test. test test. test test test. test. test test. test test test.

there is something about

high-content thc that is triggering psychosis. and we need to recognize it. >> my time's up. thank you. madam chair. >> gentlewoman's time has expired. pleasure to recognize the gentleman from montana, mr. -- am i right? mr. gianforte. >> thank you, madam chair. thank you to the panel being here today. understanding the full consequences of readily available marijuana on public health and individuals is imperative. we've heard that today. we should be concerned about the lack of federal research on marijuana because when we consider such a drastic change, we must ensure that policy is based on sound science. so the focus today on research is very appropriate. in november i joined with 16 other members of congress in

asking attorney general barr to study the societal impacts of legalizing marijuana for recreational purposes. as we start to see preliminary data from states like colorado and oregon, it's important to fully evaluate their experiments before making federal policy. i appreciate that mr. walden and mr. burgess asked for a hearing on this research and we should continue to investigate. know how to help people who need medical marijuana and how greater accept will impact communities, families and users. however, expanding access to marijuana without the benefit and guidance of the facts and sound science is of grave concern. this is incredibly concerning because we have an addiction crisis in my home state of montana. methamphetamines devastate our communities and tear up our communities. meth accounted for 86% of drugs trafficked in montana in the past five years. montana has worked hard to support people fighting addiction through drug treatment

courts. these courts help people get clean and get back on their feet while staying engaged in their communities. all at a fraction of the cost of incarceration. to consider making any schedule 1 drug legal and more readily available without adequate research is a misplaced priority when addiction continues to ravage our country. instead, we should support focusing on combatting addiction. building on this committee's bipartisan work and the success of the support act from last congress, we need to continue to support those who face addiction and need the help the most rather that making marijuana easier to access when we don't know the full effects on our communities. dr. volkow, ensuring access to mental health services is a top priority of mine. unfortunately, montana has the highest suicide rate in the country. i have introduced the national

suicide hotline designation act which makes 988 the national suicide hotline number. this important bill will protect emergency access to care for those facing a mental health crisis, especially those in rural areas who lack access to mental health professional. in your testimony, you state that serious mental illness and suicides are on the rise in our country. and while multiple factors very likely contribute to this rise, it's imperative to understand if exposure to cannabis in adolescence is one of them. does current research draw a connection between marijuana use and increased risk for suicide or mental health problems? >> there have been some large epidemiological studies that have noted an increased risk for suicide among regular users of thc, but the evidence is not as extensive as the associated with psychosis, so we cannot ignore it but we need to determine

whether it's reproducible and understand the extent to which it is contributing, indeed, to suicidology. it's been noted in large epidemiological studies. >> from your experience as a researcher in this area, do we fully understand the connection between marijuana and mental health and suicide? >> marijuana, if you take high-content thc and almost any one of us, if the content of thc is high enough, is going to make us paranoid, extremely anxious, and very, very afraid, if not fully psychotic and that can explain, one could conceive why in these circumstances someone if they feel threatened may actually attack someone else or attack themselves. so in some people that results in a chronic syndrome and that is where we don't have sufficient knowledge of understanding why is it that in most cases it is just a very short, limited, psychotic

episode and how, why is it that use of marijuana in some results in long-lasting effects? that we do not know yet. >> okay. so just to summarize, i appreciate your expert opinion, it is possible that cannabis could increase suicide rates, is that correct? >> the epidemiological data has given some evidence that it may, but i want to be cautious, again, i think that one of the issues that we've been criticizing the whole field of marijuana is that people say you are exaggerating, how do you know that a person to start with was depressed and was suicidal thinking that put them at risk to take marijuana, to auto medicate? how do you? that's what -- >> it brings us back to the fact we just have to do the research, and with that, madam chair, i yield back.

>> the gentleman yields back. pleasure to recognize the gentlewoman from delaware, ms. blunt-rochester, for her five minutes of questions. >> thank you, madam chairwoman, for this important hearing and thank you to the witnesses. as you can tell, many of my colleagues, we are going over time on our -- the time we have because there are so many questions that we have. and as i thought about this, it really is a multitude of issues that we are dealing with in this one hearing. both protecting and enhancing public health, providing economic opportunities. but in a just way. restorative and criminal justice. l as public safety. i'm encouraged at the comprehensive legislation that

addresses the justice aspects of reform. it's also a significant drain on our national economy. that's why i've introduced bipartisan legislation, the clean slate act, which would seal an individual's federal record, criminal record, for nonviolent or simple possession offenses involving cannabis. as congress continues to evaluate our nation's approach to cannabis, let us continue to include criminal justice reform as a critical part of the conversation. dr. throckmorton, as you mentioned in your testimony, the fda has approved one cannabis-derived product for medical treatment. epidiolex which is used to treat rare pediatric seizures. can you walk us briefly, very briefly, through how the fda came to approve it? >> so, happy to very shortly. we have a process that we've laid out in a variety of different ways including small business assistance and things that basically gives a roadmap to drug developers beginning with conversations with us. coming in, just basically saying i want to develop the drug to do the following and this is where

i think i might get my drug. my active pharmaceutical ingredient, so-called. we walk them through a series of meetings leading to, if successful, a drug approval of the kind that we were able to do for epidiolex. >> you have a roadmap we can actually get a copy of. >> absolutely. >> we'll request a copy of that roadmap. also, i'd like to follow up on is what you have learned through the clinical trials from that as well. since the 2018 farm bill, we've seen a massive expansion in commercially available cbd products. everything from cbd active wear to cbd toothpaste. many of these products assert that they contain various wellness benefits like reduced levels of anxiety or better sleep. i want to continue on. the fda has stated that many of these products are marketed with unsubstantiated therapeutic claims. doctor, could you talk about what the fda does to -- what actions do you take for these

bad actors? what do you -- what are you currently doing? >> sure. thank you. we'd be happy to follow up with details there, too. fundamentally, if somebody makes a claim that their product treats, diagnoses, mitigates, a disease, they're a drug. if they're doing that without approval from the food and drug administration, they're an unapproved drug. they're making claims they don't have substantiated evidence for, we take an enforcement strategy that focuses on the high-risk things. the really egregious claims. >> could you give us some examples of what you did, who you targeted, what you did? >> well, so the egregious claims that we've recently -- recently, we took an action, we sent 15 warning letters out identifying specific products that made those kind of claims or in some other way violated the food, drug and cosmetics act.

we called on them to stop whatever the violation was that they were committing. most of them had to do with labeling and gave them steps that they needed to take in order to come back into -- >> so just so i'm clear, the warning letter went to the person who's the bad actor. >> manufacturer. >> the manufacturer. and what -- how is the public informed of that, to beware? >> those letters are public. you can go onto our website and see the series of warning letters. this is actually, i think, the third time we've done this that we put out, and then we obviously have a follow-up plan for each of those companies to make sure that they come into compliance. >> well, one of the areas i didn't -- when i ran through all those intersections, i didn't run through consumer protection. and i think that's another big area. i know if i go into a store, i'm not likely to then go on your website to figure out is this dangerous for me or not? and so i think this is something else that we need to follow up as we look at research and other

issues. how to best protect the consumer. thank you so much, madam chairwoman, for this very important hearing, and i look forward to the next one and i yield back the balance of my time. >> and thank you for your important work as well. gentlewoman yields back. pleasure to recognize the only pharmacist in the congress. mr. carter of georgia. >> thank you, madam chair. >> you're recognized. >> thank you, madam chair. asked earlier in the hearing about changing a drug from one schedule to another and i wanted to expound upon that and ask you, you mentioned it can be initiated a number of different ways. when was -- what initiated the change from hydrocodone from a c3 to a c4 -- or a c3 to a c2, do you know? >> there was a petition from a doctor. >> from a doctor. why did it take so long? the opioid epidemic started in early 1990s, lasted, arguably

the epitome of it was in 2006 to '10 and yet it took you until 2014 to initiate that. or to complete it, excuse me. >> to complete it. so i believe that petition came in in -- >> so why did you have to wait on a petition? >> i'm sorry? >> why did you have to wait on a petition? >> we don't have to wait on a petition. >> then why with the opioid epidemic being as bad as it is did it take the dea until 2014 to reschedule hydrocodone from a c3 to a c2? >> actually, back when the petition came in, i would argue a lot of folks in the medical community were actually concerned about access to opioids and so a petition to reschedule marijuana despite its potential for abuse and its actual abuse kind of ran contrary to some of those other broader concerns by the medical community. >> and, okay. dr. volkow, you and i have worked together for many years now and i have great admiration for your work and great respect.

you were asked earlier, i believe it was from representative castro, if marijuana is a gateway drug, and i'll have to be quite honest with you, you gave a very scientific response. something about sensitivity. is marijuana a gateway drug, in your opinion? i ask you that as a psychiatrist. you understand. we've had in this subcommittee here, we've had panels of parents, of loved ones, who have lost loved ones to opioid addiction who have all said that it started with experimenting with marijuana. >> and, indeed, all -- most of the epidemiological studies show the first drug is marijuana. that's another big argument for saying why it's a gateway drug. the counterargument, why it's not so simple, it states if you have the vulnerability for drug taking, it is much more likely you're a teenager that you will encounter marijuana than heroin and, ergo, you start with marijuana and go into other drugs. that's why it's not such a

simple -- that's why basically say, overall, i would state based on studies not just in epidemiology but in laboratory animals that if you expose them early on, they are more sensitive to other drugs. that it has -- >> wouldn't you agree that the psychological effects of experimenting with marijuana lead to other people to experimenting with other drugs which leads to more addiction? >> yeah. >> no question about it. that's been proven time and time again. >> and the same -- but the same thing pertains to nicotine, so nicotine is another one -- >> what have we done with nicotine? put limitations on it. and i want to cut to the chase. if you want to see time fly, wait until you get up here for five minutes, but i want to go -- i want to cut to the chase. everyone up here has expressed the same concern. we need more research. tell us what we need to do.

mr. strait, what do you need? what -- do you need a schedule 1a that's not going to have anything in it except for marijuana? that's fine with me. i'll create it. i'll legislate that. but tell me what it's going to take. >> two things. >> i don't -- >> i'll -- >> please. >> two things. we have seen a 150% increase in the number of schedule 1 manufacturer -- researchers in the united states in the last five years. we are making progress. we want to do more. for sure. what do we need in terms of improving access to research? i feel as if this interagency group of folks here have worked collaboratively on a proposal that would actually do just that. >> and is that proposal you mentioned earlier about fentanyls or -- >> correct. absolutely. yes. in the context of fentanyl -- >> can you make sure we get a copy of that? >> i certainly -- >> i want to see it. we invite your input. we want to do the right thing. i saw an article just here recently that said that there's actually the -- the use of new

research found opioids were prescribed less often in states where marijuana had been legalized for medicinal or recreational use. as a practicing pharmacist for many years, i've always said the only thing worse for me than filling a prescription for someone who doesn't need it is not filling a prescription for someone who does need it. if marijuana truly does have medicinal benefit, i want to use it. i am adamantly opposed to the recreational use of it. i think it is a gateway drug. and it should not be used recreationally. but if there are benefits to it, i want it to be used. all we want here, everyone has expressed the same thing throughout this whole hearing. tell us how we can get this research done. tell us how we can find out. it is the epitome of ineptitude that the federal government has a schedule 1 drug and 11 states have approved it recreationally. embarrassing.

thank you, and i yield back. >> so there. okay. the gentleman from california is recognized for his five minutes of questioning. >> thank you very much, chairman eshoo and ranking member burgess for having this important hearing in this committee where it belongs, health subcommittee of the energy and commerce committee. too often we either talk about cannabis as either a criminal justice issue or a medical issue. the reality is that we cannot pull them apart. research has shown that for youth, in particular, incarceration is tied to poor physical and mental health outcomes later on in life. compare to those in the incarcerated, children and adolescents in the system for

more than a year were three times more likely to have functional limitations, over four times more likely to have symptoms of depression and over two times more likely to have suicidal effects into adulthood. now, i'm not talking about the use of cannabis. i'm talking about incarceration. let me make that clear. nearly 75% of all of the people arrested for cannabis-related offenses are under the age of 30. and one in four, one-fourth, are under the age of 18. that's almost a quarter of a million teenagers arrested for these types of offenses each year in the united states of america. given that we know being arrested for possession, growing or selling cannabis, can lead to incarceration, and we know that incarceration has adverse health consequences, we can establish that at a minimum, cannabis criminalization causes some negative public health consequences so the question then turns to balancing these public health concerns.

we also know that a conviction for a controlled substance can lead to difficulty with job prospects, which could lead to both unemployment and underemployment which has potentially adverse public health consequences. similarly, a drug conviction means a currently enrolled college student receiving federal student loan money would have their financial assistance terminated. this can harm the future employment, earnings, and ultimately health prospects of that youth. examining the public health harms created by criminalization of cannabis is a type of research that could be conducted without having to expand the research supply. i think it's really important for us to understand that calling cannabis a gateway drug in an anecdotal fashion is unfair to the american people and it's really not a proper dialogue that policymakers and/or researchers and/or medical experts should be having. and the reason why i say that is because if we're going to have that discussion, we should have the discussion and the question, is alcohol a gateway product or

substance? is nicotine a gateway product or substance? so, to think that cannabis is in and of itself a category 1 and an evildoer to all that touch it is something that should not be the subject of dialogue when it comes to true policymaking and also when it comes to real honest research. not anecdotal answers and questions. what i have -- i think one of the main things we need to understand as policymakers is that the inception of the united states congress calling cannabis a class 1 drug, i would encourage everybody in this room and everybody in this country to look at the footage on the floor of the united states congress

and the nonresearch, derogatory statements that were being made specifically about a certain community and how using cannabis would lead to rape and murder of women and citizens of this country. i'm cleaning it up a little bit because i think it's unfortunate that we have that stain on the united states congress and so far we haven't had the will to actually correct it. the united states congress made a mistake. and every congress since has not had honest hearings and honest dialogue and has not allowed, truly allowed, the researchers in this great country to do the true research that needs to be done for us to properly categorize cannabis in this country. and as a result of that, we have millions of individuals in this country, as i outlined earlier, who have been subjected to incarceration and a criminal record that otherwise they would have a much more productive and

better life and the society would be much better off including the taxpayers if we were to actually get this right. so hopefully we will have the opportunity to do that in future hearings of the united states congress so we can get it right and we can get the research done and we can end this anecdotal discussion and have a real, real discussion about the facts. with that, i yield back. >> the gentleman yields back. the gentleman from illinois. mr. shimkus. >> thank you, madam chairman. >> thank you, all, for being here. it's been a long day for you all. and i didn't have to sit through

all of it, at least in the hearing room, so i appreciate that you have had to do that and so i'm going to try to be fairly brief. and this one is to dr. volkow first. are you familiar with the most recent article that came out of the lancetpsychiatry about the use of drug-induced psychosis converting to full schizophrenia? >> yes, correct. >> can you comment -- i got the statutes up. can you tell me -- i mean, summarize that report and maybe comment on your observations of that. >> this report is consistent with a concern that the use of marijuana, particularly high thc, can produce chronic psychosis. overall, the statement, as i have made, is that most cases are of the use of marijuana trigger an acute psychosis that by itself will go away, and what

this does is shows those individuals that went into an emergency department for an acute psychotic episodes associated with the use of cannabis were much more likely to subsequently go into psychosis. it provides evidence that it increases your risk of transitioning into a chronic psychotic episode as is the case with schizophrenia. >> thank you. let me -- i've been -- mental illness, mental health, early use, what we call when they -- a lot of people would self-medicate through drugs based upon psychosis and i think a lot of us may have had personal experiences with family members or friends and neighbors that have kind of fallen into this trap. and i think part of it is early

drug use. i just -- at an early age. let me go to this other subject that we've been dealing with. and this would be back to you, dr. volkow, and to i think mr. strait and it really deals with this vaping and the thc and also the vitamin "e" acetate issue. so the question is, first of all, is it possible for scientists with a schedule 1 license to conduct federally funded research on thc oil in these vaping products? >> are we talking about the stuff that is actually being consumed illegally? i presume as opposed to creating a thc extract that then could somehow be tested. >> yeah. i think part of -- that is the direction, yes, sir. >> so as we said earlier, the challenge, of course, with that, we certainly understand researchers want access to that material. under the controlled substances act, researchers generally or have to obtain a controlled substance from another dea

registrant. this is something that dr. volkow has mentioned it. a failure to do so might impact their ability to keep their federal funding for their program. so some of them have expressed some concerns about that. >> and then let me just follow up, would you agree that the -- with the cdc that the scheduling status of cannabis makes it challenging for the epidemiological testing of these vaping products? dr. volkow, you're shaking your head yes. do you want to elaborate? >> yes, yes, it is. you want to -- when you start to see, for example, these emergency room admissions occurring in different states or

communities, you'd like to be able for researchers to go in and try to understand what is it in those products that is accounting for the rise in these cases? and that is not, currently not possible if you want to use funding from federal agencies like ours. >> great. thank you. and i want to yield my last minute to morgan. >> i appreciate the gentleman very much. earlier, mr. strait, we were talking about the applicants more in place. 33 applicants to grow marijuana for research are out there. you all are changing the rules. i asked if they'd be able to amend their position. you said, yeah, we did this before, we refunded their money. i don't think they want their money refunded. they want to not have to go back and start all over again with their application. so can they just amend their application? wouldn't that make sense? >> yeah, thanks for giving me the opportunity to clarify. what i meant -- what i said and meant was for -- because the applications had come in prior to passage of the farm bill, and that some of these applicants

may have actually applied to produce things that now are no longer controlled under the csa, we gave them the opportunity to withdraw their application for purposes of no longer needing it. those that have applied, they are in the queue and they will not have to reapply. we will be adjudicating every single application. >> i appreciate that. thank you. that makes more sense than what i thought i heard. i appreciate the clarification. >> you bet. >> gentleman yields back. the chair recognizes the gentleman from illinois, mr. rush, for his five minutes of questions. and we have -- we don't have very much members left and it's my understanding that votes are going to be called shortly. so i think that we'll be on time. mr. rush, you're recognized. >> i want to thank you, madam chair, for holding this hearing and this hearing is particularly timely, and more and more states are loosening their restrictions around marijuana including my home state of illinois which just legalized recreational marijuana.

beginning the 1st of january this year. more than ever, it is important that we prioritize new research on not only benefits but also new risks of marijuana. madam chairman, too little is known about when and how marijuana can be harmful. particularly after >> because the applications had come in prior to passage of the farm bill, and that some of it seems to me that many states including mine are

working to illegalize medicinal and recreational use of cannabis. particularly because there is a questi question. but the revenues declear -- particularly recreational, and it is to help correct an issue that we're facing. the question, will you please expand on the possible health risks and implications for

citizens on these things that are exhibiting what i call a mob marijuana mentality, and who are engaged in what i referred to as marijuana mania? it really exists in my state and in so many other states across the nation. >> i like in a you call it marion mane ia. it is a change in believe even though there has been no evidence that it doesn't make us safe. i don't want to mitigate that there are foblts that they will have benefits. that does not negate the possibility that we can have indications where miles per hour could be used safely.

these things are not exclusive. but the evidence is clear that the use of marijuana is associated with negative effects. and we're seeing the significant decrease in the emergency department that is being observed in the states legalizing marijuana. this is happening. by changing the culture, by legalizing it, by creating a sense that it is a safe drug, more people are being exposed to it. and as a result of that, they otherwise wouldn't have because they didn't want to do something illicit. the more people get exposed to it, the greater the likelihood that we will start to see adverse effects, which is what we are observing. so, the data is clear that it can have adverse effects, and why -- i mean, and at the same time, what we are living as a country, which is quite amazing, is how rapidly the perception of risk has disappeared among the public, and we need to actually create a balance that brings evidence of really what marijuana can do so that individuals that want to take it know the positives and the negatives, and they don't do it blindly, which is what we are

observing happening. >> there is another area that i'm really concerned about. along with this mania that exists is this empty excuse, or this expungement of records. it's okay, all right, but the cause of those records is being ignored. is there a nexus between marijuana, the effects of marijuana, smoking marijuana or ingesting marijuana, and abhorrent social behavior which creates a law enforcement issue, which my theory is that it has led to mass incarceration? i don't know whether or not you

can make the connection, but can you make that connection? >> well, i think that the point of incarceration and incarceration of individuals with a substance use disorder -- when you do the studies, it has clearly shown that not only does it not in any way benefit or protect anyone, it actually makes them much more vulnerable to relapsing and drug-taking and other adverse mental consequences. so, incarceration has an adverse effect on those that are suffering it. >> well, thank you, madam chair. yield back. >> gentleman's time has expired. it's a pleasure to recognize the gentlewoman from -- no, no, no --

>> just waiting on -- >> what? >> she's waiting? >> she's waving on. >> oh, i see. you're waving on, so i'm not going to call on you yet. so we're going to go to ms. barragan for her five minutes of questioning, and we have two members that are waving on to the committee, and i sure hope we'll be able to take your five minutes of questions as well. but ms. barragan, you're at bat. >> all right. thank you. >> five minutes. >> great. thank you. and thank you all for being here today and for providing informative information. i thought it was pretty powerful and the most powerful was to hear from congressman griffith and his story. it is the personal stories that are the most impactful. when i was very young, my father had parkinson's disease, and he had it pretty much all of my life. and i remember when i would see

him in pain, i would just ask, is there anything that could be done for him? i don't care if it's legal or not. and it was more of the sense of, you know, you're a child seeing your parent suffer and you want to give them something to make that pain go away. and so, i am firmly in the same boat of supporting efforts to make sure that we're providing things like marijuana for medical purposes to make sure patients are having access to what they need to help give them some comfort when, especially when they're near the end of their life. there's no reason that people need to be suffering. and so, his story was pretty compelling for me. i'm wondering if anybody on the panel today supports any of the bills, any of the legislation that's before us today? does anybody want to comment on any support on any of the bills?

>> we have been asked that question, and i actually -- i was asked more specifically which one i favor, and i said i favor actually the advancing of science and the ability to do things in a way that can help us accelerate research. but specifically, which is the best bill, i think that that's more on the side of you who are actually the ones that are creating them. but my colleagues, i may put them on the spot. >> and i'm not asking for the best bill. i'm asking for, you know, these are the three bills that i would support that i think would be helpful or that i think would be beneficial. >> on the one that i had -- and i've gone on the record for these that i basically -- and we've been working with my colleagues at the fda, is a creation of a subcategory that would allow us to do the

research expeditiously. and it's not just for marijuana. it's in general, schedule one substances, so that researchers don't have to go through all of the obstacles and the delay process. that's what we've been, actually one of the things that we are very specifically tried to achieve. >> and gentlemen, anything? >> i'd be happy to provide comment on any particular bill that she wanted us to help you with, obviously. i think dr. volkow said it very well before -- the goal needs to be kept in mind. so, whatever the vehicle, decontrol or whatever approaches are suggested, that are included in those legislations, we need to think about the goals in mind. and in particular, from the fda's perspective, the outcome needs to keep in mind the need for continued drug development and appropriate scientific study. >> okay. >> and from the department of justice side, none of these bills have actually been reviewed by the administration,

so there is actually no official position in terms of any of the proposals. i think in some states, they have a list of medical marijuana uses, and i have talked to patients, i've seen what sickle cell has done to patients and the pain that they've suffered, and many sickle cell patients use marijuana to address acute pain that's a symptom of the disease, and some of the states currently have medical marijuana laws but have chosen not to include sickle cell disease on the list of conditions that would qualify a patient to receive the medication. dr. throckmorton, is there a way that we can ensure that states that allow for medical marijuana have a comprehensive list of conditions that would qualify for the medication so that those who would potentially benefit from its effects are not scooted? >> which medications are you

talking about? so -- >> we're talking about the use of marijuana for sickle cell. >> okay, yeah. so, the medications for sickle cell disease that i would advocate for are the ones that we've had the good fortune to be able to approve in recent years. >> i'm asking -- >> and those medications we can and do work with providers to make certain that they understand they're available. we hope to include -- >> that wasn't the question. the question was, the states that provide the list where people can use medical marijuana, like how do we ensure that some of these diseases are included? >> i'd be happy to talk with you offline. those states are making those choices without federal input. >> okay, thank you. i yield back. >> the gentlewoman yields back. pleasure to recognize the gentleman from california, dr. ruiz, for his five minutes

of questions. >> thank you, and thank you all for being here. dr. volkow, you say in your written testimony that "cbd is ubiquitous and it is possible to purchase cbd extracts as well as food, drinks, cosmetics and other cbd-containing products that are sometimes marketed with health and wellness claims that are not backed by science." it is also worth noting that while more than 30 states allow for comprehensive medical use of cannabis and the fda has approved some derived and cannabis-related drug products, cannabis does not have the fda approval for any indication. we have seen that cannabis can be used to treat certain ailments, such as for children with particular seizure disorders that are refractory to other treatments as an appetite stimulant for patients suffering from aids or receiving chemotherapy, as an adjunct to people in the treatment of chronic pain syndromes, which is of particular interest during the current opioid epidemic, pain and specificity in multiple sclerosis is another use. however, there is evidence that shows that chronic use is not without its consequence.

for example, cannabinoid hyperemesis syndrome, a syndrome of vomiting and chronic abdominal pain, disadvantage -- attention, learning, and processing speed among teens who use marijuana regularly. these neurobehavioral changes can even be seen on brain mris of these patients. these changes can be permanent. earlier onset, as you had mentioned earlier, of schizophrenia and bipolar disorders in young users of marijuana. so, it is clear that more research needs to be done to better understand the risks and benefits. dr. throckmorton, it seems the fda has found therapeutic value in marijuana-related compounds, but for limited and specific uses. can you discuss what factors went into approving these drugs for medical use for these specific populations? >> sure. it began with the basic science

work. so it began with supporting the kinds of research that nyda supports to identify compounds and targets, therapeutic targets of interest. so, suggesting from animal models or other places that the drugs had use in those areas. and then something called translational science needs to happen, which is a drug manufacturer, a drug developer picks up that idea and comes and talks to us and says we believe this is a product that we can turn into a drug. what are the pathways -- what do we need do? what are the next steps? typically, that includes additional clinical studies, sometimes additional nonclinical studies, and the result is something called the new drug application. the therapeutic area is then chosen by the individual company. they're choosing to invest in pain or they're choosing to invest in, you know, i don't know, infectious diseases or whatever else it is, with a particular product. our job is to make sure that that assessment occurs quickly and efficiently and is

scientifically driven and results -- you know, if the data are what they need to be -- in an approval of a drug for a specific condition with an understanding of its safety and effectiveness. process, can fda extrapolate the safety of cbd for other products? >> extrapolation for effectiveness is very hard to do, and we've done it in very limited spaces. it's probably something we could talk about in more detail offline. safety is something that we are sometimes able to do more readily. a drug in a class that has an adverse effect, we'll worry about does that same adverse effect occur in other drugs in the class? we discovered over the years that very small differences in molecules have very large

impacts in terms of effectiveness. thc and cbd are very close to one another at a molecular level and yet have extraordinarily different patterns of use. >> so, your comments earlier said that cbd does not come without its risks. that's what we've all been talking about here. your testimony outlines some of these risks. can you elaborate more about what you know about cbd so far and what questions the agency may still have related to other uses? >> now you're talking about safety or are you talking about effectiveness? >> safety in other uses. >> so, safety, i think as you said, my testimony outlines several buckets.

one adverse effects that we've observed in the clinical trials leading to the approval of epidialects to unknowns, things we believe we need additional information about, i would put in that category particularly things like the liver injury -- >> i only have seven minutes, and i just want to make an important statement here, that as you conduct your data collections, you've got to ensure that you have a diverse sample of populations. too many research is done on men and non-hispanics and non-african-americans in the medical world, and i believe that in all categories of research, you need more women and you need more people of color, okay? >> agreed. >> all right. thank you. >> gentleman yields back. the chair now recognizes ms. schakowsky of illinois, waving on to the subcommittee for her five minutes. >> thank you, madam chairwoman. and i appreciate being able to wave on to the committee. i'm a proud original co-sponsor of representative jeffries' marijuana freedom and opportunity act and a co-sponsor of representative nadler's more act, which would both remove cannabis from regulatory controlled substance act and add the criminal justice and mass incarceration -- address it -- issue that we've been perpetually backing, and so, that would get rid of that. here's what -- i want to focus on research, too.

everybody has, it seems, or most people. on january 1st, illinois legalized marijuana cannabis across our state. and dispensaries sold more than $19.7 million in cannabis over the first 12 days. however, research at northwestern university, which is in my district and is a leading research institution, have no way of accessing the cannabis that is sold in these dispensaries. and instead, northwestern's scientists often face extreme difficulty in securing and maintaining cannabis and federal funding for the research. so, i'm glad that there is strong bipartisan support, at least for most of hr-3797, representative blumenauer's medical marijuana research act of 2019. the bill would streamline the cannabis research process to ensure that our academic institutions remain at the cutting edge, et cetera. dr. volkow and dr. throckmorton, how can we establish a process by which researchers in a state like illinois, where recreational marijuana has been legalized, and several different strains of cannabis are now widely available -- how could

illinois acquire the research supply through local dispensaries? it would stream line the process to make sure our academic institutions are main at the forefront. how can we establish a process by which researchers in a state like illinois where recreational marijuana has been legalized, and several different strains of cannabis are you

widely available -- how could illinois acquire the research supply through local dispensaries? >> this is a question that we've been discussing it, and the dea is the one that's actually on the process of identifying additional sources of marijuana so that researchers can investigate marijuana from different dispensaries. so, that is ongoing, but that's regulated by the dea. >> and are we -- can we look forward to some change there? >> as we have previously discussed, i think one of the challenges is, unfortunately, the fact that for your purposes, a researcher who is procuring a controlled substance for research purposes is obligated under the controlled substances act to procure that substance from another federal dea-registered researcher. >> right, right. >> so, none of these dispensaries are applying for a registration. none of them are registered with the dea, and therefore, they are unable to distribute to researchers.

>> so, we would have to get marijuana off the controlled substance act, out of it, in order to do the research that we absolutely need to do on what's being sold right now and millions and millions of dollars being spent on it and many, many users. to do the research that we absolutely need to do on what is being sold right now, and millions and millions of dollars being spent on it and many, many users? >> certainly that's your discretion and congress' discretion as one way to solve that issue. i don't know at the end of the day where this administration would come down on that approach. >> is that the only way? >> no. i think there are other legislative means by which congress can propose to change that specific requirement, but i do believe that it would require some legislative changes to the control substances act. >> i did want to say about that piece of legislation, hr-3797,

that i do have a concern that doj would have the ability to deny medical marijuana licenses based on even minor past drug convictions and hope that we can also remedy that. though i know that we don't all agree on deregulation and descheduling, i think we are -- at the very least should be able to work together to ensure adequate research is able to be conduct conducted so we know the consequences of what people are using right this very minute in the state of illinois and many other states and i yield back. >> gentlewoman yields back. votes have been called and i recognize the gentlewoman from the state of washington, miss mcmorris-rogers for five

minutes. >> thank you. thank you, madam chair. i also want to recognize the ranking member and all the committee members. i appreciate this committee being engaged on this public health and consumer safety topic around cannabis. i get asked about this a lot in washington state. we legalized both recreational and medicinal marijuana the same as colorado. i believe we were the first two states. i am a co-sponsor of blumenauer's act because i believe we need more research. i represent the washington state university, which is in the same situation in wanting to do more research around the issue. since we've legalized marijuana the number of cannabis products in the marketplace has exploded over the years and so have the marketing tactics that promise cannabis is a miracle for your health. quick search promises you that

cannabis. products will help you sleep, calm your anxiety, relieve your pain, shrink tumors, and a whole lot more. claims that aren't backed by scientific research or clinical trials. i'm concerned about manufacturers who are ignoring all the unknowns of cannabis and fueling an industry that is projected to be nearly $2 billion by 2022. i do believe this industry, like with the fda approved cbd oral solution for epilepsy, and others have mentioned this, major breakthroughs that can improve each other's lives and we should be encouraging these other developments. it should be held to a standard that people can trust so that the bad actors can't spin to make a quick buck. bottom line, this is a public health and consumer safety issue. those priorities should be at

the forefront as we unlock the mysteries of cannabis. dr. throckmorton, i wanted to ask as of today, only a prescription drug product to treat he has lepsy has been approved. that being said, all sorts of cbd products are being marketed and sold throughout the country. we have no idea what the health implications may be. so, what is the solution to this? how should it be handled? >> so not one solution. that shouldn't be a surprise, right? i personally believe one really important element is to encourage the development of a mature industry, using these products, industry used to manufacturing standards, industry used to packaging

standards, labeling standards, an industry of the kind you see when you go into walmart, costco and places like that. those products are being manufactured to a standard, which i think is very valuable. i hope by the recent increase in interest in doing research using these products, behind that will be a growth of an industry that wants to do the right thing. that wants to be science driven, appropriately labeled, manufacturing to a high-quality standard. i think that's one important element among other things. i also think it's terribly important we lay out a pathway for nondrug products containing products from hemp so there's a clear path that developers can follow to find a way forward as far as developing those products and making them appropriately available. >> do you see that happening at the state level, in any of the states where these -- where marijuana has been legalized? >> i do. >> therefore the industry and

nondrug products? >> we've really benefitted from talking with the states. i would say your state has been particularly helpful to us as we've talked to them about their experiences because you've had to deal with all of these things. the states are taking different approaches, but including your state, i know, are grappling with these issues around labeling, dosing, manufacturing quality and things like that. and we're trying to learn from those experiences as we try to formulate a policy at the federal level. >> another big concern is the increase in traffic accidents and traffic fatalities around the use of these products. and we've seen some pretty dramatic increase in numbers around accidents. at the very time that we are working here diligently to make our roads safer. and also the number of fatality accidents that involve one of these products. what needs to happen in that regard to make sure we're safe on the roads? >> it's one of the unknowns

we've identified. we studied it in children. we never did those kinds of studies because children don't drive. but we need to understand the effects of cbd on driving impairment. we need to have those data as soon as we can. >> okay. there's a lot more to explore here. thank you all for being here. thank you, madam chair. >> the gentlewoman yields back and we thank her for participating in our hearing. so, let me, on behalf of all the members of the subcommittee thank our witnesses. this is a long hearing. i might add, it is the very first hearing on cannabis in the history of the energy and commerce committee, which is the oldest committee in the congress. so, it's been a long hearing, but i think a highly, excuse the expression, instructive one

because of the participation of all of the members. and the -- we will have another hearing from other stakeholders who are not agency stakeholders. thank you again to each of the witnesses. where you weren't instructive, it was instructive to us and so much of your testimony was. we learned from you. and we have, i believe, the vehicles to develop a road map to address this lack of really substantive research that is absolutely needed. that is foundational to what, you know, so many of our undertaking. i want to submit the following statements for the record, and i also want to remind members -- of course they're not here -- pu pursuant to committee rules they have ten business days to submit

additional questions for the record to be answered by witness or to whomever questions are submitted. we count on our witnesses to respond promptly to any of the questions you may receive. i trust you will do that. i request unanimous consent to enter into the record the following documents, statement from greenwich bio sciences, statement from the american college of occupational and environmental medicine, statement from the national safety council, a letter from the national consumers league, a statement from doctors for cannabis regulation. testimony of aaron smith, executive director of the national cannabis industry association. letter from over 100 organizations in support of hr-3884. letter from five organizations representing state legal cannabis businesses, statement from the california cannabis industry association, testimony

of congressman hakim jeffries in support of 2843. a statement from chris crane, president of 4front enters. statement from the americans of safe access. report from the national cannabis industry association entitled "adapting a regulatory framework for the emerging cannabis industry." statement from the american property casualty insurance association. testimony of paul armentano, deputy director of the national organization for the reform of marijuana laws. a response letter from fda/mih to senator schotz. letter from the minority requesting a hearing on cannabis. and here we are. letter from the american academy of neurology in support of

hr-171, letter from the american academy of neurology in support of 601, bloomberg news article entitled "pot growth as u.s. stalls on medical research." quite timely. collection of six letters from organizational supporters of hr-3797, statement from the bio pharmaceutical research company, letter from smart approaches to marijuana, letter from the michael j. fox foundation in support of hr-601, a statement from the consumer brands association, a letter from the dea in reply to an application to grow marijuana research for -- to grow marijuana for research purposes and slides created by nih entitled "effects of cannabis on the human brain," without objection so ordered.

does the ranking member have anything he wishes to submit? >> i would not do anything to prolong this. >> on that happy note, thank you to each one of oufr witnesses again. to everyone that remained in the hearing room, thank you for your attentiveness and to the reporters, the press. thank you for your interest. at this time, the subcommittee is adjourned.

centers for disease control and director robert redfield is testifying today on the government's response to the coronavirus outbreak and is expected to talk about president trump's 2021 budget request for his agency. live coverage here on c-span 3.

we are live this morning, awaiting remarks from dr. robert redfield, addressing the government's response to the coronavirus outbreak. he will also talk about president trump's 2021 budget request for his agency. while we wait for this to get under way, can you follow the federal response to the coronavirus at our website c-span.org/coronavirus.