shows like this. guest, has ask the there been any talk about broadcasting media reform?

socially? that's all i have to say, thank you. mr. medlock, did you follow that? i'm not exactly sure what he means when he says broadcast media reform. essentially we have the media we have because we have the first amendment. the media has the absolute right to approach campaigns and elections in any way they wish. as useful always be as we want or comprehensive as we want. i think they tried very hard. maybe the caller is suggesting how we have all trump all the time. in any case, it could always be better.

host: walter in new york, a democrat. caller: yes, i have a question and it is not particularly political. but is that real gold on the dome of the temple, and if so, where does it come from? guest: it is real gold and my understanding it has been refurbished very recently. the iowa state capital has multiple domes. it is a pretty unusual building. my understanding is they are all gold cap. the corner ones may not have read -- been refurbished recently. unfortunately i have no idea where it came from. i think it's been there for a long time. host: david a read lock is a fellow for citizen engagement and co-author of the book why iowa. we are talking about the role i .ill place here

spencer, in arizona. republican. caller: good morning. my comment is i don't think the people in iowa, south carolina, or new hampshire understand what is going out on the west. those people voting are clueless and really don't know what's going on. you cannot tell me their primaries or elections or caucuses have anything to do with what we face out west. host: ok, let's get a response. lot doestually, i a have some idea. granted, iowa is not on the border. immigration to iowa has been significant. -- the latino population .s one of the fastest-growing it's small at the moment but it won't be for much longer.

there are folks here who are undocumented, particularly for the meatpacking industry. there have been rates from time to time by the federal government. there are real issues and people here at the caucus events i go to that talk a lot about immigration and those issues. there's also a growing political involvement by the latino community and iowa. more and more are now eligible voters, there are very strong efforts underway to get them engaged in the process so they can become part of it. to the extent the caller is talking about immigration undocumented and legal, iowa has been dealing with both for quite a number of years in both positive and negative ways. the: what about on republican side, evangelical voters and criticism they have. that their role is outside compared to what the rest of the

country has for the nomination process in iowa. the republican evangelical community is large and iowa, relatively speaking. anywhere from half to 60% of republican caucus-goers are likely to be considering themselves evangelical or born again. they do play quite a significant role. at the same time, evangelicals play a tremendous role in the modern national republican party. whether it was iowa or other candidatesleast some would be taking tremendous efforts to get their support. the iowa republican party is perhaps more evangelical christian than many of the parties. i will go back to the argument that it's not just about one state. republicans in new hampshire are different. and my sense there are more

libertarians, more of the new england republican. few balance across multiple early states, i think you get a pretty good republican reflection. caller: good morning. off, on the last caller i would have to disagree with you. reallyin the northeast don't understand what's going on with federal land in the midwest theour immigration in southern borders nearly as much as the people who live there. secondly, i just read a wonderful several pages on the web about the iowa caucus. i would like to remind people that if you are 17 at caucus time, if you will be eligible to vote for president later on, during the general, you can

actually go to caucus at 17. i think that is a really cool thing. host: i want to take that. what does that mean for campaigns that are energizing younger voters? --ald trump, bernie sanders donald trump, bernie sanders. it is a fascinating piece and i talked with 100 folks who was a key player in inventing the caucus process in 1972. the reason 17-year-olds can caucus is because one of the activists involved at the time was a high school student who was not going to be 18 by caucus date and they wrote that into the rules that he could be involved. it is important because it does mean that people younger than 18 can start getting involved ahead of the general election and cast votes. for many that show up it will be

the very first vote that they cast in an american election. for the campaigns, it means trying to reach out to them. the problem of reaching out is that unlike registered voters, it's hard to figure out where they are. cere are all kinds of list can use for unregistered voters and identify them as people not on the list are tougher to find. but campaigns make real efforts to do that and they always remind people that they can vote y're going to be 18. host: what kind of organization do you have? must you have? where do you concentrate your resources? specific counties or do you spread it across all 99? guest: it depends.

it depends a lot on the strategy the candidate has adopted and the party of the candidate. for republicans, a vote is about. anywhere you can get a republican vote is valuable to you. there are vote rich republican parts of the state especially the west and northwest in particular. but the more urban areas like des moines and cedar rapids and davenport are places with plenty dates andican candi campaigns tend to be relatively broad unless they have a specific strategy where they go after a specific order who can be identified in a particular part of the state. it is a little different. the delegates i mentioned that they were elected precincts are preset. that is the number of delegates preset the caste based on the democrats voting strength in the prior general election, not

based on how many show up. this is true for republicans as well that does not have the same impact because they report the vote count. the democratic party will not report the vote count. they will report delegate count. what that means is you could have massive turnout in a precinct in iowa city if you are bernie sanders. that will increase the number of delegates elected from a precinct. in a sense you can have almost too many voters and a precinct. where you went to a rural part of the state it might have 20 caucusing and it takes 10 of them to win have the delegates. there will be fewer delegates but instead of taking 50 people to win it may only take 10. for democrats there is a geography to the caucus and smart campaigns learned that and figure out where to build their support. generally, while you want the numbers, you really need to

delegates. today with the headline the rest of the republican rivals by for third place in iowa. candidates try to present themselves as alternatives to donald trump and ted cruz. rivals are and other subscribing to an old adage. there are three tickets out of iowa. historically that has been true, typically if you didn't fish in one of the top three slots your campaign probably wasn't going very far for much longer. certainly finishing at the bottom generally results in dropping out. this was not true for john mccain. he finished at a very close fourth and became the nominee in 2008 but otherwise it's typically true. the question of whether it is determined will be later.

polling at this point suggests ted cruz and donald trump neck and neck and marco rubio fairly far behind. the rest of the field, rand paul may be close to rubio and the rest of the field is dropping back. the real question is the value of third-place even this time, given what i have been calling the trump umbrella. the reason this matters, and we document this in the book in "why iowa? the question is how the media talks about the outcome afterwards. we see very real shifts and media attention waste on whether in, do better than expected, or do worse. if you do worse the media starts ignoring you and that is a killer for candidates typically. you do better than expected, lots of media attention shifts to you.

while herick santorum, was not announced as the winner on caucus night, he was the one or. mitt romney was second. huge media shift to rick santorum post-iowa. he didn't get the nomination but his campaign went further than it would have otherwise. the difference this time for , given whatis that we are seeing with the media and donald chunk, it is hard for me to imagine shifts in attention. donald trump wins, it will be all trump all the time and if he doesn't, it will still be all trump all the time. this is a very odd year. for the democrats, the same thing happens typically. but for democrats if a smaller field with only three candidates. if bernie sanders wins, there will be a lot of talking about how it is just like 2008 and hillary clinton lost again which will not be to her advantage.

wins, i think she's in much better shape but if she barely wins, that might be a win for sanders. then there is martin o'malley who is pulling much lower than 15%. but through various possibilities, might do better than expected. said,to add to what he this is from the washington times, saying on the republican side i don't think there's any doubt that iowa is, if not make or break, close to that for ted cruz because if senator cruz doesn't win iowa eight makes it even more difficult to imagine anyone other than mr. trump winning new hampshire. let's go to teresa in des moines. will you be caucusing? guest: absolutely. host: four home? whom. all hillary clinton.

if any of you martin o'malley voters don't win, you can always go my way. i have a question. you don't think it's stupid but i wondered this forever. who, exactly is an evangelical voter? host: not stupid at all, thank you. guest: no, not stupid. from the standpoint of categorization, we are talking about people that will tell us on a survey that they are born again christian. they will typically tell us they are very conservative. and issues like abortion and same-sex marriage are high on often just the most important issues for them. the other thing we often ask in surveys is how often people go to religious services.

evangelicals will show us very strong tendencies to go much more often than most. there are also certain denominations that can be identified but there's a lot of self identification that goes on here. many say something about horsetrading. intin o'malley as many know the democratic forum the other night told delegates the hold straw. it is trending on twitter. don'te meant by that is go over to another candidate. the problem is in some precincts, if you doesn't reach the threshold, those folks have to realign or convince enough people to join them to reach the threshold which means taking them from clinton or sanders. or literally go home.

chance to hold straw with o'malley after the first alignment if he's not viable. host: how many go home? guest: not a lot but there are always some. anecdotally in 2004, a good number of kucinich supporters when they were viable in there on precinct to go home and did not stay to realign but i think that is relatively rare. host: front page of the washington times, rnc backs down from nomination rules because the nomination rule change to trip trump. donald trump's campaign feels it can ill afford anything less than a first ballot win. the republican party this month has been privately warned not to attempt to change its rules this late in the game. several influential leaders on the republican national tomittee withdrew plans

lower the threshold and make it easier for other candidates to challenge mr. trump. walk us through this. is, tothe starting point win the nomination you need 50% plus one of the delegates at the convention. that's the most important point. there is some probability, we don't know what it is until .oters start voting if you look at the polling, mr. trump is pulling in the early states at about one third. the field may of be hard for anyone to get 50% plus one. if that happens you go to the convention on the first ballot and see what the numbers are. and the convention the horse trading begins. thebeing able to challenge front runner if it is trump or anybody. what makes it interesting is that every convention,

essentially adopts its rules as one of the first things it does. in theory, the rules are changeable right up to the last minute. inreat example way back 1976, when ronald reagan was challenging, they came to the republican convention unclear whether ford actually had 50% plus one. the very first battle was over end, the and in the ford forces one and it became clear he would win. david redlawsk co-author of "why iowa?" >> whur radio, des moines iowa, simultaneousing with c-span. >> the state of iowa. >> here in iowa. >> god bless the great state of iowa. >> hello, iowa. >> the republican party of iowa.

>> iowa. >> in iowa. >> in iowa. >> in iowa. >> in iowa. >> here in iowa. >> i'm so pleased to do this with wonderful friends in iowa. >> if you told us one year ago we were going to come in third in iowa, we would have given anything for that. >> it is good to be back in identify wafment -- iowa. >> people don't know much about the iowa caucuses. >> an average caucus? >> hard to say. the third one i have been to. they are all different. >> it's good to be back in iowa. >> thank you, iowa, for the great send off you are giving us. >> you have to show respect for iowans. >> i want to thank the people of iowa. i want to thank all the people of iowa. >> iowa is the first. >> i love you-all.

i if i lose iowa, i will never speak to you people again. >> the 2012 winner of the iowa caucuses, rick santorum, former senator holding a town hall meeting in indianola, we'll have it live in about 25 minutes at 1:00 p.m. eastern. donald trump as you probably know skipping tonight's fox news debate. instead holding a rally at drake university in des moines. we'll have that live. governor mike huckabee tweets he's going to join donald trump at that event after the earlier fox news debate. we'll have coverage tonight of what's being called a special event for veterans. at 9:00 eastern. by the way, here's the news conference in iowa earlier this week where mr. trump first announced that he won't be attending the debate. it's about 20 minutes.

>> i remember being in iowa four years ago. helping another person running for president. but i got to know iowa. got to know the people. what a great state this is. great people. personifies what america's all about. i'm here to endorse a great patriot. and it's just easy to endorse him because everything i believe in he's doing and he's going to do it when he becomes president.

i met donald six months ago in phoenix. introduced him then. 30 days ago back in phoenix, introduced him then. and it's my privilege and honor to help him to endorse him today for president of the united states. thank you very much. mr. trump: i want to thank sheriff joe. this is a man when we talk about borders, this is a man that believes in borders and getting his endorsement means a lot to me. he called and he said heed like to do t he's wanted to do that for quite some time. we said let's hold it for a little while. we are looking at the world and seeing what's happening. seeing a lot of bad things happening. and he's the kind of guy we want on our team. he's tough, he's strong. he's smart. and he's done an amazing job. he's got a great, great following of people that absolutely love him and revere him. and, joe, i would like to really

thank you. come here. thank you very much. ok. questions? >> mr. trump, senator cruz and his allies -- [inaudible] mr. trump: no deefments joe never asked me for a thing. sara palin never asked me for a thing. we got a tremendous endorsement today from jerry falwell from liberty university. jerry's a terrific man. respected by everybody. and i will tell you that what was so beautiful about it, no deals. jerry didn't say could i do this or do that? joe didn't say it. sarah didn't say t we don't make deals. not with fox, not with anybody. we don't make deals. you have a deal maker for the country. the country needs somebody that knows what they are doing because we are a country that is adrit. we are a country that doesn't know what they are doing at the top. when you look at the iran deal, when you look at the bergdahl

deal. we are adrift. we have no idea what we are doing as a country. nd it's a problem. >> say you can't be trusted as a pro-life advocate. mr. trump: that's their opinion. i'm pro-life. that's their opinion. all i can tell you as this. as you know i'm pro-life. i have been pro-life for a long time. i said -- what did i say? you didn't read t read the full statement of what i said. read the full statement. no, you're not reading the full statement. get out the full statement. read it. i know. i remember tim russert very well e was a friend of mine. good man. read the full statement. look, they have their choice. they can do what they have to do. i'm pro-life. they can do what they have to do. there will be many people that will be voting for me, that i can tell you. [inaudible]

mr. trump: i question ted cruz. i questioned very strongly. don't even think based on things i have learned over the last few days, many lawyers are coming out saying he doesn't even have a right to run. he can't run because he was born in canada you have seen it, sarah. they say that ted cruz, because of the fact that he was born on canadian soil, he cannot run for president. now, the first thing that's going to happen if he ever got the nomination, which i don't think will happen, but if he got the nomination, the first thing that's going to happen is the democrats are going to sue because there's a very real question as to whether or not he is able to run as to whether or not he's entitled to run. as you know, lauren said it's not a settled matter, which is a big problem. but other people have now comeback and say it is a settled matter. e doesn't have a right to run. i think i'm convincing them. i think -- every poll says i'm ahead. we'll see what happens.

i have bonded with the people of iowa. i'm in iowa today. i have bonded. the evangelicals, when i get jerry falwell, who just endorsed me today. a phenomenal man from liberty university. when jerry called up i was so happy to get that endorsement. he put it out a little while ago. but i have really bonded with evangelicals, the tea party, and people of iowa. we'll see what happens. who is that? i think everybody knows about me. i appreciate the nice question. i think everybody knows about e. >> what do you think the penalty should be for a woman who has a an abortion? mr. trump: i don't want to talk about that right now. everybody knows my views. my views are plain.

[inaudible] mr. trump: fox is playing games, yeah. fox is going to make a fortune. i told fox you should give money to the wounded warriors. i'm not a fan of megan kelly, think she's a third rate reporter. she's not good at what she does. i think they could do better than megan kelly. i'm going to be making a decision with fox. i probably won't bother doing the debate. i see they picked me as number one. not only number one, number one by far. but probably i won't be doing the debate. i'm going to have something else in iowa. we'll do something where we raise money for the veterans and the wounded warriors. we'll do something simultaneously with the debate. most likely i'm not going to do the debate. i didn't like the fact that they sent out press releases toying, talking about putin and playing games. i don't know what games roger ailes is playing. but what's wrong over there? something's wrong. when they sent out that press release talking about -- i said what are these people, playing games? most likely i won't be doing the ebate.

the point is that with me they are dealing with somebody that's a little different. they can't toy with me like they toy with everybody else. so let them have their debate. and let's see how they do with the ratings. and i told hem them, i said, give money to the wounded warriors. give money to the veterans. they are going to make a fortune with the debate. now let's see how many people watch. we'll have our own event. we'll lay some money for the wounded warriors. we'll raise money for the vets. when they sent out the wise guy press release as little while ago, i was set to do the debate. i cam here to do the debate. when they sent out the wise guy press release as little while ago, done by some p.r. person along with roger ailes, i said bye-bye. go ahead. excuse me. just so you understand. i have done six debates. i have done six. according to every single poll i have won every single debate. and probably the last one more than any of them.

so every single poll has me winning every single debate. i have done six of them. now you say when does it stop? how many debates do you have to do? the democrats are finished with their debates s that a correct statement in they are finished. they don't have anymore. the republicans go on forever and ever and every with debate. we have people on the stand that have zero, one, nothing. so it's time that somebody plays grown-up. when i see a press release written by a child like i just saw, i said, what do i have to do? why do i have to make fox rich? let me make the wounded warriors rich. let me make the veterans rich. i think i'll do great in iowa. i love iowa. i don't think iowa will care. i don't want to be used -- look, this country needs somebody that's a deal maker this. country needs somebody that's going to make great deals with russia and china and japan where

they are sending us millions of cars and we -- what do we get? we have deficits with these countries. we need people that know what they are doing. we don't need babies. when they send stuff out like that, they are not dealing with a baby. they are not dealing with a baby. we'll see. i don't care, i think the opponents are wonderful people. i know a lot of them. i think they are wonderful. see how many people watch. see how many people watch. i said give money to the wounded warriors. i said give money to the veterans. megan kelly is a lightweight. this is a lightweight. this is not a reporter. this to me is just a lightweight. megan kelly shouldn't be in the debate. i don't care about megan. when megan kelly didn't ask me a question, she made a statement last time, i thought it was inappropriate. everybody said i won the debate. everybody said i won the last debate. they said i won all of the debates. we have had six debates now. why should the networks continue

getting rich on these debates? give some to the wounded warriors, they are making a fortune. let's see how much money fox is going to make on the debate without me, ok? all right. let's see. yes. i would -- he's been a tremendous person in terms of not only deportation, in terms of stopping and creating a border. but i have the toughest plan in terms of border. nobody close. i'm building the wall. and now other people are saying we want to build a wall. where are they? where have they been? we are talking about building a wall. we are talking about building a strong border. sheriff joe understands that probably better than anybody because he's done a great job. he's been given very little resource. so i think the representation of having sheriff joe on my side was really great.

something i appreciated very uch. we have other people. we have other people. but i feel very strongly that immigration -- we have to stop illegal immigration. when i announced i was running for president,dy this on june 16. i brought up illegal immigration. this would not even be talked about if i didn't bring it up. wouldn't even be talked about. right now it's the biggest subject. and now it carries over to isis and all of the things that are happening with the migration and syria and people coming in that we have no idea who they are. we have no idea who these people are. they could be isis. they could be -- we don't know. it's got to stop. we owe $19 trillion as a country. we have people running our country that are incompetent. they don't know what they are doing. we have to create a strong border. we knee security for our country. -- need security for our contry. we cannot allow that to happen. -- country.

e cannot allow that to happen. you know what i'd do, i get the bad dudes out immediately. we have gangs right now that are made up in los angeles and different places, that are made up of 100% of illegal immigrants who are rough, tough dudes. they would be gone so fast. the local police know all about it. they know who they are. they would be gone so fast. ay it again. i'll get congress' approval. my whole life i have been dealing with politicians. that's what i do. i deal with politicians. politicians are fine. but now it's time to do it a lot better because these politicians have turned out to be all talk, no action. they talk. all they care about is getting re-elected. we need to get our deficits down. we need to get -- we need to bring our country back. we are losing hundreds of billions of dollars a year in trade with china.

we are losing tremendous amendments of money -- amounts of money in trade with japan. we do so much for everybody else. you look at south korea. i have friends in south korea. i have deals in south korea. i have buildings in south korea. but we have 28,000 soldiers on the line. 28,000. what do we get out of all of this? i would speak to congress. certainly i would at least speak to congress. we are losing a tremendous amount of money. right now we are losing so much money. each year, because of the illegal immigrants. people that are in our country illegally. hundreds of billions of dollars. people don't realize that. they say, oh, well, it costs a lot of money to build a wall. first of all, mexico's going to pay for the wall. the reason -- a lot of people think like some of the politicians, you can't get mexico -- of course you k they are making a fortune off the united states in terms of trade. they are going to pay for

plenty. i have great relationships with mexico. i have great relationships with the mexican people. i have right now thousands of hispanics -- you have seen some recent polls in nevada and other places, wur i'm leading in the polls with hispanics. they want jobs. people want jobs. i'm going to bring jobs back from china, from japan, mexico. we are going to bring jobs back to our contry. our country is starving for jobs. we are losing all of our jobs. we are losing our base. we are losing our manufacturing. china is devaluing its currency. making it impossible. it's making it virtually impossible for our companies to compete. and now japan is doing the same thing. japan is killing us with their yen. they are devaluing. you look at what's happening to caterpillar. it's brutal. they are getting killed. because our politicians don't know what they are doing. now we have corporate inversions where a lot of people, you just saw the one today, tyco, etc.,

coming out, moving to ireland. pfizer, moving to ireland. leaving the contry. we have major corporations leaving the country because our politicians don't know what they are doing. they have to go. no. sure. probably 50% are stopped at the border. 50% overstay. overstay is very easy to take care of. overstay -- very simple. it's called management. it's called management. that's right. they fly in. they come. they are here legally, they stay forever. can't happen. we either have a country or we don't. it's called make america great. that's what's going to happen. correct. why didn't you read that? why didn't you read that before? why didn't you read that before? you didn't read -- i hate the concept -- excuse me. excuse me. excuse me.

very trustworthy. more so than you. you know what? you didn't read the question. when you quoted tim russert, you didn't read what you just said. read it again. read it again. go ahead. you didn't read. why didn't you say -- when you asked the question before, that i hate the concept of abortion. no, no, no. no. you were quoting tim russert. you were quoting -- excuse me, you were quoting tim and me. why didn't you read my quote the way i said it? then you got to get wifi. don't ask me questions like that. you're not a very good reporter doing that. go ahead. it's a cheap shot. of course it's a cheap shot. you have a guy like ted cruz who is nervous as can be. i looked at him the other day. he's a wreck. nervous wreck. his polls are going down the tubes. i picked up 11 or 12 points in iowa over the period of last than a week. he doesn't even know. now in his -- look, i understand

him. and i always get along with him fine. i waited. i waited for him. finally at the last debate he finally started knocking the people of new york and values. i thought it was a disgrace. a lot of people thought it was a disgrace. i'm not just talking about people from new york. what's going to happen over the next period of time, nothing's going to be nice. nothing's going to be easy. but ted is a wreck. the reason is he doesn't know if -- he has checked, he's a good lawyer. he doesn't know himself whether or not he has the legal right to run and to serve as president. how can you vote for somebody when you know the democrats will bring the suit? there is a cloud on title. it's called in real estate, cloud on title. here it's a cloud over his head. nobody knows whether or not he can even run for office. i tend to doubt it. some great constitutional lawyers are now saying, he doesn't have the right to serve. he cannot run and serve as president of the united states. that's a problem. i also didn't like the fact that on his financial disclosure

form, big problem, he's going to be robin hood. he's going to protect everybody. well, he forgot to mention a couple of little facts. the banks, right. he didn't put them in. why didn't he put goldman sachs in? why didn't he put citicorp? ? he didn't. he said he forgot. he didn't know he was a canadian citizen 15 months ago. he's a smart guy. he stayed, i didn't know i was. he didn't know. he didn't know that he was a canadian citizen. he was born in canada. he was a canadian citizen. and 15 months ago he renounced his citizenship. he probably has a first. he was the first canadian citizen ever to be a senator in this country. senator from texas. but he didn't know he was a canadian. he was a joint u.s.-canadian citizen. he didn't know that he was a canadian citizen? i think my temperament's great.

i built a great corporation. i built a great company. i think when fox send out their little -- written by a child about putin, etc., etc., i say let them have their debate. i'm going to raise money during that period of time for the wounded warriors. and for the vets. let fox play its games. i love the debates. i have to tell you. i love debating. i didn't know t i never debated before. i'm a builder. i create tens of thousands of jobs over the years. i didn't know i enjoyed debating. and the first debate i enjoyed even though i thought it was a bad -- i thought she was a bad moderator in the case of megan kelly. i think she's a total lightweight. i have to tell you i didn't know i was going to enjoy the debate process. i actually love t if you check drudge and if you check time and slate and all the other online polls that judge the debates, almost every single -- i think every single, but almost every single poll said i won every

single debate. not bad. by the way, i never -- i think you could say that, yeah. i think you could say that. sure. sounds like i'm out, doesn't it? i've never threatened to quit. said i think i you should give money to the vets. i have always said that. wounded warriors and vets. i think you should give money to the vets. you have a question that now is a legitimate question? do you apologize. do you apologize? for not reading my words. no, no. for not reading my words. do you apologize for not reading my words? excuse me. do you apologize for not reading my exact words? no, no. i didn't ask that. i didn't ask that. excuse me. you quoted me and you took out the main part of the quote. i'm just asking, do you apologize?

forget you. just forget you. o ahead. it's not a cheap shot. i have had a very good life. i have been a very good person over my life. i'm a religious person. i'm a good person. i give money to charity. a lot of money to charity. i feel -- you can bring up whatever you have to bring up. yes. i'll give you an answer to that sometime in the future, yes. what can i tell you? i can tell you that most people in the country, most people in the country, agree with me. and they agree with me having to do with illegal immigration. they agree with me when we mention the words radical islamic terrorism. where the president of the united states refuses to use the term radical islamic terrorism. refuses to use it.

why? you'll have to ask him. but you can't solve a problem until you are willing to discuss the problem. why are you going to ask him. -- why? you are going to have to ask him. that's right. say it loud because i'd like to have everyone hear that. why is it that i'm leading ted cruz with the evangelicals, and why is it here i'm leading him and leading him big nationwide? because he's really a nasty person. people don't like him. senators don't like him. the people he works with don't like him. you have to have -- we can all be rebels. i'm a little bit of a rebel. you have to be able to get along with people. we have to build up our country again. our country is absolutely falling apart. $19 trillion in debt, tremendous deficits. believe me, the real number in jobs is not $5.2%, it's probably

in the 25% category because when somebody gives up looking for a job, as you know, they are statistically taken off the rolls. so we have to willed -- build up or country. to do that we have to get along. have a semblance of something. people don't like ted cruz. they don't like him. when you say why am i doing better with the evangelicals than ted cruz? because they like me bert than ted cruz. and they understand, i am a christian. i'm a good christian. and the evangelicals have figured that out very easily and very quickly. ow about one more? i don't at all, no. i want to make america great again. i have had a great life. i have employed tens of thousands of people. i have given them jobs. that means education. that means health care. i'm very proud of it. i have built an unbelievable company. just an unbelieveable -- when i filed with the fkfk, all you

people ran down. maybe he's not as big. turned out it was much bigger. i have some of the great assets of the world. i have very little debt. tremendous cash flow. i say that only because that's what our country needs, tom. that's what our country needs. our country needs that kind of thinking. we have $19 trillion, think of it, trillion, $19 trillion in debt with a horrible budget deal that was just made, horrible deal. >> we'll leave the last few moments of this. donald trump live tonight at the:00 here on c-span. take you live now to indianola, identify wafment rick santorum who won the 2012 republican caucusings heading inside to the pizza ranch in indianola to talk with voters there. live here on c-span. . rick: hello.