gottlieb and appreciate he is being aggressive in this. >> thank you senator jones. senator young. >> thank you, secretary azar. i appreciate your presence here today and your thoughtfulness as you've responded to so many wide-ranging questions. there's been quite a bit of emasis here today and i think appropriately on how the u.s. spend ps more for prescription drugs than other industrialized countries. i would like to ask you a series of questions, my expectation is they will require short responses, and then i have another topic i would likeo turn t i'm just going to give you the floor on that. so, with respect to the first question, on foreign pricing versus u.s. pricing, europe and other wealthy countries, they set their drug prices by governments as opposed to pharmaceutical companies,s that correct? >> that's correct. and then there's no choice for the patient. they're not at all at the center of that decision making, that's correct. >> do you agree every time one country demands a lower benchmark or reference price, it leads to a lower reference price used by

differ't mean to with gottlieb's statements, -- >> legislation or regulation? >> i believe by regulation we could get it but we are welcome to work with congress. >> there is another piece of legislation, a lot floating around on how to fix bits and pieces of all of ts call the creates act. they pharma is using a system call the risk evaluation and mitigation strategies to not turnover samples. we could fix that reginald -- legislatively. if the regulatory way you could look at that? >> there is an that is the type of gaming we have talked about getting after. we have already announced that the companies that have been accused of gaming the system, we put out two guidances making clear how these risk management programs cannot and should not be interpreted to stand in the way of sample availability to generic and by a similar companies. very supportive of it. >> the regulatory way, if you're allowed to do it might be better. they form a complaint they're going to have lots of lawsuits. they have lots of lawyers and they may resist the creates act. the regulator

senator johnson said in his letter to fda commissioner gottlieb, the intent is to weaken the fda. that has been my concern, it is pathway towards weakening the fda's oversight of the safety of the drugs we all rely on. host: explain more about the expanded access program if they don't know about it. how is it different than what right to try is doing? guest: the fundamental under expanded access the fda has to approve the administration of the drug. if a patient and doctor identify a drug that might be helpful, the doctor will go to the company and ask the company for approval to access the drug, which the company can grant or not grant. the dr. bogota the fda and ask for permission to administer the drug. in the past, that was burdensome , but the fda has streamlined it so it takes 45 minutes of paperwork to get that done. now the fda has the request. if it is not an emergency it will turn it around in a couple days. if it is an emergency they can turn it around over the phone in 24 hours. host: with the same people that would be eligible for right to try, would they be eligible

we were doing immunologic tests, and within six months of michael gottlieb's discovery of aids, we found women and children who had the same symptomatology and we felt that they were also aids. so it told us that this was being transmitted probably by a virus -- we didn't know what the virus was in '81, '82 -- and that it was transmitted by blood transfusions, which we found the first case of here in san francisco, and then from mothers to infants. and that expanded the idea of what was gonna happen in this epidemic. and it was really dreadful, and we used to think what would happen if this epidemic expanded. >> and i remember meeting some of the children who were infected. unfortunately, they all died very young, because there wasn't any treatment for them. the treatments were hard enough to get for the adults. >> well, it was urgent. i mean, basically, the young men with aids were dying -- there was no treatment until 1987 -- from 1981 to '87. and for children, it was hard to explain, and for the first time i think in medical history, modern medical history anyway, we had a disease tha

scott gottlieb will talk to us about the crackdown on online o opioid sales. >>> and if you're headedo the hamptons, robert frank will beat you. there he's taking off in the next hour. we'll track him through the show stay tuned, you're watching "squawk box" here on cnbc. ♪ it's time for the 'lowest prices of the season' on the only bed that adjusts on both sides to your ideal comfort your sleep number setting. and snoring? does your bed do that? don't miss final closeout savings on the queen c2 mattress. now only $599, save $300. it's the lowest price ever, only for a limited time. visit sleepnumber.com for a store near you. >>> time for the executive edge. yesterday during the show we told you about amazon's plan to buy pillpack that news combined with the new foray into delivery wiping out 17$17.5 billion from eight companies alone during yesterday's sessions fedex and u.p.s. lost nearly $3 billion in market value combined drugstores walgreens, boots alliance, cvs health and rite-aid lost $11 billion in market value and cardinal health, amerisource and mckesson lost nearly 3$3.5 bi

commissioner gottlieb also noted, mr. speaker, that the use of these technologies such as packaging merits consideration through a careful, science-based process, one that i hope we'll continue. the legislation we're considering today builds on this work and grants f.d.a. authority to require packaging and disposal technologies for schedule two and schedule three controlled substances. the reflective level of risk associated with that substance. f.d.a.'s provided with the flexibility to permit a range of options for packaging and disposal technologies, as long as such technologies demonstrate comparable effectiveness. this flexibility will be crucial to reduce barriers to generic entry, one of the concerns that was raised during our committee consideration. and to maintain appropriate patient access to these substances. h.r. 5687 also clarifies that labeling related to the inclusion of packaging or disposal technologies cannot be used as a blocking strategy by brand manufacturers. if enacted, it is my hope that the f.d.a.

always great to get his take then fda commissioner, scott gottlieb will be in the house talking all thingsare. need to ask him about amazon and where you think all of that is headed then we have the bank stress tests, we will talk to marty mosby, who has a take. grover norquist is here on taxes. six-month anniversary since the tax cuts were passed robert frank will make his way live on a helicopter to the hamptons, and that's always good for something. that's what we got >> robert frank is going to the hamptons on a helicopter and then somehow marketing that as a tv segment he's getting a ride to the hamptons and saying let's bring a camera and make it look like work >> maybe i don't know if he'll stay out there, come back who knows. >> i thought you had the best gig on this network, you don't it's robert frank, he has a better gig than everybody else >> he figured it out >> he mansions, it's a verb. what are you doing this weekend? mansioning >> what's your phrase? rpp? is that it >> rich people problems. the nancy's mercedes broke down on the way to pick up the kids rpp. >> nice to see y

scott gottlieb, okay >> totally different name, while she's here >> jonathan bush >> that's not the guyis a different guy. we don't know who they picked. he's available what do you think of this whole situation? >> i mean, the personal aspects aside and why they coincided in time with the elliott offer. i would aren't want to speculate on the exposure, but we've done a survey and we're looking at the growth in ambulatory medical records which have slowed down considerably the replacement opportunity doesn't seem that strong the offer from elliott is pretty good with 160 and if they do due diligence they will up it and maybe another ep consortium comes in with a competing bid and lex turner who is more hospital focused and we think the general will push this agenda a long and they haven't appointed a new ceo yet. >> do you think the tech company will have it >> like cerner >> like an apple or a google or microsoft. >> interesting. >> because they just did a deal with apple. >> yeah. yeah to provide this data to the consumer and ultimately that's what the company will do in the short term

. >> fda commissioner scott gottlieb. >> if you can demonstrate a product based on derivatives of marijuanaective alternative for some other -- some condition, we want to look at that. >> but cannabis-based pharmaceuticals for pain and addiction are still far off on the horizon. in the meantime, all over the country, people have taken action. unwilling or unable to wait any longer. like in maine, known for its rugged coastline, fishing villages and iconic lighthouses. and now known for overdose deaths, which have doubled here over the past three years. jamie higgins lost her brother to opioids. >> battling the opioid crisis is going to come down to us doing things that a lot of people are going to feel uncomfortable about. it's going to be i think those shocking changes that really bring change to the epidemic. >> shocking changes and bold steps. >> and the cannabis, i think you're using it really well. >> when will the medical community catch up with what their patient populations are doing? >> with two outpatient clinics in the state, dustin sulok has treated hundreds of people who have u

let me check with commissioner gottlieb on that. we put out two guidances as a follow-up to that so making clear that they should not be able to hide behind our regulatory processes to protect safety. that was part of the follow on to that. but if i could get back to you to see if -- >> okay. i would appreciate that. would you commit to working with me and my colleagues in a bipartisan way to ensure customers see generics come quickly and safely to the market as possible? >> absolutely. in fact, i would love to hear from you, as you learn of abuses in the system or entities that are manipulating patent processes, please consider an open door for any input or pointing us to those. >> i appreciate that. are you familiar with the reducing drug waste act of 2017, also bipartisan legislation? >> i am not, senator. >> okay. i would like to call it to your attention. this is a -- including members of this committee who have joined together because the hhs office of inspector general found millions of packages of waste. >> yes, i'm sorry. y

senator johnson said in his letter to fda commissioner gottlieb, the intent is to weaken the fda.hat has been my concern, it is pathway towards weakening the fda's oversight of the safety of the drugs we all rely on. host: explain more about the expanded access program if they don't know about it. how is it different than what right to try is doing? guest: the fundamental under expanded access the fda has to approve the administration of the drug. if a patient and doctor identify a drug that might be helpful, the doctor will go to the company and ask the company for approval to access the drug, which the company can grant or not grant. the dr. bogota the fda and ask for permission to administer the drug. in the past, that was burdensome , but the fda has streamlined it so it takes 45 minutes of paperwork to get that done. now the fda has the request. if it is not an emergency it will turn it around in a couple days. if it is an emergency they can turn it around over the phone in 24 hours. host: with the same people that would be eligible for right to try, would they be eligible fo

gottlieb has spoke ben how much they're -- spoken about how much they're needed and will relieve the usually when you talk about reduction of burden, people talk about generics. what's the difference, first of all? second of all, how much of a cost reduction are we talking about here? big savings? can you give a percentage or numbers? >> sure. as someone who's been making generics for almost 60 years, myelin has over 7,000 products, over 600 in the united states. we're one of the leading providers of generic medicines. when we talk about biosimilars, they're just that, they're similar to the biologic. because you're talking about living organism the and replicating and showing that they work, they're clinically equivalent, they're given the word biosimilar versus saying a generic to the biologic. that's the main difference. from a science perspective, fda has put a lot of rigor around making sure that they're going to work the same for patients. >> and then savings that can be achieved? >> significant savings. as we said, tens of thousands of dollars. we'll be launching our biosimila

commissioner gottlieb testified before the energy and commerce committee about the work the agency is doing urrently to analyze and assist opioidage geezic use for -- opioid analgesic prescribing guidelines for treatment of acute pain. it will have indicators, ensuringing it aligns with clinical need. i believe this goal we all support which i support giving f.d.a. authority to conduct such work so as to inform policies that will better protect public health and help reduce the unneeded opioids from reaching individuals that are at risk for addiction. since this amendment has been filed, we heard some concerns from stakeholders about the amendment possibly impeding the use of f.d.a.'s evidence-based guidelines in making decisions related to dispensing or coverage of opioid prescriptions. i believe that such decisions should be informed by evidence-based guidelines, such as those developed by f.d.a., and hope we can work with the amendment's sponsors and the chairman to address these concerns moving forward. with that i'd yield back. the chair: the gentleman yields back. the gentleman

gottlieb was before us and we were conducting oversight with the f.d.a., one of the things that he mentioned was there were some changes that they needed to see in federal law. the number one change they needed was permission to work some changes in federal statute for how they would work in these international mail facilities. as we said, it's hundreds of millions of packages. as congressman green said, they cannot get ahead of the work. so we have come together. the stop illicit drug importation act is something that will be helpful to getting the job done and getting these drugs off the streets. indeed, they will never get to the streets. they will never get to the streets because there will be the ability to stop them and dispose of these before they ever get to the streets. i encourage my colleagues to support this bill, and i yield back the balance of my time. the speaker pro tempore: the gentlelady yields back the balance of her time. the question is will the house suspend the rules and pass h.r. 5752, as amended. those in favor say aye. those opposed, no. in the opinion of the chair,

commissioner gottlieb has just recently couple weeks ago put guidance out to create a better pathway for sharing of information and discussions between pharmaceutical manufacturers and insurers around economic information and to plan on new product launches so they can collaborate and build the value-based arrangements as quickly as possible. we're working on guidance around government price reporting and anti-kickback statute rules that can, again, create a greater pathway around how we can help private actors and set up the value-based arrangements there. we all believe it's the future of how we need to pay for drugs, pay for outcomes, pay for health care. frankly i would love to see it if they could be more incorporated into the overall wholistic health of the patient, more of a bundled notion. i think that's probably long term the future of value-based, more than just the payment on the drug itself. >> what actions do you need from us on this side to enable you to implement value-based pricing and ensure spending for health care services and products are lined to lower overall he

scott gottlieb that heads the f.d.a., he's added the resources he could find within his agency and has brought many of these issues to our attention. he's been a real leader on this issue for the trump administration. and i thank him for his work. but it's clear this bipartisan legislation that mr. pallone brs to us today is essential as we join together to interdict and stop the flow of illegal drugs into the united states of america. so with that, mr. speaker, i would encourage passage of this bill and i would reserve the balance of my time. the speaker pro tempore: the gentleman reserves the balance of his time. the gentleman from new jersey is recognized. mr. pallone: thank you. thank you, mr. speaker. i yield myself such time as i may consume. mr. speaker,ise to voice my strong support for h.r. 5228, legislation that i authored that will strengthen f.d.a.'s ability to prevent illicit opioids from coming into our international mail facilities by providing the agency with additional enforcement authority and financial resources. in april, mr. speaker, i had the opportunity to visit