condition. >> when you deal with people suffering from addiction, nicotine is a terrible addiction, very difficult to be speeded we are talking about fda rules around frankly flavored cigars and also some of the california -- >> nicotine azide addictive substance. we are talking speed i'm well aware that it is, but again i would argue that information and education is far better than regulation and elimination. i yield. >> the time of the gentleman has expired it. pursuant to the previous order the committee stands in recess subject to the call of the chair. the committee will reconvene for ten minutes after votes. stand in recess.

[inaudible conversations] >> the committee will come back to order. the chair now recognizes mr. waltz from florida for five minutes. >> thank you, mr. chair, and thank you for your patience, commission califf. i would to talk about kind of your current policies in terms of hybrid telework. we have here for the american people watching from your website that says the white coat, white vote campus, your main campus is open but yet is open with maxim telework flexibilities. and, mr. commissioner, i sent you a letter back in january. i have received a response yet. so i'll just ask you these questions today.

and it's essentially, can you just talk about your telework policy and why we are still teleworking and when youou plano bring everybody back in in person? >> well, thanks for the question. i think to answer this question it's useful to start from before the pandemic. because when i was commissioned in 2016, we had a four out of five days on campus policy because we didn't have enough offices of the number of people that we had. it's actually a requirement and we had our zoom capabilities built up well before the pandemic. but when i arrived in 2022, the, the pandemic was well underway and we had instituted a policy of measurement, the primary accountability of the american public is getting the work done. we're meeting all of our metrics and our user fees quite well. i think you can, that's a matter of public record.

and when you look at the output of the employees, it's quite high. now, within that with a number of people who work in the laboratories. they've always gone to the facility to work because that's where the laboratory is. we are actually hundred 70 facilities all around the u.s. because we have a large inspectorate and other activities and labs that are located all around the u.s. those people are obviously going to work every day in person. >> just an interest of time, from my understanding and appearing consistently from industry, number one, the fda granted in person bidding without the hybrid component prior too covid. so how we got into more hybrid because of covid? and argue back to pre-pandemic levels of in person? because the concert is and the concern to my letter and i would appreciate an answer to some of the questions in it, is that

life-saving drugs, i'm getting this from chief medical officers, i'm getting this from providers and others, can't get the same type of due diligence. you can't have the same type and beatty and the fact i talked to a number of companies that set meetings have been delayed because they didn't have the right type of zoom capabilities when you could just come in and have the meeting. .. -- >> people are dying and the pandemic is over. >> the approval process is definitely not being delayed because those metrics are cap and we have a record number of approvals and our timelines have been met. we offered the option of in person or hybrid meetings. many times the industry chooses hybrid. >> to be there and it's more convenient and more-- they get better attendance from themselves. >> i'm hearing from industry they'd prefer in-person and

those are delayed because of investments, we need more investments in zoom and those kind of meetings and more investments in your infrastructure. >> that may be true of some of the industry, but it's definitely not true of all of the industry and we -- i would expect that in the future there'll be much more in-person from both sides wanting it, f.d.a. and the industry. i'd be shocked if we did away with hybrid. >> why in the future would there be more in-person? >> because they like to be in person when they can. >> why aren't we there now? >> because often people really find it more convenient to not have to fly over to white oak, so there's a transition, you know, period going on. >> and can you describe what's the transition issue? >> well, you know, there are a limited number of meetings roads that are completely up to speed. >> up to speed for?

>> for the hybrid meetings that we often have to have because often industry has people on both sides of that equation. people that want to be there in person and others who want to-- >> so you're saying it's industry, really driving the demand for hybrid that is making the investments. i wouldn't want to say that. often, it's both sides. the industry, you know, would like to have either option is what i would say. >> i think-- so from what i'm hearing, consistently, and i would implore you to take a deeper look into it, the industry just wants the meetings however they have to happen, they certainly don't want them delayed because of a lack of rooms that have been upgraded for hybrid, especially when there are things for things like als where people are literally dying month to month with these delays? >> i mean, i think you're -- i'm not arguing with your basic points other than to say, from everything i see we're meeting our timelines and record number

of approvals that occurred so by any metric that you would use the place is pretty darn efficient right now. >> just on the time i have remaining, i think we have a -- maybe we need to relook at the metrics. i don't know. but i'm just telling you what we're consistently hearing and if they were being improved and you were having in-person meetings and they weren't delayed. >> evaluated, le's be clear, we approve it when the data supports approval, but-- >> and you can't get to the conversations about the data if you're delaying because of meetings rooms? >> i would be surprised if delays are occurring because of meeting rooms. thank you, mr. chairman. if you could please ask your team to look at the letter, among four committees i've never had to wait four months for a response just to basic questions. thank you. >> appreciate that. >> thank you, mr. chairman.

>> chair now recognizes mr. lang worthy from new york. >> thank you, commissioner califf, my constituents who don't have the same access to a doctor's office as my colleagues in urban and sprawling suburban areas often do, they're the most impacted by the f.d.a.'s inaction and lack of clarity on prescription to over-the-counter or rx to otc switch. would this get often result in is it a lack of expanded over-the-counter medicines that have already gone through approval process at the fd and deserve serious and timely consideration so the constituents, our taxpayers can have more easy access into the care and help that they need. can you explain why we only see a small percentage of the prescription to over-the-counter switch annually and what can we do to annually increase that number? >> i appreciate that and i also appreciate the importance of

rural people, especially, of having access to medications. i mean, what the regulations require is that the company that wants to make that switch has to produce the evidence as they go to over-the-counter, that the person purchasing the product can understand the instructions and use it appropriately and therefore, doesn't need an implant immediatery in the person as a patient. whenever a manufacturer produces that evidence, you know, we're anxious to get it and to take action if they've got the data to support what they want to do. so, it's really a matter, they actually can't just make the switch because they have to show that a consumer can actually understand the instructions and apply the medication appropriately. >> well, unfortunately what we're hearing, dr. califf, for too long the switch process has

been muddled by moving goal posts. challenging engaging. a dialog with the f.d.a. and a culture at the f.d.a. that seems to reward denying reviews and approvals rather than trying to get things done, but i have limited time so i'd like to move on. essential pharmaceutical companies are disclosing years before disclosing them to the patent office which can elongate monopolies by 10 years. and due to the trademark office by branded companies, many of the most expensive drugs on the market are artificially blocked from generic competition. and this leads to billions in lost savings to taxpayers. president biden released the competition executive order that ordered them to collaborate on the issue and f.d.a. has conducted listening sessions where the issue was

apparently discussed extensively, however, there seems to be no recent progress on this front. so what real solutions is f.d.a., in fact, considering to address this problem and when can we expect to receive an update? >> well, we'd be happy to give your staff an update any day. i disagree with the view there's no progress being made. and as active with the patent office in an effort to reduce the number of inappropriate patents that get in there and block the generic competition. we can give you an update what's happened on that. we had a long discussion earlier this afternoon, but let me just say that the patent office has a primary responsibility for determining if there's something unique that merits a patent. that's not an f.d.a. call. and you see what's coming for

pharma, that's confidential by law we cannot release to anyone else. what we want to do is make sure that there's good communication so that the patent office understands when it's actually valid, new patent that would extend that protection from competition. >> okay. thanks. in my remaining time i really want to switch gears here. according to the american economy of pediatrics, numerous studies linked the range of health issues with the consumption of plant-based beverages by children. furthermore, there is considerable confusion and misinformation about the substitution of nondairy products for cow's milk. the f.d.a. determined that based on 13,000 public comments, quote, consumers do not understand the nutritional differences between milk and plant-based milk alternatives. so, commissioner, could you comment on the effort to earn force dairy products standards of identity, particularly the use of the term milk and the actions your agency is taking

to mitigate by the nonmislabeling of using established dairy terms? >> well, i'm glad you refer to the nutritional content because that's the primary deficit here and we are requiring that that nutritional information be prominently displayed as part of the effort. what we're not doing is specifying exactly what can be called milk because this is -- how do i say it, the cow is out of the barn already. it's been decade that that terminology has been used and whenever those kinds of issues, when we make a rule to require it to be called something different, we've lost those cases in court. what is important, when people purchase something they understand the nutritional content and that's heavily emphasized in what we're currently putting fourth. >> thank you very much, i

appreciate you answering my questions and mr. chairman, i yield back. >> and yield back and i've had a lot of members yield me time and now i'm going to ask my questions. >> commissioner in this hearing you've said the term harm reduction is an industry term or a term that industry uses, but to be clear, the institute of medicine used this term in the title of its report titled, clearing the smoke, assessing the science base for tobacco harm reduction. so, it's not just industry that uses this term. the institute of medicine uses it. and the concept of harm reduction has been embraced in other countries. that is they accept and communicate that there are options less risky than a traditional cigarette. are we ever going to get to that point in this country? do you accept this idea? >> definitely accept the idea and industry is the only.

speaking of harm reduction, combustible tobacco kills people and neither using combustible tobacco or vaping is the best thing to do. and they think that none has residues quite concerning for long-term use. if you're a combustible tobacco user if you switch to vaping, that's less harm, that's good as long as the product is not packaged in a way to encourage the youth to get addicted to nicotine. what i want to get away from millions of youth addicted to nicotine from vaping products. we have to get to the middle ground. when we use the term harm reduction, it's part of a vast advertising campaign that's not taking count of the addiction side in you. >> but you admit that vaping is less harmful than cigarettes?

i mean, we've-- >> right. >> and it sounds like i'm confessing to something, no, i agree, i agree. >> so, let's talk about all the applications that have been submitted. millions of applications, i think, you've approved 25 or something-- >> almost 27 million. >> have been applied. >> right. >> have requested applications, but you haven't approved but just a handful. so, is the reason for the back logs-- is that going to-- are you working on it, trying to approve more or throwing the towel in and saying we're not going to have anything? >> no, we're working every day. >> so you think there will be more approval? >> commissioner i meet with the center for tobacco products leadership every week and we go over this. but again, we can only approve a product by law if the company

produces the data that demonstrates and they meet the public health standard and that's the reduction and risks that we just talked about to adults who use combustible tobacco, and risks. >> you've heard a lot of people ask the question. on both sides of the aisle. we don't agree about a whole lot in this committee on a bipartisan manner, but the f.d.a. refusal for these tobe products, created these from china. they received warning letters from f.d.a., but i don't think that china loses a whole lot of sleep from a u.s. governmental agency, especially in the biden administration. a lot of people have questions why there are so much chinese counterfeit products on the market and asked us. and that's why so many members asked you about it. what are we supposed to say? we say it's the f.d.a.'s

responsibility. why is the f.d.a. enabling these chinese products? i believe there's a solution here. >> i wouldn't use the term enabling, but i would say that this is a huge production issue coming out of china into our ports. we need to stop the use of illegal products. >> this administration has proven it's unable to do anything at the border with respect to security, but wouldn't a foreign manufacturer rule address this problem, a rule that pertains to foreign manufacturers from the f.d.a. for this? >> i mean, as we said many times today, we're the referees, you make the rules. so if you choose to do that, you may. i would also say a lot of profit is being made in the vaping industry. if they pay--

if they had user fees we would-- >> are these chinese companies papering the user fee. >> whoever sold the product would have to pay the user fee. >> last question with respect to cbd. what do you see in the next months, you mentioned you're close, you're focused on the center for tobacco, but what shifting with cbd oil, hemp, things like that? is the f.d.a. dose to anything on that. >> i think it's congress's decision to make. to come up with pathway that you think is reasonable and take actions. >> this concludes the questioning phase unless mr. conley is on the way back or anything? well, we appreciate you being

here and i'm going to let-- yield to ranking member raskin if he has any closing remarks, thanks, mr. chairman. and commissioner califf, i just want to thank you for your great devotion to the task here and your model public servants in trying to advance the public interest at every turn. the scope of issues that you are asked to address on a daily basis is staggering and the challenges faced by the f.d.a. are mammoth and we should not be adding to your burden by beating you up for pet ideological causes and i was disappointed that some of our colleagues went in that direction today. i just wanted to clear up a couple little things. one is the inflation reduction act is not responsible for drug shortages and contrary to republican claims it's already

substantially lowered costs for life saving medications even though it's to reduce the deficit by 237 billion dollars. and you asked how we pulled off the reducing the 235 a month what people have to pay for insulin shots while diabetic while at the same time saving hundreds of billions for the taxpayers. it's simple. we took a strong stand that the federal government should be able to negotiate with big pharma for lower drug prices and so we've saved hundreds of billions of dollars. at the same time that we've dramatically reduced the cost of production drugs despite the unfortunate and categorical partisan objection of our republican colleagues. so the shortages we're seeing today are primarily in generic medications and republican opponents of inflation reduction act claim it's

stifled the production of brand name drugs which is fault. and hhs published a white paper for what needs to be done to address drug shortages, none of which involves repealing the reduction act. instead working with the f.d.a. to shore up supply chains and the commissioner laid out a number of ideas here today and we would do well to defer to his expertise and take it to heart and remiss not to clarify that ivermectin is not effective against covid-19 and no reason to think anything wrong of people who want to check it out for the purns purposes as the commissioner said, it's not the role of the 5th circuit to determine whether a drug is safe or effective, whether it be ivermectin or mifepristone.

the quality and research, some of our colleagues chose to blame the f.d.a. exclusively for infant formulas when they could have joined us on our side of the aisle in investigation of abbott. never received the documents provided by abbott and for the transparency that we owed. across the aisle we share concerns about the illegal vapes coming into the country from china. i hope our colleagues will join 0 whole against he smuggling of illicit products. including federal law enforcement agents. we should not just be concerned about illegal substances from china, but from any country and every country of concern. so, we thank you for your patience and your seriousness

today. mr. chairman, i thank you for calling the hearing which i think has been very productive and i yield back to you. >> the gentleman yields back. i'll conclude by again, commissioner, thank you for being here today. i think this was a very substantive hearing. we covered topics from seafood inspection all the way to just about every other topic that i think could be imaginable throughout the past five and a half hours. i do want to correct-- i always have to correct my colleague across the aisle, the inflation reduction act was the title, but i think it will be known throughout history as inflation creation act and that's why i don't believe a single republican voted for it and with respect to transparency that mr. raskin said that we deserve, i agree we deserve transparency, hopefully in our investigations the administration will turn over the e-mail, the e-mails and the tape, the heard tapes

and other relevant items to our investigation that we have p ongoing. with respect to-- >> and still ongoing? i wasn't sure, oh, it is. >> well, see, you need to stop watching cnn. you need to go to main street and ask people. but at the end of the day, we appreciate your attendance. we've requested a lot of information and hopefully we'll poll up each individual member that asked questions, as i travel america and travel kentucky, we have a lot of people in the private sector that are concerned with the pace at which f.d.a. moves to approve medical device. there's a lot of concern, as i've stated to you in the last two days, with respect to the uncertainty around the tobacco products, the lack of enforcement of the chinese illegal vape products that are

the ones that are creating so much havoc with our young people and across america. and so much uncertainty in the cbd industry as well. so we look forward to working with you on that. with that, and without objection. all members have five legislative days which to submit materials and written questions for the witnesses which will be afforded to the witnesses for their response. there's no further business, without objection, the committee stands adjourned. dj. [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> today on c-span, theouse is back for general spehes at 10 a.m. eaern, followed by legislativeusess at noon. members are working on legislatures in rpoe to iran's air strikes against israel this past weekend. on c-span2, the senate returns 10 a.m. to consider a district court nominatn for the northern mariana islands. in the afternoon, the senators are expect today formally receive articles of impeachment for alejandro mayorkas. an oral argumt in a case the criminal statute used to charge a janry 6th defendant. and le coverage on the free c-span nowid app with

homeland security secretary alejandro mayors manufacturing before the homeland security committee. that begins at 10 a.m. eastern. >> c-span is your unfiltered view of government who are funded by these television companies and more, including charter communication. >> charter is proud to be recognized as one of the best internet providers and we're just getting started. building 100,000 miles of new infrastructure to reach those who need it most. >> charter communication supports c-span as a public service, along with these other television providers, giving you a front row seat to democracy. >> next, senate leaders chuck schumer and mitch mcconnell respond to the iranian air strikes against israel over the weekend and call for passage of a senate-passed bill that would