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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 cannabis derive medication 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. patient who's rely on medical cannabis. 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 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. high with state laws around cannabis and its derivatives of evolved over the years, much of the federal frame work 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 f)om a panel of agency witnesses who agreed to appear before the subcommittee 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. i do want to recognize representatives 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, madam chair. i have two minutes left if anybody wants it. if not, eye yield back. >> mr. chairman, i'll take it. sure. i yield to mr. griffith. go ahead. >> 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 cancel. 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 rational

medical marijuana policy, 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 on the floor of the virginia 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 that 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 finally have an opportunity to improve issues on

cannabis. representatives burgess, griffin, 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. this means that researchers seeking to investigate cannabis must work with the food and drug administration and the drug abuse enforcement administration just to meet the federal guidelines specified in the 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. as far as i know unless safeway inserted 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 derived from the hemp plant have become common place across the country, pharmacies, food stores, even fast food chains since hemp was removed in the 2018 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 of cbd products 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 the agencies are struggling to catch up. nationwide, exposure in youth is increasing. from 2006 to 2013, children's exposure to marijuana products 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 numbers of 8th through 12th grade students regularly vaping marijuana, a subject we have talked about before this committee. we need research and data. americans are consuming more policy on this. policy decisions have 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 robust data 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 completely deschedule cannabis, removing it from the controlled substances act, even though we do not have the necessary data to justify doing so in my opinion. descheduling cannabis is a step too far and something that i can't support as 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 as we improve the state relationship and the marijuana policy gap. 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 poping 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 today. dr. nora 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 strait, senior policy adviser for the control division of the drug enforcement administration. welcome to each one of you. 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, 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 inviting 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 can body oil or cbd which is not requiring or of interest because of 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. cannabinoid receptors also mo l

immo immoebilate 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, and preterm delivery. in adolescence, cannabis use has been consistently associated with lower academic achievement, higher risk of dropping out of school, lower iq, disruptions in brain connectivity and structure as the brain transitions into adulthood. 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 studied. the availability of high thc products have marketedly increased emergency department visits and hospital visits associated with cannabis exposures. vehicle-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 lung injury or a condition reported in june 2019, predominantly associated with thc vaping that has over six months resulted in over 2,500

hospitalizations and # a5 deaths. consumption of cannabis edibles packaged food and drinks are partly related to emergency department visits. there's low absorption can prompt user to take further doses resulting in very high thc levels. toxicity most frequently manifests as acute psychosis, 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 spasticity multiple sclerosis and for 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 and the adolescent brain cognitive development study will follow more than 11,000 children into early adulthood to investigate how cannabis affects 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. >> you're recognized. >> the chairwoman eshoo, ranking member burgess and members of the subcommittee, i'm dr. douglas throckmorton at the food 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 represents 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, break through therapy, accelerated approval, and prior 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 development of plant-based drugs including those derived from cannabis. using these resources, the fda has successfully approved one cannabis-derived drug product, containing cannabidiol. and three synthetic cannabis drug products. 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 derived 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 food to which certain drug ingredients have been added. in addition, drug ingredients are excluded from the definition of dietary supplement. because cbd is an active ingredient of an approved drug, these restrictions apply to products made with cbd. these provisions make sense. it's easy to understand why we generally don't want blood pressure medicines or pain medicines in our food or in our dietary supplements. additionally, fda is concerned the marketing of cbd and non-drug products could put put consumers at risk, such as making claims to prevent or cure serious diseases such as cancer or alzheimer's disease. the proliferation of such products may deter customers from getting medical treatment

for serious illnesses. there can be drug interactions, sleepiness that could impair driving and potential liver injury. there are many unanswered questions about the safety and quality of products containing cbd. and the agency has made it a priority to address questions including the safety of 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, and by the elderly. to address these gaps, fda is in the process of systematically 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 in hemp. to close, fda understands the broad interest in making these compounds more available to the public and is considering the 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 new information about their safety and effectiveness. it is critical that we continue to do what we can to support quality science needed to develop new products from cannabis. with that, i thank you and i look forward to 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. >> thank you. chairwoman eshoo, ranking member burgess, and members of the committee, on behalf of administrator dillon and the 9,000 men and women of the drug enforcement administration, i appreciate the ability to be here today to discuss dea's regulatory requirements for those who perform research with schedule one controlled substances including marijuana. much like our partners at hhs, the department of justice, and dea fully support research into

the effects of marijuana and the potential medical utility of its component parts. the procedures for evaluating an application for registration by statute is an interagency process. the food and drug administration conducts a review of the qualifications and competency of the researcher as well as the merits of the scientific protocol. dea is charged 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 research protocol and has 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. first, in december 2015, dea executed a change intended to

ease the requirements to modify existing registrations in order to conduct research with cannabidiol or cbd. which at the time was being investigated to treat children with certain epileptic disorders. i think this action contributed to the 2018 approval. in august 2016, the department of justice and dea took steps to increase the number of entities registered under the controlled 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 federal agencies continues to be engaged in a policy review process. in august 2019, dea published a list of the 33 entities who have applied for registration and whose applications remain pending to grow marijuana pursuant 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 its development and implementation of an online portal for researchers to safely and securely submit their research protocol, curriculum vitae, and institutional approval. materials required by dea regulations to be submitted for fda and dea review. this online portal has streamlined the process and improved the amount of time for obtaining a schedule one research registration. 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. finally, two months ago, dea increased its quota for marijuana which was based on our close collaboration with nida, who provides high-quality

marijuana to nih and non-nih researchers. the quota represents 575% increase since 2017. i believe these efforts are working. today dea has 70% of researchers providing research with marijuana or its constituent parts, making it far and away the most researched schedule one controlled substance in the united states. 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. unfortunately, this perception has translated into a false narrative that dea does not support research. i'm here today to tell you that this is simply not true. this belief has hampered efforts to pass practical common sense legislation aimed at addressing the over 30,000 overdose deaths

in the united states from fentanyl and fentanyl-related substances. in just 23 days, dea's temporary scheduling action which placed schedule one controls on substances chemically similar to fentanyl will expire unless congress acts. dea and the department of justice have worked with hhs to put forth a proposal that addresses this public health emergency while improving access for research. on behalf of the department of justice, i urge the committee to take up this important legislation. in conclusion, dea is fully committed to supporting research with schedule one controlled substances. we will continue to work with our partners within the administration to find common sense approaches, to approve and 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 but the testimony of the witnesses. we're going to move to members' questions now.

and i recognize myself for five minutes. i'd like to ask a few foundational questions of the panel, and i think that the following can be answered with a simple yes or no. is more medical research needed on the therapeutic effects? and the health consequences of cannabis? >> yes. >> yes. >> is the cannabis from the university of mississippi which is the only approved cannabis for federal research adequate for medical research? >> no. >> no. >> we would like additional sources. but we also recognize that importation is allowed in certain circumstances. >> should legitimate researchers be able to access a wider array of cannabis products for their research? >> yes. >> it would help drug development. >> yes. >> okay.

have there been, in your view, real-life consequences to researchers not being able to conduct research on a variety of cannabis products? >> yes. >> product development has been slowed. >> so there has been an effect because of that? >> mm-hm. >> i don't disagree with my colleagues. >> i know at one point we have not discussed enough which is has been our ability to actually recognize when problems may be particularly harmful. so that's another aspect of the limitations. >> 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 respectively. so how can cannabis be schedule

one and considered to have no accepted medical use -- because that's part of schedule one -- but both of its major active ingredients can be considered to have medical use? >> i defer to my colleague at the fda for answers to that. >> sure. >> separately those two compounds are safe enough for intended uses and so meet the statutory standard for accepted medical use. >> how do you pull them out and separate them? >> that's what the drug development process is meant to encourage. is to have people -- >> so if fda decides to pull those out to be applied to and used and be part of a certain drug, you just automatically vanish -- schedule one vanishes as a result of that? >> when congress defined what the schedules were to be, they

said there were tests to be applied for whether you had accepted medical use. and there are five that we'd be happy to talk through in greater detail offline. and when you apply those tests to marijuana, at least when the fda and nida have applied those tests to marijuana three times in the recent 20 years or so, our conclusion, our recommendation to the dea is that it did not meet the test for accepted medical use. most has to do with whether there's a value for the product and whether you can describe it. >> does the fda have all that it needs to regulate cbd products for consumer safety? >> i believe we do. >> are you sure? >> when i talk to drug developer that is come in and talk to me, they say we're interested in

studying a compound found in cannabis whether it's cbd or whatever 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 would treat any other drug in development. except i'm going to give you adishal resources in the form -- >> good. i still have more questions. now, the fda has estimated that it will take three to five years to complete rule making in relation to cbd products. is this still accurate? >> we understand the interest that people have. it's unfortunately it's not a yes or no question. we know that there is interest in moving quickly. we understand that three to five years is longer than people would like. >> what's the estimate today? >> we're looking at a full range of options including -- we're interested in -- >> you don't want to tell me. it seems to me that maybe three to five is still in place, but you don't want to say so. in your testimony you say the

fda knows of cbd products that may not contain the amount of cbd indicated on the label or may contain other potentially dangerous compounds. has the fda issued any labeling requirements for cbd? my time is -- but you can answer. >> the labeling requirements would be imposed on the approved drug. epodilex. that product is well 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 unapproved products that have been marketed in the states. >> thank you. well, my time is expired. and i recognize the ranking member now for his five minutes of questions. >> thank you, madam chair. i wanted to stay with you on the epodilex question. when i look at my drug discount app, it's like $1,300 a month for a therapeutic course of

that. so somebody that didn't have $1300, could they just go buy cbd oil and supplement it? >> we always recommend you use an approved product for a number of really good reasons. but what we learned when we did 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 condition. >> just along the lines of the time frame the chairwoman asked about 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? so three to five years actually sounds like you're moving with great dispatch. would that be a fair statement?

>> the three to five years comes from our general experience with rule making rather than any specific -- >> so it isn't research? >> how long it is related to drug development or 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 schedule of a drug without being prompted by congress? >> oh, absolutely yes. we initiate scheduling actions with some frequency. it could come through a petition received from a public citizen. it could come as a direct result of approval of a new drug. >> would that not come through the fda though? >> yes. in that circumstance, yes. >> it would. so, you couldn't just do that and say we're going to change the schedule of this on an administrative basis. >> the agency 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 we are given by our colleagues over at hhs. >> i don't know if that's inappropriate. being tethered to science can be a good thing. you had in your written testimony about risk of addiction with marijuana. is that a real thing? >> it is a real thing, and it is thc, the active ingredient responsible for the addictiveness of marijuana, and the plants contain higher and higher thc. >> is marijuana a gateway drug. some people call it that. is it a fair statement? >> it decreases the likelihood that you are sensitive to the effects of other drugs and that's why it has been coined the term of a gateway drug. it makes you more sensitive. >> yesterday we spent a full hearing in the oversight

investigations on the scourge of opioid addiction, we do worry we go too far in one direction or another year, and ten years from now we will be having a hearing perhaps we have gone too far with what we did with liberalizing marijuana laws. but let me just ask you this, you also mentioned the national highway traffic safety administration, the effects of driving under the influence. are traffic laws and state partners, have they kept up with all of the changes in marijuana policy that have occurred across the country? >> no. one of the major challenges in doing so is that it is very difficult to quantify whether someone is intoxicated with marijuana or not. with alcohol you actually measure the alcohol content in plasma, but that measure does not guarantee for marijuana that you are under the influence of the drug or not. so, you can have very high levels of taking it three days ago for a regular user.

>> so you can't really quall tate it to the degree of behavioral disruption that may occur. >> that is much harder to do. >> and as a consequence for our law enforcement partners and our partners at the state that are writing state traffic law, that becomes the difficulty, is that correct? >> correct. and that's an area that we're inclined to bring up new strategies to identify the intoxication with marijuana. >> as a practical matter, that happened in my district, a pedestrian who was struck by an automobile, the driver of the automobile had under the 0.8 limit in their blood alcohol but also had a positive quantitative test for thc. the individual is no billed by the grand jury -- i don't know whether that was right or wrong. but it seems to me that the potential for the additive effects should be something that law enforcement would bear in mind when deciding whether or not to bring a case like that. it was clearly a very tragic situation, young high school athlete who got hit. so it was a high profile case in the community and something i will never forget. thank you, madam chair, i yield

back. >> the gentleman yields back. it's a pleasure to recognize the gentle woman from california, ms. mastsui for her five minutes of question. >> thank you very much, madam chair, and i really appreciate the hearing we're having today. this issue needs to be examined and thank you very much for witnesses for being here today. at the university of california, researchers are doing important work to study the health effects of public safety and the environmental impacts of marijuana. i'd like to discuss 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 in california, to sell at local dispensary, under current law, researchers must obtain their study samples from a contracted site in mississippi. in order to study what the public is purchasing at dispensaries, uc researchers have applied for a license to

cultivate cannabis locally. however these researchers have not heard back from the doj and the dea as of the status of the applications. mr. strait, where is the department of justice, and its process of granting or denying applications that researchers have put forth at a university to study to cultivate cannabis at the university. >> as i said in my opening, we certainly support all research endeavors. one of the challenges we see that often leads to this misperception about delays on the dea side is we look for a complete application before we forward that application to our colleagues at the department of health and human services. so, there's three things that we need. we need a protocol which most researchers if they're federally funded or even state funded have. >> yes. >> a cv for the researcher, which every researcher 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 state system with their university has not met or reviewed the application. >> i know the university of california, i think they're pretty good about doing this. so, we would 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 agency's position on the current status of cbd? is there a distinction between marijuana-derived cbd and hemp or synthetically derived cbd when it comes to regulating these products? >> from our perspective, we're interesting on understanding

what are the effect was chemical compound that goes by the name of cbd. with respect from a pharmacological actions, the potential of negative effects and the potential of therapeutic actions. so, for us, the molecule is the one that is of interest. at the same time, though, we are doing research to try to investigate how when it's mixed with other cannabinoids, that maybe influence its effects. >> dr. throckmorton, do you agree? >> yes, one of the things that happened in the results of the farm bill was that cannabidiol was removed from the controlled substances act and in some sense that allows us to encourage its conduct of studies and things using it, without interacting with -- >> it opens it up. >> we believe that's a powerful, potentially powerful in terms of getting new studies done. >> mr. strait? >> and dr. throckmorton is 100% correct.

i think the passage of the farm bill created a little bit of a question mark as to the legal status of synthetic cbd versus that derived from natural sources. very clearly, that which is derived from natural sources, if it contains less than 0.3% thc, it is no longer controlled under the csa. >> dr. throckmorton, if a researcher wants to conduct clinical cannabis research that may lead to a new drug, what requirements need to be fulfilled at the fda? >> 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. one arrow, the farm bill compliant cannabidiol, and other compounds extracted from hemp,

we view as subject to the food drug and cosmetics act. they are able to be used for investigational use, come in and talk to us, we will treat you as we would treat any other drug substance for study. if it's high thc cannabis, then that still applies. but in addition weld want to make sure they work with the dea because there are other requirements under those circumstances. >> okay, fine. thank you and i have gone over my time. i yield back. >> the gentlewoman yields back. mr. strait, would you respond, after you get back to your agency, with congresswoman matsui on university of 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 a ruckus but i'll stand with my statement. representing the greatest private university in the world. stanford.

it's now a pleasure to recognize the gentleman from michigan, mr. upton, for his questions. >> you're just lucky pete olsen isn't here this morning, but i don't have my jersey. thank you, madame chair for this hearing. i do have a couple of questions. dr. throckmorton, you mentioned that the drugs approved two others in addition to, that what are the illnesses or the conditions that they were approved for. >> epodilex is approved 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 syringe basically. the other compounds are all synthetic. they're not extracted from the cannabis plant and they're

approved for wasting diseases, they're nausea and vomiting associated with chemotherapeutics. we can get you a full list of those. but it is more general. those compounds contain thc, so they have a different active granite than the epidiolex does. >> as consumers, 33 states now, have approved medical uses, 11 states -- michigan is one that's both medical as well as recreational for adult use. and i guess consumers are interested in how much is in here. we know when we drink a beer different alcohol content, whether it's a craft beer, maub maybe a state has a smaller threshold like utah. in addition you've got the law enforcement issues. i was with one of my sheriffs last week. unfortunately we had a situation

like dr. burgess with a student returning back to michigan state and sadly he was involved in a terrible auto accident and in fact afterwards -- he survived, but they found out that he had a high level of thc as i understand it. where are we in terms of some visible standards, or some review that folks can look at, as it relates to the cookie, or the brownies or whatever it is, the cereal, that they're going to eat and consume as it relates to perhaps the safety of that, and where are we as it relates to law enforcement who, it's not like the breathalyzer. they've got to do a variety of different cognitive exercises to try and determine whether or not that individual's taken too much in a blood sample. but where are we in terms of trying to help the consumer know the right information if they

choose to take in these states a legal substance? it's open for all of you. >> i can speak from the research perspective. we're interested in understanding what the content of the thc is associated with the pharmacological effect, including side effects, and so 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 perspective, is to create a unit of marijuana that can be utilized consistently across research to help us understand how exposure to different content thc -- >> and how long, when is that study, when is that research going to be completed? >> the research on those have been done, the research on creating a unit of thc that can be used consistently is

something we're working on to try to consolidate and what is the effect of the differences and what are the consumptions -- >> are we a year out? how long do you think that would take? >> i would hope that we could implement a standard dose for research doses for research purposes within 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 doses and you mentioned for the cookies but that varies also between 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 like cbd.

so as the fda thinks about how to develop those products, one thing we remember is that there would be requirements on products that we approved. regarding accurate labeling. regarding dosing. 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 cookie, along with that packaging, would come labeling, it would say it contains ten milligrams or 100 milligrams or whatever else, it could include other conditions of use that could help understand when it would appropriately be used and things like that, so part and parcel with the work we're doing is to think about the consequences, the important consequences which would include that kind of labelling. 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 authority for that labeling now? >> it is absolutely, we have that authority, what we need is to determine the pathways to take for those non-cbd, those non-drug containing cbd products. >> yield back.

>> the gentleman yields back. it's a pleasure to recognize the 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 cannabis products available through 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 public health challenge as it impedes the ability for researchers to truly understand the impact of products regularly used by consumers and prevents from advancing sound science. so doctor, you noted in your testimony that having only a single domestic source of research cannabis limits the diversity of product, and formulations available to

researchers, and slows the development of cannabis-based medications. so, let me ask yes or no, dr. volkow, 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. >> and mr. strait, as you mentioned in your testimony, dea is actively working to consider applications for additional cannabis growers. what's the status -- this is not yes or no -- what's the status of this effort, and what can we expect that the agencies would finalize the rule making? >> so we actually have a draft regulation in place. in august of 2019, we were able 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. it was on august 27th, 2019. we know that we have to probably do notice and comment rule making to implement regulations on two matters. one is how we're going to evaluate all of our pending applications, and then, two, what additional types of regulations might need to be in place in order to -- you know, in order to impose on those that would grow. so that regulation is in the draft form. i can't talk too much about it, but rest assured we have submitted to omb. it's 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. however fda has suggested it could take three to five 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 the safety of cbd and other products such as fad and dietary supplements? >> sure. and i want to start by saying that three to five years was an estimate that we understand the 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, as i mentioned in my opening remarks, exists, and for the agency to change, we need to find a mechanism to allow a path forward for nondrug cbd products to be developed. we're in the process of doing that. the rule making is one thing that's under consideration. as has been mentioned, there have a number of legislative 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. but we need to be grounded in science. you mentioned yourself, many of us have mentioned, fundamentally, there are many 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 more about. we need to know more about its uses in vulnerable populations,

and for long periods of time because if it's placed in a non-drug product, there won't be a learned intermediary. there won't be a doctor or nurse or anyone that will talk to the patient about their use of the drug in the morning. you can get up in the morning, take your cbd, to get started, in your coffee, take another dose of cbd for lunch, when you have your sandwich, and then end in the late afternoon with an alcoholic beverage containing cbd. and the aggregate amounts of cbd then matter. we need to decide how to do that 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 help inform what the right, best steps are. >> thank you. thank you, madam chair.

>> 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? >> that's correct. focused i believe in the nondrug space. >> so you have the money and now you've got to get it going. it's a pleasure to recognize mr. guthrie for his five minutes of questioning, the gentleman from kentucky. >> thank you very much. thank you for being here. and doctor, we've heard ha it can take up to a year to get a schedule one registration, that process of adding new cannabinoids to existing registration, getting approval for modifications is time consuming. and how does the dea registration processes for modifying a schedule one registration to conduct research 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 or recommendations included in the committee's staff report on opioid distribution. to date we have not received the dea's response, and i would ask that after the hearing that we follow up together if to see if we can get dea's responses. >> i would be happy to follow up with that. >> thank you, sir. getting to the question, and you said it was 52 days to get registration. it seems we're hearing different than 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 schedule one, that's 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's complex. and another issue that makes it harder is that the dea state local agents interprets it 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 also seeing an impact on schedule one is that there are certain scientists that don't even want to go there because they say i don't want to even bother. it is going to take too much effort to do research on a scale, and we lose potentially valuable science into looking at things that are important. >> do you have any comment on that? >> yes, thank you. thank you for giving me the opportunity. this is a common refrain we've heard from our partners over at hhs. 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 dea, but we are kind of cited with pii, that they can't disclose information us to, that they're prohibited from doing it. so, we struggle to try to understand who the people are that are having these 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 make is the inconsistent applicability of our dea regulations across our 23 field divisions or the concerns of that. as i mentioned to some staff before we started this call, we're actually getting ready to host a management conference across our entire decision, from all across the country and we're going to invite dr. volkow or her designee 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. griffin. >> thank you very much. virginia actually has the oldest medicinal marijuana law on the books passed in 1979 when chip woodrough, now deceased as the house patron, and former member of this committee, rick boucher, the senate companion, saying they would allow the medicinal use of marijuana in the commonwealth of virginia. however, the dea hadn't allow ed it and the doctors didn't want to risk their license by prescribing it, 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 it was like california's law, if 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 three to five years, we have to 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 opioids and opiates and barbiturates but somehow marijuana should stay schedule one. that is illogical to me. marijua shouldn't be barbecue its, and i lay that out. >> he's the problem is they could not swallow it that's why their friends are smuggling it in doctors are turning a black eye. so they can smoke it and that is not, so we need a solution will, should start to work on this back in 1979 or earlier but we haven't done. it >> back to you the gentleman yield back. >> pleasure to recognize the gentlewoman from florida for her five minutes. >> thank you madam chair for calling this hearing, thank you

to the witnesses for being here today, i think cannabis research has caught up in collecting regulations and you cannot remove the schedule one because and it's a medical formula use, you cannot research to determine to say whether it's included in schedule one, doctor you and your testimonies by saying that campus resurging urgently needed so let's see how we can streamline the process? >> and possibly other schedule one substances. >> first what are the requirement for conducting researchers? >> the main difference relate to the fact that you have to get to the da registration. that can take time, that deters

research on the substance. in thinking about how league would use those, from researchers, and possibly other schedule one substances and, if you are a few of the various what do you recommend, should change in the process and where. now >> we've been working among the agency of trying to come up, susan felicitated and accelerate the research. so coming up, with integrity through enable researchers to be able to accelerate this any doing research without in any way jeopardizing in it that the da the fda and their work here together. >> and number of bills have been highlighted area that the prime unity this consideration

today who would you point to those? >> reporting you are what we are seeing in a little awkward position because there are six of them, will basically bring science, what i can tell is that the science, tell us marijuana is a substance of addiction, we also know the history that it's likely, one of the hannah base, and their marijuana some of the six was among the acts, that can accelerate research, that is that that's why it. i'm. we have. to weigh. . >> so kate has at the a the number of patients from research products, low thc, cannabis products, and there are not considered a schedule one substances?

>> thank you for the questions, short answer is yes. >> you support removing problems, removing's marijuana from controlled substance? pressure >> at the president my, focuses on grenoble island, a slime supporting those new investigational studies that we have seen requests. your first question your just is it worth, we are going back in just a moment, we now have almost 40 years we will be different researchers. we believe there is the opportunity for us in terms of investigating in cbp and the compound, jockey backroom, and to make sure they are given every opportunity every support that we possibly can, the question about marijuana is more complicated it depends on what we mean by marijuana.

>> so it's a different kind of canary want to making a coalition, those marijuana, somehow has to medical blood all you, it's a challenge scientifically. that's one of the findings that in, we are obliged to make. more we will try to make recommendations to the dea to marry schedules. so marijuana from schedule one final scientific schedule, they're sneaking a challenge, and we have to look at it, and each time we have decided as i have mentioned before it was not possible putin where we worked comes with the side. >> it's like the cat is already out of bag it's amazing fisa public about marketing for the cbd what would you advise the public about the efficacy of the products on the market today? do they really help? do we even have a handle on what is truly in all of those

products? >> those questions we do not know. don't know we do not know whether various claims he believes, to the standards that i would expect horse drop products don't, and we don't know well enough, what products are being sold, under a variety of state, initiated, we need more data in both of these claims the regards to advocacy and my job is to make sure those manufacturers around 40 that want to study this they can do it quickly study and quickly and the agency understand we that's what we need to collect all the information on the safety in order areas of uses, that's a challenge for us, we are in the process of an effort to collect all those available data, we've identified some gaps, i think i

mentioned some in mind testimony previously, things we believe we absolutely need to know. we're in the process of figuring out how to close those >> gaps. >> > the gentlewoman's time has expired. on i recognize mr. griffith. i'm looking for another good story. >> i have lots of stories, but we may not have time. mr. strait, i know you disagreed with the earlier assessment on the university of california. having attended the great university of virginia tech, which i'm proud to represent. going back to dr. >> burgess's question. is the d.e.a. required to comply with that rescheduling recommendation? >> if he recommended rescheduling, we are bound to their it's the

statute actually says that the attorney general shall be bound by the recommendation of the secretary, as it pertains to scientific and medical matters. >> as the secretary determines? >> correct. >> so you can confirm that the d.e.a. has never refused to schedule a compound after being given a recommendations from the fda or the secretary? >> i'm certainly not aware of any occasion where that would be the indication. >> > the single convention on floor cottic drugs which imposes manufacturing and distributing restrictions on marijuana, some have cited our involvement in that agreement as a potential reason why the federal government should not lift restrictions on marijuana. regarding american domestic manufacturing, research-grate cannabis, why is it that other countries such as canada, israel, ireland, new zealand, australia and the netherlands have several legal manufacturers of research-grade cannabis and their products are legally, and the u.s. has only one, the university of

mississippi, as we heard earlier. >> you're precisely right. there's a growing number of countries that have implemented law in their countries that fully effectuate their requirement, under the single convention on narcotic drugs. we have, too. that's the reason why we have the university of mississippi or this drug supply program. what we're trying to do, as we expand the number of grow respect, we're trying to take a look at whether or not there are things that need thob changed, altered, i would say not newly created, but just altered slightly, in order to make sure we are in compliance with our treaty obligation. >> i hope you you work on that quickly. you said applications for research are being approved, but you said regulations and paperwork democrat i'm paraphrasing are perceived to

be so onerous that people won't do it. connect the dots. the paperwork and the regulations, the perception becomes reality, as we have heard from dr. volkow, sometimes that becomes a problem. i think that's why you haven't received more applications. you want to say something on that point? i just have a couple minutes. >> i did want to go back to your comment and that of congresswoman kastcastor's, as it relates to some important legislation dealing with the permanent control of fercht independent related substances, we as an administration came out with some common-sense, practice solutions to address all of the concerns raised by the research community. we're happy to share that. >> if you could share that and whatever help you need

from us, i think this committee would be willing to help. the d.e.a.'s 2016 policy statement said it would be consistent with the treaty if the d.e.a. were to religion sister research-grade marijuana growers outside the system, as long as the growers agreed to only distribute marijuana with prior written approval from the d.e.a., but you say d.e.a. has changed course saying that since publication of the 2016 policy statement, the department of justice determined that adjustments to the d.e.a.'s policies and procedures may be necessary to be consistent with certainly treaty functions. what changes need to be made? >> i can't get into too many details. again its a deliberative process that we are engaged in right flow. >> can you get that to me as quickly as you can. >> i can.

>> i appreciate if you would give it to the committee and me as well, i would appreciate it. can you produce in additional rats natural beyond the volume of the applicant pool? >> i'm sorry, can you repeat that? >> can you provide any additional rationale that would mandate d.e.a. to reevaluate the 2016 policy statement beyond the volume of the applicant pool? >> i would say the size of the applicant pool is probably the single greatest issue we're trying to contend with. how to meet the statutory text of the basis on which we're supposed to be evaluating the applications. >> we can change that statutory test if need be. i yield >> back, thank you, chair. >> > the chair recognizes mr. sarbanes for his questions. >> thank you, madam chair. i thank the panel for being here today. dr. volkow, first of all, thank for you your work, which i know well, and you've brought a lot of important testimony to this committee in the past. i've heard from schools in my state such as the university of maryland in baltimore, that have communicated the difficulty in conducting research due to the current regulations and are nervous that any unintended violation could restrict in loss of their

federal research grants. obviously we've had a lot of discussion about that here today despite these, just last year, the university of maryland's school of pharmacies started to offer they now have this degree and focus opportunity. i have a her here, madam chair. i would like to submit this for the report, from the university of maryland. i would ask that this be accepted into the report. dr. volkow, as more patients are accessing cannabis in states where they've been legalized, that the provider >> workforce should be educated, and able to respond to questions? >> i agree we need much more education with respect to actually how and actively impact or help someone, the problem is that we do not have sufficient evidence that could helped us mount the programs in a way that actually would be required. at this point i don't feel like the

evidence like the national academy of science concluded, is sufficient to say we're going to recommend this product by used there are many concerns, and it's not trivial. one of the problems that was noted is many patients, for example that elderly may be given some of these products. they're on other medication, and the total effects of the combination of thc with these pled indications, and the clinicians don't even know about it, nor do the patients. i do believe in the

important of expanding or knowledge so that we can then develop educational training programs that are based on knowledge, not on adeck dotenecdote. >> i think you're highlighting the impediment to creating workforce categories that can be a resource of expertise and perspective when it comes to cannabis, that is presented by the kind of research issue that we're

talking about today, because 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 workforce and help push it forward and sustained it is made more complicated. i note that a survey of health providers from 2015 concluded at the health providers themselves perceive a knowledge gap related to cannabis, dosing, development of therapeutic treatment plans, differences between various cannabis products and other areas. so the providers themselves have

certainly perceived the need for more research and expertise to be developed i assume you would great that incentivizing medical research on cannabis, for starters, would help bridge these knowledge gaps. >> i think we have an obligation to do the research to determine what are the consequences of the products that people are taking, with the expectation that they're going to be beneficial? we owe that to

them. i completely support the further research in diverse populations. >> thank you. i yield back. >> > the gentleman yields back. the chair recognizes it is gentleman >> oh, the gentleman from oregon, senator walden. >> thank you. i snuck back in from the other hearing. i know how important this is. mr. strait, i want to switch gear to say hemp. there's a lot of interesting from my district, for growing cbs, and they're working with the ag research service. given that the 2018 farm bill rue vived hemp, is a d.e.a. registrations required to conduct research on hemp-derived cbd? >> no. >> no. relatedly, the final 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 the u.s. department of agriculture no pun intended. sorry about that. >> there you go. >> was predicated on the content that those performed testing probably made reasonable sense in the event that they ended up procuring a sample that was not hemp, it actually ended up being hot and contained more than 0.3% thc. that's an interim final rule. i know they're soliciting comments on that, and i know that that's an issue of concern that's been raised by some in the public. >> there are quite a few of these issues. i notice somebody who had a commercial driver's license using cbd oil to deal with something, or taking it, then did a drug test, and it triggered the drug test as if he had used marijuana, which of course affected his cdl. these are issues we're running into real life. he wasn't a marijuana user, he tried cbd. dr. throckmorton, when can tums to cbd, can you tell you if fda is close tore determining appropriate regulatory rules in the work as supplements, and is

>> the lack of research on the substance been an impediment to that process? >> i can tell you that process is a high priority for us. we understand the interested. as i said before, we're committed with working with you to find a path forward on that. i would also say the lack the information we have about the safety regarding cannabiadol is a challenge for us that we're looking to fill, in order for us to decide how so place it best in non-drug products. >> i want to push a little in terms of embedments in getting answers. this is plays owl in real life. i have friends who swear by cbd. i have friends whose doctors have said don't worry, take it, it doesn't impact anything else. do they know that? have you done the research? >> in fact, we know that's likely not accurate. based on what we know from the approval of the product that contains cannabiadol. it does interact with other drugs. in fact, there are interactions that could occur that could be clinically significant. i think blood thinners are one, for instance. >> yes. >> we would

want to make sure that information is available to people. >> let me suggest they don't know that's available. they're actually being told by medical providers, at least this one case i know, that don't worry, there's no interaction, and this is legitimate doctor telling a patient. this is happening in real life. i've got colleagues that have been on television proclaiming the importance of cbd in food products and drinks and consuming it. fine, that's up to them, but i don't think if people use it, that's their business. i got it, but i just want people to have the facts and data. we're trying to figure out what are the embedments to getting that data and what does it take to get the agencies to a point where

you're leading, not way trailing. the states are way ahead of where we are federally. >> we've been fortunate to work with the states. you're right. the states are further ahead in some ways, because they've had to be. you've had to face the use of these products in your own jurisdictions. the states have been have had interested in understanding the same things. the state public health officials get that we need to understand the safe use, and then make it, educate the prescribers, educate the choices they're making very quickly. unfortunately, historically marijuana was used for the thc content. it's only been recently that the cultivars containing large amounts of cbd have come to the fore. historically the research

has been in another direction. >> i understand that. if you can't get me that list, is it on the fda website? >> absolutely. >> please do. thank you, and thanks for your indulgence, madam chair and i yield back. >> > i think it's terrific that we have our next member, the gentleman another gentleman from oregon, so we have a set >> of bookend, mr. shrader for his five minutes of questions. >> thank you very much, madam chair. i think it's great that we have all three witnesses agreeing we need medical research into the effects of the hemp or cbd or

marijuana products. the sad part is we're not testing the right stuff. i fail to understand, with all due respect why we have one bloody facility in an artificial environment >> in mississippi is really the sole nexus for research and analysis of cbd products. can you explain why that is? >> so that location is actually probably better asked of dr. volkow. it's pursuant to a contract administered by the national institutes of health. >> if i can't briefly interrupt, it seems to me we ought to be testing the products that are on the marketplace. that's where fda, d.e.a. you are most concerned. what is the consumer? what is the american citizen actually being exposed to or hopefully benefiting from? the idea we're using a specific

facility that does not mirror what people are actually ingesting, smoking, whatever, is ludicrous. i'm worried, you're talking about more regulations, we should be making less regulations and say there's a legally approve facility in the state of oregon, colorado, district of columbia, those are things that people will actually be exposed to. we approve that research for that facility. why are we not doing that? >> i can't agree more in what you're saying. that is certainly a conversation we've

been having internally. the challenge, of course, so that the underlying principles of the csa, the controlled substances act, require that people who are going to lawfully possess, distribute, conduct research with schedule i controlled substances, have to procure those substances from a valid source. that valid source at this point it is another d.e.a. registered >> valid source in the eyes of the federal government. >> correct. >> is this is whatever. i'm arguing, respectfully, that the committee should be looking at legislation, if need be i don't think we need legislation, but something that the agencies can say, there's all these approved facilities out there in these states. we are not adjudicating whether or not it's a controlled substance, they are here being used for certain products that consumers are being exposed to, we need to investigate them and make sure they're not affecting adlessants adseriously, fetal development, male fertility, and get it tout will. my colleague from oregon talked about benefits. i have a farmer in the state of oregon, a farm that is very conservative by nature. they had a father that was ailing, pain relief was not getting done, they turned to cbds, their father was able to

communicate for the first time, at least with them, and he had a productive quality of life to the very end. these are the products we need to be getting engaged in. talk to me, mr. strait, a bit about approvals byabout pharmaceutical research. how come some get through and not other products? >> i'm not familiar with those two companies in particular, but there are instances where pharmaceutical companies can be manufacturing flu synthetic means, some of these substances, then making those substances available for research purposes. >> it concerns me you're not aware of those being approved by d.e.a. i would like to get more information after the hearing on that. there's an apparent tedancy to approve more foreign do mesit

applications than domestic. we have, what, 12, 15 applications pending, but there this long exhaustive regulatory on process, that seemsen congruent with the products are out there now, everyone on the panel have agreed to the research. what is the holdup? >> we have the same frustration you do. >> very good. madam chair, i will yield back. i appreciate everyone as interest. we just need to move forward and test the products people are being exposed to. >> i agree 100%. i still don't understand the agencies that are before us can't get this done. we'll keep questioning, and the next >> one to question is the gentleman from indiana. >> thank you very much. this hearing is really very important. i was a physician before i was in congress, i'm still a physician, i just don't

practice. as a doctor, data is critical. i practice medicine based on facts and data. i do support the legitimate medicinal use for thc, but our knowledge how this subject actually is very limited. and needs more research. dr. volkow, i'm going to >> along the lines of developments brain, up to what age would you say the brain continues to develop? >> the fastest growth is during the first two decades, and probably until age 24, then it slows down, but it never really goes away. >> i think people have a lot of times have a misunderstanding, actually the developing goes up substantially until your mid 20s. you've presented this, but we a know thc can have damaging effect. the fact the studies that you conducted, the national institute of drug abuse show a direct correlation

between persistent cannabis use and cognitive decline. epps deem lodge sick studies have further found that youth who regularly use cannabis have lower academic achievements and higher risk of drop out of the school. frequent use during adolescence, and madam chaimwork i have a slide deck that was presented a number of years ago. i would like to introduce that into the record. >> so ordered. >> it outlines some of the things you've been talking about today. additionally, this is where i'm going to focus my question. nida recently put on the 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

teenager, in the united states 40% of the teenagers have vaped in their lives. despite the fact that this is a new technology. three years ago most of the vaping was related to flavors. three years ago most of the vaping was related to nicotine. while we saw last december is there was a significant doubling of the number of teenager vaping for thc. considering that vaping thc delivers a very high content of thc, this is worrisome. as you know, injuries from the accuse injuries have predominantly associated with vaping of the trc. this is concerning, and we are seeing also significant increases from in the past two years, or on the regular use of cannabis, which we think are driving in part by the vaping, so it's affecting the pattern of use of among teenagers. >> so then along those lines, are researcher able to conduct federal and vaped liquids sold at vape shops and states that have legalized marijuana for recreational use, and if they can't, why not? >> the researchers are afraid that if

they used funds to purchase products that are illicit by buying them in dispensaries, they will lose their funding. as a result of that, overall research is not done by investigators that are being funded through the nih, which is a federal agency. >> base on what you just talk about, would you say that we need to do something about that? >> i would completely agree. we need though investigate what citizens are being exposed to. >> i think it confirms what all of us have been saying. i'm concerned that the law enforcement is not equipped to deal with these cases. >> a young lady was sledding, and the person who 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, there's obviously no reliable

test. for that i introduced hr-3890 in 2019 to direct the department of transcription to provide funding for grants and pilot programs to address impaired driving. dr. volkow, according to your organization, illicit drugs is the most frequently and in your testimony you described the risk of being involved in a crash significantly increases after cannabis use, do you agree we need more funding to provide advanced measuring testing for cannabis impaired driving? >> as i mentioned before, the problem we have contend in alcohol, you know a center level is associated with

certain experiment. if you are regular marijuana user, you may have high levels and even if you are not intoxicate intoxicated. so to actually incentivize, determining whether someone is intoxicated or not. >> my time is expired. that again outlines why we need more >> research. >> i think of anything that comes out of this

hearing is the research is essential, absolutely. there is so much of this is two and two equals five. well, it does not. the gentleman from massachusetts, mr. kennedy is recognized for five minutes. i want to say how much i appreciate the input he gave the chair and we will as he said earlier have a follow-up hearing with other state holders and important to start out with our three government agencies, i think that our subcommittee will benefit from the additional testimony of others. he's recognized for five minutes of questioning. >> thank you, >> madame chair. thank you for adding the weight behind this conversation. as some of you know i was hesitant to support legalization. my concerns stem from my work of the health community. many advocates told me they worried about the impact of increase control of the substance. i try to understand how to protect the public health concern is. i talk to experts, i talked to advocates and regulators and some of you. that's where i get frustrated. our federal policies are still rested on nixon's putting marijuana on the same category of heroine. when i ask regulators and

agencies how we can make sure this drug like all drugs subjected to the highest safety standards, i was told we could not until we have more research. i asked, how do we get more research? how do we do that? well, we need more research. meanwhile, millions of americans, mostly black and brown have been locked up. desperate parents are forced to turn to a black market with no concerns of their safety to get their children what they need. our cities and states are trying to put in place of a framework of zero support from our federal partners. a brand new corporate industry is rising up, economic injustices and bringing up whatever the government fails to regulate. expand critical research and i think this bill appears policy on the table today, makes it to restore. the witnesses today, i understand and appreciate the

details approach that you outlined. i commend and share with the public health safety. it is clear that we are also out of town. states are not waiting anymore and the long path and little research is not enough. the federal government wants to be active and honest and stake holders in their policy. so, in your testimony, you pointed to restriction imposed by research. dr. vokkow, you indicated and i want to make sure that i am clear in your opinion - >> what was the question? >> with those restrictions be eased in marijuana is descheduled? >> the scaling of marijuana and that's why i didn't want to comment on it, that's not specifically why we do it. we have to recognize that marijuana has harmful effects. it can be consequential. at the same time, my perspective is that that's why people say what is the policy that'll affect the public while accelerating

our opportunity to take advantage of the - that's my perspective. whether it is the schedule or not, that's not worth our agency's talk. >> with the barrier to research, the ease if marijuana was desketchde descheduled? >> if it were to be desketchcheduled, it would be easier to do research. >> well, we do not regulate marijuana, we do research >> so our agency is not involved. that'll be

transpiring to us. >> your agency would not be harmed in any way by continuing to conduct it. >> by the scaling at the same time it may have the consequences and that more people. that's again why we

bring the science and the policy decisions of the optimal way like the ones fda has. i understand the balance tonight

and i appreciate that and we are all trying to strike today. does the role of your agency change if marijuana is >> descheduled? >> no. >> it would matter how it happens obviously. drugs containing compound of marijuana, going through the control substances act and as well as the food and drugs kos et cosmetics act, or maintained, it would not have an impact. >> i assume the answer for you yes, it would change. >> yes. >> since our obligation is to control the substance. >> >> i understood. >> recognizing the gentleman from florida for his five minutes. >> thank you, i thank you the witnesses for testifying today. it has been informative. i was telecommunications for a while. i am back now. dr. volkow, did you think the process for conducting research on schedule one substances coupled with the limitations on the supplier research grace cannabis discouraged some researchers investing the compound. >> yes. >> a couple of questions here. would you agree that scientists studying cannabis and its effect either bad or good is a

final, legalizing or discussing medical or recreational cannabis. >> absolutely. just like our colleagues at hhs wants research of marijuana. >> very good. >> next question is for those particular products, are they calmingly available to clinical investigators through federal sources and if not how would that post a risk on the public health. >> i would not able to comment on the availability to the non-drug center. i focus on the drug

side. with the passage of the farm bill, hemp derive compounds, we are eager to support that any way we possibly can. we think that's an exciting new avenue to get some of the questions that we need answer. >> with the recent spate of illnesses related to the vaping product, what were some of the key take away lessons learned regarding of the federal state oversight and research of as a result of that, we didn't know how to diagnose it and we are sitting in the

medical emergency rooms. we are just assuming based on what the patients are telling us is we are enable to samples from the sources we are consuming. that's one sampleexample of why we need to understand the difference products of marijuana. we need to have evidence to show the case and we need to understand how to omtptimality dosage. >> thank

you, dr. throckmorton. patterns of use, changing year to year things like that and the ways these are being consumed and doses and populations and the perceived benefits are all changing. we as a federal architecture need to find some way to track that to understand and identify new risks as they emerge quickly and things like it. it is a challenge for all of us working in the area. >> i thank you very much and i agree. i am going to yield the rest of my time to mr. griffin. >> thank you. >> four years ago da accepted for the research grade marijuana in order to increase the diversity of products for scientists to study. as we heard earlier today da intends to propose new regulations that would govern

for scientific medical research. can we have your assurance that the dea will work to review applications to produce marijuana for federally approved scientific research and will current applicants be amended to their applications to conform to the new rule. >> and your first comment is yes, we definitely will move expeditious ly. we appreciate your patient on that. your second question. >> if you have an application pending and the rules changed and instead of having to start back at go, perceive directly to go. can they amend so they can move forward? yes or no because my time is up. >> on that point, when we announced the notice of

application in august of 2019, some of those applicants had applied two years ago, we gave them the opportunity then to get a full refund and we would do that. >> gentleman's time is expired. >> the chair now recognizes the gentlewoman from michigan, her five minutes of question. >> thank you, madame chair. i want to associate my comments today with everybody at this podium. i think it is bipartisan frustration on this issue. i think my colleague mr. kennedy probably summarized where i am very deeply. michigan is one of the states that is now a legal state of this is being traded in. i will be very blunt, i did not support it when it was on the ballot. i come from a family that has seen what drug addiction does to people. like my colleague, mr. griffin and

shrader, my husband suffered from great pain and many people said marijuana would be the only thing? would he try it? he would not try it because it was not legal. we did not know the side effects and it may have given him relief in the end. but, i was the keynote speaker at hash bash this past year. yes, you should laugh, it was my staff - i don't know how it got scheduled if you want to know the truth. i am still trying to figure that out. >> it was not scheduled one. >> i got up and said i never smoked marijuana and don't think i will ever smoke marijuana. i made the point. i talked to a lot of the scientists and there

were clear of three things that need to happen. i am committed as anybody of the need to get more research of the issue. we all ask the same question because we don't understand what the answers are or why if we all agree we need more research and we need it for automobile and i am working on legislation right now to everyone of us got a story from our districts some how or some way that there is a problem and we are in the biggest catch 22 that you can ever see and imagine. you got to help us figure out how we are going to get out of this catch 22. it is one of the reasons i introduced with my colleagues, just in case you can't tell. i am pretty passionate about it now. even though it is legal for recreational usage for michigan

state and 11 states. we just started it. the national academy of sciences done a study that found the research on the health effect of cannabis have been limited in the united states and this lack of knowledge poses a public health risk. i would like to make sure it is submitted for the record madame chair. >> so having agreed with all of my colleagues here and having the three of you already establish we got problems, can we go back and look at some of these questions that everybody keeps on asking. dr. vokow, you talked about administrative burden mandated, we keep on asking you why it takes months to navigate. we are looking for those details. how would figure signifying to improve to conduct the research? what do we need to do? why is it only one kind of marijuana that is

okay at the university of mississippi? can you give us more details and highlight why federal research is done only a single source of cannabis, how does this reliance on a single source limit understanding the health impacts. >> i wish marijuana has no effects. it would be remarkable. unfortunatelty high content thc can have advese effect. now, there is the national economy mentioning, there is evidence, it is not solely enough for fda approval that there are some benefits clinically for active ingredients of marijuana. what is one of the things that we

are proposing? again, we are not legislatures and it is the fda and the da that regulates. what we want to achieve, that allows researchers to do research with a proper revelation but expedited. that's one of the things that we have been working with our colleagues on. >> how do we keep you from working and getting it done? >> we nodeeed to actually solve the problem. i also think that we need to figure out a way to be able to also take advantage of some of our new producers of different plants in order to evaluate the diversity approach that's out there as opposed to limiting us to our mississippi farms. these are regulations. it is research

and knowledge. >> i am out of time. i have asked a lot more questions. thank you, madame chair. >> the gentlewoman yields back. pleasure to recognize the gentlewoman from indiana for her five minutes of questions. there is another hearing going on so i have been going back and forth a bit. your testimony is critically important for us. my colleagues across the isle, there is frustration because we are trying to figure out what specifically we need to be doing help to accelerate medical research, that's the top priority of this committee i believe and the purpose in having this hearing. with that and you know hearing testimony and knowing friends who have suffered from tremendous pain particularly from cancer and others, i want to focus a little bit on pain therapy, we talked a little bit about it and dr. volkow, thank you all

of you for your work. i have mixed feelings of the issues around marijuana, having long ago being a criminal defense attorney and seeing so many of my clients have substance abuse problems and many of them starting at a young age with marijuana and later working with the dea and involving in disrupting trafficking organizations and 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 is with cancer or other things where marijuana has helped them with their pain or those that end their lives as we heard their stories. we are conflicted here. we have a lot of issues around where we are trying to breakthrough and move the ball forward because it is

taking years and we just don't have answers and we are so behind. what barriers, dr. remaining at nih to study around pain and where cannabis can help with pain and even addiction therapies we are hearing. can you share with us what are the barriers around the research specifically relative to pain. >> we are aprioritizing as it relates to our research, potential value of the treatment of pain and addiction and also for hiv and anti-inflammatory. researchers are being for cbd and tlc. we would like to have more investigators involved. that's where the whole discussion had been going back and forth. many investigators don't have the structure to support what's necessary shy away because they feel it is too much of an

obstacle to try to go through a scheduled one. >> dr. volkow, will these be private investigators or university investigators? what type of kind of investigators do we need? >> we want both of them. one of the areas we are interested is actually academic investigators with industries so the products that are being developed can go into the market. we found different mechanisms to facilitate those interactions. you don't want to limit it. you want to facilitate research by the private sectors. are there any significant pieces of research that have been completed. i know you talked about 11 years or studies over the long period of time of adolescences you are following. and-what number of

years are you typically looking to research. >> it depends on what we are aiming for. to try to understand marijuana and how it effects the developing brain you need to follow it out. it will take 10 or 15 years. if you are determining what thc can have an effect of or patients suffering from low back pain, that may be a story that can complete in four years. it depends on what the aim is. how many studies are we funding now, focused specifically on pain management? >> on pain management, we are funding $39 million of cannabis therapy, i would say 35% to 40%

may be pain. i have to check but just guessing. >> any negative results that have shown in your research? >> too early to say from the ones that are ongoing. >> thank you for your work. i yield back. >> the gentlewoman yields back. pleasure to recognize the gentlewoman from illinois for her five minutes of questions, miss kelly. >> thank you to madame chair and the witnesses for being here. my state was the 11th state to aoprove adults using cannabis. i am interested to hear research. i am the chair of the congressional black caucus, i have worked with my colleagues to create legislative and policy solutions to reduce health disparities and promoting good health. dr. volkow your testimony discusses

adverse health effects of cannabis coming to adolescence >> development, are there studies that focus on the minority population? >> yes. based on the science we do know that the use of thc during pregnancy associated negative outcome for the newborn for the mother. >> it is early on in development and they guide how the brain are moving and connecting. so, it is something that needs to be taken with caution. we know that in adolescence, every single story has shown overall independently that it leads to worse educational outcomes. what we are using is sophisticated technology and larger samples who understand the back doors of one individual and the other. we have shown that in

adverse social environments have a negative effect in amplifying results into the brain. if you come from a deprived environment, your brain is going to to have a much slower development. and those circumstances draw a greater negative effect. so these are stories that are ongoing but it is clear, drug and marijuana is not a good thing for the developing brand. >> i am glad to hear that you have a more diverse sample than it sounds like you did from the beginning. you are bringing more diversity. >> absolutely, we need to understand diversity in terms of ethnic background and in terms of economic opportunities because those are influencing multiple factors on that development of a child. >>

dr. throckmorton, you mentioned the fda is learning more of the safety of cbd and cbd products. among the list is understanding the effects of cbd of special population such as elderly, children, adolescence, pregnant and lactating women >> the best data that we have available comes from the control trial, product foresee seizure disorders. it was conducted in young children. we don't have randomized control child in those population. we acknowledge. when we approve it, we posted it on the web of what we know of the demographics of response to the drugs. you can go onto what we call our drug trial snapshot page. it will

show you the safety and effectiveness of it broken down by sex, gender age and ethnicity. we need to have a lot more information to expand that to understand the impact on the elderly, for instance, pregnant and lactating women. they were not in the trial so we did not have that opportunity yet. it is something we recognize and we are working to fill as quickly as we can. >> assuming you are working to get more diversity in the trials. >> absolutely. >> i like my colleague and i go back and forth about how i feel about recreational marijuana. i don't know if that's because i went to college in the 1970s if that's the reason why. i read in the paper, chicago allowed us starting in january 1st and the paper talked about how the emergency room business have gone up because of this and even places that treat dogs, i guess careless of the edibles,

i don't know. they found more dogs are getting sick too and this seems to be like we need to educate the public more to about the effects and i don't know if it is an early over exhuberant. >> i am going to comment on that. one of the aspects that are coming back, one, it has negative effect and the ones that i am more concerned is that i affects it affects young people. as a psychiatrist, the prevalence of schizophrenia is the same across the world is 1%. so happens that's not the case. in

some places it is 6% or higher. those places are associated with a high content of thc. in the netherlands which has the highest rate of schizophrenia linked with the consumption of thc. you can have plants of 38% of thc. and this is not explained by having the genetic risks. there is something about high content thc that is triggering psychosis and we need to recognize it. >> gentlewoman's time is expired. >> thank you madame chair. and the panel being here today. we should be concerned of the lack of federal research on marijuana because when we consider a drastic change, we

must consider that policy is based on science. the focus on research is appropriate. in november, i joined with 16 other members of congress and asking attorney general barr to study the societals impacts of legal izing marijuana. as we start to see preliminary data from states like colorado or oregon, it is important to evaluate their experience before making their policies. we should continue to investigate. we should know how best to help people who need medical marijuana and how greater access to recreational marijuana will impact our communities, families and users. however, expanding access to marijuana without the benefit in guidance of the

facts and sound science is of great, grave concern. this is incredibly concerning because we have an addiction crisis in my home state of montana, methamphetamines and now opioids devastating our community. montana has worked hard to support people in fighting addiction and that's through drug treatment courts. it helps people get clean and get back on their feet while staying engaged in the community. to consider making any scheduled one drug legal and more readily available without adequate research is a misplaced priority when addiction continues to ravage our country. we should support focusing on combatting addiction. building on this community's bipartisan works and the success of the support act from last congress. we need to continue to support those who faces addiction and need to

help the most rather than making marijuana easier to access when we don't know the full effect of the communities. dr. volkow, ensuring access to mental health services is a top priority of mine. montana has the highest suicide rate in the country. i have introduced the national suicide hotline designation act which makes 988, the national suicide hotline the number. it will protect emergency access to care for those facing mental health crisis especially those in rural area who lacks access to mental health professionals. you state that serious mental illness and suicides are on the rise in our country and while multiple factors very likely contributed to this rise is imperative to understand the exposure to cannabis in adolescence is one of them. does current research draw connections between marijuana

use and increase risks for suicide or mental health problems? >> there has been some studies that have found noted increase risk of suicide among research of thc. the evidence is not that extensive associated with sigh cytosis. we can't ignore it. it is something that's noted. >> from your experience as a researcher in this area, do we fully understand the connection between marijuana and mental health and suicide? >> marijuana if you take high content of thc, the content is going to make us extremely

anxious and very afraid. that explains and one could conceive why in those circumstances, someone feeling threaten may attack someone else or attack themselves. so, in some people that results in the chronic syndrome, that's why we don't have the knowledge understanding why it is limited of short episodes and the long lasting effect. that we do not know yet. >> just to summarize, i appreciate your expert opinion. it is possible that cannabis could increase suicide rates, is that correct? >> the data has given some evidence that it may. i want to be cautious again. i think one of the issues we are being

criticized in the field of marijuana is that people say you are exaggerating, how do you know a person to start with was depressed and suicidal thinking, that puts them at risk to take marijuana, to medicate. how do you know - >> it brings us back to the fact that we have to do research. with that, i yield back. >> the gentleman yields back. recognizing miss rochester. many of my colleagues are going overtime on our time we have because there are so many questions we have. as i thought about this, it really is a multitude of issues that we are dealing with in this one hearing, both protecting and enhanceing public health providing economic opportunities and as well as public safety. i am encouraged

at the inclusion of comprehensive legislation that addressed this and some of the social justice aspect of cannabis reform. it is also a significant drain on our national economy. that's why i have introduced bipartisan legislation, the clean slate act which could seal an individual's federal record for non violent or as congress continues to evaluate our nation to approach to cannabis, let us continue to include criminal justice reform as a critical part of the conversation. dr. throckmorton, as you mentioned the fda approved medical treatment

which is used to treat rare pediatric seizures. can you walk us briefly through how fda came to approve it? >> so, happy to very shortly. we have a process that we laid out a variety of different ways including small business assistance and things that gives a road map to drug developers beginning with conversations with us, coming in and basically saying i want to develop a drug to do the following and this is where i think i may get my drug, my active pharmaceutical ingredient ingredient ingredient ingredient so-called. we walk them to a meeting of drug successful, a drug approval. >> you have a road map that we can get a copy of. >> absolutely. >> we'll request a copy of that road map. also, i would like to follow up on what you have learned through clinical trials from that as well. since the 2018 farm bill, we have seen a massive expansion of cbd products, everything from cbd

active wear to cbd tooth paste. many products containing benefits like reducing levels of anxiety or better sleep. i want to continue on, the fda has stated that many of these products are marketed with un unsubstantiated therapeutic claims. can you talk about what the fda does, what actions do you take for these bad actors. what do you currently doing? >> thank you, we'll be happy to follow up. fundamentally if someone makes a claim that their product treats diagnoses, mitigate or prevents a disease, they're a drug and if they are doing that without approval from the food and drug administration, they are on approved drug, this subjects to our enforcement. they're making

claims they don't have substantiated evidence for. we take an enforcement strategy focuses on the high risk of things. the really egregious claims. >> can you tell us what you did? who you targeted? >> we sent 15 warning letters out, identifying specific products that made those kind ofss of claims, we called on them to stop whatever the violation was that they were committing. most had to do with labelling. we gave them steps they needed to take. >> just so i aim clear, the warning letter went to the person that's a bad actor. >> manufactures. >> and how is the public informed of that to be where? >> those letters are public, you can go on our website of the series of warning letters. this is the

third time we have done this and we put out. we have a follow up plan for each of those companies to make sure they come in compliance. >> one of the areas i didn't run through consumer protection. i think that's another big area. i know if i go into a store, i am not likely to go into your website to figure out is this dangerous for me or not. i think this is something else that we node to follow up as we look at research and other issues and how to best protect consumers. thank you so much madame chairwoman for this important hearing. i look forward for the next one. i yield back the balance of my time. >> thank you for your important work as well. >> mr. charterarter of georgia. you are recognized. >> i want to start with you mr. strait.

changing a drug from one schedule to another. you mentioned that it initiated in a number of different ways. that what initiated the change of hydro codon from a c-3 to c-2? >> petition from a doctor. >> why did it take so long? the opioid epidemic started in the 1990s and 2006 to 2010 and it took you until 2014 to initiate that or to completed, excuse me. >> yes, i believe that. >> why did you have to wait on a petition? >> we didn't have to wait on a pet the petition. >> well, actually back when that petition came in, a lot of folks in the medical community were concerned of access to

opioids. to reschedule marijuana despite its potential abuse kind of ran contrary to some of the broader concerns. >> i have great admiration for your work and great respect. you were asked, is marijuana a gateway drug. you gave a scientific respond. is marijuana a gateway drug in your opinion. i ask you that as a psychiatrist. you understand and we had in this subcommittee here, we have panels, of loved ones who lost loved ones to opioid addiction who all said it started with experimenting with marijuana. >> that's

another big argument of why it is a gateway drug. the counter argument is not so simple. the state that if you have the vulnerability of the drug taking, you start are marijuana and you go into other drugs. that's why it is not so simple and basically i would say overall, i would state based on studies not just in laboratories, if you expose them early on, they are sensitive to other drugs. >> do you agree the psychological effect experimenting with marijuana leads to other drugs and more addiction. that's proven time and time again. >>

and the same thing pertains to nicotine. nicotine is another one. >> what have we done with nicotine but putting limitations to it. i want to cut to the chase. if you want to see time until you get up here for five minutes. every one up here has expressed the same concerns, we need more research. tell us what we need to do. mr. strait, what do you need? do you need to schedule 1 a that's not going to have anything in it but marijuana? i will legislate that. >> two things. we have seen 150% increase in number one schedule 1 researcher in the united states. we are making progress. we want to do more for sure. what do we need in terms of improving access to research, i feel as if this agency group of

folks here have worked collaboratively on a proposal that'll do just that. >> as you mentioned earlier of fetanyls. >> we invite your input. we want to do the right thing. there is actually the use of new research found opioids prescribed less often where in states marijuana was legalized from medicinal use. is marijuana truly does have medicinal benefits, i want to use it. i oppose to the recreational use of it. i think it is a gateway drug and it should not be used recreationally. if there is benefits to it, i want it to be used. everyone is expressing

the same thing throughout the hearing. tell us how we can get the research done and how we can find out. it is the epiphany, 11 states have approved it recreationally. embarrass embarrassing. thank you, i yield back. >> so there. okay. the gentleman from california is recognized for his five minutes of questioning. >> thank you, very much and ranking members for having this important hearing in this committee where it belongs, the health of the committee. too often we either talk about cannabis as a criminal justice issue or a

medical issue. the reality is we can't pull them apart. research shown for youths in particular and incarceration is tied to poor physical and mental health outcomes later on in life. children and adolescence in the system for more than a year were three times more likely to have functional limitations over four times likely to have symptoms of depression and overtimes more likely to have suicidal effect into adulthood. i am not talking about the use of cannabis, i am talking about incarceration. let me make it clear. nearly 75% of all the team arrested for cannabis related offenses under the age of 30. one and four are under the age of 18. that's so much a quarter of a million teenagers arrested for these types of offenses each year of the united states of america. given that we know being arrested for possession, growing or selling cannabis can lead to incarceration incarceration. we

know it is adverse health consequences, we can't accomplish that at a minimum, cannabis criminalization causes some negative public health consequences. the question then turns to balancing these public health concerns. we also know that a conviction for controlled substance can lead to difficulties with jobs prospect which have adverse public health consequences. this can harm the future employment, earnings and health prospects of that youth. examining the public health harms created by criminalization of cannabis is a type of research that can be conducted without having to expand the research supply. i think it is really important for us to understand that calling cannabis a gateway drug

in an antidotal fashion is unfair to the people. the reason why i say that because if we are to have that discussion, we should have the discussion and the question, is alcohol a gateway product or substance? is nicotine a gateway product or substance? so, to think that cannabis is in of itself a category one and evil doer is something that should not be the subject of dialogue when it comes to true policymaking and also when it comes to real honest research, not anicdotal. i think one of the main things that we need to

understand as policymakers that the inception of the united states congress, calling cannabis a class one drug, i would encourage everybody yn this room and everybody in this country to look at the footage on the floor of the united states congress and the non-research derogatory statements being made about a specific community, how using cannabis would lead to rape and murder of women of citizens in this country. i am cleaning it up a little bit because i think it is unfortunate that we have that stain on the united states congress and so far we have not had the will to actually correct it. the united states congress made a mistake. and every congress since has not had honest hearings and

dialogues and has not allowed researchers in this great country to do the true research that needs to be done for us to properly categorize cannabis in this country. as a result of that, we have millions of individuals in this country as i outlined earlier who have been subjected to incarcerations and a criminal record that otherwise they would have a much productive and better life and society would be much better off including the taxpayers would actually get it right. hopefully we have the opportunity to do that in future hearings of the united states congress so we can get it right so we can get the research done and end this antidotal discussion and have a real discussion with the facts. with that, i yield back. >> the

gentleman from illinois. >> thank you, madame chairman. >> all things 911. thank you all for being here. it has been a long day for you all. i appreciate that you have had to do that and so i am going to try to be fairly brief and this one is to dr. volkow first, are you familiar of the article that came out of the risk of >>

drug induced psychosis leading to schizophrenia? yes, i am. >> can you tell me, summarize that report >> and maybe comment on your observations of that. >> this report is consistent of the concern of the use of marijuana, producing chronic psychosis. it shows those individual thats that went into an emergency department for acute episode were much more likely going to a chronic psychotic. it increases your risk of transferring into a psychotic episode as in the case of schizophrenia. >> i have been on mental illness and mental health and early use of

what we call when a lot of people are doing self-medicated. a lot of us may have personal experiences with family members or friends and neighbors that kind of fallen into this trap. i think part of it is early drug use. let me go to this other subject that we have been dealing with and this would be back to you dr. volkow and mr. strait and really deals with the vaping and the thc and also the vine etamin e issue. >> are we talking about the stuff that's being consumed illegally? i presume to creating a thc extract that can

be tested. >> that's the direction. >> the challenge of course with that is we understand researchers want access to that material. under the controlled substances act. researchers generally or have to obtain a control substance from another dea. this is something dr. volkow has mentioned a failure to do so, might impact their ability to keep the front of the program. >> with the cdc that the scheduling status of cannabis makes a challenging for the testing of these vaping products? dr. volkow, you are

shaking your head, yes, you want to elaborate? >> yes, you want to when you start to see these emergency rooms of different states or communities, they would like to be able to for researchers to go in and understand and what's accounting for the rise of these cases. that's not currently not possible if you want to use funding from federal agencies like ours. >> thank you, i want to yield my last minute to morgan. >> i appreciate the gentleman very much. mr. strait, we were talking about the applicants that are already in place. 33 applicants that grow marijuana for researcher out there, y'all are changing the rules, i asked if they would be able to amend

their petition and you said well, we did this before. we refunded their money. i don't think they want their money refunded, i think >> they did not want for giving me the opportunity to clarify. because the applications had come in prior to passage of the farm belt, that some of these applicants may apply to produce things that now are no longer controlled under the csa, we gave them the opportunity to withdraw their application for purposes of no longer needing it. those that have applied, they are in the cue, they'll not have to apply. we'll be adjudicating every single application. >> i appreciate that. that makes more sense that what i thought i heard. i appreciate the clarification. >> you bet. >> gentleman yields back. the chair recognizes the gentleman from illinois, mr. rush for his five minutes of questions questions. we don't have many members left. it is my understanding that folks are

going to be called shortly. i think that we'll be on time. mr. rush, you are recognized. >> thank you, madame chair for holding this hearing and particularly timely and more and more things are loosening their restrictions around marijuana including my home state of illinois which is legalizing recreational marijuana. its important the we prioritize research on not only i'm aware, madam chairman, that too little is known about when

and how 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 crisis that these states are confronting. the revenues increased from marijuana sales and legalizing marijuana, particularly recreational use, to help

correct the budgetary issues that they are facing. and i want to ask dr. volkow a question. will you please expand on the possible health risks and implications for citizens, both adults and adolescents, of these states who are exhibiting what i call a mob marijuana mentality and are engaging in what i refer to as marijuana mania, that really exists in my states and similarly situated states across the country. >> i don't want to negate the possibility that in some instances,

cannabis can have therapeutic benefits. we cannot deny the fact that it has some very untoward effects. that does not mean that twlahey can't come up with indications where marijuana can be used safely for therapeutic purposes. these are not exclusive. but the evidence is clear that marijuana can be associated with negative effects. we are already seeing it in emergency department admissions being observed in the states that are legalizing marijuana, as well as hospital admissions. this is happening. by changing the culture, by legalizing it, by

creating the sense that it is a safe drug, more people are being exposed to it. and as a result of that, that otherwise they wouldn't have, because they wouldn't want to do something illicit. the more people that get exposed to it, the greater likelihood that we will see adverse effects, which is what we are seeing. the data is clear there are adverse effects. at the same time, what we are living as a country, which is quite amazing, is how rapidly the perception of risk has disappeared among the public. 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's another area that along with this mania that exists is this empty excuse or this expungement of records. it's okay. but because of those records, it's being ignored. is

there a nexus between marijuana marijuana, the offense of marijuana, smoking marijuana, ingesting marijuana, and aberrant social behavior which creates a law enforcement issue, which my theory is that it 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 at the point of incarceration and incarceration of individuals with a substance abuse disorder, when you do the examination, you see it does not in any way benefit or protect anyone. it actually makes them much more vulnerable to drug taking and other

adverse consequences. incarceration has an adverse effect on those that are suffering it. >> thank you, madam chair. i yield back. >> the gentleman's time has expired. it's a pleasure to recognize the gentlewoman from oh, i see, you're waving on, so i'm not going to call on you yet. we'll go to ms. berrigan. >> we have two members waving onto the committee. i hope we'll be able to take your five minutes as well as. ms. berrigan, you're at bat. >> thank you. >> five minutes. >> thank you. and thank you all for being here today and for providing informative information. i thought it was pretty powerful and the most powerful was to hear from

congressman griffith and his story. it is the personal stories that are the most impactful. when i was very young, my father had parkinson's disease and he had it pretty much all my life. and i remember when i would see him in pain, i would just ask, is there anything that could be done for him, i don't care if it's legal or not. it was more in the sense of, you're a child seeing your parents suffer and you want to give them something to make that pain go away. so i am firmly in the same boat of supporting efforts to make sure we're providing things like marijuana for medical purposes, to ensure patients are having access to have been they need to help give them some comfort when especially when they're near the end of their life. there's no reason that people need to be suffering. and so his story was pretty compelling for me. i'm wondering if anybody on the panel today supports any of the bills, any of the legislation that's

before us today. does anybody want to comment on any support on any of the bills? >> we have been asked that question. and i actually was asked more specifically which one i favor. and i said i favor actually the advancing of science and the ability to do things in a way that can help us accelerate research. but specifically which is the best bill, i think that that's more on the side of you who are actually the ones that are creating it. but i may put them on the spot. >> i'm not asking for the best bill. i'm asking for, you know, these are the bills i support that i think would be helpful or that i think would be beneficial. >> the ones that i heard, i've gone on the record for these, we've been working with michael weeks at the fda, is the creation of a category for

schedule 1 substances that would allow us to do research expeditiously. and it's not just for marijuana, it's in general, schedule 1 substances, so 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 we very specifically tried to achieve. >> gentlemen, any? >> i would be happy to provide comment on any particular bill that you 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 week, decontrol or other approaches that are suggested and included in some of those legislation, we need to think about the goals in mind, and in particular, from the fda's perspective, the outcome needs to keep in mind the need for continued drug development and appropriate scientific study. >> and from the department of justice side, none of these bills have actually been

reviewed by the administration. so there is actually no official position in terms of any of the proposals. 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 decisionmaking. whether that be legislative or within the executive branch, absent legislation. >> 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 have a list of medical marijuana uses. and i have talked to patients, i've seen what sickle cell has done to patients and the pain they've suffered. many sickle cell patients use marijuana to address acute pain that's a symptom of the disease and some of the states currently have medical marijuana laws but have chosen not to include sickle

cell disease on the list of conditions that would qualify a patient to receive the medication. dr. throckmorton, is there are a way we can ensure that states that allow for medical marijuana can have a comprehensive list of conditions that qualify for the medication so that those who would potentially benefit from its effects are not excluded? >> so which medications are you talking about? >> we're talking about the use of marijuana for sickle cell. >> 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 >> right, that's not that was the the question. the question was the states that provide the list where people can use medical marijuana, how do we ensure that some of these diseases are included. >> i'm happy to talk

with you offline. those states are making those choices without federal input. >> okay. thank you. i yield back. >> the gentlewoman yields back. a pleasure to recognize the gentleman from california, dr. ruiz, for his five minutes of questions. >> thank you, and thank you all for being here. dr. volkow, you say in your written testimony that cbd is ubiquitous, the products are sometimes marketed with health and welfare claims not backed by science. it's also worth noting that while more than 30

states allow for comprehensive medical use of cannabis and the fda has approved some derived and cannabis related drug products, cannabis does not have the fda approval for any indication. we have seen cannabis can be used to treat certain elements such as children with particular seizure disorders that are refractory to other patients, as an appetite stimulant for patients suffering from aids, is an adjuvant to patients with chronic pain syndromes, of particular interest during the current opioid epidemic. however, there is evidence to show that chronic use is not without its consequence. for example, cannab innoid syndrome, a syndrome of cyclic and intractable vomiting, disadvantaged learning and processing speed among teens who use marijuana regularly. these neurobehavioral changes can even be seen on brain mris of these patients. these changes can be permanent. earlier onset, as you had mentioned earlier, the schizophrenia and bipolar disorders from marijuana. it is

clear more research needs to be done to understand the risks and benefits. dr. throckmorton, it seems the fda has found therapeutic value in marijuana-related compounds but for limited and specific uses. can you discuss what factors went into approving these drugs for medical use for these specific populations? >> sure. it began with the basic science work that groups like nyda does. it began with supporting the kinds of research that nyda supports to identify compounds and targets, therapeutic targets of interest. so suggesting from animal models or other places that drugs had use in those areas. and then something called translational science needs to happen which is a drug manufacturer, a drug developer, picks up that idea and comes and talks to us and says, we believe this is a product that we can turn into a drug, what do we need to do, what are the next steps. typically that includes additional clinical studies, sometimes additional nonclinical studies. and the

result is something called a new drug application, chosen the therapeutic area is chosen by the individual company. they are choosing to invest in pain or they're choosing to invest in, i don't know, infectious diseases or whatever else it is with their product. our job is to make sure that occurs quickly and efficiently, is scientifically driven, and results in the approval of a drug for a specific condition with an understanding of its safety and effectiveness. >> can fda extrapolate the safety of cbd for other products? >> extrapolation for effectiveness is very hard to do. 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've 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 and other uses. >> so safety i think, as you said, my testimony outlines, i would say, several buckets. one, adverse effects we've off the record in clinical trials leading to approval. two, unknowns, things we believe we need additional

information about. i would put in that category things like the liver entry. >> i just want to make an important statement here, as you conduct your data collections you have to ensure you have a diverse sample of populations. too many research is done on men and non-hispanics and non non-african-americans in the medical world. i believe that in all categories of research, you need more women and you need more people of color. okay? >> agreed. >> thank you. >> the

gentleman yields back. the chair now recognizes ms. schakowsky of illinois, waving on to the subcommittee for >> her five minutes. >> thank you, i appreciate being able to waive onto the committee. i'm a proud original co-sponsor of representative jeffer's act and representative nadler's act which would 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 to everybody has, it seems, or most people, on january 1st, illinois legalized recreational cannabis across the 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 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 3997. representative blumenaur's medical 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 stains of

can a strains of cannabis are widely available, how can illinois acquire the research supply through >> local dispensaries? >> this is a question that we've been discussing it. 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 can we look forward to some change there? >> as we had 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 the controlled substances act to procure that substance from another federal dea registered research. >> right. >> so none of these dispensaries are applying for a registration. none of them are registered with the dea. and therefore they are unable to distribute to researchers. >> so we would have to get marijuana off the controlled substance act, out of it, in order to do the research that we absolutely need to do on what is being sold right now, and millions and millions of dollars being spent on it, and many, many users. >> certainly that's your discretion and congress'discretion as one way to solve that issue. i don't

know at the end of the day where this administration would come down on that approach. >> is that the only way? >> no. i think there's 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 recommended that. though i know that we don't all agree on deregulation and descheduling, i think we are at the very least should be able to work together to ensure adequate research is able to be 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.

>> the gentlewoman yields back. votes have been called, and i recognize the gentlewoman from the state of washington, ms. mcmorris rogers, for five minutes. >> thank you. thank you, madam chair. i also want to recognize the ranking member and all the committee members. i appreciate this committee being engaged on this public health and consumer safety topic around cannabis. i get asked about this a lot in washington state. we legalized both recreational and medicinal marijuana the same year as colorado, i believe we were the first two states. i am a co-sponsor of blumenour's research act. i also represent washington state university that's in the same situation as ms. schakowsky's university around wanting to do more

research around the issue. since we've legalized marijuana, the number of cannabis products available in the marketplace has exploded over the years. and so have the marketing tactics that promise cannabis as a 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 breakthroughs that can improve people's lives. 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. we have no idea what the health >>

implications may be. what is the solution to this, how should it be handled? >> so not one solution, that shouldn't be a surprise, right? i personally believe one really important element is to encourage the development of a mature industry, using these products. industry used to manufacturing standards, industry used to packaging standards, labeling standards, an industry of the kind you see when you go into walmart 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 and interest in doing research using these products, behind that will be the growth of an industry that wants to do the right thing, that wants to be science driven, appropriately labeled. i think it's terribly important that we lay out a pathway for nondrug products exchange compounds from hemp so that there is a clear path that

developers can follow to find a way forward as far as developing those products and making them appropriately available. >> do you see that happening at the state level, in any of the states where these where marijuana has been legalized? the industry or the nondrug products. >> we've really benefitted from talking with 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 these things. the states are all taking different approaches. many of them, including your state i know, are grappling with these issues around labeling 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 then 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 cannabidiol. children don't drive, but we need to understand the effects of cbd on driving impairment. we need to have those dad as soon as we can. >> okay. there's a lot more to explore here. thank you all for being here. thank you, madam chair. >> the gentlewoman yields back. and we thank her for participating in our hearing. so let me, on behalf of all the members of the subcommittee, thank our witnesses. this is this was 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, so many of our undertakings. i want to submit

the following statements for the record. i 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. testimony of congressman hakeem jeffries in support of 2843. a statement from chris crane, president of 4front 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. testimony of paul armentano, deputy director of

the national organization of the reform of marijuana laws. a response letter from fda/nih to senator schotz. 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. 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 on 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 for to grow marijuana for research purposes. and slides created by nih entitled "effects of

cannabis on the human brain." without objection, so ordered. does the ranking member have anything he wishes to submit? >> i would not do anything to prolong 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.

witnesses look at what organizations are doing to combat the scams and they hear from a utah resident who was a recent victim held by the senate ag commission. says two hours. >> the committee will come to order. good morning, today the special committee on aging is releasing its updated