dr. gottlieb? >> i think a lot of our ability, and thank you for the question -- a lot of our ability to make the process itself more efficient, and lower cost, is trying to develop better tools, better scientific tools to evaluate products being brought through the development process to ascertain their safety and effectiveness in more efficient ways. in ways that are faster, that can be done at a lower cost. and that is a process of developing better science, better regulatory science, for evaluating technology. there is a lot of work we're doing in concert with the nih, in collaboration with dr. francis, a couple initiatives i would point to you are the tissue on a chip initiative. which is an initiative for developing better tools for toxicology and looking at issues of safety and effectiveness. and the partnership for accelerating cures, which is another collaboration we are developing these tools. i'll just close by saying, i think that if we can develop this better science, this is a case wh

dr. gottlieb? >> a lot of our ability to make the development process itself more efficient and lower cost is trying to develop better tools, better scientific tools to evaluate products better that are being brought to develop a process to ascertain their safety and effectiveness and more efficient ways, in ways that are faster, they can be done at lower cost. that is a process of developing better sides, better regulatory science for evaluating technology. there's a lot of work we're doing in concert with the nh ann collaboration with dr. francis, a couple of initiatives i would point to you by the tissue on the chip initiative which is for developing better tools for toxicology and looking at issues of safety and effectiveness in the partnership for somebody cures which is another collaboration where developing these tools. if we can develop this better size this is the case will we can have the best of both worlds, the process of our cost and more efficient but also would give us a better measu

dr. kadlec, dr. gottlieb, let's talk about the flu. this is the 100th anniversary of the 1980 influenza pandemic that killed an estimated 50 million people worldwide, 600,000 in the united states. according to the center for disease control, year in and year out between 12,000 and 56,000 americans die as a result of seasonal flu. we heard last week in our opioids hearing that opioids kills more americans than car accidents, and those statistics that i just read would suggest that in a severe year, so could the flu. dr. collins, the head of the national institutes of health, has made the prediction before our committees that if we keep up our investments in biomedical research, which senator blunt, senator murray, the rest of us have been doing pretty well the last three years, that we may have a universal flu vaccine as well as a vaccine for zika within the next decade. dr. fauchi at nih said the most effective method for protecting americans against another pandemic influenza is to encourage and invest in the development and stockpili

dr. larry nassar for up to 175 years is not closing the door on serious questions about the institutions accused of inaction over his years of sexual abuse of young gymnasts. the fallout swift. last evening just hours after nassar's sentencing, the president of michigan state university, where nassar worked, resigned. tonight against growing calls for an independent investigation, we've obtained revealing insight into how the university and usa gymnastics governing body are defending themselves. more from nbc's senior national correspondent kate snow. >> they were selfish. >> reporter: for lindsey lemke who was co-captain of the michigan state gymnastics team and says larry nassar abused her hundreds of times, his sentencing was just the beginning. >> we aren't going to start healing until the people who need to be held accountable are held accountable and get what they deserve for not speaking up when they should have. >> reporter: usa gymnastics says it now supports an independent inves

dr. larry nassar for 175 years is not closing the door on serious questions about the institutions accused of inaction over his year of sexual abuse of young gymnasts. the fallout swift. last evening just hours after nassar's sentencing, the president of michigan state university, where nassar worked, resigned. tonight against growing calls for an independent investigation, we've obtained revealing insight into how the university and usa gymnastics governing body are defending themselves. more from nbc's senior national correspondent kate snow. >> they were selfish. >> reporter: for lindsey lemke who was co-captain of the michigan state gymnastics team and says larry nassar abused her hundred of times, his sentencing was just the beginning. >> we aren't going to start healing until the people who are held accountable are heldbleab held accountable. >> reporter: usa gymnastics says it now supports an independent investigation to figure out what went wrong. michigan state university says, w

dr. gottlieb. [ applause ] >> thanks a lot. thanks for the opportunity to be here today. dr. sar of seen it and i have had a dialogue for many years and i appreciate the relationship we've had talking about policy issues. when he was at fda i wrote an article calling on the agency to start releasing the complete response letters, and then i wrote a subsequent article saying what's taking you so long, josh? so i've been waiting for him to return the favor. and i just got a copy of it, so i appreciate it very much. thanks for the opportunity to be here today. thanks for johns hopkins for hosting this and pew for providing the space. transparency can be a powerful tool for innovation, as was noted. new platforms for analyzing and visualizing large, complex data sets present important new opportunities for the research and development community for regulators and for clinicians it allows foam harness date to advance the safe and effective and efficient development of new therapies, to address unmet medical needs, to tailor clinical care to individual patient preferences, and to c

doc or sub three and dr. gottlieb let's talk about the flu. this is the 100th anniversary of the 1980 influenza pandemic that killed an estimated 50 million people worldwide 600,000 in the united states. according to the center for disease control year in and year out between 12,000 an 56,000 americans die as a result of the seasonal flu. we heard last week in opioid hearing that opioids kill more americans than car accidents and those statistics that i just read would suggest in a severe year so could the flu. dr. collins ahead of the national institute of health has made the prediction before a committee that we keep up our investments and biomedical research. senator blunt senator murray and the rest of us have been doing pretty well for the last three years. we may have a universal flu vaccine as well as a vaccine for zika within the next decade and dr. fauci at nih has said the most effective method for protecting americans against another pandemic influenza is to encourage in development stock piling of influenza vaccines that will prote

what we did is i assume is similar to something that dr. gottlieb is having someone at fda do is we chopped them up into seven different domains like safety, effectiveness, pharma, pharma and so forth. and each was assigned to these seven domains. we actually get further into what we call subdomains, but i've left that out of this talk. and then we look at the percentage of crls that had a matching press release. question one was what's in the crl because nobody really knew. and the second part was given that we at the fda could see the crl, what was it that the public could see? what could they see in a press release? what percentage of the statements appear in the press release? or do they release a press release and if so, how much information was actually disclosed? and we actually look at the fcc filings to see if there was any supplementary information over there. again, the first question was why does the fda turn down a drug? and that a fundamental question to when there was no public answer. and in the absence of information there

but dr. gottlieb said his actions will go further. when he was nominated, some said he had too many ties to the agency he's regular lating. since dr. gottlieb has took over, the fda has gotten one opioid off of the market, after raising concerns of risk of abuse. >> i don't think this will be a five-year effort. but it will take a year, maybe two to get to the optimal place here. >> reporter: you say a year or more, that's more people becoming addicted and a lot more people dying. just this month the fda put limits on opioids in cough medicines for children. >> i look to the past to try to understand what we did wrong, to inform what we can do right going forward. i don't want to look back five years and say i wish i had done more. >> reporter: dr. gottlieb told us about several more aggressive new measures he's instituting at the fda. the agency has notified 74 manufacturers and the most common lly prescribed painkille they will have to provide more training for doctors. he repackaging pills in smaller quantities so a trip to the den

gottlieb, he's taking sort of modest steps. you know, he's starting with the csrs. he's assigned someone to look at 100 complete response letters. he seems to have a few ideas on how to get the companies to move forward. you know, he seems to be saying that part of the deal will be a different, maybe more coherent review if they sign-up for this. but what are the kinds of things that you think people can do, maybe not just investment community but others if they want to support what the commissioner is doing and really see him go further? >> well, i think it's a matter of public policy. i don't think this prisoner's dilemma can be solved by exporting companies to release information. they're not going to unless everybody else does and everybody else isn't going to unless they have to for some reason. so it seems to me that i'm not the expert on the legalities here, but mulultimately it fallo some kind of legislation or policy decision by regulators to say we are going to make available this information or we're going to require that companies make available certain

. >>> coming up, fda commissioner dr. scott gottlieb is our guest. can we ask him about that drug from yesterday $850,000 for a single treatment. but you either go blind or you get -- i'd try to -- >> the problem is trying to get the insurance companies to cover it. >> well, we're talking generics but that's a big number for the single treatment >>> plus the latest on the winter storm and the extremely cold weather gripping much of the country. it's cold because it's warm. plus patriots coach bill belichick with some words of wisdom for his players as the blizzard works its way toward new england. playoffs are coming up "squawk box" will be right back. . >>> coming up, the push for more access to generic drugs for the fda in 2018. we'll hear from fda commissioner scott gottlieb. >>> u.s. equity futures are in the green, dow opening almost 70 points higher. we're back in a moment >>> good morning, welcome back to "squawk box" here on cnbc, we're live at the nasdaq market set in times square. >>> among the stories front and center, jace pea repo.c. pen

azar: i don't know if you have worked with dr. gottlieb on this yet. he's very concerned. there's this issue of these generics distortions that have happened and how can we build more competition and invite it in. i'm very committed on that. senator mccaskill: do you believe the patent system is being abused? mr. azar: i believe there are abuses. senator mccaskill: do you believe that the orphan drug law is being abused? mr. azar: i do think we need to -- i don't know if i want to call it abuse. i know that there are issues around continued exclusivity across all indications or expansion where there's an orphan indication. i want to look at that. it may be simply what the law provides in which case if we don't like that, that's a legislative question for us as opposed to manipulating aloophole. i don't know. i would like to learn more about that. senator mccaskill: when we were there last week, it was announced it went from zero to $15,000 a bottle. that drug has been around for decades. and they slapped $15,000 on one bottle of it. there's something really wrong here. we'

wu-tang was convicted. >> i don't know if you have worked with dr. gottlieb on this yet. he's very concerned. there's this issue of these generics distortions that have happened and how can we build more competition and invite it in. i'm very committed on that. >> do you believe the patent system is being abused? >> i believe there are abuses. >> do you believe that the orphan drug law is being abused? >> i do think we need to -- i don't know if i want to call it abuse. i want to look at it more because i don't know enough to use that word. but i know that there are issues around continued exclusivity across all indications or expansion where there's an orphan indication. i want to look at that. it may be simply what the law provides in which case if we don't like that, that's a legislative question for us as opposed to manipulating a loophole. i don't know. i would like to learn more about that. >> when we were there last week, it was announced it went from zero to $15,000 a bottle. that drug has been around for decades. and they slapped $15,000 on one bottle of it. ther

gottlieb commissioner of the fda. this is the first of two hearings we plan to have on this topic. the second tuesday january 23. senator murray and i each have been openingng statements or any opening remarks they may haverk after that we will introduce our panel and hear their testimony then each minute -- member has up to five minutes for any remarks or questions. first welcome to the chairman for giving me the opportunity to have this hearing that discusses the topic critical to national security and has seen many years of bipartisan work in this committee and congress. we have developed strength in the name work with and other nuclear threats with the potential to jeopardize the health of all americans. this created a framework as we have learned. we should be proud of the accomplishments in the progress made over the last decade. resulting in strong partnerships with our states inhi counterparts, create a greater certainty and accountability to bring forward medical countermeasures to establish a clear strategy with which we can combat the fullom range of public health threat

dr. gottlieb made this incredible movement in helping the closer collaborator with the companies. you don't feel like it's an obstruction. i think we are seeing the number of approvals who's seen this year. that doesn't mean we are having a fantastic interaction such as paving the chorus from our products to be coming out more quickly. maria: he's getting good marks, isn't it? >> he understands what we do in the industry and what do consumers need, but is also not being risk averse. sharing the risk which is what patients want. advocates will tell you who want these for the people. maria: retyped oncology. you're also invested in cardiovascular. >> what's interested in peeking in oncology about the genetic basis of disease and applying it to these primary care diseases. we have a company called myocardial which focuses on the genetic basis of heart failure. a very personalized approach towards treating cardiovascular disease which is very exciting and as we are talking before, mapping the genome, the per diem, unders and in all of this sort of biology and how it comes together is

gottlieb on this yet, he's very concerned. there's this issue of these generics -- >> and competition -- more and how can we build competition and invited in. i very committed on that. >> deeply the patent system is being abused? >> i believe there are abuses. >> do you believe the orphan drug law is being abused? >> i do think we need, i don't know if i want to call it abuse. i want to look at it more because i don't know enough to use that word. but i know there are issues around contingent exclusivity across all indications or expansion where this an orphan indication. i want to look atwa that. it may be simply what the law provides in which case if we don't like that that's a legislative question as opposed to manipulating lupo. i don't know. i would love to learn -- >> last weekgi it was announcedt went from zero to $15,000 a bottle. that drug is been around for decades. for decades and they just slapped 15 15 grant on one bote of it. there's something really volunteer. i'm going to take you att your word. we all skeptica

dr. gottlieb, head of fda said he will push them. one thing to get approved by fda. another thing to get the drug company to have the drug. the third thing is insurance going to cover it? who will pay for it. a huge step in the right direction. it already passessed senates cause up in committee in the house. koch brothers are trying to push it through. after this, the president came out like this, i predict it is going so pass. very important. stuart: very important for terminally ill people, you have a stream of genetically engineered treatments coming on stream. >> exactly what we talked about on the show. immunotherapies, genetically engineered therapies, we talk about it almost every week. some drug will work with dying patient or very ill patient, with als or terminal cancer, they haven't quite made it through approval for the fda, we need them what choice do i have? i will die would you it. stuart: very important subject. >> extremely. i thought he was very eloquent about it. stuart: next, i'm calling the president trump's first state of the union a success. fo

gottlieb is there approach to balance for consumer advertising, ask correct and do we have data, ask working and are patients taking the right messages. >> oh, it's working, the people, most heavily advertised is heavily prescribed. my question is should the taxpayers be helping foot the bill. capitalism, you believe in capitalism and free markets? >> i do. >> and one of the most basic tenets of free market is negotiations for prices on volume. correct. >> yes. >> wal-mart became the b behemoth they are, because they negotiated to pass on to the consumer. >> yes. >> you said earlier today, quote, every incentive is towards higher prices in pharmaceuticals. so do you believe that negotiation, in fact, would be incentive to lower prices. >> negotiations do lower off list prices. >> so that would be an incentive that's currently in your testimony not, there's no incentives for lower prices. >> list prices and that's what's unfortunate. it's not an incentive on list prices. we have negotiations that pulls down what the taxpayer pays and what the individual pays, yes, but that list price

. >> the commissioner dr. gottlieb is he moving quicker in terms of approval getting more he drugs out there. >> he really had a focus on complex generics has very much lived up to what his goals were when he came into fda he talks about wanting to focus on those first market generics very important for the consumer and patient and system, and so we've seen definitely not only a rise in generic approvals but we have seen a nice uptick in the focus on complex, i said mylan received, approval one of the first for 40 milligram expecting generic out there first generic approval in that very important market. >> we have been talking about the tax plan, and what that means for the bottom line of corporations, you acquired meta one year ago you did a big deal are you interested in some savings to do another big deal this year. >> no look we are very much focused on we have been very steadfast on paying down our debt our balance sheet is never stronger we've got over he two billion free-cash flow finished-billion-doll

gottlieb is in another superstar in franklin the front lines of this as is i mention an agent dr. collins and the surgeon general, talking about a full on, you talk about a full on offense really on this issue. i think that's a positive because that's face it. with supply and oversupply comes more demand. i want to go back to something i said 40 minutes ago which is because it's an mom and dad medicine cabinet in your house, liquor is locked up, and nobody's doing come nobody is in a back alley with a needle coming out of the thing pickets and mom and dad medicine cabinet and that tiny bottle has a label that there's of these family doctor local pharmacy. that is what makes this so different and so i think unsuspecting in cities and many commuters. so that we have to make sure people know just because it's a very, it's a safer you are in the house, doesn't mean it's for you and does it mean you should try it. now for the medical perspective. >> just a couple things. i think one of the things were grateful for is cdc has put out some guidelines around prescribing which i think a ve

with our encouragement dr. collins has organized and a h researchers and partnership with private companies to speed up the process, and the fda commissioner dr. scott gottlieb is on board to fast-track the effort within the bounds of safety and efficacy. but i read at least some of your book to say that this holy grail may never be found. even some scientist who say it should not be found. so hope you will tell us what you think about this. should we not continue to try to find nonaddictive pain medicine to relieve suffering without addiction? is that not the obvious antidote to opioid epidemic? the secretary of a dope to learn from you about is what we can do from washington, d.c. we have tried in a foreign waster dreads the ravages of this crisis which we've all experienced in our states, in 2016 congress passed a comprehensive addiction and recovery act, and the 21st century cures act to give states and communities those on the front lines the tools and resources they need to combat this crisis. for example

with our encouragement, dr. collins has organized nih researchers in partnership with private companies to speed up the process and the food and drug administration commissioner, dr. scott gottlieb is on board to fast track the effort within the bounds of safety and efficacy. but i read at least some of your book to say that this holy grail may never be found. you even quote some scientists who say it should not be found. so i hope you'll tell us what you think about this. should we not continue to try to find nonaddictive pain medicine to relieve suffering without addiction? is that not the obvious antidote to opioid epidemic? the second area i would hope to learn from you about is what we can do from washington, d.c. we have tried in important ways to address the ravages of this crisis, which we have all experienced in our states. in 2016, congress passed the comprehensive addiction and recovery act, c.a.r.a., and the 21st century cures act, that gives states and communities, those on the front lines, the tool

scott gottlieb. great to see you >> thanks for being here >> we have so many things to talk about we'll talk about smoking and those issues let's talk about the flu that has been something that's been an issue around the globe and in the united states it's been virulent >> it was an early season. we think it will peak earlier. probably close to peaking. maybe a couple more weaks. weeks. the flu this season is less virulent, for the most part people are getting less sick, but that means there's more people walking around with the flew so more cases are getting transmitted because of that. that doesn't mean some people are getting very sick. the predominant strain, when they manufactured the vaccines it was a good match, but when they manufactured the vaccines, they manufacture them in eggs. you have to make the virus that will grow well in the eggs the eggs produce the antigen that goes into the vaccine when the virus was egg adapte, d it made it less protective so it's not as good vaccine. >> so it's