this week, live coverage for the house debate and vote to limit u.s. military action against iran. california democratic representatives barbara lee and ro khana to repeal the 2002 congressional authorization for use of military force against iraq and block federal funding from being used to take military action against iran without congressional authorization. watch on demand at c-span.org. listen on the go with the free c-span radio app. next a hearing on federal marijuana policy heard from members of the national on drug abuse, fda, testifying about

steps congress can take to allow more research on cannabis compounds and products.

good morning, everyone. welcome to everyone here in the hearing room. the chair now recognizes herself for five minutes for an opening statement. according to the department of health and human services national survey on drug use, 44 million americans reported using cannabis in the last year. 33 states now allow the medicinal use of cannabis and 11 states and the district of columbia have legalized cannabis for adult use. but state laws and federal policy are a thousand miles apart. as more states allow cannabis, the federal government still

strictly controls and prohibits it even restricting legitimate medical research. given the widespread availability of cannabis, the purpose of today's hearing is to examine the pressing need for medical research about cannabis and its chemical compounds with cbd being one of them. a half century ago, congress listed cannabis has a highly controlled schedule one substance. other schedule one drugs include heroin, lsd, and ecstasy. schedule one drugs have no medical value and high potential for abuse. schedule two drugs such as cocaine and vicodin through schedule five drugs such as robitussin all have some medical value but differ in ranking depending on their potential for abuse. the schedule one designation restricts legitimate medical

research about cannabis. today scientists who wish to study cannabis must seek approval from three federal agencies. the nih, the fda, and the dea. once scientists are federally approved which can take more than a year, they're allowed to only research cannabis grown by a government authorized farm at the university of mississippi. this cannabis lacks the properties and potency of commercially available cannabis and leads to inadequate research. so researchers are in a catch 22. they can't conduct cannabis research until they show that cannabis has a medical use, but can't demonstrate as a medical use until they can conduct research. doesn't make sense. at least to me. so why is it concerning that research about cannabis is blocked by federal law? first, cannabis has therapeutic potential for chronic pain, nausea and the treatment of neurological disorders such as

seizures. in 2018 the fda approved the first knabis-derived medication, epodol epodolix, which treats seizures in patients 2 years of age or older. second, the restrictions on research has led to unanswered questions about the safety and quality of products containing cbd. in december 2018, the farm bill removed hemp including cbd derived from hemp from the controlled substances act. the farm bill explicitly preserved the fda's authority over cbd products, but the fda has yet to issue regulations due to its unanswered questions about the intrinsic safety of cbd. the fda says it will take three to five years to finalize cbd regulations. and in the meantime, the cbd market is predicted to reach $20 billion in sales by 2024. meanwhile, cbd is now available in everything from fast food hamburgers to scented lotions to

over-the-counter pills. today, we're considering six bills that offer a range of solutions to update federal policy, to advance research on cannabis and its compounds. i want to thank the leaders of the bills. representatives barbara lee and congressman earl blumenauer. who have joined us. they're sitting in the front row. thank you for being here and for your work. congressman jerry nadler, hakeem jeffries, matt gaetz and our fellow subcommittee member morgan griffith. thank you to each one of you for your good work. now i would like to yield to mr. kennedy for the remainder of my time. >> thank you, madam chair. i want to thank you for the time for yielding. this is a critical debate and it is long overdue. our felt system has failed from

our criminal justice system to our health care system to our state and local governments that are forced to navigate an impossible landscape. to that end, government officials and elected representatives are important witnesses in bringing an important perspective to this conversation. but there are also critical stakeholders who are missing. those whose lives have been directly touched by our broken marijuana policies. those who have been incarcerated. researchers with expertise yearning to learn more. small business owners find new footing. i'm thankful for the chairwoman who will work with us on a second hearing in this debate. thank you, madam chair. i yield back. >> the gentleman yields back. it's a privilege to recognize dr. bridges, the ranking member of our subcommittee for his opening statement. >> and i thank the chair. i appreciate -- and thanks to our witnesses, who are here with us today to help advise us in this important matter. i appreciate that we're holding the hearing today to discuss this policy. it's a topic that's of interest

to many members of this subcommittee. in fact, that was evidenced when we had our discussion on the smokeless tobacco products. at the end of last year, some of the republican members of the full energy and commerce committee and myself sent a letter to request a hearing on three of the bills before us today that focus on easing pathways to marijuana research. so i'm glad we followed through with that and included hr-171, the legitimate use of medical marijuana act. hr-601, the medical cannabis research act of 2019. and hr-3797 the medical marijuana research act of 2019 in this hearing. states and localities across the country have moved forward with different policies to address marijuana, including both recreational and medicinal. i am concerned that there is a lack of available research on the benefits and risks of

recreational use of this product and that we don't really justify the actions that some of the states have taken. thus far, the food and drug administration and the national academies have found that there is a lack of evidence to demonstrate effective medical use for marijuana. so certainly we need more research. it's concerning that there are arguments over what may or may not be a great medicinal use for marijuana. but we don't have any data. so it's time to get the data and let the decision be driven by the data. additionally, some of the data we do have includes some concerning results. for example, kaiser permanente found that cannabis use among pregnant mothers doubled between 2009 and 2016. researchers also found that prenatal marijuana may narrow fetal development. but added that more studies are necessary as the thc potency continues to vary but appears to

be continuing to rise. so as someone who has practiced obstetrics for a number of years, i worry about the health of the mothers and their babies that could be at risk. so one of the key hurdles to research is that researchers require dea approval. and for decades, they have only been allowed to obtain marijuana from one source, the university of mississippi, which is the only contract that the national institute for drug abuse has for research grade cannabis. in the past, it may have made some sense to have this for research purposes. certainly if there are variations in quality or gradation, that can be minimized by having that single source. but because of the diversity now of the quality, potency, and other aspects of the marijuana that is available for individuals to obtain for medical and recreational purposes, and it does vary across the united states, research using this single

source marijuana may not adequately assess what the current landscape represents. not to mention it is difficult to obtain the quantity necessary to conduct research in the existing structure. to that point, the drug enforcement agency, we're grateful you're with us this morning, announced in 2016 that it would establish a new policy to increase the number of approved sources of research grade marijuana. but i don't think that has quite gotten across the finish line. maybe we can hear about that today. i hope we will get an update on the administration efforts to streamline the research process today. and i hope we can identify ways to work together to achieve that goal. while three of the bills before us today aim to enhance research efforts, there are two that may go a step too far. hr-2843 and hr-3884 completely remove marijuana from the

controlled substances list. it is worth noting and i believe the food and drug administration will explain this in more detail na in order for the drug enforcement agency to reschedule a drug, doing it administratively the food and drug administration must conduct a medical evaluation of the drug and provide a recommendation to the drug enforcement agency as to what the scheduling should be. this recommendation is binding. therefore the dea must do what the food and drug administration recommends. my opinion completely descheduling marijuana using our congressional authority which can override this scenario could possibly be a dangerous move especially given the lack of research to back up the decision. so it is critical that the american community and medical

community has an understanding of what marijuana can do. it is critical that we have a full understanding of all of these factors. some of the bills before us is a step in the right direction. some go too far. but i look forward to learning more about our federal agencies and the efforts they are taking to work on this problem. thank you all for being here. i'll yield back my time. >> the gentleman yields back. it's a pleasure to yield five minutes to the chairman of the full committee, mr. pallone, for his opening statement. >> thank you, madam chairwoman. today the subcommittee will have a federal hearing about federal cannabis policies. around cannabis.

that regulates cannabis has stayed the same. in my home state of new jersey, for example, state law allows for the use of medical cannabis and at the end of last year, stay lawmakers passed a referendum that would put the question of legalizing adult cannabis use to new jersey voters on the 2020 ballot this coming november. new jersey is not alone in its state-level changes. in fact, the national conference of state legislatures reports that 33 states as well as puerto rico, guam, the u.s. virgin islands, and the district of columbia approved programs while 11 states, d.c., guam, northern mariana islands approved adult use cannabis. although some states have changed their own policies national laws such as the controls substances act have yet to change in the same way. this is why we're looking forward to this hearing from a panel of agency witnesses who agreed to appear before the committee today. they all play crucial roles on federal cannabis policy, from researching benefits and harms to protecting the american public from bad actors. and i hope that we can learn about what the agencies believe works and what needs to be changed. we'll discuss six bills offered by both democrats and republicans, some bipartisan. these bills propose various

policy changes such as rescheduling or descheduling marijuana, providing a safe harbor for patients and veterans who use medical marijuana and streamlining cannabis research processes. given the landscape, these bills are worthy of discussion and i'm particularly interested in learning how we're removing barriers to research and enabling research on cannabis to thrive. i'm also interested in how the agencies are working together to regulate a derivative from the controlled substances act. that's a cbd or cannobid dial. i guess that's how it's pronounced. representatives first -- first representative blumenauer. i know they've talked about this on a regular basis. we're pleased to see you're here in the audience today. they are the co-chairs of the bipartisan cannabis caucus with representatives young and joyce. together they foster a continued

dialogue on cannabis issues and both helped author bills before us today, and i thank them for joining us and commend them for their ongoing leadership in this area. and thank you again, mad ma'am air. i don't know if anybody -- i have two minutes left, if anybody wants it. if not, i'll yield back. >> mr. chairman, i'll take it. nobody else wants it, i'll take it. >> you want the time? sure. i yield to mr. griffith. >> i appreciate that. as one of the sponsors of the bills, a lot of times people think why does a conservative republican get into this and champion it? well, let me tell you the story. when i was a young man in the 1980s, some of my friends were smuggling marijuana into the hospital in our community there in the valley. because there was an individual whom i did not know who was dying of cancer. but he wanted to spend every day he could with his son, who was about 2 at the time.

and that formed my policy that we need to have a national medical marijuana bill. thus the luma bill. but i decided when i got to congress, it's kind of controversial and maybe i shouldn't do that. but i would talk about it. when i was at a high school town hall as i call them, i go out to the high schools and talk to the students. they ask about marijuana policy. i told them my position on medical marijuana, which i went public with in 1998 in the house of delegates. i was standing there, and all the hands went up. and i thought one of the kids was going to say to me, what about just for recreational use or for fun. and i'll never forget it. i was in wise, virginia. a young man on this side of the room raised his hand and i expected to get the recreational question. and he said they did that for my daddy too. now, my district's a big district. these two communities 20 years

apart -- 30 years apart and hours apart from one another and yet doctors were turning a blind eye to allow marijuana to be brought into the hospital because they recognized for those patients who were dying, this was the only way they could have a little bit of relief and get the nutrients they needed to stay alive a little bit longer to spend a little bit more time with their children. i came back to d.c. and i said you know what? i'm in congress now. i can do something about the dea and the fda not making marijuana available for patients who need it. and today is that day. i yield back. >> and i yield back, madam chair. >> the gentleman yields back. there's nothing like a real life story. it's a pleasure to recognize the ranking member of the full committee, my friend mr. walden for five minutes for his opening statement. >> thank you, madam chair.

we appreciate the hearing today because we'll have an opportunity to improve federally sanctioned research on cannabis. representatives bur fwchlt ess, griffi griffith, rogers and others, we sent a letter asking for this hearing and we appreciate your willingness to have it, madam chair. it is a scheduled one controlled substance under the controlled substances act. that means that researchers must work with the national institute on drug abuse and drug enforcement administration just to meet the federal guidelines specified in the to conduct research. in addition, international obligations set forth in the united nations drug controlled treaties impacting the supply of research grade cannabis. so researchers now can only use cannabis products sourced through the nida's drug supply program single dea licensee, the university of mississippi. now, unfortunately that cannabis is distinct from what's

commercially available from state legal dispensaries, such as in my home state of oregon, meaning that we have little to no data on the health impacts of products in states that have legalized cannabis for medical or recreational use. now, in oregon you can purchase a range of thc-infused products like these cookies. we have a photo of right there. if you look up on the screen behind you, i guess. it's sort of stereo on this other side, but right there. and each of you, by the way, has a cookie in front of you. i have a pizza stand opening in an hour out in the hallway. now, don't worry. i didn't get that carried away. you can actually eat these. unless there's something beyond the normal ingredients, it's just a cookie. the question is, how do you know if your child stumbled upon it? so serious side, oregon, these

cookies in this photo are limited to five milligrams of thc per serving. 50 milligrams per package. if you go across the columbia river to washington state, they have a different limit. 10 milligrams and 100 milligrams per package. the difference is arbitrary. you see, we lack data. we do not know -- well, what we do know is there have been an elevated number of cannabis related poison center calls, emergency room visits, and impaired driving incidents. we need the research that reflects the reality of what's on today's market. additionally, products containing cbd dearririved from hemp plant has become commonplace, even at fast food chains since hemp was removed in 2018 from the farm bill. the claims are hemp can treat

depression, cancer, alzheimer's. none of these claims have been evaluated or proved by the food and drug administration. which means patients may be relying on the unsubstantiated claims and foregoing other proven medical treatments. and while there's potential for cbd to provide real patient benefit, the research and science lags far behind the market and agencies are struggle ing to catch up. nationwide, exposure in youth is increasing. from 2006 to 2013, children's exposure rose 147.5% nationwide. and in states that have legalized medical marijuana, exposure has risen 610%. while alcohol use is going down in teens, last month reported record numbering of eighth through 12th grade students regularly vaping marijuana, a subject we talk about regularly in this committee. we need research and data. americans are consuming more policy on this. been made in a virtual information vacuum. states that legalize marijuana, like my state,

have done so with far less information than we have on legal substances that are easily abused such as alcohol or tobacco. rescheduling cannabis may help to improve research landscape and allow for more medical treatments. however, rescheduling necessitates on potential medical uses and the current research restrictions on fully studying cannabis have effectively created a catch-22 in this rescheduling debate. evaluations by the fda and national academies have both concluded that lack of research was a significant factor in denying previous rescheduling petitions. i'd like to note that two of the six bills we're reviewing today remove it from the controlled substances act even though we don't have the necessary data to justify doing so in my opinion. descheduling cannabis is a step too far and something that i cannot support, because descheduling removes it from the controlled substances act and cuts the dea completely out of the schedule. any descheduling must be preceded by understanding the

full risks of cannabis use, which we currently do not have. research is the first step in making it easier to conduct research on cannabis is common ground we should pursue. with that, madam chair, i yield back. and you can eat your cookies now. >> gentlemen yields back. the chair -- excuse me -- would like to remind members that pursuant to committee rules, all members written opening statements shall be made part of the record. now i would like to introduce our witnesses for today's hearing and to thank each one of you for being with us. dr. norah volkow is the director of national institutes of health. thank you to you. dr. douglas throckmorton is the deputy director for regulatory programs at the center of drug drug evaluation and research at

the fda, food and drug administration. and mr. matthew strout, senior policy adviser for the control division of the drug enforcement administration. thank you for essentially your life's work that brings you to the table to testify today. we look forward to the testimony that each one of you are going to offer. i think you're familiar with the lights. it's like a traffic system. green is go, yellow is caution. and when red turns up, it's time to stop. so so we'll start with dr. volkow. you're recognized for your five minutes of testimony. and, again, thank you not only for your work, but for being with us here today. turn your microphone on. that's all right. >> i want to say good morning to everybody and i want to thank chairman eshoo, ranking member

burgess and the members of this committee for welcoming us to this hearing on cannabis research. cannabis is the most widely used illicit drug in the world and the united states. thc is the reason. and it content has tripled in the past two decades. on the other hand, the content of cbd which is not requiring or of interest because of the potential therapeutic effects has decreased in cannabis plants while food, drinks, and other products containing it have proliferated it. thc exerts its effects by interacting with cannabid receptors, which is part of our own system. the system is involved in brain development and multiple brain functions. memory, emotions, reward, among others. cannabid receptors also immobile

ate hormonal and metabolic processes in our bodies. thus, it is not surprising that cannabis can negatively effect health. of particular concern are its effects on the developing fetal and adolescent brain. cannabis exposure during pregnancy has increased and it's associated with fetal growth restriction, lower birth weight. in adolescence, cannabis use has been consistently associated with lower academic achievement, hire risk of dropping out of school, lower iq, disruptions in principal connectivity and structure as the brain transitions. cannabis use increases the risk of addiction to cannabis and to other drugs. another area of major concern is the association of cannabis use with psychosis. the risk of which increases with consumption of high content thc.

while most episodes of psychosis are short lasting, they can become chronic. concerns have also emerged regarding higher risk for depression and suicide, though these associations have been less emergency department visits. vagal related injuries while driving under the influence of thc are one of the main causes. another frequent cause is severe psychosis, nausea, vomiting and abdominal pain referred to as cannabis syndrome. however, our understanding of the adverse effects of cannabis is incomplete. this was made clearly evident by the outbreak of e-cigarette or vaping product use associated with lung injury. a condition reported in june

2019, predominantly associated with thv vaping which has resulted in more than 2,500 hospitalizations and 55 deaths. consumption of cannabis edibles packaged food and drinks are partly related to emergency department visits. the low absorption can prompt user to take higher doses, resulting in very high thc levels. toxicity most frequently manifests as severe anxiety and cardiovascular complaints. and they also contribute increasingly to intoxication in children. cannabis plants have been legalized for medical use for multiple indications in many states, even though the fda has not approved any of them for any indication. though not meeting fda requirements, there is evidence, though, that cannabis may be effective for treating multiple

sclerosis and pain but otherwise there is little evidence of benefit for other indications for which our patients are using it. nih is helping to close this knowledge gap. including supporting to examine cbd for treating pain, inflammation, ptsd, and addiction. understanding the effects of cannabis on brain development is another priority. the adolescent brain cognitive development study will follow more than 11,000 children into early adulthood to investigate how cannabis effects their brains. despite the urgency for advancing research, the fact that cannabis has posed major challenges. contract with the university of mississippi's currently the only dea source of research cannabis and researchers are unable to access cannabis for research from dispensaries and other sources, resulting in a gap in our understanding of their impact on health. cannabis research is urgently

needed. both to guide policy and develop therapeutics. the importance of facilitating the ability to do so. thanks very much. >> thank you, doctor. we'll now recognize dr. throckmorton for his five minutes of testimony and thank you again for being here today. have your microphone on? >> i do, thanks. >> the chairwoman eshoo, ranking member burgess and members of the subcommittee, i'm dr. and drug administration. thank you for this opportunity to be here today to discuss the important role that fda plays in research involving cannabis and cannabis derived compounds potential medical uses in the united states. i would also like to discuss the recent work the fda is doing to respond to the recent legislation affecting the availability of compounds derived from cannabis such as cannabidiol.

first, with regards to drug development, the fda continues to believe that the drug approval process is the best way to ensure that safe and new effective medicines, including medicines derived from cannabis, are available for patients. fda stands ready to report on the progress and process and specific requirements needed to develop a human drug that is derived from plants such as cannabis. for example, fda has drug development, including programs such as fast track right through therapy accelerated approval and priority review. all designed to facilitate the development of and expedite the approval of novel and effective drug products. we have also established a botanical review team to assist the developments of plant based drugs. including those derived from cannabis. using these resources, the fda has successfully approved one

cannabis-derived drug product, containing cannabidiol. while fda is aware of the activities of states in this area, to date fda has not approved any other cannabis cannabis derived or other cbd products currently available on the market. turning our activities to recent work under legislation, in december of 2018, the farm bill removed hemp defined as cannabis and its derivative with low concentrations of thc from the definition of marijuana in the controlled substances act. the farm bill preserved fda's authorities over products deriveed from hemp, such as cbd. which means these products must still meet any applicable fda requirements and standards just like any other fda regulated product. because we understand the broad interest in making compound found in cannabis more widely available to the public, fda is

working hard to respond to these changes quickly and appropriately. for example, we have reached several conclusions about the use of cbd in non-drug products. first it is prohibited under our statute to introduce into interstate commerce any human or animal supplements because it is an active ingredient of an unapproved drug with these restrictions apply to the products made with cd. it's easy to understand why we don't wan want blood pressure medicines or pain medicine in our food or dietary supplements. additionally, they are concerned the marketing of the non- drug products could put consumers at risk to cure serious diseases such as cancer or alzheimer's disease. the proliferation may deter put consumers at risk, such as making claims to prevent or cure serious diseases such as cancer or alzheimer's disease.w that

the proliferation of such products may deter customers cts from getting medical treatment a for serious illnesses. there can be drug interactions, sleepiness that could impair driving and potential liver injury.coo addr there are many unanswered questions about the safety and quality of products containing e cbd. and the agency has made it a priority to address questions including the safety of have v long-term use of cbd by different populations. for example, we have very little information about the use of cbd by pregnant women, by children, thd by the elderly. to address these gaps, fda is ic the process of systemically collecting all of the data available to us to make the best science based and public health focused decisions about the availability of the compounds ie hemp. to close, fda understands the of broad interest in making these hompound more available to the public and is considering the r

possibilities of new legal pathways for cbd products. however, it is important to maintain adequate incentives for drug development as we do so. drugs have important therapeutic value and are approved after rigorous scientific studies that provide important information about safety and effectiveness. it is critical that we continue to do what we can to support quality science needed to develop new products from ers cannabis. with that i look forward to ommt answering any questions i can. >> thank you, doctor. it's a pleasure to recognize mr. matthew strait for his five minutes of testimony. and thank you again for joining us today.y. >> thank you.ne contr chairwoman eshoo, ranking member burgess, and members of the committee, on behalf of the mu000 men and women of the drug enforcement medication, i appreciate the ability to be f

here today to discuss dea's regulatory requirements for supr those who perform research with schedule one controlled pote substances including marijuana. much like our partners at hhs, n the department of justice, and dea fully support research into the effects of marijuana and the potential medical utility of itn component parts. the procedures for evaluating aa application for registration bye statute is an interagency cy oft process. the food and drug administratio. conducts a review of the wit qualifications and competency of the researcher as well as the merits of the scientific protocol. dea is involved with ensuring adequate steps are in place to safeguard against diversion. these procedures have been in place for several decades and in my 20 years there has not been a single incident in which a researcher who has put forth a valid protocol and implemented safeguards to prevent diversion has been denied. given the public interest in marijuana research, dea has taken a number of proactive

steps to do its part in improving research with marijuana.irements first, in december 2015, dea executed a change intended to use the requirements to modify existing registrations in orderd to conduct research with cannabidiol or cbd. although the time it was being used to treat children with certain epileptic disorders.ce i think this action contributedo to the 2018 approval. in august 2016, the department h of justice and dea took steps to increase the number of entitiest registered under the controlledt substances act to grow marijuana to supply researchers. to ensure that this program is consistent with applicable laws and treaties, the department in consultation with other federala agencies continues to be engagee in a policy review process. in august 2019, dea published a list of the 33 entities who havn applied for registration and t whose applications remain pending to grow marijuana

marsuant to that policy. a forthcoming proposed rule which has been drafted and submitted to the office of management and budget remains under development at this time. third, in february 2018 dea announced the online portal for researchers to safely and securely submit their research protocol, curriculum, and institutional approval. materials required by dea regulations to be submitted fore fda and dea review. this online portal has streamlined the process and improved the amount of time for obtaining a schedule one research registration. imp presently the average time it takes to approve a new application is 52 days. while the time required to modify an existing registration is far less.na nih

finally, two months ago, ota dea increased its quota for marijuana which was based on our close collaboration with nida, who provides high-quality the marijuana to nih and nonnih h researchers.. the quota represents 575% wicrease since 2017. i believe these efforts are working. today 70% of the researchers, r 605 in total, are performing ts research with marijuana or its r constituent parts, making it far and away the mostc researched schedule one controlled substance in the n united states. resea despite these efforts and our successes, the multi-step process for approving research with schedule one controlled substances is perceived as onerous by some in the research community. that unfortunately, this perception l has translated into a false efr narrative that dea does not support research.e i'm here today to tell you that

this is simply not true. of this belief has hampered efforts to pass practical common sense u legislation aimed at addressing the over 30,000 overdose deaths in the united states in fentanyl and fentanyl-related substances. in just 23 days, dea's temporary emerduling action which placed schedule one controls on substances chemically similar to fentanyl will expire unless s congress acts.tment dea and the department of stice, justice have worked with hhs to put forth a proposal that addresses this emergency while approving access for research. on behalf of the department of g justice, i urge the committee to take up this important t legislation.nistra in conclusion, dea is fully impritted to supporting research with schedule one controlled substances. we will continue to work with r. our partners within the administration to find common a yonse approaches, to approve ani enhance research with marijuana. thank you and i look forward to. your questions. >> thank you, mr. strait. now we've concluded not only the opening statements of members o

but the testimony of the witnesses. quest we're going to move to members' questions now.ed with i recognize myself for five minutes. i'd like to ask a few foundational questions of the panel and i think the following could be answered with a simple yes or no. is tore medical research needed on the therapeutic effects?ty om and the health consequences of s cannabis? >> yes. >> yes. >> is the cannabis from the university of mississippi which is the only approved cannabis do for medical research adequate r for medical research? >> no. >> no.o. s all >> we would like additional sources. but we also recognize that importation is allowed in certain circumstances.urther >> should legitimate researchers be able to access a wider array of cannabis products for their o

research?pm >> yes. >> it would help drug development.es >> yes. >> okay.search have there been in your view real-life consequences tot deve researchers not able to conduct researchers for cannabis products? >> yes. >> product development has been slowed. >> so there has been an effect because of that? e with >> i don't disagree with my colleagues. enoug >> i have one point that we haven't discussed enough which has been our ability to actualle recognize when problems may be r particularly harmful.>> so that's another aspect of the limitations.is >> the main reason cannabis research is restricted is because cannabis is listed as a schedule one drug. yet two active compounds in cannabis, thc and cbd are both approved ingredients for drugs .

that are scheduled as schedule three and schedule five d cons respectively.id so how can cannabis be schedule one and be considered to have no accepted medical use because ngi that's part of schedule one butl both of its major active ingredients can be considered t> have medical use? >> i defer to my colleague at a the fda. meet >> separately those two compounds are safe enough for l intended uses and so meet the t statutory acceptance. t >> how do you pull them out and separate them? >> that's what the drug those development process is meant to encourage. part o is to have people -- >> so if fda decides to pull t those out to be applied to and used and be part of a certain drug, you just automatically

vanish -- schedule one vanishesu as a result of that? >> when congress defined what the scheduled were to be, it said there were tests to be i applied for whether you had n accepted medical use. and there are five that we'd be happy to talk through offline. and when you apply those tests to marijuana, three times in the -- did not meet the medical use.epted most has to on whether there's a value for the product and be it. whether you can describe it. >> does the fda have all that it needs to regularity cbd producti comeconsumer safety? >> i believe we do. when i talk to drug

developers -- >> are you sure? >> when i talk to drug nabino developers that come in to talk to me, and they say we're interested in studying a compound found in cannabis, whether it's cbd or whatever ye else, i say if you can get me a legal source for that compound, a legal source for that compound, i'm going to treat you exactly the same way i with re other drug in development except i'm going to give you additional resources in the form ofwi -- >> good. i still have more questions.s.te now, the fda has estimated that it will take three to five years to complete rule making in nforu relation to cbd products. is this still accurate?uestio >> we understand the interest that people have. it's unfortunately it's not a e yes or no question. we know that there is interest in moving quickly. we understand the three to five' years is longer than people hree would like.you d

>> what's the estimate today? >> we're looking at a full range of options including -- we're ty interested in -- >> you don't want to tell me. it seems to me that maybe threen to five is still in place, but you don't want to say so. in your testimony you say the l fda knows of cbd products that n may not contain the amount of cbd on the label or may contain other potentially dangerous compounds has the fda issued any labeling requirements for cbd?ll my time is -- but you can answer. >> the labeling requirements would be imposed on the approved drug. are sub epodilex. that product is well tates. manufactured.. we have no concerns like that that i'm aware of. the products -- the warning letters are subject to that comment related to are the dru unapproved products that have g been marketed in the states

>> thank you. well, my time is expired. and i recognize the ranking member now for his five minutesl of questions. >> thank you, madam chair. i wanted to stay with you on the epodilex question. it's like $1300 a month for a wa therapeutic course of that. so somebody that didn't have $1300, could they just go buy cbd oil and supplement it? don't >> we recommend we use an approved products for a number u of really good reasons. but what we learned when we didy that sampling of unapproved products is that we don't know what will be in that oil if you choose to take it. it may contain things that would be dangerous to you. we also know it's reasonably likely that it could not contain the amount of cbd that you were looking to take for whatever mh thedition. >> just along the lines of the time frame the chairwoman asked $1out for point of reference, when we did the 21st century bill pretty much standard accepted lengths of time in fda for approval of a new drug was about 14 to 16 years and a billion and a half dollars.

do i remember that correctly?eeo so three to five years actuallyr sounds like you're moving with great dispatch. spe would that be a fair statement >> the three to five years com s from our general experience wite rule making rather than any ruecific -- >> so it isn't research?ve chang >> how long it is related to product development. it's just the rule making has its steps we have to use. >> we'll move along toward dea . with this. has the dea ever done an administrative change in the anm schedule of a drug without being prompted by congress? >> absolutely yes. resunitiate scheduling actions drth some frequency. it could come through a petition received from a public citizen. it could come as a direct resulh of approval of a new drug. >> would that not come through the fda though? >> yes. in that circumstance, yes. >> so you couldn't just do that and say we're going to change the schedule of this on an administrative basis. >> the administration obtains the ability to have its own

proposal as well. in that instance -- >> initiate. but you can't complete it without input from the fda. is that correct? >> as you said in your opening remark is we are kind of tethered to the science. that wr colleagues over at -- >> i don't know if that is testm inappropriate, being tethered to science can be a good thing. there was written testimony about the risk of addiction with cannabis products, presumably you talk about marijuana, that's a thing, that's a real thing?hea >> it is activ real thing, and s thc, the active ingredient responsible for the addictiveness of marijuana, and the plants, higher thc. >> is marijuana a gateway drug.. some people call it that.fects is o it a fair statement? >> it decreases the likelihood that you are sensitive to the k effects of other drugs and that's why it has been coined the termigatio of a gateway dru. it makes you more sensitive. a >> yesterdayddicti with the ove

investigations on the scourge of opioid addiction, we do worry we go too far in one direction or another year, and ten years from ne a hearing it be havingh w w perhaps we have gone too far with what we did with liberalizing marijuana laws. but let me just ask you this, youou also mentioned the nation highway traffic safety administration, the effects of driving under the influence, are traffic laugs and our state partners, have they kept up with all of the changes in marijuana policy that haveecoun occurred the country? >> no. one of the major challenges in r doing so is that it is very difficult to quantify whether someone is intoxicated with marijuana or not. weun can measurede the alcohol content in plasma but that measure does not guarantee for marijuana that you are under the influence of the drug or not soo you can have very high levels l. taking it three days ago. than has been a may jr. o

challenge. >> so you can't really quall tate it to the degreecc of behavioral disruption that may occur. >> what is muchpart harder to d >> and as a consequence for ourc law enforcement partnersomes anr partners at the state that are writing state traffic law, that becomes the difficulty, is that correct? >> correct. and that's an area s thattrateg inclined to bring up new strategies to identify the y dis intoxication withtr marijuana. >> and in a practical matter p that happened ined my district, by an ian who was struck automobile, the driver of the v automobile had under the 0.8 limit in their blood alcohol but also had a positive quantitative test for thc, and the individual is no billed by the grand jury, i don't know if thatntial is rir wrong, but it seems to me that the that potential for the addi effects should t be something tt law enforcement would bear in mind when deciding whether or not to bring a case like that. it was clearly a very tragic situation. a young high school athlete who got hit. so it was a high profile case in

the community. something i will never forget.ey thank you, madam chair, i yielda back. >> the gentleman yields califor. it's a pleasure to recognize the gentle woman from california, e ms.ci mastsui for her five minus of question. >> thank you very much, madam chair and i really appreciate nk the hearing we're having today,g this issue needs to be examined and thank you very much for ersr witnesses for beinge here today. at the university of californiac researchers are doing important work to study thehe health effects of public safety and the environmental impacts of marijuana. to discusssfrom how our existing federal regulation may be inhibiting researchers from fully understanding cannabis as the potential risks and benefits. now, despite the fact that cannabis is being cultivated right law in california, to sel local dispensary, under current law, researchers must obtain their study samples from a , res contracted site in mississippi.c in order to study what the

public is purchasing at . dispensaries, researchers have m anplied for a license to cultivate cannabis locally. however these researchers have s not heard back from the d.o.j. and d.e.a., as of the status of the applications. mr. straight, where is the department of justice, and its process of granting or denying s applications that i researchers have put forth at a university to study too cultivate cannabis esearc at the university. >> as i said inh my opening, we certainly support all research endeavors.th one of the challenges we see that often leads to this misperception about delays on the d.e.a. side is we look for r completetm application before w forward that application to ours colleagues at the department of health and human services, so there's three things that we need, we need a protocol, that state funded have, ade cv for t researcher, which every in earcher certainly has, but

sometimes the delay is the result of the third piece, which is that institutional review approval. sometimes for purposes of timing, the researchers will submit an application, knowing that their state university or their state system, their university has not met to review the application. >> i know in california, i think they're pretty good about doingi this, and so we like to be able to expedite as much as possible, so because their research is going to be very important as far as all of this. from a research areas perspective, i understand there is some ambiguity around the act to conduct research for synthetic cbd for potential applications in humans. for the panel, what is your d agency's position on the current status of cbd, is there a distinction between marijuana derived cbd and hemp or syntheticcally derived cbd whenc it comes toti regulating these

products? >> from ourffects perspective, interesting on understanding what are the effect was chemicaa compound that goes by the name e of cbd. with respect from a pharmacological actions, the potential of negative effects and the potential of therapeutic accuracie actions, so the molecule, with indirect, at the same time, we're doing research to try to investigate how, when it iss mixed with other cannabinoids, that may be influences effects.l >> dr. throckmorton, do you agree? >> yes,t o one of the things th happened in the results of the a farm bill wast that cannabidiol was removed from the controllede substances act and in some sense that allows us to encourage its conduct of studies and things using it, without interacting et with -- i >> it opens it up. >> we believe that's a powerful,

potentially powerful in terms of getting new studies done.corr >>ec mr. straight? >> and dr. throckmorton is 100% correct. i think the passage of the farms bill created a little bit of a question mark as to the legal status of synthetic cbd versus that derived from naturalalfr sources. very clearly, that which is derived from natural sources, if it contains less than 0.3% thc, it is no longer controlled undee the csa. >> dr. throckmorton, if a t are researcher wants to conduct clinical cannabis research thata may lead it a new drug, what re requirements need to be fulfilled at the fda?lian >>ce when you say cannabis, are you talking about farm bill compliant otc cannabis? it's important, when we talk to investigators, we think about it in sort of two tracks. and an arrow going one way, an arrow going the other. and one arrow, the farm bill t to t

compliant cannabidiol, and other compounds extracted from hemp, we view as subject to theford o drug and cosmetics act. they are able to be used for investigatele use, come in and talk to us, we will treat you as we would treat any other drug lb substance for std.ut requi unudy. if that is cannabis, they want to make sure they work with the mya because there aree other requirements t under those circumstances. >> okay, fine. thank you and i have gone over a my time. >> mr. straight, would you ty respond, after you get back to r yourni agency, with congresswom matsui on university of c california's application, please? >> absolutely. >> this is the greatest public university in the world. they know how to do, they know how to do applications. they know how to do applications. this is causing sta a ruckus bu i'll stand with my statement.

representing the greatest private university in ple the w. stanford. it's now a pleasure to recognize the gentleman from michigan, mr. upton for his questions. >> thank you coupl for being hed i don't have my jersey on, thank you, madam chair for this hearing, i do have a couple of questions, dr. throckmorton, you mentioned that ep -- lielax one of the three drugs approve and two others in addition to, that what are the illnesses or the conditions that they were approved for. >> ep dialex is approvaled for two genetic seizure disorders, severe seizure disorders in children and that contains cannabidiol. >> and how is it that injected is, it oral, a shot -- >> it is oral. it is given in an oil form. it is a fat soluble, and so not

syringe basically.he the other compounds are all synthetic. they're not ex tacted from the cannabis plant and they're approved for wasting diseases, u they're nausea and vomiting f associated with chemotherapeutics. we can get you a full list of fn those. but it is more general. those compoundsive ing contain they have a different active granite than the ep dialex does. >> as consumers, 33 states now, have approved medical uses, 11 states initiated one that is both, medical as well as recreational, adult use. i guess consumers are very interested how much is in here, i mean we know when we drink a beer, different alcoholic content, whether it is a craft beer, you know, maybe a state e has a a smaller threshold like utah, but in addition, you've got the law enforcement t issues, with one of my sheriffs

last week, unfortunately we had a situation like you had in youa district with auto student returning back to michigan state and sadly he was involved in a terrible auto accident and in fact, he survived but they found out he had a high level of thc, as i understandnd it. where are we in terms of some t visible standards, or some review that folks can look at, e asy it relates to the cookie, the brownies or whatever it is, the cereal, that they're going to eat, and consume, as it es t relates tola perhaps the safetyf that, and where are we as relates to law enforcement? it's not like the breathalyzer, they've got toto variety of taking different cognitive t exerciseso try and determine whether or not that individual is taking too rig

is a blood here sample, but where are we in terms of trying to help the consumer know the right information, if they choose to m take in these states illegal substance. >> irstand can speak from the rh perspective. a we're interested on part understanding what theic conten of the thc is associated with the pharmacological effect, nywh including side ereeffects, and n research has been done to show if you consume anywhere from two and eight milligrams you're going to get high, but in general, you don't have adversive effects. so what we would like to be able to do from that research arijuaa perspective, is to create a unit of marijuana that can be utilized consistently across un research tods help us understan howow exposure to different content thc -- >> and how long, when is that study, when is that research going to be completed?can be >> the research on those have been done, the research on

creating a unit of t history c that can be used consistently is something we're working on, to d try to consolidate and what is d the effect of the differences and what hope t are the consump- >> are we a year out? how long do you think that would take?m >> i would hope that we could implement a standard dose for research doses for research purposes for one year. but that is very different from processes that are not accepted federally and that's the states themselves, are trying to work ] on themselves the standard dosea and you mentioned for the cookies but that various also betweenly the states. >> anybody else have a comment? >> you raised an incredibly important point that is important to understand about the development of nondrug products containing things liker cbd. so as the fda thinks about how to develop those products, one t thing we remember is that there would be requirements on label products that we approved.

regarding accurate labeling. dosing.g so for instance, the cookie that we're discussing, if that packaging was approved, if we found a pathway that would enable us to allow cbd in a sat cookie, along with that packaging, would come labeling,d it would say it contains ten ue milligrams or 100 milligrams or whatever else, it could include other conditions of use that pt could help understand when it e would appropriately are be use things lik that, so part and onu parcel with the work we're doing is to think about the consequences. the important consequences. which would include that kind of labeling. p we have more understanding, people would have a better understanding. they also have more assurance , that the product actually contained the cbd -- >> i know my time expired but a yes or no, do you have the have authority for that labeling now? >> it is absolutely, we have that authority, what we need iso to determine the pathways to take for those non-cbd, those non-drug containing cbd

products. back.ld >> the gentleman yields back. it's a pleasure to recognize thf chairman of the full committee, for his five minutes of questions. >> thank you, chair woman. as i said in my open statement, the cannabis policy landscape is evolving across the states and territories yet at the federal level the policy has remained largely the same and one issue the researchers across the nation have raised with the committee is the fact that they are not able to conduct research on products through cannabis from state cannabis dispensaries. and testimony, the consumers, it is much more potent than the past and that means that federal researchers can't adequately study the health potential or adverse health consequences for those products readily available. so this poses a legitimate pr us challenge as it impedes the ability for researchers to truly understand the impact of k products readily used by consumers and prevents us from advancing sound science. so doctor, you noted in your

testimony that having only a siy single domestic source of research cannabis limits the diversity of product, and formulations available to researchers, and slows the so development of cannabis-based medications, so let me ask yes or no, doctor, do you believe federal researchers should have access to cannabis as state authorized dispensaries. >> yes. >> and dr. throckmorton, yes or no, would access to cannabis outside the university of mississippi be beneficial to drug developers in the u.s.? >> yes.nd >> and mr. straight, as you mentioned, in your testimony, d.e.a. is actively working to consider applications for additional cannabis growers. what's the status, this is not yes or no, what is the status of this effort, and what can we expect that the agencies would e finalize the rule making? >> so we actually have a draft regulation in place.lace inin august of 2019, we were abl to get to the point of our policy review process, where we

were able to publicly acknowledge, consistent with our regulations, who our pending applicants were, on august 27, 2019, we know that we have to probably do notice and comment rule making to implement regulations on tworu matters.di going to we'reng evaluate all of our pending t ne applications, and then, two, what additional types of regulations might need to be in place in order to, in order to impose on those that would grow. so that regulation is in the ca draft form.nnot i t can't talkk too much about it, but rest assured we have submitted to omb, it has been drafted and tomorrow, many of us will be getting on a call to talk through it. >> thank you. i want to switch to cbd. a google search can lead any consumer to web sites that offer cbd infused gummies, cereal, cookies, this is in addition to personal care products and dietary supplements and one recent estimate by independent companies suggested that the cbd

market could bring in as much as $15 billion by 2025. so dr. throckmorton, senior agencies working to regulate cbd products but the fda suggested i that it could takefy three to fe years before rule making to clarify the regulatory pathway work be completed. can you explain to the committee the scientific and regulatory activities the agency believes are needed to ensure that, to ensure the safety of cbd and other products, such as food and dietary supplements?>> t >> sure.is by saying to start that three to five years was an estimate that we understand thet importance that people have in identifying in a rapid process, to a pathway for nondrug cbd products. having said that, rule making is the one pathway that's identified in statute, for an exception to the prohibition against use of drug substances

in foods and dietary supplements. so that prohibition, as i just, age as incy mentioned in my openingc remarks, exists, and for the chn agency to change,ism we need tw find aard mechanism to allow a h forward for nondrug cbd products, to be developed. th of doing process that. the rule making is one thing slv that's under consideration. as has been mentioned, there have a number ofngs w legislati ideas that people have had. we have had other meetings where people have had other suggestions, regarding this as well. bottom line, is we get it. bottom line is we understand that we need to understand a path as quickly as we can. sci buten we need to be grounded in- science. you mentioned yourself, many of us have mentioned, fundamentally, there are many n unknowns about cannabidiol. there are things that we know that it can do. adverse events that, adverse effects that i mentioned in my testimony. related to liver injury, related

to potential male reproductive injury, that we need to know to more about.nd we pro need to know more about uses in vulnerablele population and for long periods of time, because if it's a placed in a nondrug product, there will be no learned intermediary, there won't be a doctorhe or a nurse anyone that will talk to the patient to help them make their choices about the use of that product. you can get up in your cb the m take your cbd, to get started, in your coffee, take another the dose of cbd for lunch, when you have your sandwich, and then end in the late afternoon with an v alcoholic beverage containing cbd, and in the aggregate amounts of cbd then matter.. wema needtt to decide how to dot safely. our fundamental focus for foods and dietary supplements is safety. and we need to have more data than we do available at present in order to make that determination, in order to helpe inform what the right, best steps are.

>> thank you. chair.ou, madam >> and in the appropriations bill that was passed last year, there were moneys that go directly to fda for, to move up the work on cbd, correct? now y >> that's correct. focused i believe in the nondrug space. >> now you have the money, now you got to get it going.o it's a pleasure to recognize mrg guthrie, for his five minutes of questioning. the gentleman from kentucky. >> thank you very much. thank you for being here.r to and doctor, we've heard ha it can take up to a year to get a schedule one registration, that process of adding new honnabinoids to existing registration, getting approval for modifications is time consuming and how does the d.e.a. registration processes for modifying a schedule one registration to conduct researcd of cannabis impact the ability

to do research. ? also i understand, you said, oh, i wanted to ask you something first if that's all right. before i get to the answer of your questions, last october, myself and others, sent a letter asking about the implementation of recommendations included in f theor o commit's staff report o opioid distribution. to date we have not received the d.e.a.'s response and i would ask that after the hearing that we follow up together if to see if we can get d.e.a.'s responses. >> i would be happy to follow up with that. >> thank you, sir. getting to the question, and you said it is 52 day. f, 52 days t get a registration and it seems we're talking about something different and can you talk about the time consuming process for that. >> one of the issues has to do with the process how length i it is to get an approval to do a human subjects protocol, and a y scale one that is much longer. and on average, it is about 52 days by the dea, actually counts the moment that that protocol

has been then complete and moves forward. what we hear from that researchers, is that it is not so straightforward to get the protocol in a way that the dea can work with it, because it is complex. and another issue about it becomes, it makes it harder, is that the dea space, local inders agents, interprets t the rule differently. and as a result of that, that further hinders the problem. those are the issues that we see. the other aspect where we are s also seeing an impact on schedule one is that there are certain sciences that don't even want to go there. because they say i don't want to bother. takekeoing to too much effort to do research on a scale, and we lose potentially valuable science into are lookit things that are important. >> do you have any comment on that? >> yes, thank you. thank you for giving me the fro opportunity. this is a common refrain we've heard from our partners over at hhs. get inf

one of the challenges that they have is that when we try to get information from them about who the concerns are being raised by, maybe it plays into the fear of d.e.a., but we are kind of cited with pii, that they can'to disclose information us mto, tht they're prohibited from doing it, so we struggle to try to understand who the people are that are having these hem sp difficulties, so that we can give them some special attention, and we're happy to give them that special attention. the other point i wanted to makb is the inconsistent polit applicability of the field divisions and there are concerns about that and as i mentioned to some staff before we started this call, we're getting ready v tois host a management conferen across our entire decision, from all across the country and we're going to invite dr. vokehour or

to come in and address that because i think that is something that we can solve easily.>> that is not anything that we need congress's help on. >> i will yield the minute and a half my remaining time to mr. c burke. >> thank you very much. virginia actually hasa law the a medicinal marijuana law on the books passed in 1979 when chip woodrough, now deceased as the house patron, and former member of this economy, rich boucher, m the senatemonw companion, sayin they would allow the medicinal use of marijuana in the commonwealth of virginia, and however the d.e.a. had allowed it and the doctors didn't want to risk their license by sk the frescribing it,ir it required a legitimate prescription and this is what my bill came from, this is what virginia has stood for in, for decades. in 1998 there was an attempt to repeal it because they thought t california's law, if act it makes you feel good, you can try it by virginia rejected. but still the dea is not active.

and when i hear it will take ea we have to the years, do the research, my question is, why hasn't the research been done? and dr. throckmorton, i would have to say, it causes me some great concern that apparently the fda thinks it's okay for open yoids and opiates and bar bit rats but somehow marijuana should stay schedule one.ut that is illogical to me. and i lay that out. marinol, in the case of my two p fathers was available.in the the problem is they were so sick, they couldn't swallow it tud hold it on their stomach, that'srn why their friends were smuggling in with the doctors turning a blind eye, smuggling in the marijuana so they could o smoke it and thenn eat. so we need to find a solution, and we should have started working on this back in 1979, or earlier, but we haven't done it. i yield back. >> the gentleman yields back. excellent point. pleasure to recognize the gentle

woman from florida, ms. castor for her five minutes. >> thank you, madam chair for calling this hearing, thank you for the witnesses for being here today, i think it is clear that cannabis research is caught up a in conflicting regulations, you can't remove cannabis from schedule one, because it lacks c proof, for medical and controlled, or controlled recreational use, but you can't research to determine it's safe because it's included on schedule one. doctor, you ended your testimony by saying that cannabisch is is urgently needed so let's -- cannabis research is urgently needed so let's focus on the ata research process forre cannabis and possibly other schedule onef substances. first, what are the requirements and challenges for conducts research on schedule one substances? >> what i was commenting before, the main difference relates to the fact that you have to get a d.e.a. registration, so that

makes the process much more complex than research with any other substance and that's going to take time. >> and that clearly deters thoe research on those substances. >> correct. >> this thinking about how we reduce those barriers, for repr reflexes with cannabis and possibly other schedule one -- research withh cannabis and possibly other schedule one substances, did you say to mimi representative guthrie, youwe c pointed out what should change o in the process right now. to >> we have been all working wite agencies to try to come up with a process that wilt allow to safeguard the public, and at the same time, to facilitate or accelerate research. so those are the two issues, o o coming up with a way that enabless researchers to be able to accelerate the pace at which they are doing research, without in any way jeopardizing the public, and that's where, and again, the dea, the fda, the nih, have been working togetherm >>be therer are a number of bil

that have been highlighted for thee committee's consideration today. would you point to any of those pieces of legislation that would help streamline the process >> appropriately? >> you're putting me in a little bit of a difficult position because there are six of them . and we don't legislate, we basically bring science, and what i can tell is that the science tells us that marijuana is a substance that can producea addiction. now, we also knowt from studyiies that there is potential for therapeutic use for the cannabinoids within marijuana, and thus, to the extent that wei among the sixle ones that you'r proposing, can accelerate the research, while affecting the public, that's what you all have to weigh. >> correct.ange i dr. throckmorton, has the fda seen an uptick or change in the number of applications from otr researchers to conduct research on hemp l or other low thc thati

cannabis products since these are no longer considered d schedule one substances? >> thank you for that question. and the short answer, yes. >> do you support removing marijuana from the controlled substances act to remove barriers to research? >> at present, my focus is on gn cannabidiol, and focus on supporting those new inds, thosr new investigational studies that no have seen inhouse. so your first question is worth going back to for just a moment. we now have almost 40 investigators that have come in to us, proposing to use cbd, and other substances found in hemp. we believe that represents an important new opportunity for us in terms of investigating cbd and those compounds for drug development. and i want to make sure that we give them every opportunity, tok every support thate we possibl can. the question about marijuana is more complicated. it has to doo with what you mean by marijuana.t

obviously, one street corner sells one kind of marijuana. col and another street corner sells a different kind of marijuana. s making a conclusion that both of those marijuanas somehow have medical value is challenging scientificcally. and i think dr. volkow would tt agree with me on that, and that is that one of the findings that weo resc would be abliged to ma ma to make a specti recommendation to the fdave to reschedule marijuana from schedule one, so from a scientific perspective there are real challenges to making that t conclusion.me we've been askeds in to look atd three times in theed past. and each time, we decided, as it hadad mentioned before, that it was not possible given where we were with the science.>> >> w whenhen it comes to cbd, like the cat is already out of the bag, it is amazing the marketing for cbd.the effi what would you advise the public about the efficacy of the products on the market today?

do they really help? and do you, do we even have a handle on what is truly in all of those products? >> both questions would be we du not know. we don't know whether the various claims being made are a accurate, to the standardnd tha. would expect for a drug productt being developed, and we don't d know well enough what's found in those products that are being in soldit under aia variety of sta initiatives. we need more data in both of those places, with regards to efficacy, my job is to make sure that those manufacturers, those around 40 that want to study this, are able to do that quickly. study what works.uick study whatly. doesn't.t. quickly. safety, the vailabo e agency understandsle that we desperately need to collect allt of the vabld information abouti the safety of cbd and all of those various uses. that is challengingngprocess f. we've been in the process of a

yearar long effort to collect a of those available data. we've identified some gaps. i think i mentioned some in my testimony previously.y. things we believein t we absolu need to know. we're in the process of figuring out how to close those gaps. >> gentle woman's time has expired. it's a pleasure vir to recognize gentleman from virginia, mr. . griffth. >> thank k you. >> looking for another good story. >> i may or may not have, i have lots of stories but we play not have time. mr. straight, i know you dd eati disagreed with therg earlier assessment on the university of california, having attended the great university in blacksburg virginia, virginia tech, which i am so proud to represent. that being said, going back to dr. burge guess's question, if the fda recommends that the on d.e.a. reschedule the come poupt, compound, is the zaechld

required to comply with the recommendation. >> if thehe a fdatt recommends,e bound -- the statutecomm says t the attorney general shall be bound by the recommendations of the secretary as it pertains tot scientific and medical matters.. de as the secretary determines. >> correct. >> all right. so you can confirm that the d.e.a. has never refused to rese reschedule a compound after being given a recommendation to inst by the fda or the secretary? >> i'm certainly not aware of any>> s instance where that woue the case. >> all right.nited now, continuing, mr. straight, as you know, the u.s. is a part of the united states single f dg convention on narcotics drugs which imposes manufacturing and distributing restrictions on marijuana. some have s cited our involveme in thatat agreement as a potentl eason why the federal government should not lift uring restrictions on marijuana. regarding american domestic manufacturing of research grade cannabis, why is it that other countries who have signed the wl

same treaty suchan as canada, israel, ireland, new zealand, australia, the netherlands, have several legal manufacturers of research grade cannabis and uneir products are legally imported to the u.s.,iv but the u.s. has only one, the university of mississippi, as t we've heard earlier? >> so you're precisely right there. is a growing number of countries that have implemented laws in their countries that fully effect wait their requirements,e their obligations under the single convention under narcotic drugs. we have too. and that's the reason why we have the university of mississippi, or this nida drug supply program. what we're trying to to do as we expand the number of growers, we're trying to take a look at e whether or not there are things that need to be changed, altered, i would say, not newly-created, but just altered slightly, in order to make sure that we are in compliance with our treaty obligation. >> and i hope that you will work on that quickly. i mean you said earlier, and

applications for research are being approved but you said regulations and paper work and that perceived g are to be so onerous that people won't do it.n is connect the dots of the paperwork and the regulations, the perception becomes reality and as we heard from dr. volkow, sometimes that becomes a problem and i think that's why you haven't received more applications. you want to say something on that point? i will i just have a couple of minutes. >> if i may. i will be very quick. dy want to go back to your comment and that of s congresswoman castor's, which is to say that there is a solution that this inter-agency group, and others worked on all o summer, as it n relates to some important fentan legislation dealing with the permanent control of fent knoll related substances and schedule one. we as an administration came out with kind of some common sense h practical solutions to address all of the concerns raised by the research community. we're happy to in w share that. >> and if you could share that

and whatever you can, whatever help you need from us, i think this committee would be willing to help in any way it can. the dea's 2016 policy statement says it would be consistent with the 1961 single convention on ia narcotic drug treaty if the dea were to register research grade marijuana growers outside of the nida contract system so long asy the growersou agreed it only distribute marijuana with priord written approval from the dea. however, in your testimony, you say the dea has changed course, saying that quote since publication of the 2016 policy statement, the department of justice determined that adjustments to the dea's policies and procedures maybe necessary to be consistent with certain treaty functions. what changes need to be made in order to be consistent with those treaty functions? >> well, i can't really get into too many details because ght no it is a deliberative process . that we're engaged with as we speak with the office of management and budget. >> you can get that to me as quickly as you can. >> yes, i will. >> i appreciate. that if you can give that to me and the committee as well. i appreciate it. can you provide any additional

rationale that would mandate the dea to re-evaluate the 2016 nd t policy hestatement, beyond the volume of the applicant pool? >> can you repeat that? >> can you provide any additional rash national that would mandate dea to re-evaluate the 2016 policy statement, beyond the volume of the applicant pool. >> a ipplica would say that the the applicant pool is probably one of the single greatest issues that we're trying to contend with at is how to meet statutory text of the basis by with we're supposed to be sched evaluating allul applications f both manufacturers of schedule one controlled substances.. happy to change that statutory test if need be. i yield back. thank you, madam chair. >> the gentleman yields back. pleasure to recognize the mar gentleman from maryland, mr. sarbanes for his five minutes of questions. >> thank you, madam chair. thank the panel for being here today. dr. volkow, first of all, thankw

you for your work, which i know well, and you've brought a lot of important testimony to this e committee in the t past. i've heard from schools in my state such as the university of maryland, baltimore, that have communicated toe to t me the difficulty in conducting research due to the current regulations and are nervous that any unintendsed violation of these strict and arduous restrictions could result in loss of their federal research d grants.scussi obviously, we've had a lot of discussion about that here today. despite these barrier, schools and researchers are eager to tu advance the understanding of the topic,c, and just last year, th university of maryland school of pharmacy began offering a master of science in medical cannabis science and therapeutics. they now have this degree and focus opportunity. i have a letter here, madam the chair, i would like to submit this for the record, from the ot

university of maryland,he c baltimore, on the topic of cannabis research, and cannabis training programs for the record. i'd ask that this be accepted that the record.. volkow, would you agree that as more patients are accessing cannabis products in states where they have been legalized for medical or recreational use and in maryland, of course, tep would be taking thatth step in medical topiuse, that our provi work force should be educated on these topics and ready to respond to >> ipatient's questi? >> i agree that we need to have much more education. with respect to actually what, how, and the use of my one approach can negatively impact or help someone, the problem iso that we do not have sufficient evidence that would help us mount those problems in a way that it actually requires. so at this point, i don't feel t that the evidence, like the national academy of science,

concluded, is sufficient to say we're going to recommend that these probably be used by these patients. there are many concerns and it is not -- one of the problems and what is noted is that many patients, for example, the elderly, may be given some of e these product, they are on othei medication, and they don't know the effects of the combinations of effects of thc with these medications and the physicians don't even know about it with the patients.expa sondin i do believe the importa of expanding our knowledge so that we can then develop educational training programs t thatba are based on knowledge. not on anecdotes. and that is why i highlighted the urgency of doing research.e on therapeutics. as well as in potentially adverse effects. >> i mean you're highlighting the impediment to creating work force categories that can be a resource of expertise and

perspective when it comes to cannabis that is presented by bee kind of research issued that we're talking about today, if you can't, it's sort of a chicken and egg situation, you can't open the doors to more effective research than obviously creating specific work force categories that can take advantage of that, and help push it forward, and sustain it is, made morere complicated. i note that a survey of health providers from 2015 concluded that the health providers themselves perceive a knowledge gap in areas relating to medical cannabis dosing, development of therapeutic treatment plans, prc differences between various cannabis products, and other areas, so the providers themselves have certainly perceived that there is the need

for more research and expertise to be developed in this area. and i assume you agree that incentivizing research on medical cannabis for starters would help address these knowledge gaps, and support a more informed and robust provider work force. >> yes, i think we have an obligation to do the research to determine what are the consequences of the problems that people are taking, with the expectation that they're going to be beneficial. we owe it to them to give them that knowledge, whether it is true or not, that's why we do research. so i completely agree on the urgency of expanding of our understanding of the so-called medical properties of marijuana. in the diverse patient populations. >> thank you. i yield back. >> the gentleman yields back. we recognize the gentleman, the

gentleman from oregon.n fro mr. walden for his five minutes. >> coming from the otherearing hearing, madam chair, so thank you, because i know how important this issue is to all l of us, especially to organizians. mr. strait, i want to switch gears to hemp because there is a lot of interest in my district from farmers who arefor cbd gro hemp for cbd, and oregon state university is working with the usda ag research service to launch hemp research. given that the 2018 farm bill oi removed hemp from the csa, is a d.e.a. registration required to conduct research on hemp derived cbd? >> no. >> no. relatedly, usda's interim filing rule for hemp production, d.e.a. is supposed to participate in oversight. is the d.e.a. prepared to handle registration of the private and public labs to handle hemp compliance sampling? >> the issue of hemp testing, which is actually baked into th.

u.s. department of agriculture -- so pun intended,. sorry about that. >> there you go. >> was predicated on the concept was that those who perform testing probably made reasonable sense for them to hold a schedule one license, in the event that they ended up procuring a sample that was not hemp, it actually ended up being hot, and contain more than 0.3% thc. so that is an interim final rule. i know they're soliciting comments on that. and i know that is an issue of concern that has been raised by some in the public. >> there are quite a few of these issues. i know somebody had a commercial driver's license who was using cbd oil to deal with something, or had taken it, and then did a drug test, and it triggered the drug test as if he had used marijuana. which of course, affected his cdl. so these are issues we're running into, in realwn opi lif. he is not a marijuana user. you can have your own opinion on

that, but he tried cbd.. to go to dr. a throckmorton. when it comes to krbz, are ycbd able to tell us if the fda is any closer to determining if there are appropriate regulatory frameworks for nondrug uses beee including productsnt marked as food and dietary supplements and has the lack ofh pri research bd impediment to that process? >> i can tell you that process wo a high priority for us. we understand the interest, as n said before,d we're committed working with you, to find a path forward on that. i would also say that the lack of information we have about the safety regarding cannabidiol ise a challenge for us that we're looking to fill. we need to understand this, thed use of cbd, the safety of cbd, in order for us to decide how best to place it in products. >> i guess i want to push a little just in terms of the impediments to getting answers.r

because this is playing by c ou real life. i have friends that swear by ouy cbd. i have friends whose doctors have said don't worry, go ahead and take it, it doesn't impact anything else you you d may be . they know that. have you done the research? >> in fact, we know that's of te not accurate. that based on what we know from the t epdialex, the approval of the product that contains cannabidiol, cannabidiol do resd interact with other drug, and wc can get you that tilist, if youe interested, but in fact there t are interactions that could occur that could be clinically significant and i think blood thinners are one, for instance. >> yes. >> so you would want to make y sure that information is don owt available to people. >> let me suggest i that they dl know that's available. they're actually being told by medical providers at least in one case that i know, that don'i worry, there's no interaction, and this is legitimate doctor telling a patient. procl this is happening in real life.a i meannc i've got colleagues w

have been on television, proclaiming the importance of tt cbd's u in food products, and drinks, and consuming it. fine, that's up to them. but i don't think, and if people want to use it, that's their business, i got it, but i just want people to have theim facts and the data, so i think what we're trying to do here is figure out what are the it t impediments toak getting that data. and what does it take to get the agencies to appoint, where you're leading not trailing.ut because the states are where ahead of where we are federally. we have latency rules to try to figure out here. >> and it is important to work with the states so you're right the states are further ahead in ways becausee they've had to be. you've had to face the use of these products doeen in in your jurisdictions. ealthates that have been very interested in understanding these same things, the state public health officials get tham we need to understand the safety use of cannabidiol and then mak.

it, educate the prescriber, educate the choices that they're making, very quickly.be unfortunately,en historically, r marijuana was used for its thc content. >> sure. >> it's only large then recentl the cult vars containing large a amounts of cbd have sort of come to theot fore. the state data collection has been historically and largely focussed in that other direction, and so they're i changing f you course. r >> oh, yes, eadino, i understanl of that.. if you could get me that list, if it's readily available, is it on the fda web site? do is it, i and mean -- >> absolutely. >> please do. thank you. and thanks for your indulgence, madam chair, and i yield back. n >>ext the gentleman yields backd i think it's terrific we have w oure next member, another boo gentleman from oregon. so we've got a set of book est > here. mr. schrader for his five you minutes of questions. >> thank you very much, madam chair. i think it's great that we have

all three witnesses, great, we o need medical rresearch, into thi effects of the hemp or cbd, or marijuana products. u the sad part isnder we're not testing the right stuff. hav i fail to understand, with all due respect, mr. strait, why we have one bloody facility in an artificial environment in mississippi, as the really, the soul nexus for research analysis of cbd products. could you explain why that is? >> so that location is actuallyt more, probably better asked of dr. volkow because it is pursuant to a contract brief administered by the nationally a institutes of health.me w >> ie guess my, pardon to interrupt here briefly here, limited time, it seems to me, we ought to be testing the products that are on the marketplace. that's where the fda and the d.e.a., you are concerned. what's in the consumer, what's the american citizen being s exposed to or hopefully irror

benefiting from? w the idea that we're using a specific facility that does not mirror what people are actuallyo ingesting, ussmoking, whatever,s ludicrous. i am worried, you're talking t about more regulationshere i co out, we should be making less lo regulations, and just say there is a legally approved facility in the state of oregon, colorado, district of columbia, those are things that people are actually going to be exposed, ty we approve that research for that facility, why are you not doing that? bee >> and dr. strait, i can't agree with you more than what you're saying and a conversation we're internally. challenge of course is that the underlying principles of the ho csa, the controlled substances act, require that people who are going to lawfly possess, distribute, conduct research, with schedule one controlled substances, have to procure d those at substances from a vali source. and that valid source is, at f

this ederalpoint, it is another registered --go >> wellve valid source, in the eyes of the federal government, and you,the perhaps, is this, i ihatever, i'm arguing, respectfully, that the committee should bee looking at legislation, if need be, i don't think we need legislation, just should be something the fda and the eia and d.e.a., say hey, there are all of these approved facilities out there in these t states, we are not adjudicates whether or not it is a controlled substance or not, they arere e here, they are bei used for certain products that consumers are being exposed, to we need to investigate them, and make sure that they're not et it affecting dlentss adversely, efs fetal development, male fertility, whatever the deal is and get it out there. there are so many benefits. my colleague from oregon talked about benefits. i have a farmer in the state of oregon, a farm that is very conservative by nature, this very a father that was ailing, facing terminalal illness, pain relief was not getting done,

they turned to cbds and their father was able to communicate for the first time, in weeks with them. and they had a productive quality of life to the very end. these are the products we need a to be starting to get engaged in, and i just don't see that happening. talk to me a little bit, dr. strait, of approvals by tillray and buy pharmaceutical research, talk to me a little, these are not from mississippi, how come they get through and not other products? >> i'm not familiar with those two companies in particular. but there are instances where pharmaceutical companies can ben manufactures through synthetic means some of these substances and making some of these proved substances b available for research purposes. >> it concerns me thattdea you'i not aware of those being hearin approved by g.dea, i guess i wod like to get more information after the hearing on that. there's an apparent tendency to approve more foreign y

applications than domestic applications, and they get held for years. we've got, what, 12 or 15 different applications that are pending, and going through this long exhaustive regulatory process, and that seems incongruent with the fact that these products are out there right now, we need to research, everyone on the panel has agreed to the research, let's just get it done. what's the holdup? >> congressman, we have the same frustration you do. >> very good.erest. madam chair, i'll yield back. i appreciate everyone's interest. and we just need to move forwar0 to test the products of people h beingy exposed to. >> i agree.'t get 100%. i don't understand, i still don't understand why the done agencies, the three that are before us, can't get this done. but we'll keep questioning and the nextman one to question is gentleman from indiana. >> thank you very much, madam chair woman. this hearing is really very

important. i was a physician before i was in doc congress,to i'm still a physician.ce i just b don'tas practice. and as doctor, the data is critical. you practice medicine based on facts and data. i really appreciate this hearing. and i do support the legitimate ande medicinal use of thc but or knowledge of the subject is actually very limited and needs more research. dr. volkow, i'm going to go along the lines of developing g brain. up toa what age would you say that the brain continues to develop? >> the fastest growth is during the first two decade, and then to age 24 and then it slows down but it never really goes away. >> so i think people, a lot of times, have a misunderstanding, with ween he are talking about the developing brain, people think it is little children, but actually, it really goes up substantially, until your mid-20s. >> right. >> thanks. and you presented this, butrain all knowth thc can have damagin effects on the y developing brac

as you mentioned, in fact, the e studies you conducted, the national institute of drug abuse, show a direct correlation between persistentdhood t canna and cognitive decline from one's childhood tooepid mid life. epidemiologic studies have further usedents a that youth t flarely use cannabis have lower academic achievements, higher risk of dropping out of school. frequent cannabis use during ao dlents is associated with changes in the area of the brai. involved in attention, memory, p emotions andre motivation.he and madam chair woman, i have ay slide deck that that dr. volkow presented to the doctor's caucuo aut number of years ago, and i would like to introduce that into the record. >> so ordered. >> >> it outlinesll focus some things that you have been talking about today. additionally, and there is where i'm going to focus my question on. nida recently put out research, describing record levels of teens vaping marijuana. vaping thc products. can you elaborate on that data? >> yes, we have seen overall

vaping has increased among teenagers, and in the united states, 40% of the teenagers have vaped in their lives and despite the fact that this is a new technology, three years ago, most of the vaping was related to flavors, and three years ago, most of the vaping was related to nicotine. and while we saw last december was there was a significant adopting of the number of teenagers vaping for thc. now, considering that vaping thc delivers very high content of thc, this is worry some. it is also worry some because as you know, that injury, the acute injuries from vaping are predominantly associated with vaping of thc. so this is concerning. and we are seeing also significant increases from, in a thet w past year, of on the regr use of cannabinoids which we think are drink in part by the vaping so it is affecting the pattern of use of marijuana among teenagers. >> so then, along those lines,

are researchers able to conductt federal research on thehe thc av e-lingds and tlc-vaped liquids can' states shops in that have legalized marijuana for wreck national use. and if they can't, why not? fed >>eral the researchers are afra that if they use federal funds to purchase them, by buying them in dispensaries, they will use their funding. so as a result of that, overall, research is not done by investigators that are being funded through the nih which is a federal agency. >> based on what you justng teea about, about the say we rapid im in vaping amongst teenagers, would you say that we need to do something about that? >> i would completely agree. we need to be able to move fied rapidly into the field and understand the problems that patients, or citizens are being exposed to. >> i think that just confirmed what all of us have been saying throughout this hearing. i'm also concerned that law enforcement is notis equipped

addressss cannabis-impaired ers driving. i did also have a case in my district where a young lady was sledding and hit by a car and the person had that that hit her was not impaired by alcohol, or opioids, failed a field sobriety test, and subsequently we find out it's marijuana. but there's no legal standard. unlike alcohol, obviously, there's no reliable test. for that reason, i introduce hr-3890, to combat irm paired t driving act, in 2019, to direct the department of transportatiod to provide funding for grants . and file programs to address impaired driving.but dr. hav volkow, according to yoi organization marijuana is the frequently most found in thecrash blood of drivi involved in crash, including fatal ones and your testimony, you explain the risk of being e involved in a crash significantly increases african bis use. can you discuss the difficulties law enforcement have in testing agree ijuana and do you we need more funding to provide

advanced measures of cannabis ci impaired driving? >> yes, as i mentioned before, the problem that we have that the content in alcohol, we know a certain level is associated with moderate impairment, for marijuana, it has a very long half life and it and accumulatee fatty tissues of your boydy. if you're a regular user, you may get high and three hours later have very high levels even though you're not intoxicated.d. in other words, if you're a naive user, consume marijuana, there's not a one to one correspondence. we're trying to incentivize researchers to come up withdeei is intoxicated or not. expired.e has madam chairman, that -- i yield back. >> i think if anything comes out of this hearing is the research is absolutely essential. absolutely sempl. there's -- so much of this is two and two equals five.zed

well, it doesn't. min so the gentleman from massachusetts, mr. kennedy, is recognized for five minutes and i want to say how much i his -- the input that he gave the chair, and we will as he said earlier have a follow-up hearing with other stakeholders. i thi important to start out with our three government agencies but i think our subcommittee will benefit from the additional testimony of fro others so he'sk niced. >> thank you, madam chairman. thank you to our witnesses for being here for your service, for your work and for your diligence.o as some of you know i was initially his taesitant to suppt legalization. my concern stems with my work with the mental health community. many advocates toldmy they worrb about the impact of increased access to another controlled substance on the patients that serve.ried

but as states have moved forward with legalization including my pr i tried to understand how itt we could protect for the public health concerns.me of i talked to experts, talked to d families, talked to advocates, i talked toi talked to some of you. richa frustrated that as a federal legislator my hands were tied. our federal policy rests on trad richard nixon's decision to putd marijuana in the same category heroin. frustrated as constituents told me marijuana was the only thing pain.n.sed their when i asked regulators and agencies how we can make sure th -- i was told we couldn't until we had more research. d r gover how do we get more research? marijuana could be schedule 1, i'm told. lon how do we do that?nd we need more research. ameri federal government has hidden t behind the catch 22ly for a lon long time.p for ofanwhile, millions of americans, mostly black and

brown, locked up for nonviolent drug offenses. menwhile, desperate parents aree forced to turn to a black market to get their children the relieu their need. meanwhile, cities and states arf trying, at times stumbling, to put in place thoughtful and thorough regulatory framework with zero support from federal partners.ry is meanwhile, brand-new corporate industry is rising upppred, p t predictable economic injustices that spring up whenever government fails to regulate. prohibition has clearly failed and america isn't waiting for its government anymore. that's why i decided to co-sponsor congressman nadler's act which would finally y reschedule, not cannabis. expand research. superior to the policy on the table witnetoday, makes a commitment pr justice in communities of color. to the witnesses today i understand and appreciate the sy deliberative detailed approach t outlined. i commend and share your commitment to public healthng a

safety. clearly that's why we're here. we're also out of time. states are noth isn't waiting . incremental justice, long path,d a s little more research aren'ty enough. the federal government wants to be active and honest and a smart stakeholder in marijuana policy, we have to break free from the catch 22. so pointed to restrictions imposedt in your research because marijuana is a schedule 1 drug. you've already indicated, i just want to make sure i'm clear, your opinion, would those barriers be eased if marijuana was descheduled? dr. volkow? >> what is the question specifically? >> would the regulations be eased if marijuana was descheduled? >> the scheduling of marijuana, that's why i didn't want to comment on it because that's specifically what we do, we have to understand marijuana has harmful effects. we flow thknow that. it is a drug that is addictive. my perspective is, why i keep on

saying it, what is the policy that will protect the public of the adverse effects of marijuana while at the same time accelerate our ability to take advantage of the potentially beneficial effects that the plant has? that's my perspective. whether it's descheduled or not, that's not what our agency does. >> understood. and let me just be clear about the question, would the barriers to research be eased if marijuana was descheduled? >> if it was descheduled, it would be easier to do renk. >> would your office and agent s sy -- >> we do not regulate marijuana. we do research. our agency is not involved. that would be transparent to us. >> so your agency would not be harm in any way by continuing to conduct its regulatory authority. >> not. i mean, it is -- by sca

the drug, it's going to accelerate the ability to do the but at the same time may have unintended negative consequences in more people may bebe afflicted. so that's, again, why we bring the science and policy e decisions, what's the optimal way of moving forward, takes other factors into consideration like the ones that the fda has. >> doctor, aagain, just to ingo clarify, i understand the balance and appreciate that balance. i think that's what we're all trying to strike today. my question was, does the role ch if r agency changer agenen marijuana is descheduled? >> no. >> it would matter how it happened, syste obviously. it's in essence another system on a subset of drugs under development. so drugs containing compounds for marijuana potentially are used -- go through the controlled substances act as well as the food, drug and cosmetics act. to the extent that that step was

removed and the authorities of the food, drug and cosmetics act were maintained, it wouldn't have an impact. >> mr. state,rait, i assume thee answer for you would be it would change for dea. >> our obligation is to enforce the -- >> understood. yield back. thank you. >> gentleman yields back. pleasure to recognizeeleasurur the que gentleman from florida, mr. b l bilirakis. >> thank you, madam chair.ile, b i thank theut witnesses for testifying today. back it's been very informative. unfortunately, i was in telecommunications for a while, so, but i'm back now. dr. volkow, do you think that the process for conducting research on schedule 1 substancesesthe the s coupled w limitation on the supply of research-grade cannabis, have discouraged some researchers from investigating the compound? >> the answer is yes. and it has slowed it down, yes. >> let's see.

i have a couple questions here i want to go over. mr. strait, would you agree that scientists study fing cannabis d its effects, neither bad or good, is a fundamentally different question than legalizing, decriminalizing, or even discussing medical or recreational cannabis? >> absolutely. we wantant jur dea just like ou colleagues at hhs want to be rs tethered to science as it pertains to marijuana, research with marijuana. >> very good. let's see. next question is for mr. throckmorton. dr. throckmorton. excuse me. are products available in state-regulated markets like edibles, concentrates, oils, wax, tropicals, for example, ets cetera, i mean, those particular products, are they commonly available to clinical investigatorsfederal through fe sources? and if not, how might that pose a risk to the public health?

>> i wouldn't be able to comment on their availability to the non drug centers.s.>> that isn't part of what i regulate. i focus on the drug side.m on the drug side with the hey passage of the farm bill, hemp-derived compounds are now available for research.in any and we're eager to support that any way we possibly can. we think that's an exciting new avenue to get some of the questions we really desperately need answered. onenetor, more question.lnesse with the recent spate of lung illnesses related to illicit thc vaping products, what were some of the key takeaways, lessons learned, regarding the federal ? state of oversight and research into current products and consumption methods? >> sorry, i thought you were asking -- >> this -- >> you're bringing up an example

about why we need so much more knowledge. not know about it until 2006 and result of that, we eme didn't know how to diagnose rgi. now we're seeing it in the medical emergency rooms and it's associated with high-content thn and chronic use. but we are just assuming based l on what the patients are telling use frrces t since we're unable actually sample from the sourcet that they are consuming and that's just one example about why we need to understand the consequences of consumption of different products of effec mar because we are seeing adverse effects. and so if we want to proclaim, well, there are medical qualities to it and we need to n have evidence to show that it is the case, we also need to understand how to optimally dosa it and what product characteristics are safe and we don't have that data. >> thank you. dr. throckmorton? >> i want to say dr. volkow is raising an incredibly important

point. patterns of use, how these stauns substances are being used, are changing year to year. ayd uses, vaping, things like that, just the ways these are being consumed, the doses they're being consumed, the populations, the perceived benefits, are all changing. we as a federal architecture def need to find some way to track that, to understand it, to identify new risks as they emerge quickly, ideally find nei ways to assess efficacy and things like -- they're identified. it's a central challenge, i think, for all of us working in. this area. >> thank you very much. and i agree.oing t i'm going to yield the rest of my time to mr. griffith, please. >> thank you very much. mr. strait, several studies found that research-grade marijuana from the university oa mississippi is genetically distinct from the marijuana coming from state dispensaries r such as we heard ofs earlier in the testimony from oregon. m four years ago dea announced it would accept applications for the manufacture of research-grade marijuana in ct order to edincrease the a diver of products for scientists to

sta study. thus far, the agency has not t acted. dea intends to propose new we regulations that govern the marijuana grow eers program for scientific and medical researchr can we have your assurance that the dea will work expeditiously to review legitimate applications to produce per marijuana for federally approved scientific research and will current applicants be permitted to amend their applications to conform to the new rules so they're not caught in ar catch 2 or a vortex of time? >> on your first -- not >> yes, sir. or >> -- comment, we definitely will move expeditiously. we are moving expeditiously although i know it's not acceptable for anyone here in public office, so we appreciate your patience on that.appl and your second question -- >> second question was if you already have an application pending and rules change, instead ofofdireo not having to and go, proceed directly to go,t do not collect your ha$200, can they just amend to move forward?

yes or no because my time is up. >> yeah, on that point, when we announced the notices of application in august of applio some of those applicants had been -- had applied two years ago. we gave them the opportunity then to get a full refund and, of course, we would do that -- >> gentleman's time has expired. the chair now recognizes the gentlewoman from michigan, ms. dingell, for her five minutes of questions. >> thank you, madam chair. i want to -- i want to associate my comments today with everybody at this podium. i think there's bipartisan frustration on this issue. i think my colleague, mr. kennedy, probably summarized where i am very deeply.michigan i -- michigan is one of the is states that is now one of the . legal states that this is beingt traded in. i was -- i will be very blunt, i did not support it when it was on the ballot. a i come from a family that has c

seen what drug addiction does to people, but like my colleague, mr. griffith, mr. schrader, my husband who many know in this ia room, suffered from great pain and many people said that marijuana.d he t would be the o thing. it would he try it? he would not try it. y because it was not legal. you did not know the sideough ii effects. and it might have given him relief in the end. but i was the keynote speaker at hash bash this past year. yes, you should laugh. my staff told me -- i don't know how it got scheduled, if you want to know the truth, but i'm still trying to figure that out. >> it wasn't schedule 1. >> but i got up and said i've never smoked marijuana, don't think i ever will smoke marijuana. i was getting a lot of indirect

bututth i made the happ point -- i talked to a lot of y the scientistson and there are ve very clearly -- the need to get more research on this issue. we all keep asking you the same questions because we're not -- we don't understand what the answers, why if we all agree we need more research and need it for medicinal purposes, we need it for automobile -- i'm working on impaired driving legislation right now, too. every one of us has got a story from our district somehow, someway, that there's a problem and we're in the biggest catch 22 that you can ever see our imagine. so you've got to help us figure out how we're going to get out of this catch 22. it's one of the reasons i spro deu introduced with my colleague, the medical marijuana research act, just in case you can't tell, i'm pretty passionate on it now. even though it's legal for

recreational use in 11 states, michigan being one. we've just started it. it's gone -- recreation tal ma e marijuana the last couple weeks. national academy of sciences has thne a study which i resea have here that found the research oni then health effects of cannabi has been limited in the united states and this lack of knowledge poses a public health risk. i would like to make sure uses a it's submitted for the record, madams chair. >> so ordered. >> so having agreed with all of my colleagues here, having the three ofof you already establish we've got problems, can we go back and look at some of these e questions everybody keeps asking? dr. volkow, you talked about the administrative burden. we keep asking why you it takes months to navigate. we're looking for those details. how would simplifying federal guidance surrounding schedule 1

registration n improve nida's ability to conduct this research? what do we need to do and why is it only one kind of marijuana that is okay to the university of mississippi?an can you give us more detail and highlightd why as, you know, why federal research is done only a single source of cannabis? how does this reliance on a single source limit our understanding of the health impacts?re frust >> yeah. cha we agree. we're also, of course, frustr e frustrated by the challenges of advancing the science and the same time recognizing we have a problem. i wish marijuana had no untoward effects. high content thc can have pretty adverse effects. now, there is, as the national academy mentioned, there is evidence, though it's not solid enough for fda approval, that there are some benefit clinically for some effects of the active ingredients of

marijuana. so how could it -- what is one of the things that we've been promoezin in proposing? again, we're not legislators and it is the fda and dea that regulate. what we wanted to achieve is a retegory for schedule 1 that allowsgu researchers to do research with the proper regulations, would expedite it. that is one of the things we've been working with our colleagues on. >> how do we keep you from working and getting it done?ne g >> we need to actually solve the problem, and i -- and i agree. i also think we need to figure out a way to be able to also take advantage of some of the new producers of different cannabis plants in order to evaluate the diversity of products that are out there as opposed to limiting us with a mississippi farm. these are regulatioregulations.

it's important, important research and knowledge. >> i'm, unfortunately, out of time, but i could have asked a lot more questions. thank you, madam chair. >>he gen gentlewoman yields bac. pleasure to recognize the gentlewoman from indiana, ms. brooks, for her five minutes of questions. on thank you, madam chairwoman. foapologize to the panel. there's anotherrt hearing goingn so i've been going back and forth a bit. but your testimony is critically important to us and i think frog my colleague across the aisle, e there's been frustration because i think we are trying asd to mes of congress to figure out what specifically we need to be doing to help with the -- help to tht accelerate medical research. i think that's the -- that is the top priority of this committee, i believe, and the purpose in having this hearing. and so, and with that, you knowm hearing testimony and knowing ds friends who have pai suffered f tremendous pain, particularly

from cancer and other, i want t. focus a little bit on pain therapy. we talked a little bit about it. dr. volkow, thank all of you foe your work. i have mixed feelings about the issues around marijuana. having long ago been a criminal defense attorney and seeing so many of my clients have substance abuse problems and many starting att a young age with marijuana and later as a attorney cking states working with the dea, it orhood involved disrupting trafficking organizations, drug trafficking organizations that ruined neighborhoods and communities and caused a lot of significant problems, but yet, i also have a number of friends and people i know who have suffered tremendously, whether it's with cancer, other things, where marijuana has them wi helped th their pain or those at end of c life, as we've heard those stories, so we're really conflicted here. we as a congress, i think, have a lot of issues around we're ro trying to figure outto how to

break through and move the ball forward because it's taking ben years and we just don't have answersd. and we are so behind.n so what barriers, dr. volkow, remain at nih, to study the new therapies around pain and where cannabis can particularly help with pain and even addiction therapies, we're hearing? can you share with us what are the barriers around the we are research, specifically relative to pain? >> and if we are prioritizing as it relates to cannabis researcho it's potential value for the treatment of addiction, and also for hiv and as an anti-inflammatory drug. so -- and researchers are being funded both for thc as well as for cbd. we would like to have more nd ta investigators involved and that is where the whole discussion has been going back and forth.

many investigators that don't p have the infrastructure support that's necessary shy away because they feel it's too much of an obstacle to try to go to a schedule 1. >> are these private -- >> we are funding research. >> dr. volkow, would these be private sector investigators or university investigators or -- what type of investigators do we -- what kind of investigators do we need? >> we want both of them and one of the areas that we're very t interested is actually pairing academic investigators with industry so that the products going e beingprlope developed d can go into the market. so we fund different mechanisms to try to facilitate those interactions. so you don't want to limit it tp just to theri admissions, you wt to also facilitate research by the private sectors. >> are there any significant pieces of research that have been completed? i know you talked about 11 -- studies over the long periods of time ofof and chi adolescents and of children that you with following and i appreciate.

what are the numbers of years that you're typically looking for relative to research? >> well, it depends on what you're aiming for. frekts, to try to understand how marijuana affects the developin1 brain, you need to follow it up during brain development so that would take 10, 15 years. if you're trying to determine, for example, to what extent thc can have effects, say, in a patient suffering from low back pain, just -- i'm just -- that t may be a story that you canhree complete in three or four years. so it depends very much what the aim is. what the study is going to be doing. >> and approximately how many studies are we funding now -- focused specifically on pain management? >> on pain management, we're funding $39 million for therapeutics of cannabis and of them, i would sort of say t fo probablyr 35% to 40% maybe pain

>> okay. >> but i have to check the figures but i just -- guesstimate. >> off the top of your head, are there any significant negative results that have shown in your current research? >> too early to say. >> okay. >> from the ones that are ongoing. >> thank you so much. thank you all for your work. i yield back. ge gentlewoman yields back. pleasure to recognize the gentlewoman from illinois, ms. in my, for her five minutes of questions. >> thank you, madam chair, and thank you to the witnesses for being here today. my state of illinois was the 11th state to approve adult-use cannabis. with that said, i'm interestedaa in hearing about the research vuat exists about cannabis, particularly for vulnerable populations. i'm the chair of thecus congressional black caucus and have worked with my colleagues to create legislative and polics solutions to reduce health disparities and promote good health in all communities.ses ad so, dr. volkow, your testimony

discusses the health effects of cannabis when it comes to prenatal and adolescent development. what is the state of the science in this area, and are there studies that focus on minority populations? >> yes. and based on the science we do know the use of thc during utcoe pregnancy is associated with. significantly negative outcomes for the newborn and the mother. there are cannabinoid receptors in the placenta and receptors emerge very early on in fetal development and guide how the brain actually -- how neurons in the brain are moving and connecting. so it is something that needs to be takene movingnecting.someth . we know that in adolescence, as has been mentioned, every singll study has shown overall independently that it leads to worse educational outcomes. lar and what we're now using is more sophisticated technology, larger samples, to understand how factors differ between what thrg individual and theh other.

for example, through the abcd study, we have shown that adverse social environments have a very negative effectentify in amplifying the consequences into the brain. so if you come from a deprived environment , your brain is actually going to have a much lower development than if you are in an environment that has, enriches your experience and in those circumstances, drugs have a greater negative effect. so we -- i mean, these are studies that are ongoing. and, but it is clear drug and marijuana is not a good thing for the developing brain. >> i'm glad to hear that you have a more diverse sample than it sounds like you did from the. beginning. you said you're bringing in more diversity. >> absolutely. we need to understand diversity, diversity in terms of ethnic backgrounds. diversity in terms of economic opportunities because those are influencingactors o multiple fa

a child.opment of >> and dr. throckmorton, in your testimony, you mentioned that the fda is actively working to learn more about the safety of cbd and cbd products. among the list is work to understand the pop effects of c of special populations such as the elderly, children, adolescents and pregnant and lactating women. can you elaborate more on this?e >> i -- the best data we have available comes from the controlled trials that were usel to approve epidialects for rano seizuremi disorders, conducted t youngio children. we simply don't have extensivee randomized controlled trials in those populations that we all sort of acknowledge are terribly important. when we approved epidialects, we also posted on the web what we t

do know about theo demographic of response to the drug. so you can go on to what we call our drug trial snapshot page and it will show you the safety and effectiveness of epadialects e r broken down by sex, gender, age, ethnicity, and you can look and see for yourself what we know about epidalects but need a lot more information to expand that to understand the impact on the elderly, for instance, and on pregnant and lactating women because they just simply wrerent in the trial so we haven't had that opportunity yet, but it is something we recognize and we're working to try to fill as quickly as we can. >> and assuming you're working to get more diversity in the dv trials. >> erabsolutely. yeah. >> i like my colleague -- i go back and forth about how i feel about recreational marijuana.e s i don't know if it's because i went to college in the 1970s an that's the reason why.emer i read ingenc the paper chicago

allowed it starting january 1st and the paper talked about how the emergency room visits have p gone uplace because of this. wih even places that treat dogs because people are, i guess, careless with the edibles, i don't know, and they found more dogs getting sick, too. so it just seems like we need th educate the public more, too, about the effects and i don't s know if it's just an earlybec r overexuberance because it just became legal or will we continue to see increased emergency room visits. >> again, and i'm just going to comment on that because actually one of the aspects that have been coming back and back, marijuana is not a safe drug. s it has negative effects and among the ones that we're more concerned is that what affects young people. but one of the ones of greatest concern has been the association of the use of marijuana with psychosis. and stoudies across the world, for example, as a psychiatrist,

i was trained the prevalence of schizophrenia is the same across the world, it's 1%. it so happened that that is not the case. some cases it's sixfold to eightfold higher. those places, it's associated with very high content thc. in the netherlands, for example, which has the highest rate of schizophrenia linked with the consumption of thc, you can have plants that have 38% thc, so this is not just explained by having themethin genetic risks. there is something about thc tht 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. to recognize the jebt gentleman from montana, mr. -- am i right? mr. gianforte. >> thank you, madam chair. thank youou 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 tha lack of federal research on marijuana because when we consider such a dracstic change we must ensure that policy is co based on sound science. so the focus today on research is very appropriate.ining wi in november i joined with 16 other members of congress in asking attorney general barr toi study the societalon impacts of legalizing marijuana for recreational purposes. as we start to see preliminary r 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 g acce greater accept willss impact anmmunities, 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 ies montana. methamphetamines devastate our m communities and tear up our communities.e years meth accounted for 86% of drugs trafficked in montana in the tht past five hryears. montana has worked hard to support people fighting hel treatmentthroughp drug courts. these courts help people get cm clean and get back on their feet inile 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 w focusing on combatting succ

addiction. building on this committee's bipartisan work and the success of the support act from last adi congress, we need to continue to support those who face addictioi and need the help the most t. rather that making marijuana easier to access when we don't know the full effects on our communities. dr. o ensurevolkow, ensuring ac mental health services is a topn priority of e mine. unfortunately, montana has the d highest suicide rate in theuc country. i haveicide introduced the nati suicide hotline designation act which makes 988 the national suicide hotline number. this important bill will protect emergency access to care for a l those facing a mental health crisis, especially those in rural areas who lack access to a mental health professional.seri inou your testimony, you state e that serious mental illness and suicides are on the rise in oure country. and while multiple factors very likely contribute to this rise,a

it's imperative to understand if exposure to cannabis in adolescence is one of them. for does current research draw a connection between marijuana us? and increased risk for suicide e 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, i dendeed, suicidology. it's been noted in large epidemiological studies. >> from your experience as and 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,n and very, very afraid, if not s fully psychotic and that can explain, one could conceive why in these circumstances someone e if they feel threatened may actually attack someone else or attack themselves. so in some people that results ' in at chronic syndrome and tha is where we don't have sufficient knowledge of understanding why is it that in 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 possi appreciate your expert opinion, it is possible that cannabis could increase suicide rates, id thatat correct? >> the epidemiological data has

given some evidence that it may, but i want to be cautious,at w again, i think that one of the thsues that we've been criticizing the whole field of marijuana is that people say you are exaggerate iing, 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 automedicate? how do you?>> t 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 he gbacs pleasure to recognize the gentlewoman from delaware, ms. blunt-rochester, for her five minutes of questions. >> thank you, madam chairwoman,i for this important hearing andt thank you to the witnesses. as you can tell, many of my re colleagues, we are going over na 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 dealingng with in ts one hearing.

both protecting and enhancing public health, providing economic opportunities.ecst w but in aay just way. restorative and criminal justice. as well as public safety. i'm encouraged at the can le comprehensive legislation thata addresses the justice aspencts f reform. it's also a significant drain oh ourav national economy. that's why i've introduced bipartisan legislation, the clean slate act, which would seal an individual's federal leo record, criminal record, for r s nonviolent or simples possessio 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, thc fda has approved one cannabis-derived product for

medical treatment.atric epidialects which is used to treat rare pediatric seizures. c 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 beginning elopers with conversations with us. coming in, just basically sayinr 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 dc for epidialects. >> you abs have aol roadmap we 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 expan 2018 farm bill,f seen a c massive expansion in commercially available cbd products. everything from cbd active wear to cbd toothpaste. many of these products assert f that they contain various wellness benefits like reduced levels of anxiety or better sleep. i want to p continue roducton. the fda has stated that many ofi these products are marketed with unsubstantiated therapeutic claims.oes 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 if currently doing is. sure.e. thank you. we'd be happy to follow up with details there, too. fundamentally, if somebody makes a claim that their product treae s, diagnoses, mitigates, a disease, they're a drug. if they're doing that withoutrea 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 claimt 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, at drug and cosmetics act. we called on them to stop whatever the violation was that committing. most of them had to do with t labeling and gave them steps that they needed to take in order to come back into -- >> so just so i'm clear, the g t 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 ande

see the series oftt 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 planp for each of those companies to make sure that they come into ne compliance. >> well, one of the areas i didn't -- when i ran through all those intersections, i didn't run through consumer protectioni and int think that's another bis 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 a wes well. gentlewoman yields back. pleasure to recognize the onlyg pharmacist in the congress. mr. carter of georgia. >> thank you, madam chair.

>> you're recognized. >> thank you, madam chair.ther. 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. doctor. a why did it take so long? argua 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 but i 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?e don' >> why did you have to wait on a petition? >> we don't have to wait on the petition. >> then why with the opioid epidemic being as bad as it is

did it take the dea until 2014 to hydrocodone from a c3 to a c2?rned abo >> actually, back when the petition came in, i would argues a lot of folks in the medical h community were actually concerned about access toesched 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 r worked together for many years now and i have great admiration for your work and great respect. a you were asked earlier, i believe it was from representative castro, if marijuana is a gateway drug, and , yo be quiteu honest with you, you gave a very scientific response.is that something about sensitivity. is marijuana a gateway drug, in your opinion? i ask you that as a psychiatr t

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 r theijuana end demlogical studie 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 s say, overall, i would state based on studies not just in epidemiology but in laboratory n animals that if you expose them early on, they to areer 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 morebe 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 -- done with e we nicotine? put limitations on it. and i want to cut to the chase. if you want to see time fly, f wait until you get up here for five minutes, but i want to fivm go -- i want toin cut to the chase. everyone up here has expressed the same concern.s we need more research. tell us what we need to do. mr. strait, what do you need? what -- do you need a schedule e 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. -- 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 mo five weyears. we are making progress.d

we want to do more.impr for sure. what do we need in terms ofcess improving access to research? i feel as if this interagency tooup of folks here have worked collaboratively on d a proposal that would actually do just that. >> and is that proposal you mentioned earlier about fentanyls or -- >> mak >> correct. absolutely. yes. in the context of fentanyl -- - a can you make sure we get 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 the recently that u said that there actually the -- the use of new research found opioid s were prescribed less often in states where legaliziz marijuana had been ph seized for medicinal or recreational use. as a practicie ining pharmacist many years, i've always said the only thing worse for me than i i filling a prescription foror someone who doesn't need it is not filling a prescription for someone who does need it. if marijuanaarijua truly does h 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. used. but if there are benefits to it, i want it to be used.ressed t all we want here, everyone has r expressed the same thingch findo throughout this wholeut hearing. tell us how we can get this he d research erdone.ernmen 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 s a c committee.

too often we either talk about cannabis as either a criminal justice issue or a medical and issue. the reality is that we cannot pull them apartsearch. research has shown that for th o 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 liolescents in the system for more than ake year were three times more likely to have functi functional limitations, over four times more likely to have of dtoms of depression and over two times more likely to have suicidal effects into adulthoodn now, i'm not talking about the use of cannabis. i'm talking about incarceration. clear. cannaat nearly 75% of all of the people -related 30.cannabis offenses are under the age of u 30.th a d one in four, one-fourth, are under the age of 18.ested that's almost a quarter of a ato million teenagersf arrested for these types of offenses each year in the united states of america.

given that we know beingsessio 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 to bal consequences so the questionan then turns to balancing these public health concerns. we also know that a conviction for a controlled substance can lead to difficulty with job nemp prospects,loym wihich could lea both unemployment and h underemployment which has potentially adverse public health consequences.ans a similarly, a drug conviction means a currently enrolled college student receiving federal student loan money would have their financial assistances terminated. this can harm the future employment, earnings, and ultimately health prospects of that youth. examining the public health het harms created by criminalizatioc ofon cannabis is a type of pandt research that could be conducted without having to expand the research supply. i think it's really important

foris a us to understand that calling cannabis a gateway drug in an anecdotal fashion is unfair to the american people and it'sr to really t not a pro dialogue thatt policymakers and/or researchers and/or medical experts should be thats having. and the reason why i say that is be if we're going to have that discussion, we should have the discussion and the question, is alcohol a gateway product ort 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 beu the subjecte of dialogue when i comes to true policymaking and also when it comes to real qunest 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 is t inception of the d states congress calling cannabid a class 1 drug, i would encourage everybody in this room and everybody in this country to unok at the footage on the floor of the united states congress and the nonresearch, derogatory statements that were being madeh specifically about a certain community and how using cannabiw would lead toom rape and murderf women and citizens of this ning country. little bit it up aittle because i think it's unfortunate that we have that stain on the united states congress and so o far we haven't had the will to actually correct it.

the united states congress madeh a mistake. and every congress since has not had honest hearings and honest dialogue and has not allowed, reuly allowed, the researchers in this greatse country to do t true research that needs to be done for us to properly categorize cannabis in this onsf 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 heo record that otherwise b they wod 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. th 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. bac. with that, i yield back. >> the gentleman yields back. the jegentleman from illinois. mr. shimkus. >> thank you, madam chairman. >> thank you, all, for being h here. it's been a long day for you all.earing 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 e recent article that came out ofr the lancetenia psychiatry about use of drug-induced psychosis converting to full schizophrenia? >> yes, correct. >> can you comment -- i got thet 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 cn 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 psychotic episodes associated with the use of cannabis were much more likely to subs subsequently go into psychos 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,health e use, what we call when they -- d 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.d that i 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 issu 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 o these vaping products?s?quick. >> 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.h.yes i think part of -- that is the direction, yes, sir. >> so as we said earlier, the channel, of cours challenge, of course, with that, we certainly understand researchers want access to that material.materialontrolle under the controlled substancesa 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 impactr their ability to keep their ssec federal fundingon 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 --u with the scdc that the schedulig

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 the e elaborate? >> yes, yes, it is. you want to -- when you tastarto 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 federall agencies like ours. >> great. thanknk>>ciate th withdreyou. and i want to yield my last minute to morgan. >>pplica i appreciate the ntama very much. earlier, mr. strait, we were talking about the applicants more in place. 33 applicants t s to grow marij 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 ney. before, we refunded their moneyn i don't think they want their a. money refunded. they want to not have to go back and start all over again with their application. so can they just amend their qu application? wouldn't thatat 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 s to may passage of the farm billd that some of these applicants may have actually applied to produce things that now are no e longery controlled under the ci we gave them the opportunity to withdraw their application for e purposes ofd 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.cl 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 es 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 stateh are loosening their restrictions around marijuana including my home state of illinois which just legalized recreational marijuana. beginning the 1st of january this [iyear.oritize 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 about and when marijuana can be harmful, particularly after frequent and long-term use. and that said, it seems to me that many states, including mine, are stampeding to legalize both medicinal and recreational use of cannabis, particularly because there is a budgetary crisis and these states are confronting.

revenues increased by marijuana sales and legalized marijuana, particularly recreational now to help correct the budgetary issues that they are facing. and i want to ask the doctor a question. will you please expand on the possible health risk and implications for citizens, both adults and adolescents, of thest things, which are exhibiting what i call a mob marijuana mentality and who are engaged in what i would refer to as a marijuana mania that really exists in my state and similarly situated states across the nation?

>> yes, and i like the way you call it the marijuana mania, because it is actually a change in belief without the fact that. there hasn't been any evidence to make us think that it is safe. and i don't want to negate the possibility that in some instances, the cannabis can have therapeutic benefits, but we can't deny the fact that it has some very negative facts. that does not negate the possibility that we can come up with indications where marijuana can be used safely for therapeutic purposes. these things are not exclusive. but it is clear -- the evidence is clear that use of marijuana is associated with negative effects. and we are already seeing it by the significant increase in emergency department admissions that are being observed in the i states that are legalizing marijuana as well as hospital admissions. 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 quy -- i mean, and at the same time, what we are living as a country, which is quite amazinga 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, ort

this expungement of records.s. it's okay, all right, but the cause of those records is being ignored. d 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 inearly shown that not only does it not in any way benefit or protect wanyone,ith it actuallr makes them much more vulnerable

to adrelapsing and drug-taking d other adverse mental erse 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.e 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 powerfur

and the most powerful was to fih hear from congressman griffith and his story. it is the personal stories thats are theto most impactful. when i was very young, my father had parkinson's disease, and he had it pretty much all of my y life. and i remember when i wouldm w y him in pain, i would just ask, t is there anything that could be done for ie can 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 ot what they need to help give thet 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?ort for 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 ie favor actually thenc advancing 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 t 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 thed onethat that i had r i've gone on the record for i these that i basically -- and t

we've been working with michael leaks 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 the mind. and in particular, from the ouc fda's perspective, the outcome in mind the need for continued drug development and appropriate scientific study. >> okay. >> >> and from the department of

justice side, none of these o tr bills have actually beene reviewed by the administration, soso there is actually no offics position in terms of any of the proposals. but as we're all talking about today and as i think we all have kind of mutually agreed upon, the key is science and having the access to the data to support sound decision-making, whether that be legislative or g withinis the executive branch, absent legislation. >> right. so, i want to shift for a moment on the issue of sickle cell and the impact it's had on african-americans. i think in some states, they i have a listhave of medical maria uses, and i have talked to patients, i've seen what sickle cellth has done to patients and the pain that they've suffered, and many sickle cell patients t use marijuana toof address acut pain that's a symptom of the bt

disease, and somee of the stateo currently have medical marijuana laws but have chosen not to toe 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 p 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 -- st >> that wasn't theion w questio. 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. to i yield back. >> the gentlewoman yields back. pleasure to recognize the gentleman from california, ruiz, for his five minutes of questions. er >> thank you, and thank you all for being here.e.imony dr. volkow, you say in your written testimony that "cbd is ubiquitous and it is possible to purchase cbd extracts as well ad food, drinks, cosmetics and other cbd-containing products that are sometimes marketed with health and wellness claims that are notno backed byti science." it is also worth noting that nde while more than 30 f states all for comprehensive medical use of cannabis and the fda has approved some derived and a cannabis-related drug products, cannabis does not have the fda

approval for any indication.cert 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 ad jukt to people in the treatmentt of chronic pain syndromes, which ir of particular interest during pd the current opioid e epidemic, pain and specify 'tisity in t multiple sclerosis is another use.ence. however, there is evidence that shows that chronic use is not without its consequence. for example, canabanoid pain syndrome, a syndrome of vomiting and chronic abdominal pain, disadvantage -- aattention, learning, and processing speed among teens who use marijuana s regularly. thesein neurobehavioral changesy can evenen be seen on brain mri of these patients. these changes can be permanent. earlier onset, as you had r diso

mentioned earlier, of schizophrenia and bipolar disorders in young users of o bn marijuana.r so, it is clear that more research needs to be done to better understand the risks andf benefits. dr. throckmorton, it seems the fda has found therapeutic value in marijuana-related compounds,s but for limited and specific uses. spn you discuss what factors went intoec approving these dru for medical use for these b specific populations? >> sure. it began with the basic scienceo work. so it began with supporting the kinds of research that nyda supports to identify compounds and targets, therapeutic targets of interest.odels 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 believeu

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 studie 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, p you know, i don't s know, infectious diseases or to whatever else it is, with a particular product. our job is to make sure that that assessment occurs quickly and efficiently and is a 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 t understanding of its safety ando effectiveness. >> and based on this approval process, can fda extrapolate the safety of cbd for other products? >> extrapolation for effecti effectiveness is very hard to k 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 jeffers' marijuana freedom of 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 blumen year'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? >> 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 de enkdea, and therefore, te 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. >> well, 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 is other legislative means by which congress could propose to change that specific requirement, but i do believe that it would require some legislative changes to the controlled 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 at the very least should be able to work together to ensure adequate research is able to be conducted so that 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, ms. mcmorris rodgers, for five minutes. >> thank you. thank you, madam chair. and i also want to recognize the ranking member and all of 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 year as colorado. i believe we were the first two states. i am a co-sponsor of

blumenhauer's research act, and i also appreciate washington university, which is in the same situation as ms. murkowski's university of wanting to do more research. since we've legalized marijuana, the number of cannabis products on the marketplace has exploded over the years, and so have the marketing tactics that promise cannabis is the miracle for your health. a quick search promises you cannabis products will help you sleep, relieve your pain, calm your anxiety, shrink tumors, cure diseases, and a whole lot more. the concern is that these claims aren't yet backed by scientific research or clinical trials. i'm concerned about manufacturers who are ignoring all the unknowns of cannabis and spinning health promises to fuel an industry that is projected to be nearly $2 billion by 2022. i do believe that this industry,

like with the fda-approved cbd oral solution for epilepsy -- and others have mentioned this -- is on the verge of major breakthrough that can improve people's lives, and we should be encouraging these developments. like other cures and treatments, cannabis products 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 a consumer safety issue. those priorities should be at the forefront as we unlock the mysteries of cannabis. dr. throckmorton, i wanted to ask -- and others have been on this topic also -- but as i mentioned earlier, the fda has approved only one cbd product -- a prescription drug product to treat epilepsy. that being said, all sorts of cbd products are being marketed and sold throughout the country

and 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 standards, used to packaging standards, labelling standards, an industry of the kind that you see when you go into walmart and costco and places like that. those products are being manufactured to a standard, as you said, which i think is very valuable. i hope that 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 quality standard.

i think that's one important element among other things. i also think it's terribly important that we lay out a pathway for nondrug products containing compounds from hemp so there's a clear path they can follow as far as developing the 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? >> yeah, i do. >> therefore, the industry or the nondrug products? >> we've really benefited from talking to the states. i would say your state has been particularly helpful to us as we talked to them about their experiences, because you've had to deal with all of these things. the states are all taking different approaches, but many of them -- and i would say including your state, i know -- are grappling with these issues around labelling and dosing and 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 that also the number of fatality accidents that involve one of these products. what needs to happen in that regard to make sure that we're safe on the roads? >> so, it's one of the unknowns we've identified for canabadile. we studied it in children. we never did those kinds of studies because children don't drive, but we understand, 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 of 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 we will have another hearing from other stakeholders that are not agency stakeholders. so, thank you, again, to each one 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 roadmap to

address this lack of really substantive research that is absolutely needed. that is foundational to what, you know, so many of our undertaking. so, i want to submit the following statements for the record, and i also want to remind members -- of course, they're not here -- that pursuant to committee rules, they have ten business days to submit additional questions for the record to be answered by the witnesses or to whomever questions are submitted. we count on our witnesses to respond promptly to any of the questions that you may receive, and i trust that you will do that. so, i request unanimous consent to enter into the record the following documents -- a statement from greenwich biosciences, a statement from the american college of occupational and environmental

medicine, a 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, a letter from over 100 organizations in support of hr-3884, a letter from five organizations representing state legal cannabis businesses, a statement from the california cannabis industry association, the testimony of congressman hakeem jeffries in support of 2843, a statement from chris crane, president of four, the number four, and the word front ventures, a statement from americans for safe access, a report from the national cannabis industry association entitled, "adapting a regulatory framework for the emerging cannabis industry," a statement

from the american property casualty insurance association, the testimony of paul armentano, deputy director of the national organization for the reform of marijuana laws, a response letter from fda/nih to senator schotts, a letter from the minority requesting a hearing on cannabis -- and here we are. anna said yes. a letter from the american academy of neurology in support of hr-171, a letter from the american academy of neurology in support of 601, a bloomberg news article entitled "pot imports grow as u.s. stalls on medical research" -- quite timely -- a collection of six letters from organizational supporters of hr-3797, a statement from the biopharmaceutical research company, a letter from smart approaches to marijuana, a

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 -- 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 the hearing. >> all right, so on that happy note, thank you to each one of our 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.

>> the first votes of campaign 2020 are just days away. watch our unfiltered coverage of the iowa caucuses, live monday, february 3rd, as we follow the candidates on the campaign trail, take you inside caucus voting sites and show live caucus results beginning at 7:30 eastern on c-span, online at c-span.org, or listen with the free c-span radio app. treasury secretary steven mnuchin, along with other international financial leaders, gave an outlook on the 2020 global economy and talked about trade and unemployment figures around the world. they spoke at the world economic forum in switzerland. it's about an hour. >> good morning. warmly, warmly welcome all of you coming to this session, as this is one of the last