dr. gottlieb. >> ever thanks a lot, chairman alexander, ranking member murray. thank you for the opportunity to testify at this hearing to discuss the implementation of the 21st century cures act. cures set out to optimize our investments in science by modernizing how fda overviews breakthrough technologies. you asked us to advance innovations more efficiently while maintaining our gold standard for protecting patients. this focus on innovation couldn't come at a better time across multiple fields of science we stand at an inflexion point in medicine where new technology is creating foundational opportunities to treat and cure disease in ways that weren't possible just a short time ago. take, for example, our recent experience with gene therapy. we have seen two recent approvals of therapies for cancer where a patient's own immune cells are reengineered using the tools of gene therapy to target a patient's individual cancer. this form of gene therapy represents a whole new paradigm in treating canc

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. gottlieb? >> senator burr, ranking member murray and members of the committee, thank you for the invitation to testify today. our nation has faced many emerging public health challenges and unfortunately, will face additional challenges in the future. thankfully, our preparedness and the ability to respond to such challenges has improved greatly since the original enactment of the pandemic all hazards preparedness act. each emergency is unique. many are the result of emerging infectious threats, but the technology for manipulating science for diabolical purposes is becoming ubiquitous and widely understood so we face new and pervasive risks. 2017 was marked by the risks posed by several extreme natural disasters which caused significant devastation and human suffering. these tragedies tested our nation's capabilities to respond. today, i'm going to focus my remarks on the impact of these storms on medical products manufactured in puerto rico and the actions we are taking to mitigate existing an

dr. gottlieb says more aggressive action is now needed. >> i think prescribing patterns absolutely have to change. so you really should see most patients getting a two or three or four-day prescription not a 30-day prescription. >> reporter: he's pushing for more doctor training and nonopioid alternatives to treat pain. >> but it will take us a year, maybe two, to get to the optimal place here. >> reporter: when i hear you say a year or more, that's a lot more people becoming addicted and a lot more people dying. >> there's a lot of things we're doing in the interim. i don't want to look back five years from now and say i wish i had done more. >> reporter: since dr. gottlieb took over, one drug has been taken off the market after concern about the drug's risk of abuse. >> cynthia mcfadden in new york, thank you. >>> tonight residents in paris are bracing for what some are fearing may be the flood of the century. the city is on alert for potential record flooding after days of heavy rain. some parts of the city are already under water in places where the river seine burst its banks. out of

dr. gottlieb took office, one has been taken off the market after concern about the drug's risk of abuse. >> cynthia mcfadden in new york, thank you. >>> tonight residents in paris are bracing for what some are fearing may be the flood of the century. the city is on alert for potential record flooding after days of heavy rain. some parts of the city are already under water where the river seine burst its banks. the louvre has partially closed down. >>> still ahead, cheap airline tickets. why those lower cost basic economy seats may not be such a bargain after all. >>> also, the famous face you won't be seeing at this year's vo: gopi has built her business with her own two hands. each unique piece comes to life in the same way... a messy, sloppy, splattery way. but now she's found a way to keep her receipts tidy, even when nothing else is. brand vo: snap and sort your expenses with quickbooks and find, on average, $4,340 in tax savings. smarter business tools for the world's hardest workers. quickbooks. backing you. my dbut now, i take used tometamucil every day.sh it traps and removes the

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

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

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 were at least some people who believed the drugs were sometimes not approved for lack of a crossed "t

dr. gottlieb said his actions will go further.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 dentist doesn't become a month-long supply. >>> we're goin

dr. 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

dr. scott gottlieb is our guest.out 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. penneyg its year guid

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'

dr. 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.ou 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 re

dr. gottlieb is there approach to balance for consumer advertising, ask correct and do we have data, askworking 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 t

dr. 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.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. forget the scorn fro

dr. gottlieb is he moving quicker in terms of approval getting more he drugs out there. >> he really had 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-dollar share repurchase program very focused on delivering shareholder value focused on locking at products that complement our portf

dr. 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

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, provision by senators warren and capital was included that made it clear pharmacies could only fill part of certain prescriptions like oxycodone, and opioid, that when a mom is going her sons pain medication could ask only for

dr. scott gottlieb.reat 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 a