woodcock. we'll now begin a series of a round of five-minute questions. dr. woodcock, i think all of us on the panel, maybe every senator, are interested in drug prices low as is reasonable. the statutory mission of the fda is safe and effective drugs. it's not to set drug prices. am i correct? >> correct. >> is it also correct, though, that one of the effects of the -- and 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 lowering of drug prices. >> did you say $1.7 trillion in savings? >> estimated. $1.7 trillion has been estimated. >> $1.7 trillion. and 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've 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 t

woodcock is accompanied by mr. keith flanagan, director, director of the office of generic drug policy whose expertise might be needed during questioning. by prior arrangement we are going to release an excuse doctor woodcock at approximately 10:30 a.m. and she is testifying in another committee in order to accommodate this we are squeezing it in and appreciate your participation in both. you you will be excused at 10:30 a.m. she will be replaced by mr. keith flanagan and we'll swear him and at the same time. mr. howard schiller is the interim chief executive officer of value pharmaceuticals, we appreciate you being here. miss nancy -- at turing pharmaceuticals and mr. martin school rally. we appreciate you being here all witnesses are to be sworn before they testify. we will also be swearing and mr. flanagan. if if you would please all rise and raise your right hand. do solemnly swear that the testimony you are about to give will be the truth, the whole truth, nothing but the truth? >> thank you. let the record re

woodcock's written testimony. >> recognize the gentleman from virginia, mr. connolly. >> lord almighty. just to try to understand how pharmaceutical research works, basic research is done by the government, isn't it? >> yes. representative, i am here -- >> i understand but your understanding of where research is done as a precursor to the development of approved drugs is usually done by the government, is it not? >> i am a technical expert concerning the generic user fee act. i am sorry. i am not the right person to answer that kind of question. >> this red's , have i got that name right? retzlaff, in testimony in response to miss norton's question about how could you go from $13.73 to 750 in your new company and you had a helluva first year, model for every one. you said we need to use it, that revenue, to help finance research on other life-threatening conditions, address other kinds of diseases with life-threatening conditions. that was your testimony. >> the conditions as well. >> is it your testimony that the company you bought this drug from was not doi

so doctor woodcock gave her testimony, did you agree with all of her testimony? >> yes, sir. >> said he agreed with her. she her. she testified also in the senate just a few days ago and are you familiar with her testimony there. >> yes, sir sir. >> so with that senate testimony we talk about the practice where making and how we are 90% we have made great progress, but i look at her testimony looks like you have only approved 25% of the applications over a three-year period. do you call that a you winning percentage? >> so right now -- >> yes or no, winning percentage 25% over three years. >> i can answer can answer the question yes or no. it usually takes on average for review cycles to approve generic drugs. it's not that way for the brand side. on the brand side there's about a 90%. >> i'm talking about generics. so let's look at this. if you put up the first five or me one of those concerns i have is with the ambiguity and we have this particular letter which is actually a letter from doctor woodcock says the terms of the application process, that with certai

woodcock was testifying, my bs detector went off.she said, i've got a number of applications way down. but she also mentioned a great many of them were, i think her words were, returned due to technical defect. are you artificially decreasing your wait time as a result of someone returning something without a t crossed or i dotted? >> no. >> give me an example of what one of those technical defects would be. i see it with the va all the time with the casework i do, you don't have this piece of paper, you don't have that, you go to the back of the line. my fear is we've got a bureaucracy at work here that is costing the taxpayers money in the amount we have to reimburse medicare and medicaid for, and it's costing the insured more than based on higher rates they have to pay for their premiums, and the taxpayers are having to pay in premium supplements under obamacare. >> mr. chairman, can i -- >> you have the time to answer. >> please answer the question. >> so you asked for two examples. one example would be if the application doesn't

doctor woodcock, thank you for joining us. since the passage of this generic drug user fee act of 2012 has passed, the intention here was to generate roughly $1.5 billion in user fee money coming out. in the office of generics, people working on this, tell me what has happened to the staffing levels in 2012? >> well, across the program we have hired over 1000 people. >> working specifically on the approval process for generics? >> correct. >> can you give us a very specific number. not right here in this hearing, but as a follow-up i want to be able to see that. >> i need to understand your question. i don't understand your question. >> i want to see which offices they are actually working in and i want you to break that down, not verbally off the top of your head, but i suggest as a follow-up to this hearing can you provide this committee that information? >> yes. >> i want to get into these priority review vouchers that were intended to incentivize treatment for rare pediatric and tropical diseases. the vouchers were suppose

post is a janet woodcock, howard schiller, and ng's chief commercial officer, who is right there, as you just saw. you can watch all of this live on bloomberg live go. ♪ betty: good morning, and welcome back to "bloomberg markets." let's go to julie hyman at the markets desk. julie: after sumner redstone stepped down as the chairman of cbs -- there have been questions about his mental acuity as he ages and we have seen the shares of cbs rally. he is still the chairman of viacom. the board of that company will be meeting on thursday. les moonves took over as chairman. the ceo of viacom there are questions about whether he would take on an additional role or whether the company would bring in someone else. there have been some struggles at viacom that have been more acute than that of cbs. i'm charting these companies versus one another. cbs -- the idea that time is that cbs would be the more study company. viacom, the owner of paramount pictures and mtv, might be more of a growth company. it does not turn out that way, at least measured by the stock price. cbs doing better than five,

in our hearing about three weeks ago, i asked janet woodcock, the head of the food and drug administration, if there had ever been a case of 3-d printing of a drug, and she said yes there has been one. they used 3-d printing to manufacture a medicine for epilepsy. that is not all, mr. president. last year when the president announced his precision medicine initiative, he introduced a young man whose cystic fibrosis has been cured by a new medicine. he takes a medicine every day, and if he does, he's cured of cystic fibrosis. and while that only affects some cystic fibrosis patients, the drugs that are used to cure that number of patients are the same kind of drugs that they believe eventually will cure every patient with cystic fibrosis. the president on that day announced what he calls his precision medicine initiative, and that he wanted to assemble one million human genomes so that if my doctor is prescribing for me a medicine by knowing what my genome is and what that medicine has done in other genomes, he can make a very specific sort of prescription, one that's more likely to help me