cigarettes dying, 30 out of 100 people with a heart attack. the difficulty -- at the rates of use of tobacco drop so much. not because -- >> is out because of informing the public or because of government regulation? >> i think it is a combination. >> i would argue it is better to get people to change behavior by informing them of the consequences of that behavior as opposed to putting up arbitrary rules. >> i would like that in general -- >> that is the reality of the human condition. >> when you are dealing with people suffering from addiction -- >> we have not gotten into a conversation about addiction but about fda rules around flavored cigars and some of the cigarette rules around cigarette bans.

>> i would argue that information and education is better than regulation and elimination. >> pursuant to the previous order at committee stands in recess. the committee will reconvene 10 minutes after the floor votes. all

>> can you tell a -- can you talk about your telework policy and when you plan to bring everyone back in in person? >> to answer this question it is useful to start from before the pandemic.

when i was commissioner in 20, we had four out of five days on campus. it was a requirement. we had zoom capabilities built up well before the pandemic. when i arrived in 2020 two the pandemic was well underway and we instituted a policy of measurement, the primary accountability of the american public is getting the work done. we are meeting all of our metrics and user fees quite well. i think that is a matter of public record. when you look at the output of the employees, it is quite high. within that, we have a number of people who work in laboratories and they have always gone to the facility to work. we have 270 facilities around the u.s. because we have a large

inspectorate and other activities and labs located all around the u.s. those people are obviously going to work every day in person. >> my understanding, and i'm hearing consistently from industry, number one the fda granted in person meetings without a hybrid component prior to covid. have we gone to more hybrid because of covid? are you back to pre-pandemic? the concern is, and the concern in my letter and i would appreciate an answer to some of the questions in it is that life-saving drugs and i'm getting this from chief medical officer's, providers and others cannot get the same type of due diligence -- you can't have the same type of meeting and i've talked to a number of companies sang their 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 so it is delaying the approval process. >> first of all -- >> 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. >> i'm hearing from industry that they would prefer in person and those are delayed because of investments, we need more investments in zoom and those kinds of meetings or the infrastructure. >> that may be true of some of the industry but it is not true of all i.

i would expect in the future there would be more in person with both sides wanting it but i would be shocked if we did away with hybrid because that is often what the industry wants. >> why in there for -- why in the future where there be more in person? >> they like to be in person when they can. >> why are we there now? -- why aren't we there now? >> it is more convenient than flying everyone to white oak. >> ha>> there is a limited number of meeting rooms up to speed. up to speed for the hybrid meetings that we often have to have because often the industry has people on both sides of the equation. people want to be there in person. -- gamma it is interest-rate driving the demand for hybrid. >>, i would not want to say

that. often it is both sides. the industry would like to have either option is what i would say. >> from what i'm hearing consistently and i would implore you to take a deeper look into this, the industry wants the meetings however they have to happen. they don't want them delayed because of a lack of rooms that have been upgraded for hybrids especially when there are things like als where people are literally dying. >> i'm not arguing with your basic points other than to say that from everything i can see we are meeting our timelines and a record number of approvals have occurred. >> i think we have -- maybe we need to relook at the metrics. i don't know. i'm telling you what we are

consistently hearing and if they were being approved and it -- and you are having in person meetings and they were being delayed -- >> our job is to evaluate and not just approve. we approve it when the data supports approval. data -- >> you can't have the conversations about the data because you are delaying because of meeting rooms. if you could please ask your team to look at the letter -- i'm on four committees and i've never had to wait four months for a response to the basic questions. >> the chair recognizes mr. langworthy from new york. >> my constituents, many of whom don't have the same access to the doctor's office as my colleagues, they are the ones most impacted by the fda's in

action and lack of clarity on prescription to over-the-counter or in other words, rx to otc switch. what this can result in is the lack of expanded over-the-counter access for medicines that of already gone through an approval process and yet -- through the fda and deserve serious and kindly consideration so our taxpayers can have easier access to the care they need. can you explain why we only see a small percentage of the prescription over-the-counter switch annually? and what can we do to increase that number? >> they appreciate that and also the importance to rural people of having access to medications. what the regulations require is that the company that wants to make the which has to produce the evidence that if they go to over-the-counter that the person purchasing the product can understand the instructions and

use it appropriately and therefore does not need an intermediary to do the prescribing and the interaction. i would say whenever a manufacturer produces that evidence, we are anxious to get it. and to take action if they have the data to support what they want to do. they actually cannot just make the switch. they have to show that a consumer can understand the instructions and apply the medication appropriately. >> what we are hearing is that for too long the switch process has been muddled by moving old posts, it challenges engaging in a dialogue with the fda and the culture of the fda that seems to award denying reviews and approvals rather than trying to get things down. i have limited time so i'd like to move on. from a pseudocode companies are disclosing their inventions to

the fda years before disclosing them to the patent office which can elongate commercial monopolies inappropriately -- inappropriately by 10 years. many of the most expensive drugs on the market are artificially blocked from generic competition. this leads to billions of dollars in savings to patients. president biden released the pharmaceutical competition executive order encouraging fda and the patent trade-off is to collaborate on this issue and fda has also conducted listening sessions where the issue was apparently discussed extensively. however, there seems to be no recent progress on this front. what real solutions is fda considering to address this problem and when can we expect to receive an update? >> we would be happy to give your staff and update any day.

i disagree with the view that there is no progress being made. there is an active collaboration with the patent office and an effort to reduce the number of inappropriate patents that get in there and block the generic competition. we will give you an update on what has happened with that. we had a long discussion about this earlier this afternoon. let me just say that the patent office has the primary responsibility to determining if there is something unique that merits a patent. what we want to do is make sure there is good communication and that the patent office understands when it is a valid, new patent. and extend the protection from competition. >> according to the american

academy of pediatrics, numerous studies have linked the range of health issues to the amount of consuming plant-based foods for children. there is considerable misinformation and the substitution of cows milk. the fda determined based on 13,000 public comments that consumers do not understand the nutritional differences between milk and plant-based alternatives. can you comment on the fda's efforts to reinforce the vulnerabilities?

>> mr. chairman, i yield back. >> i have had a lot of members yield me time. in this hearing you have said that the term harm reduction is an industry term or a term that the industry uses.

but, to be clear, the institute of medicine used the term and the title of its report titled clearing the smoke, assessing the science base for tobacco harm reduction. it is not just the industry, the institute of medicine uses itch. and the concept of harm reduction has been embraced in other countries. they understand their -- that there are options less risky than a cigarette. will we get to that point in this country? >> i definitely accept the idea and your point is well taken and what i want to avoid, we talked about combustible tobacco killing people. vaping, compared to none of the above has residues that are quite concerning for long-term use. if you are a combustible tobacco

user, if you switch to vaping, that is less harm which is good as long as the product is not packaged in a way encouraging you to get addicted to nicotine. i want to get away from millions of youth getting addicted to nicotine by vaping products. we have to ask -- we have to find the middle ground. i'm worried that "harm reduction" is part of a vast advertising campaign that is not taking into account the addiction side of youth. >> but you admit that vaping is less harmful than cigarettes -- >> admitting -- it sounds like i'm confessing something but i agree. that's talk about the applications that have been submitted.

we have approved almost 27 million. is the reason for the backlog -- is that -- are you working on it or have you thrown in the towel? >> we are working every day. i meet with the center for tobacco products leadership every week. we can only approve our product by law if the company produces the data that demonstrates that they meet the public health standard which is the reduction of risk to adults. >> on both sides of the aisle, you have heard people ask this

question -- the fda's are -- the fda's refusal to approve these products have created a thriving market for unsafe products from china. these products receive warning letters from the fda but i don't think china loses a lot of sleep over a warning letter. a lot of people have questions as to why there are so many of these chinese products on the market and they asked us. that is why so many different members have asked you about this. what are we supposed to say? why is the fda enabling these chinese products? >> i would not use the term enabling but i would say 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 is unable to do anything at the border with respect to security. but, wouldn't the foreign manufacturing -- >> as we said many times today, we are the referees but you make the rules. if you choose to do that you may. i would also say that a lot of promises are being made in the vaping industry. if they have user fees -- >> are these chinese companies paying the user fees? >> whoever makes the product has to pay those. >> what do you foresee from the next 12 months with respect to cbd?

you mentioned that you are closing communication -- communicating but what about shifting gears with cbd oil, industrial hemp? >> i think it is the decision of congress so we would look forward to working with you all as quickly as possible to come up with a regulatory pathway that you think is really -- is reasonable enabling us to take action. >> with this, we conclude the questioning phase. we appreciate you being here. i'm going to yield to the ranking member for any closing remarks. >> i just want to thank you for your great devotion to the task and your -- and you are a model

public service trying to advance the public interest at every turn. the scope of issues you have to address on a daily basis is staggering. and the challenge faced by the fda is mammoth and we should not be adding to your burdens by beating you up for ideological causes. 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 that the inflation reduction act is not responsible for drug shortages and contrary to republican claims it has already lowered costs for life-saving medications even as it is projected to reduce the deficit and you ask how we pulled off the feet of reducing the $35 a month which people have to pay for insulin shots if

they are diabetic while at the same time saving hundreds of billions of dollars for the taxpayers. we took a strong stance that the federal government should be able to negotiate with big pharma for lower drug prices and so we have saved hundreds of billions of dollars while that the same time we have reduced the cost of prescription drugs despite the unfortunate and categorical partisan objection of our republican colleagues. so the shortages we are seeing today are primarily in generic medications. and republican opponents of inflation reduction act claim it has already stifled the production of brand-name drugs which is just false. hhs published a white paper with multiple recommendations to address drug shortages and none of them involved repealing the inflation reduction act.

we would do well to deferred to the commissioners expertise and to take it to heart. we would be remiss not to clarify that ivermectin is not effective against covid-19. and there is no reason to think anything wrong of people that wanted to check it out as the commissioner testified but it did not work. the fifth never said otherwise and it is not the role of the fifth circuit to determine whether a drug is safe and affect. it is a job that relies on the quality and integrity of the science and the research. some of our colleagues chose to blame the fda exclusively for infant formula shortages when they should -- when they could have joined us in our investigation in habits.

we never received the documents we were promised by abbott's. our friends across the aisle chose not to help us provide the transparency to the american people that they all deserve. i hope our colleagues will join the democrats in supporting the whole of government approach to counter smuggling of illicit substances and products including adequately funding law enforcement agencies. we should not just be concerned about illegal substance coming from china but of every country of concern. we think you for your patience and your seriousness today. mr. chairman, thank you for calling for the hearing. >> i will conclude by thanking the commissioner for being here. i think it was a substantive hearing. we covered topics from seafood

inspection all the way to just about every other topic i think could be imaginable throughout the past five and a half hours. i do -- highways 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 the inflation creation act and that is why i don't think a single republican voted for it. and i agree that we deserve transparency hopefully in our investigations the administration will turn over the emails and the tapes and all the other items of relevance to our other investigation we have ongoing. with -- >> it is still ongoing? i wasn't sure. >> you need to stop watching cnn. at the end of the day, we

appreciate your attendance. we requested a lot of information and hopefully each individual member that asked questions will follow up here as i travel america and kentucky, we have a lot of people in the private sector that are concerned with the pace at which fda moves to approve medical devices. there is a lot of concern with respect to the uncertainty around the tobacco products, the lack of enforcement of the chinese illegal vape products, the ones creating so much havoc with our young people and across america. and so much uncertainty in the cbd industry as well. we look forward to working with you on that. with that, and without

objection, all members will have five business days to submit materials and any additional questions which will be forwarded. the committee stands adjourned.