[inaudible conversations] >> good morning the subcommittee will now come to order. welcome to everyone that is here in the hearing room. the chair now recognizes

herself for an opening statement. according to dhs national survey on drug use, 44 million americans reported using cannabis in the last year. thirty-three states now allow the medicinal use of cannabis and in the district of columbia have legalized for adult use. state laws and federal policy are 1000 miles apart. the federal government's still strictly prohibits even restricting legitimate medical research. widespread availability of cannabis is the purpose of the hearing to examine the pressing need for medical research of cannabis and the chemical compound with cbd being one of them. half a century ago the congress listed cannabis as

schedule one substance including heroin heroine, lsd, and ecstasy. schedule one drugs have no medical value in high potential for abuse. scheduled to drugs such as cocaine and vicodin even schedule five drugs as robitussin has medical value but a ranking depending on abuse. schedule one designation restricts legitimate medical research. today scientist who wish to study cannabis must seek approval from three federal up agencies fda, nih and the dea. once federally approved which could take more than a year the labs can only research cannabis grown on the government farm at the university of mississippi. if it lacks the properties and potency of commercially

available cannabis and leads to inadequate results. they cannot do research but they cannot demonstrated as a medical use until they can conduct research. that make sense. at least to me so why is it concerning the research is blocked by federal law? first the therapeutic potential for chronic pain, nausea and treatment of neurological disorders such as seizures. . . . . to update fedo

research on cannabis and its compounds. they joined us and they are sitting in the front row. thank you for being here and for your work.

now i would like to yield to mr. kennedy for the remainder of my time. this is a debate that is long overdue. the criminal justice system to the healthcare system to the state and local governments that are forced to navigate an impossible landscape. to that end, government officials and representatives are important witnesses in bringing perspective to the conversation. but there are also critical stakeholders that are missing, those whose lives have been touched by a broken marijuana policy, the people under incarcerated and allowed medical cannabis and researchers with expertise yearning to learn more. they tried to find a fair voting in the industry. i'm grateful for the chairwoman

who is committed to working on the second hearing in this debate. thanthank you madam chair and i won't yield back. >> it is a pleasure to recognize the ranking member of the subcommittee for his opening statement. i think the chair and appreciate thanks to the witnesses here today to help advise us in this important matter and i appreciate we are holding the hearing today to discuss the policy. it is of interest to many members of the subcommittee and in fact that was evidence when we had our discussion on the smokeless tobacco product at the end of last year.

on the medical cannabis research act and hr 3797 the medical marijuana research act of 2019. states and localities across the country have moved forward with different policies. i am concerned there is a lack of available research on the benefits and risks of both medical and recreational use of the product and we don't justify the actions of some of the states have taken. thus far the food and drug administration and academies found there is a lack of evidence to demonstrate effective medical use for marijuana, so certainly we need more research. we do not have any data.

they also found that it may impair fetal growth and development. as the potency continues to be arise. with the help of the mothers and their babies that could be at risk it requires the dea approval and for decades only been allowed to obtain from one source to the university of mississippi.

previous research purposes they could be minimized by having a single source and because of that diversity now anthediversiy potency of other aspects for the medical and recreational purposes as it does vary across the united states, researched using the single source marijuana may not adequately assess what the current landscape represents. it's necessary to conduct research in the existing structure. they 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 is quite across the finish line. maybe we can hear about that today. i hope that we can identify ways to work together to achieve that goal while three of the bills before us today and t yesterdaye research efforts, there are two that may go a step too far completely remove marijuana from the controlled substances list. it is worth noting and i believe the administration will explain this in more detail that in order for the drug enforcement agency to reschedule a drug. they must conduct a medical evaluation of the drug and provide a recommendation to the drug enforcement agency has to let the scheduling should be.

this recommendation is finding therefore the dea must do what the food and drug administration recommends. they could override the scenario to possibly be a dangerous move especially given the lack of research to back up that assertion. so, it is critical understanding what it does to our body and bring different potencies and we have a long way to go before a full understanding of the factors some of the bills are a step in the right direction and some go a step too far but i look forward to learning more about the issues of the federal agencies and the efforts they are taking to work on this problem. thank you for being here and i will yield back my time. mr. pallone for his opening statement.

>> today the subcommittee will have an important hearing about federal cannabis policies while state laws and public perception around cannabis and its derivatives have evolved over the years. much of the federal framework that regulates cannabis has stayed the same. my home state of new jersey for example, it allows the use of medical cannabis, and at the end of last year, the state lawmakers passed a referendum that would put the question of legalizing adult cannabis use to the new jersey voters on the 2020 ballot this coming november. new jersey is not alone in its changes and in fact the national conference of state legislators pushed for 33 states as well as puerto rico, the u.s. virgin islands and the district of columbia approved medical cannabis programs. the approved adult use cannabis and although some state states e their own policies, national walls such as the controlled

feedback have used to change the same way. they've agreed to appear before the subcommittee today the drug endorsement agency, the fda, the national institute all play crucial roles on the cannabis policy from researching its medicine to the monster protecting the american public from bad actors and i hope that we can learn about what works and what needs to be changed. we will discuss these by both democrats and republicans, some bipartisan. they propose various changes such as rescheduling or the scheduling marijuana, providing a safe harbor for patients and veterans who use medical marijuana and streamlining cannabis research. given the evolving landscape that bills are worthy for further discussion and i'm particularly in rested in hearing how they are reducing barriers to research and enabling research on cannabis. i'm also interested in how the agencies are working together to

regulate a cannabis derivatives recently removed from the controlled substances act and that is a cbd or cannabis dial is how it is pronounced. they are the cochairs of the bipartisan cannabis debate for cannabis mr. chairman, i think you want a timeshare?

when i was a young man in the 1980s, some of my friends were smuggling marijuana into the community and the family. that formed my policy that we need to have a rational medical marijuana policy, thus the bill. but i decided when i got to congress its kind of controversial and maybe i shouldn't do that, but i would talk about it and when i was at a town hall what about just for

the recreational use or for fun and i will never forget i was in virginia, by unanimous side of the room raised his hand. these two communities 20 years apart, 30 years apart, and hours apart from one another and doctors were turning a blind eye to allow marijuana to be brought into the hospital because they recognized for those patients who are 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 and spend a little bit more time with their children. i came back to dc and i said i

am in congress now. i can do something about the dea and not making marijuana available for patients who need it. >> and i will yield back. >> we appreciate the hearing today because we will have an opportunity to review the initiatives. representatives rogers and others, we sent a letter asking and appreciate the willingness to have it. it's a schedule one substance and this means researchers seeking to investigate cannabis must work with the food and drug administration and the national institute on drug abuse and the

enforcement administration and this beats federal guideline requirements specified to conduct research in addition to the international obligations set forth in the united nations drug control treaties that impose additional requirements of the substance inducting the supply of research grade cannabis. so, researchers now can only use cannabis products sourced through the drug supply program single license, the university of mississippi. now, unfortunately that it is commercially not available from the state legal dispensaries in oregon on the products and states would legalize cannabis for medical or recreational use. now in oregon, you can purchase a range of thc infused products like these cookies we have a photograph of right there if you look up on the screen behind you i guess.

i have pizza out in the hallway. [laughter] don't worry i didn't get that carried away. you can eat these. beyond the normal ingredients of the normal cookie. the question is how do you know if your child stumbles upon it. so serious side, these cookies in the photo are limited to 5 milligrams of thc per serving. if you go across the river to the state to milligrams and 100 milligrams per package and the difference is arbitrary. we lack data and we do not know but what we do know if there was an elevated number of cannabis related the poison center calls

that reflects the reality of what is on today's market and products containing cbd derived from the plant have become commonplace across the country and pharmacies, food stores since hemp was removed in the farm belt, these products contain claims they can effectively treat depression gum inflammation can even cancer and alzheimer's. none of these have been evaluated or proven by the drug and food administration which means patients may be relying on the unsubstantiated claims of products and forgoing other medical treatments. the patient benefit if lag far behind the market into the agencies they are struggling to catch u up so nationwide exposue is increasing from 2006 to 2013 children's exposure to marijuana products grossed 127.5%

nationwide. and in states that have legalized medical marijuana come exposure has risen 610%. while alcohol use is going down, last month, he reported record numbers of eight through 12 grade students regularly vaping marijuana. americans consuming more cannabis positions on the substance have been made in the virtual information vacuum. they are easily abused such of alcohol and tobacco. rescheduling it may help improve research landscape and allow for more medical treatment however the administrative scheduling on the users it's created a catch-22 in the scheduling debate and evaluations by the fda and the national academies have both concluded lack of research was an actor to the

previous rescheduling petition, so i would like to note that two of the six bills today already scheduled and removing it from the controlled substances act even though we do not have the necessary data to justify doing so in my opinion. it is removed from the act and cuts the dea completely out of the picture so any discussion must be preceded by the full understanding of the risk associated with cannabis use that we currently do not have making it easier to get the research cannabis we should pursue as we improve the federal and state relationship in the policy gap and with that i will yield back. >> they would like to remind members that pursuant to the committee rules, the members opening statements shall be made

a part of the record i would like to introduce and thank each one of you for being with us today. the director of the national institute on drug abuse at the national institutes of health, thank you to you. doctor douglas is the deputy director for recovery programs at the center for drug evaluation and research at the fda food and drug administration and mr. matthew strauss, senior policy adviser for the diversion controls division of the drug enforcement administration. so, welcome to each one of you. thank you for your wife 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 are familiar with

the traffic system green as go, yellow with caution and when red comes up it is time to stop. we will start with doctor you are recognized and thank you not only for your work but for being with us today turn your microphone on. good morning to everybody, and i want to thank the chairwoman, the ranking member and all of the members of the committee for inviting us to discuss the research. it's the most widely used illicit drug in the world and the united states. thc is responsible -- the content has tripled in the past two decades it isn't requiring its potential effects have

decreased in the plan while food, drinks and other products containing it have. by interacting with receptors that are part of our own cannabinoids system. the system is involved in brain development, and multiple brain functions. memory, emotional and others and also hormonal and metabolic processes. it isn't surprising that basically hijacks the system of particular concern are the developed at on the vehicle and adolescent brain and exposure as was mentioned before during pregnancy has increased and is associated with restriction of lower birth weight and delivery.

it has been consistently associated with lower academic achievement, high risk of dropping out of school, lower iq, disruptions in brain connectivity instructor. it increases the risk of addiction. another area of concern is psychosis the risk of high content of thc. while most, they can become chronic. they've also regarded high risk for depression and suicide, so these associations have been less solid. the ability of the products has increased emergency department visits and hospital admissions with these exposures. these injuries while driving under the influence of thc are

one of the main causes. however can't or understanding is incomplete the predominant association that happens resulted in more than 2,500 hospitalizations. the related visits take further assist resulting in high levels.

most frequent for speed [inaudible] multiple indications in many states even though the fda has not approved any of them for any indication. not meeting the fda requirements, there is evidence that it may be effective for treating multiple sclerosis but otherwise there is little evidence of benefit further indications for which the patients were using it. including supporting stories for pain, inflammation, ptsd and addiction understanding of the effect of brain development and deny the priority and the adolescent brain and cognitive development story will follow more than 11,000 children into

investigating how it affects their brain. it is a process with major challenges. neither with the university of mississippi the only source of research into the researchers from other sources resulting in the gap in our understanding of the impact on health. thank you very much. >> thank you, doctor. we will now recognize for the five minutes of testimony thank you again for being here. you are recognized.

>> chairman, ranking member and members of the subcommittee, i am from the center for drug evaluation and research at the food and drug administration. thank you for the opportunity to be here today to discuss the importance will fda place in research involving cannabis and derived compounds and potential medical uses in the united states but i've also like to discuss the race and work the fda is doing to respond to the recent legislation affecting the availability of the compounds derived from cannabis just come out of iowa. first with regards to the drug development, the fda continues to believe that the drug approval process represents the best way to ensure safe and a sd effective new medicines including medicines derived from cannabis are available for the patients and stand ready to provide information to investigators on the progress and prospects in the specific requirements needed to develop a the human drug that is derived from plants such as cannabis. for example, they've wasted a

developmenthedevelopment includs such as fasttrack, therapy, accelerated approval priority review all designed to facilitate the development of and expedite the approval of the novel and effective drug products. we've also established a botanical review team to assist the development of the plant-based drugs including those derived from cannabis. using these resources, the fda successfully approved one drug product containing cbt and the recent cannabis derived drug products while they are aware of the activities of states in this area, to date they haven't approved any other cannabis or cbt products currently available on the market. turning our activities to the recent work under the legislation, in december, 2018 of the farm bill removed temp and its derivatives with extremely low concentrations of

thc from the definition of marijuana in the controlled substances act. the farm bill explicitly preserve the authority under those derived which means these products must still meet any applicable fda requirements and standards just like any other fda regulated products. because we understand the broad interest in making the compounds more widely available to the public, fda is working hard to respond to the changes quickly and appropriately. for example, we have reached several conclusions about the use of cbt in the known drug products. it is prohibited under the statute to introduce into the 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 supplements because it is an active ingredient of an unapproved drug with these restrictions apply to the products made with cd.

it's easy to understand why we don't wan want blood pressure medicines or pain medicine in our food or dietary supplements. additionally, they are concerned the marketing of the non- drug products could put consumers at risk to cure serious diseases such as cancer or alzheimer's disease. the proliferation may deter consumers from seeking improvement, safe medical therapies for serious illnesses. we also know that it can cause adverse effects including drug interactions, sleepiness that could impair driving and potential liver entry. there are many unanswered questions about the safety and quality of the products containing cbd. and the agency has made it a priority to address these questions including the safety of the use of cbd.

we have very little information about the use of cbd by pregnant women, children and the elderly to address the gaps the fda has been processing collecting all the data available to us to make the best science-based public health focused decision about the availability of the compounds. they understand the broad interest in making these compounds more available to the public and considering the possibilities of the pathways for the products. however it is important to maintain adequate incentives for the development as we do so it is critical that we do what we can to develop the products.

>> we recognize mr. matthews for his five-minute testimony. thank you again for joining us. >> thank you. chairwoman, ranking member purchase, distinguished members of the committee. on behalf of the administrator and 9,000 men and women of the drug enforcement administration, i appreciate the invitation to be here today to discuss the regulatory requirements of those that perform research with schedule one controlled substances including marijuana. much like our partners at hhs, the department of justice fully support research into the effects of marijuana and potential utility of its component parts. the procedures for evaluating the application for the registration by statute is an interagency process. at hhs the food and drug administration conducts a review of the qualifications and

competency of the research as well as the merits of the scientific protocols. they are charged with ensuring that adequate steps are in place to safeguard against this. these procedures have been in place for several decades and in my 20 years, there hasn't been a single incident in which a researcher who's put forth a valid research protocol and has implemented safeguards to prevent diversion has been denied. given the public interest in the research they've taken a number of proactive steps to give its part improving research with marijuana. first, december 2015 to ease the requirements to modify existing registration to conduct research which at the time was being investigated for use in children with certain epilepsy disorders. i believe this action ultimately contributed to the 2018 approval of the dialect. second, august, 2016, the

department of justice and the dea took steps to increase a number of entities registered under the controlled substances act to grow marijuana and supply research. to ensure that the 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, the dea published a list of the 33 entities who've applied for registration and whose applications remain pending to grow marijuana pursuant to that policy. in forthcoming proposed rules which has been drafted and submitted to the office of management and budget remains under development at this time. third in february, 2018, the dea announced its development and implementation of online portal for the research to safely and securely submit their research protocols, curriculum and institutional approval. materials required by the regulations to be submitted for

the fda 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 improve an application is 52 days. while the time required to modify an existing registration is far less. finally, two months ago, they increased the aggregate production quota for marijuana from 3,200 kilograms, the increase was based on the close collaboration provides high-quality marijuana nih and on nih funded researchers. the 2020 quota represented 575% increase from marijuana since 2017. >> i believe these efforts are working. today, the dea has 829 active researchers. 70% of the researchers from 605 in total are performing research

with marijuana or its constituent parts, making it far and away the most researched a schedule one controlled substance in the united states. >> despite these efforts and our successes, the multistep process for the improving research was schedule one controlled substances is perceived as onerous by some in the research community. unfortunately, this perception is translated into a narrative that does not support research. i'm here today to tell you that this is simply not true. this has hampered efforts for the past practical commonsense legislation addressing more than 30,000 overdose deaths in the united states from sentinel and fentanyl related substances. in just 23 days of the temporary scheduling action which place was schedule one controls on substances chemically similar to fentanyl will expire unless congress acts. the dea and the department of justice have worked with hhs and put forth a proposal that addresses the 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, the dea is fully committed to supporting research to schedule one controlled substances. we will continue to work with our partners in the administration to find commonsense approaches to improve and enhance research. thank you and i look forward to your questions. >> thank you mr. straight. now we have concluded our model may be opening statements of members, but the testimony of the witnesses. we are going to move to members questions now and i will 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 war medical research needed on the therapeutic effects, and the health consequences of

cannabis? >> yes. is that cannabis from the university of mississippi, which is the only approved cannabis for federal research adequate for medical research? >> no. we would like additional sources, but we also recognize it is allowed in certain circumstances. >> should legitimate researchers be able to access a wide array of cannabis products further research? >> it would help drug development. >> has there been real-life consequences to the researchers not being able to conduct research on a variety of cannabis products? >> yes. product development are slow. >> so, there has been in effect

because of that. >> i don't disagree with my colleagues. >> i know that one point we haven't discussed enough, i believe that it will actually recognize the particular councils of that is another aspect of the limitations. >> the main reason cannabis researchers restricted is because it 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 is part of the schedule one but with its active ingredients can be considered to have medical use. >> i would defer to my colleague at the fda for an answer.

>> separately those compounds are safe and effective for the intended use and so they do meet the statutory standard for the accepted medical use. >> how do you pull them out and separate them? >> that is what the drug development process is meant to encourage us to have people -- >> until the fda decides to pull those out to be applied to and used as part of a certain drug you just automatically vanish from a schedule one vanishes as a result of the? >> when congress defined with the schedules were to be, they said that there were tests to be applied for whether you were accepted as a medical use, and there are five that we would be happy to talk about in greater detail of wine. and when you apply those tests, to marijuana, at least when the fda have applied the tests to marijuana, three times in the recent 20 years or so the

conclusion of the recommendation of the dea is that they did not need to tesmeet the test for thd medical use. mostly it has to do with whether you have identified a therapeutic value for the product and whether you can describe it. >> more of a trigger than anything else. >> does the fda have all of the authority it needs to regulate cbd products for consumers? >> i believe we do. when i talk to the -- when i talk to drug developers that come in and talk to me and they say we are interested in studying a compound found in cannabis whether it is cbd or one of the other 80 cannabinoids or whatever else i say, i would say if you can give me a legal source of that compound, i'm going to trade you exactly the e same way that i would treat any other drug in development except i'm going to give you additional

resources. >> i still have more questions. >> now they've estimated that it will take three to five years to complete the room making in relation to cbd products. is this still accurate? >> we understand unfortunately it isn't a yes or no question. we know that there is interest in moving quickly and we understand the three to five years is longer than people would like. >> what is the estimated a? >> we are looking at a full range of options. >> 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 that they know of the products that may not contain the amount indicated on the label or may contain other potentially dangerous compounds. as the fda issued any labeling requirements for cbd? >> my time is up. >> the labeling requirements would be imposed on th only appd

drug of the dialects. the product is well manufactur manufactured. we have no concerns like that but i am aware of. the products, the warning letters are subject to that comment related to our unapproved products that are being marketed in the states. >> thank you. my time is expired. and i recognize the ranking member now for his five minutes of questions. >> thank you madam chair and i want to stay with you for a minute on the open by a question when i look at my drug discount apphave come it is like searchig for therapeutic cours a therapef that. so, somebody that didn't have $1,300, could they just go buy that we'll en have supplanted te use of these? >> we always recommend you use an approved product for a number of really good reasons, but what we learned when we did that sampling is that we don't know

what it will be if you choose to take it. it may contain things that would be dangerous to you. we also know that it's reasonably likely for the bill it is pretty much standard for the approval of a new drug was 14 or 16 years and about $1.5 billion. do i remember that correctly, three to five years sounds like you are moving would that be a fair statement? >> three to five years comes from our general experience with rulemaking rather than any specifics. if it isn't related specifically to the drug development or product developmendeveloper proe rulemaking we have to use. >> has the dea ever done an administrative change without being prompted by congress?

>> absolutely, yes. >> the scheduling actions with some frequency can come through the petition that dates from public citizen or as a direct result of an approval of a new drug, new molecular -- >> that doesn't come from the fda though. >> in that circumstance. >> so you could just say we are going to change the schedule of this medication. you mentioned in your testimony the risk of addiction with cannabis products presumably

that is a real thing. >> it is the active ingredient responsible for the addictiveness that contain higher content. >> is a gateway drug? >> it increases the likelihood that you are sensitive to the effects of other drugs and so what makes you more sensitive. >> so yesterday we spent time in the investigations of this opiate addiction and we do worry that we go too far in one direction or another and years from now we will be having a hearing perhaps we have gone too far with what we did in neutralizing the marijuana law. let me just ask you this. you also mentioned the national traffic and highway administration and driving under the influence. our traffic laws in our state,

have they kept up with all of the changes in these policies that have occurred across the country? >> one of the major challenges in doing so is that it is difficult to quantify whether someone is intoxicated or not. it doesn't guarantee you are under the influence or not. you can have very high levels having taken it three days ago so that has been a major challenge. >> so you can't quantify what may occur. >> as a consequence for the partners of state, it becomes the difficulty is that correct? >> that is perfect and that is an area that we are trying to bring up strategies to identify. >> at practical matter that happened at my district. there is a pedestrian struck

under the .08 limit and the blood alcohol but they also have a positive quantitative test for thc. it seems to me that the potential for the additive effects should be something that law enforcement wit would bear n mind when they are deciding whether or not to bring a case like that. it was clearly a very tragic situation. so it was a high-profile case and something i will never forget. >> the gentle and yields back and it's a pleasure to recognize the gentleman from california for her five minutes of questions. >> thank you madam chair. i appreciate the hearing we are having today. it means that this issue are needs to be examined and thank you for the witnesses for being here today. at the university of california researchers are doing important

work to study the health effects of public safety and environmental impacts of marijuana. i'd like to discuss how the existing federal regulation made from fully understanding cannabis as a despite the fact that it is being cultivated right in california to select local dispensaries into the current law research must obtain the samples to deny that contracted site in mississippi. in order to study with the public is purchasing and the dispensary, researchers have applied for a license to cultivate cannabis locally. however, the researchers haven't heard back from the doj. and the status of the applications. where is the department of justice in its process of granting or denying patients researchers have put forth at the university to study, to cultivate the 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 perception of delays on the side is we look for a complete application before we foreword its application to our colleagues at the department of health and human services. so that there are three things we need. we need a protocol which most researchers that are federally funded or state-funded half for the researcher which every researcher certainly has, but sometimes the delay is the result of the third switch that institutional review approval. sometimes for purposes of timing the researchers will sub net application knowing the state university or state system reached hasn't met to review the application. >> i think they are pretty good about doing this and so i would like to be able to expedite as

much as possible. is the distinction between cbp when it comes to innovative products from my perspective we are interested in understanding what are the effects of the chemical compound that goes by the name of cbp with respect to the pharmacological actions that have the negative effects into the potential therapeutic actions so the molecule is to

investigate how when it's mixed with other than that i jus don'y be influenced. >> one of the things that happened in the result of the farm bill is it was removed from oversight and that allows us to encourage its conduct a way beliebelieve that is a powerfull in getting studies done. >> 100% correct i think that the passage of the farm bill created a little bit of a question as to the legal status of synthetic versus natural sources very clearly that which is derived from the natural sources from less than 0.3% thc is no longer

controlled. >> is the research but what are the requirements that must be fulfilled at the fda? >> when you say cannabis, are you talking about the bill compliance? it's important that we think about it into tracks. one arrow the farm bill compliance we view and other compounds extracted, we view as subject to the food, drug and cosmetics act able to be used for investigational use to come in to talk to us. if it is high thc cannabis is the place but in addition we would want to make certain that they work with them because there are other requirements under those circumstances. >> thank you and i've gone over

my time. >> the gentleman yields back. would you respond after you get back to your agency with congresswoman matsui on the university california is application please? >> absolutely. >> this is the greatest public university in the world. they know how to do applications. [laughter] is causing a ruckus. i will stand with my statement representing the greatest private university in the world, stanford. it is now a pleasure to recognize the gentleman from michigan. >> thank you madam chair for this hearing. i do have a couple of questions.

you mentioned one of these three drugs that has been approved and two others. what other illnesses or conditions were approved? >> is approved for two genetic seizure disorders and that contains another cannabinoids. >> how is it injected? >> is in a syringe basically. they are not extracted from the cannabis plant and therefore wasting diseases he can get you a full list of those is a different active ingredient in the dialect.

the friend alcohol content whether it is craft beer, maybe a state like a smaller threshold like utah but in addition you've got the law-enforcement issues as with one of my shirts last week we had a situation like this district with a student returning back to michigan state and sadly he was involved in a terrible auto accident. where are we in terms of some

visible standards that folks can look at as it relates to the cookies and brownies or whatever it is the serial that they are going to eat as if relates to the safety of that and where are we as it relates to law enforcement it's not like the breathalyzer, they've got to do a variety of different cognitive exercises to try to determine whether or not the individual is taking too much but we try to help the consumer note the right information if they choose to take i can speak from the research perspectiva researchpen understanding what the content of thc is associated with particularly psychological effects including side effects research has been known to show thadone to showthat if you conse

between three to 8 milligrams you're going to get high but in general you don't have these adverse effects. from the research perspective it is to create a unit of marijuana that can be utilized consistently across research to help us understand how exposures of different compounds -- >> when is that research going to be completed? >> it is a unit that can be used consistently. are we a year out, how long do you think it would take? >> i would hope that we would be able to implement a standard dose for the research purposes but that is different from implementing for those that are not legally accepted and

[inaudible] >> anybody else have a comment? >> you've raised an incredibly important point about the development of bond drug products containing things like cbp so as they think about how to develop the product one thing we remember is that there would be requirements of the product that we approve in the accurate label and dosing super instance if it was approved and we found a pathway that enabled us to allow cbp in a cookie along with the package and would come labeling that would say it contains ten or 100 or whatever else could include other conditions used to help us understand when it was appropriately be used in things

like that so part and parcel with the work we are giving us to thindoing is tothink about tf important consequences that would include that kind of labeling. people would have a better understanding and also more assurance that the products contained -- >> yes or no, do you have the authority for the labeling now? >> absolutely we have that authority that w but we need to determine the pathway to take for those non- drug containing products. the gentleman yields back and it's a pleasure to recognize the chairman of the full committee for his five minutes of questions. ..

>> of products that are more readily available for go this is a public health challenge to understand the impact to prevent us from advancing sound science. you know that having only a cannabis limits the diversity for those formulations available to researchers so let me ask yes or no do you believe federal research should have access would it be

beneficial to drug developers. >> and actively for cannabis growers what is the status of this effort when can we expect this for rulemaking crack. >> we have the draft regulation in place august 2019 we could get to the policy review process to publicly acknowledge who the pending applicants were. we know we probably have to do rulemaking and how we evaluate all of the pending applications and what additional type of regulation might need to be in place in

order to impose those that would grow? i cannot talk too much about it a rest assured we have submitted for it to be drafted and tomorrow many of us will talk through it. >>. >> and with the cbd infused dummies this is additional care products to bring as much is $15 billion by 2025. and to regulate cbd products to clarify the pathway to be completed. what are those activities needed to ensure the safety of

cbd and other products such as dietary supplements? >> three through five years is the importance to identify that process. having said that that is the one pathway that is identified to the prohibition to the use of drug substances. so that prohibition as i mentioned in my opening remarks exist for the agency to change we need to find a mechanism to allow a path forward for a nondrug cbd product to be developed we are in the process of doing that the rulemaking under consideration there are a number of legislative ideas

with other meetings where people raised suggestions regarding this as well but bottom line we understand we have to identify a path to be grounded in science. many of us have mentioned fend on - - fundamentally there are things that we know we can do as is adverse effects as i mentioned in my testimony to liver injury and productive - - reproductive injury we need to know more about. we need to know more about it uses in vulnerable populations. if it's placed in a non- drug product there will be no one who can talk to the patient to help them make their choices about the use of the product. you can get up in the morning

take your cbd to get started in your coffee take another dose at lunch when you have your sandwich and then in the late afternoon with an alcoholic beverage and those aggregate amounts do not matter we have to decide how to do that safely for those dietary supplements that is what the best steps are. >> and the appropriations bill passed last year there are money going directly to the fda to move up the work on cbd. >> correct. >> now you have the money.

it is a pleasure to recognize mister guthrie. >> thank you for being here. it could take up to year to get a schedule one getting approval for protocol modification is time-consuming how does the dea registration process for modifying that to have research of cannabis and to also understand that i want to ask something first. before i answer your question those that had the implementation and recommendation included in the staff report for opioid distribution we have not received the response and after the hearing to see if we can get that response.

>> i would be happy to follow up. >> it's a time-consuming process. you said it was 52 days for registration. and talk about that time-consuming process. one of them has to do the schedule one is much longer. but 52 days by the dea that the multiple moves forward but from researchers but then the dea can work with it because it is complex. another issue that makes it harder is dea local agents that further hinders the problem. but the other impact is that

there are certain scientists you don't even want to go there to say it takes too much effort. so we potentially lose valuable information missing things that are important. >> thank you for giving me the opportunity. this is a common refrain we have heard from our partners at hhs one of their challenges when we try to get information from them about who the concerns are being raised by it plays into the fear of dea we are cited because they cannot disclose information to us they are prohibited from doing it so we struggle to understand of the people

having difficulties so we can give them special attention and we are happy to. the other point i want to make is the inconsistent applicability of dea regulations across the field division or the concern of that. as i mentioned to staff before we started this, we are getting ready to host management conference across our entire division all across the country this is something that we can solve easily this isn't something we need congresses help. >> virginia has the oldest medicinal marijuana law passed 1979 and former member of this committee who was a state senator to say they would

allow the use of medicinal marijuana in the commonwealth of virginia however the dea allowed it in the dos loaned us the doctors did not want to risk their license over a legitimate prescription and that is where my bill came from. this is where virginia stood for decades. 1998 there is the attempt to repeal it because of the california law that says if it makes you feel good you can try it. but the dea has not acted. people say it will take between three and five years my question is why it hasn't the research been done? and doctor, causes me great concern that apparently fda thinks it is okay for opioids and opiates and barbiturates that somehow marijuana should stay schedule one. that doesn't seem logical so i lay that out the problem is my

fathers were so sick and could not hold it in their stomach that's why their friends were turning a blind eye - - a blind eye so they could smoke it and then eat for go we need to find a solution we should have worked on this in 1979 or earlier and we haven't done it. i yelled back. >> excellent points. of pleasure to recognize the gentleman from florida spinner thank you madam chair for calling the hearing it is clear that cannabis research is caught up in conflicting regulations but you cannot remove cannabis from schedule one because it lacks proof for medical or controlled recreational use you can't research to determine its safe

because it is included on schedule one. doctor come you ended your testimony by saying cannabis research is urgently needed. let's focus on how we can streamline the research process for cannabis and possibly other schedule one substances. what are the requirements and challenges for conducting research? expect the main difference that you have to have the dea registration that makes it much more complex. and that can take time. >> that clearly deters that. in thinking of reducing those barriers, you did answer to representative guthrie to point out the barriers so what do you recommend should change in the process right now?

mimic we have been working with the agencies to come up with a process to allow us to safeguard the public that yet facilitate and accelerate research. the issues of enables researchers to accelerate the pace to do research without jeopardizing the product. that is where the nih and fda have been working to gather. >> a number of bills have been highlighted for consideration would you point to any pieces of legislation to streamline the process. >> we don't want to legislate we just bring science. but what i can tell that marijuana is the substance.

but we also know that it is likely there is potential of the cannabinoids within marijuana. and to that extent of the ones you are proposing that while protecting the public. >> doctor has there been a change in the number of applications with research on him or other low cannabis product that is no longer considered schedule one quick. >> short answer yes. >> removing marijuana to remove barriers to research? >> at present my focus is on supporting the investigational

studies that we receive and how so your first question, we now have almost three investigators that have come into us proposing to use cbd and other substances found in hand - - have that is important for cbd and the compounds for drug development we have to make sure we have every opportunity that we can but the question of marijuana it has to do by what you mean by marijuana. obviously one street corner sells one kind one street corner sells a different making the conclusion that both of those somehow have medical value this is challenged scientifically that one of the findings if we were to try to make a recommendation to reschedule

marijuana. so from that perspective there are challenges that we have been asked to look at it three times in the past and each time we have decided it is not possible given where we are with the science. >> when it comes to cbd the cat's out of the bag the marketing is amazing so what would you advise the public of the efficacy of the products on the market today? do they really help her do we even have a handle on what is truly in those products? >> both questions we do not know we do not know if the various claims being made are accurate to the standard i would expect for a drug product being developed. we don't know well enough for those that are sold under

those initiatives. we need more data in both of those places but my job is to make sure those manufacturers that want to study this can do that quickly study what works and what doesn't quickly. with regards to safety the agency understands we desperately need to collect all of the available information with all of those various uses. we have been in the process of a year-long effort to collect that data we have identified some gaps that we believe we absolutely need to know where in the process of figuring out how to close those gaps. >> your time is expired. the gentle man from virginia.

we are looking for another good story. >> i have lots of stories but we may not have time. i know you disagreed with the earlier assessment university of california attending the great virginia and virginia tech that i'm proud to represent. going back if the fda recommends they reschedule the compound is the dea required to comply with the recommendation? mimic if they recommended rescheduling we are bound to the statute that the attorney general shall be bound by the recommendations of the secretary as it pertains to science and medical matter. >> as the secretary determines. >> correct you can confirm the

dea has never refused to reschedule after be giving a recommendation by the fda. >> we are not aware of any instance that is the case. >> so now continuing as part of the united states convention of drugs that has manufacturing and distributing restrictions on marijuana some have cited our involvement as a reason why the federal government should not lift restrictions on marijuana regarding domestic manufacturing why is it other countries who have signed the same treaties such as israel ireland new zealand australia and the netherlands have several legal manufacturers of research grade cannabis and their products are legally imported but only the us has university of mississippi? there is a growing number of countries that have implemented laws in their countries that fully

effectuate their requirements and obligations. and so have we that's why we asked the university of mississippi but as we expand the number of growers we are trying to take a look at whether or not things need to be altered to make sure we are in compliance with our treaty obligation. >> i hope you work on that because applications for research are being approved but regulation and paperwork are perceived to be so onerous that people won't do it the paperwork and the regulations that perception is reality and then that becomes a problem. that is why you have not received more applications.

>> i will be very quick but to go back to your comment that there is a solution this interagency group works on throughout the summer with the important legislation of fentanyl related substances. as the administration we came out with an active role solutions to address all of their concerns by the research community. >> share that in whatever help you need and to be consistent with a 1961 convention on the treaty to register research grade marijuana as long as they agreed to only distribute with written approval but you say that testimony has changed

course. and the department of justice and then to be consistent. >> i cannot get into too many details with this process we are engaged in right now with omb. >> get that to me as quickly as you can. >> i appreciate it. >> and to the committee. can you provide any additional rationale to evaluate the statement beyond the volume of the applicant pool? >> the size of the applicant pool is on the single greatest issues we try to contend with to meet the statutory text at

which we were to evaluate manufacturers schedule one spinnaker happy to change that. thank you madam chair. >> it's a pleasure to welcome the gentleman from maryland. >>. >> thank you madam chair in the panel for being here today. doctor, thank you for your work which i know well. i have heard since the university of maryland baltimore that difficulty in conducting research due to the current regulation of any unintended violation of these

restrictions could have discussion about that here today despite these barriers they are eager to understand the topic. just last year the university of maryland began offering a master of science and therapeutics to have the degree and focused opportunity. madam chair i would like to submit this for the record university of maryland baltimore on the cannabis training programs. i would ask this be accepted into the record. would you agree as more patients accessing medical or recreational use that we

should take that step that the provider work for should be educated on these topics and ready to respond to patients questions? >> i believe we need to have much more education with respect to actually how. and if it could negatively impact. the problem is we do not have sufficient evidence for those programs in a way that is required. with the national academy of science concluded it is to say we will recommend. there are many concerns. one of the problems with the effects of thc with these medications and then expanding

our knowledge with those programs that are based on knowledge and not on anecdotes. that's why i highlight the urgency. >> that you are highlighting the impediment to creating workforce categories that can be a resource of expertise and perspective. and that comes to cannabis presented by the research because it is the chicken and egg situation. you can't open the doors to more effective research and creating specific workforce

categories and that to sustain it has made more complicated. i know a survey of health providers from 2015 concluded the health providers themselves perceive a knowledge gap relating to cannabis therapeutic treatment plans and the differences between various cannabis products and other areas. and for that need to be developed and to incentivize research for starters would help direct those knowledge gaps with the more robust provider workforce. >> and to do the research of

the consequences so they think without expectation they will be beneficial we owe it to them that's why we do research. and that is the urgency to expand our understanding of the miracle properties of marijuana. >> a pleasure to recognize the gentleman. from oregon. >> i came back in from the other hearing. i want to shift gears. there is a lot of interest in my district from farmers growing him for cbd for the hemp research with the farm

bill to remove hemp is the dea registration required to conduct research on hemp derived cbd? >> no. relatedly the final rule for hemp production dea is supposed to participate in oversight. is the dea prepared to handle registration of the private and public labs to handle hemp sampling? >> the issue of hemp testing which is actually baked into the us department of agriculture. no pun intended. sorry about that. . . . . your t

but he tried cbp and when it comes to cbp are you able to tell us if they are any closer to determining if there's appropriate frameworks and as a lack of research has it been an impediment to that process? >> it is a high priority for us

we understand the interest as i said before we are committed to working to find a path forward and i would also say the lack of information we have about the safety is a challenge we are looking to fill. we need to understand the use of cbd in order for us to decide how best to place it in the non- drug products. >> i want to push in term punchf the impediments to get an answ answer. i have friends that swear by cbp and whose friends doctors have said it doesn't impact anything else you may be taking. they know that. have you done the research? based on what we know from the dialects and the approval of the products that contain it does interact with other drugs and we

can get you that list if you are interested. there are interactions that could be clinically significant and i think for instance you would want to make sure that information is available to people. >> let me suggest they don't know it is available and they are being told by medical providers as one case i know don't worry there is no interaction, and this is legitimate a doctor telling a patient this is happening. i've got colleagues that have been on television proclaiming the importance of cbd in food products aninto theproducts andd consuming it which is fine, that's up to them the data is whaone of the impediments to getting the data and what does

it take to get the agencies to a point where you are leaving because the stakes are way ahead of where we are federally we have a legacy role to figure out where we are here. >> we've been fortunate you are right the states are because they've had to be effective face the use of these products in your own jurisdictions do states have been interested in understanding the same things and the state public health officials get that we need to understand the use and then make it and educate the prescribers and the choices they are making very quickly. unfortunately, historically it was used for its thc content and it's only been recently that those containing large amounts have come to the floor. the state data collection has been largely focused in the other direction and so they are

changing course. >> if you could get me that list if it is readily available on the website. >> absolutely. >> please do and thank you for your indulgence and i will yield back. >> i think it is terrific that we have our next member so we have a set of bookends esther schrader for his five minutes of questions. >> thank you madam chair i think it's great we have all witnesses we need medical research into the effects of cbd or marijuana products. the sad part is we are not testing the right stuff. i fail to understand with all due respect why we have one facility and an artificial environment in mississippi that is the sole access to the

research analysis of the cbd products. can you explain why that is? >> that location is a contract administered by the national institutes of health. >> lets me interrupt you briefly here for a moment of time. it seems to me we ought to be testing the idea that we are using a specific facility that does not mirror what people actually are ingesting, smoking, whatever is ludicrous. i am worried you talk about more regulation coming out. we should be making less regulations and say there is a legally approved facility in oregon, colorado, district of

columbia. we oppose the research for the facility. why are you not doing that? >> that is certainly a conversation we have been having. the challenge of course is the underlying principles the controlled substances act requires that people who are going to wall fully possess, distribute research with the substances have to procure to substances from a valid sores and at that point it is another register. >> in the eyes of the federal government i am arguing respectfully that the committee should be looking at legislation if need be. i don't think we need legislation it's just something they can say there are products

that consumers are being exposed to and we need to investigate them and make sure they are not affecting adolescents adversely and get it out there there is so many benefits pain relief wasn't getting done and they turned to cbp talk to me a little bit about approvals by the pharmaceutical research.

how can they get through and not other products? >> there are instances where pharmaceutical companies can be manufacturing through synthetic means in some of the substances and then making their own substances available for research purposes. >> those being approved by the dea i would like to get more information after the hearing. there is an apparent hearing for the more foreign applications to the domestic applications to get held for years. we've got what, 12 or 15 different applications that are penned in and coming to this long exhaustive regulatory process the products are out there now if we need to research and everyone on the panel has agreed to the research. let's just get it done. >> we had the same frustration

you do. >> well, madam chair, i will yield about it i appreciate everyone's interest. i agree 100%. i still don't understand why the asian tease can't get this done the next one to question is the gentleman from indiana. >> thank you very much madam chair. this is very important. as a doctor, data is critical you practice based on facts. i do support the legitimate medicinal use for thc and/or knowledge on the subject is very limited and needs more resource.

a a lot of times they have a misunderstanding and people think it's little children but actually it only goes up substantially until the mid mid-20s. you presented this but we all know it can have damaging effects on the brain as you mentioned. the studies you conducted the national institute of show a direct correlation between persistent cannabis use and talkative decline from one's childhood to midlife. epidemiological studies show the regular use have lower academic achievements and the risk of dropping out of schools, frequent cannabis use during adolescence is associated with changes in the brain involved in the memory, emotions it about

ovation. i have a slide presented to the doctors in number of years ago and i would like to introduce that into the record. it outlines some of the things talked about today. additionally coming if this is,e i will focus my question. recently putting a research describing the record levels of the teams vaping marijuana thc products [inaudible]

they are associated with this and so this is concerning and the regular use that we think are driven in part so it's affecting the pattern of use. along the lines sold at the shops and states that have legalized marijuana for recreational use and if they can't, why not? >> the researchers are afraid that if they use federal funds to purchase by buying them in dispensaries as a result of that

overall the research isn't done by investigators being funded through the nih. >> based on what you talked about in the rapid increase of vaping among teenagers, would you say we need to do something about that? >> i would completely agree we need to be able to move rapidly into the field i had a case in my district where a young lady wathe young ladywas sledding anr and the person that hit her was not impaired by alcohol or opioids and subsequently would find out its marijuana. but there is no legal standard unlike alcohol obviously there's no reliable test and for that reason i introduced 3890 to the

act in 2019 to direct the department of transportation to provide funding for the grants to address impaired driving. the drugs most frequently found but have been involved in vehicle crashes and your testimony you described at the risk of being involved in a crash significantly increases so can you describe the difficulties they may have been testing for marijuana and you've agree we need more funding for providing advanced measure testing for cannabis impaired driving? >> as i mentioned before, the problem that we have is a certain level associated with impairment. i had a very [inaudible] you may get high and three hours later still have high levels even though you are not intoxicated.

there isn't a one-to-one responded. so, to actually incentivize to determine whether someone is intoxicated or not and finding research and math. >> again that outlines why we need more research. i yield back. >> if there is anything to come out of this hearing is that the research is absolutely essential to. so much of this is two and two equals five, but it doesn't. the gentleman from massachusetts is recognized for five minutes, and i want to say how much i appreciate his input that he gave the chair and as we said earlier we will have a follow-up hearing what other stakeholders to start out with our government

agencies but agency but i thinke subcommittee will benefit more from the testimony from the five minutes of questions. i was hesitant to support legalization. many advocates told me they are worried about the impact of increased access to another controlled substance on the patients they serve it i tried to understand how we could protect the public health concerns. i talked to experts, doctors, families, advocates, regulators, some of you and that is when i started to get frustrated that as a federal legislator, my hands were tied because the policy still rested on richard nixon's same category as heroin.

frustrated us constituents told mayor marijuana is the only thing to ease their pain and some of the stories today. when i asked regulators and agencies how we can make sure that the strong clinical drugs are subject to the highest patient safety standard, i was told we couldn't until we did more research so i asked how do we do more research. marijuana can schedule one. how do we do that? we need more research. federal government had behind the catch-22 for a long time and meanwhile millions of americans mostlmostly black and brown were locked up for nonviolent offenses. they turned to the black market with no concern for patient safety to get their children what they need. meanwhile, cities and states are trying at times stumbling to put in place thoughtful and thorough regulatory framework with zero support from federal part of this. meanwhile, brand-new corporate industry is rising up predictable economic injustice

is. there is more. expanding critical research and the policy on the table today makes it intentional and aggressive to restorative justice. with our witnesses today i appreciate the deliberative process and i commend and share your commitment and that is why you are here but it's clear that we also out of time the states just are not waiting anymore. in the long path and a little more research isn't enough the federal government will be activatedeactivate honest and st stakeholder marijuana policy to breakthrough from the catch-22. so, in your testimony because it is a schedule one drug he's already indicated that i just want to make sure that i'm clear

in your opinion. >> with those restrictions are they rescheduled --

your agency would not be harmed in any way to continue to conduct its regulatory source? >> by dodgeball is not. it's going to accelerate the ability to do research but at the same time, it may have only the consequences of that again is why we bring the optimal way of moving forward to take other factors into consideration like the one.

>> i understand that the balance and appreciate the balance and wandwe are always trying to stre today. does the role of your agency changed its marijuana is federal? >> it would matter how it happened obviously. in essence it is another system on the subset under the developed and two and force the substance act. >> the gentleman and yields back. >> pleasure to recognize the gentleman from florida for his five minutes of questions. >> thank you, madam chair and thank you to the witnesses for

testifying today. it's been very informative. i was in telecommunications for a while, but i'm back now. do you think the process for conducting research on schedule one substance is coupled with the limitations on the subway research grade cannabis discouraged some researchers and investigate the compound is? >> the answer is yes and is voted down, yes. >> i have a couple of questions here i want to go over. would you agree that studying cannabis and its effects either bad or good is a fundamentally different question in legalizing or discussing medical recreational cannabis? >> absolutely. we want just like our colleagues as it pertains to the research

are they commonly available to the clinical investigators through federal sources and if not how might that pose a risk? >> of the drug side with the passage of the farm bill, they are now available for research and we are eager to support out in any way we can. we think that is a new way to get some of the questions that we desperately need answered.

>> with the recent long illness is relateillnesses related to tt thc were some of the take away lessons learned regarding the federal state oversight and research into the current products and consumption methods? >> as a result of that we didn't know how to diagnose it and we see them in the emergency medical rooms. we are just assuming based on what the patients are telling us we are able to sample from the forces that they are consuming and that is just one example about why we need to understand

the consumption of different marijuana because we see an adverse effects and so if we want to proclaim that there are many we need to understand how to optimally does not and we don't have that data. >> how they are being used as changing from year to year. the way these are being consumed and the doses they are consumed are all changing. we as a federal architecture need to find a way to track that understanding to identify the risks as they emerge quickly and ideally to find ways to address

efficacy but it's a central challenge for all of us working in this area. >> i'm going to yield the rest of my time to mr. griffith. as we heard earlier in the testimony, four years ago they announced that we accept applications for the manufacture for research grade marijuana to increase the diversity of products for scientists to study. they haven't acted and as we heard today they intend to propose regulations to govern the program for scientific medical research. can we have your assurance publicly and on the record that they will work expeditiously to be few legitimate applications to produce marijuana for federally approved scientific research and will print applicants be permitted to amend their applications to conform to the new rules so they are not

caught up in a catch-22 or vortex of tying? >> on the first comment, yes. we definitely will move expeditiously. we are moving expeditiously, although i know it is not acceptable for anyone here in public office. so we appreciate your patience on that. >> you already have an application pending and the rules changed, proceeding directly to go and do not collect $200 -- >> on that point when we announced the notices of applications in august of 2019 some of those applicants have been applied two years ago and we gave them the opportunity to get the reese -- refund. for the five minutes of

questions. there is bipartisan frustration on this issue i think my colleagues probably summarized where i am very deeply. michigan is one of the states this is being treated in. i will be th blunt i didn't supt it when it was on the ballot. i come from a family that has seen what drug addiction does to people. but like my colleague mr. griffin, mr. schrader, my husband suffered great pain and many people said that marijuana would be the only thing. would he try it, and he would not because it wasn't legal and he didn't know the side effects

though it might have given him relief in the end. but i was the keynote speaker this past year. i don't even know how it got scheduled if you want to know the truth. i'm still trying to figure that out. >> it wasn't a schedule one. [laughter] >> but i got up and said i've never smoked marijuana and don't think i ever will smoked marijuana. i was getting involved in direct spoke that day, but i talked a little scientists and there were three things that need to happen, and i am as committed as anybody on the need to give more research on this issue. ..

>> that's one of the reasons i introduced with my colleagues with the marijuana research act. even though it is legal for recreational use in 11 states. a study which i have right here that founds research with the health effects of cannabis has been limited in the united states. and the lack of knowledge

houses a public health risk. i want to make sure it's submitted for the record. having agreed with all of my colleagues with the three of you already established can we go back to look at some of these questions? talk about the administrative burden asking why it takes months to navigate. so what about the guidance surrounding schedule one and the ability to conduct this research? what do we need to do and why is it only one kind of marijuana? and why federal research has been done with a single source of cannabis.

>> also we are frustrated by the challenges of advancing the science and at the same time recognizing we have a problem. but it is pretty adverse effects. there are some benefits with the active ingredient in marijuana. so how -- one of the things that we are proposing, we are not legislators. it allows researchers to do research with proper revelations but expedited and

that is what we have been working on. >> how do we keep you from working and getting it done? >> we need to solve the problem and i agree and we need to figure out a way to be able to figure out new producers. and e value eight the diverse city as opposed to limiting the mississippi farm. these are revelations, not just wanting to say we are the only place that can provide it. >> i asked a lot more questions. >> the gentlewoman yields back. with pleasure to recognize the gentlewoman from indiana, miss brooks, for five minutes. >> i apologize to the panel. there is another hearing going on. we have been going back and forth a bit but your testimony

is critically important and for colleagues across the aisle there has been frustration because we are trying as members of congress to figure out what specifically we need to be doing to help accelerate medical research. that is the top priority of this committee and the purpose of having this hearing and with that, hearing testimony and knowing friends who have suffered from tremendous pain particularly from cancer i want to focus on pain therapy and talk a little about it and thank all of you for your work. i have mixed feelings about the issues of marijuana having been a criminal defense attorney and seeing these problems and many of them - united states

attorney working with the dea with tracking organizations that ruin neighborhoods and cause significant problems but i also have friends and people i know who have suffered tremendously, where marijuana has helped with their pain or those -- we are conflicted here. we at congress have a lot of issues we are trying to figure out how to break through and move the ball forward. it has taken years and we are so behind so what barriers remain to study the new therapies around pain and where cannabis can - or addiction therapies we are hearing. can you share what are the

barriers around the research specifically relative to pain? >> we are prioritizing. and hiv and inflammatory drop, and researchers for thc and cbd. we would like to have more investigators involved and that is where the discussion has been going back and forth. many investigators don't have structure, or shy away because they feel it is too much of an obstacle. >> would these be private

sector investigators or university investigators or what type of investigators, what kind of investigators do we need? >> one of the areas we are directed is academic investigators with industry so the problems being developed go into the market. so we have different mechanisms to facilitate those interactions, you don't want to limit its but facilitate research by the private sector. >> are there any significant pieces of research that have been completed? you talked about adolescents and children you have been following and what were the numbers of years you are typically looking for relative to research? >> it depends what you are aiming for. you need to follow up on brain development. if you are trying to talk about what extent there could be in

effect, and low back pain, that may be as solid as you can complete in three or four years. it depends very much what the game is. >> how many studies are we funding now relative, to focus specifically on pain management? >> we are funding $39 million for cannabis and of them i would say 35% gain. i have to check. >> off the top of your head are there any significant negative results that have shown your current research? >> from the ones that i do. >> thank you for your work. i yields back. >> the gentlewoman yields back. the gentlewoman from illinois.

>> thank you to the witnesses for being here today. my state of illinois the eleventh state to approve adult used cannabis was with that said i'm interested in the research that exists about cannabis particularly for vulnerable populations. and my colleagues to create legislative policy solutions to reduce health disparity and promote good health and all communities. so doctor volkow, you discuss the health effects of cannabis when it comes to prenatal and adolescent development. what is the state of the science in this area with minority populations. >> during pregnancy associated

with negative outcomes and the receptors emerge early on, and the way they are moving and connecting. it is something that needs to be taken with caution. we know in adolescence, every single story, it leads to worse educational outcomes and more sophisticated technology samples to understand how factors from one to the other. for example, for social environments, very negative affecting amplifying the consequences into the brain. if you come from a private environment your brain is going to have a much lower

development that enriches your experience and in those circumstances a greater negative affect. these are stories that are ongoing. it is clear drug and marijuana is not good for the developing brain. >> glad to hear you have a more diverse sample than it sounds you did. you are bringing more diverse city. >> in terms of ethnic backgrounds and economic opportunities. those are influencing multiple factors in the development of a child. >> doctor throckmorton, you mentioned the fda, it is more about the safety of these products. among the list, with special

populations like the elderly, children, adolescents and lactating women. can you elaborate more on this? >> the best data we have available comes from controlled trials used to approve dialects, product and procedure disorders. it was conducted largely in young children so we simply don't have any extensive randomized controlled trials in those populations. we acknowledge they are terribly important. we also posted on the web what we do know about demographics of response to the drugs so you can go on to drug trial snapshot page and it will show you the safety and effectiveness, have them broken down by sex, gender, age, ethnicity and you can see for yourself what you know about that but we need a lot more information to expand that to

understand the impact, because they simply weren't in the trials. they haven't had that opportunity yet but it is something we are working to fill as quickly as we can. >> assuming you are working to get more diverse city in the trial. >> absolutely. >> i go back and forth about how i feel about recreational marijuana. i went to college in the 1970s and that is the reason why. i read in the paper, starting january 1st, the papers talked about how emergency room visits have gone up because of this and places the treat dogs, people careless with edibles, they found more dogs getting sick too. we need to educate the public about the effects. i don't know if it is early

over exuberance because it just became legal, what we continue to see increased emergency room visits. >> i will comment on that. it has negative affects. what affects young people, and one of the greatest concerns is association of the use of marijuana and as a psychiatrist, i was strained at the prevalence of schizophrenia, one%. it so happened that is not the case and in some places it is higher. and it is a high content so in the netherlands which has the highest rate of schizophrenia, you can have plans that have

38%, it is not explained by having the genetic risk. there is something about high content thc triggering psychosis. >> the gentleman's time is expired. pleasure to recognize the gentleman from montana. >> thank you for the panel being here today. understanding of the consequences of regularly available marijuana and individuals is imperative. we should be concerned about lack of federal research on marijuana because when we consider such a drastic change we must ensure that policy is based on sound science so the focus on research is very appropriate. in november i joined 16 members of congress in asking william

barr to study the societal impact of legalizing marijuana for recreational purposes. as we start to see preliminary data from colorado and oregon it is important to fully evaluate their experiments before making federal policy. i appreciate that mister walden and mister burgess have asked for a hearing and we should continue to investigate. we should know how 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 and guidance of the facts and sound science is of grave concern. this is incredible concerning because we have an addiction

crisis in montana. methamphetamines and now opioids devastate our communities and tear up our families. meth accounted for 86% of drugs, trafficking in montana in the past five years. montana has worked hard to support people fighting addiction through drug treatment courts. these courts help people get clean and get back on their feet and stay engaged in their communities. all at a fraction of the cost of incarceration. consider making any drug legal or more readily available without adequate research of this place priority, when addiction continues to ravage our country. we should focus on combating addiction, building on this committee's bipartisan work and the success of the support act from last congress. we need to continue to support those who face addiction and need the help the most rather than making marijuana easier to access when we don't know the full effect on our communities. doctor volkow, ensuring access to mental health services is a top priority of mine.

unfortunately montana has the highest suicide rate in the country. i have introduced the national suicide hotline designation act which makes 988 the national suicide hotline number. this important bill will protect emergency access in rural areas who lack access to mental health professional. in your testimony you state mental illness and suicide in the country and multiple factors very likely to understand of exposure to cannabis in adolescence is one of them. can research draw connection between marijuana use and increased risk for suicide or mental health problems? >> there have been larger

studies that have noted increased read for suicide among regular users of thc but the evidence is not at his extensive as psychosis so we cannot ignore it but we need to determine if it is reproducible and understand the extent. something that has been noted by larger epidemiological studies. >> from your experience in this area do we understand the connection between marijuana and mental health and suicide? >> marijuana if you take i content thc is going to make paranoid extremely anxious and very afraid if not fully psychotic. one can conceive why in those circumstances, they feel threatened and attack someone else or attack themselves.

in some people that results in chronic things wrong and that is where we don't have sufficient knowledge of understanding why it is a very short psychotic episode and the use of marijuana with long-lasting effects. >> appreciate your expert opinion. it is possible that cannabis could increase suicide rates. is that correct? >> the epidemiological data has evidence that it is made. one of the issues, in the field of marijuana, people say you are exaggerating. how do you know a person to start with was suicidal thinking, put them adrift to take marijuana without the medicaid so how do you know

about that as opposed to another medication? >> it brings us back to the fact that we have to do the research. with that i yield back. >> the gentleman yields back, the gentlewoman from delaware for her five minutes of questions. >> thank you for this important hearing and thank you to the witnesses, as you can tell many of my colleagues are going over time or the time we have because there are so many questions we have. it was a multitude of issues we are dealing with in this hearing, both protecting and enhancing public health, providing economic opportunities, restorative and criminal justice as well as public safety. i am encouraged that the inclusion of comprehensive legislation that addresses the social justice aspects of cannabis reform. even a minor criminal record can lead to barriers in employment, housing and

education. it is a significant drain on our national economy. i introduced bipartisan legislation, the clean slate act which would seal an individual's federal record for nine -- nonviolent forcible position involving cannabis. as congress continues to evaluate our nation's approach to cannabis, let us continue to include criminal justice reform is a critical part of the conversation. doctor throckmorton, as you mentioned in your testimony the fda has approved one cannabis derived product for medical treatment which is used to treat rare pediatric seizures. can you walk us briefly through how the fda came to approve it? >> happy to very shortly. we have a process we laid out in a variety of ways including

small business assistance that gives a roadmap to drug developers beginning with conversations with us, i want to develop a drug to do the following and this is where i think i might get my drug, my active pharmaceutical ingredients so-called. we walk them through a series of meetings leading to if successful the drug approval of the kind we were able to do. >> a roadmap we can get a copy of. we will request a copy of that roadmap and i would like to follow up on what you learned through clinical trials as well. since the 2018 farm bill we've seen in expansion in commercially available cbd products, everything from cbd activewear to toothpaste. many of those contain various wellness benefits with reduced levels of anxiety or better sleep. the fda stated many of these

are marketed with unsubstantiated therapeutic claims. could you talk about what the fda does, what actions do you take for these bad actors? what are you currently doing? >> fundamentally, if someone makes a claim that their product treats diagnosis, mitigates or advances a disease, they are a drug. if they are doing that without approval from the fda they are in an approved drug subject to our enforcement actions. they are making claims they don't have any substantiated evidence for, we take an enforcement strategy that focuses on the high risk things. the really egregious claims. >> can you give us examples of what you did, you targeted, what you did? >> the egregious claims, we took action, we sent 15 warning

letters out identifying specific products that made those claims or in some other way violated the food, drug, and cosmetics act, we call on them to stop whatever the violation was they were committing, most of them had to do with labeling and gave steps they needed to take to - >> the warning letter went to the person who is the bad actor, how is the public informed of that to be where? >> those letters are public. you can see a series of warning letters. this is the third time we have done this and we have a follow-up plan for each of those companies to make sure they come into compliance. >> when iran through those intersections i didn't go through consumer protection. if i go into a store i'm not

likely to go on your website and figure out if this is dangerous or not. this is something we need to follow up on research and other issues, how to best protect the consumer. thank you so much for this very important hearing and i look forward to the next one and i yield back the balance of my time. >> thank you for your important work. the gentlewoman yields back. a pleasure to recognize the only pharmacist in congress, mister carter of georgia. >> we asked about changing from one schedule to another. i want to ask, you mentioned it is initiated in a number of ways. what initiated the change of hydrocodone from c-three to see

for. the you know? >> it was a petition from a doctor. >> why did it take so long -- 2016-10, it took until 2014 to initiate that. >> to complete it, i believe the position came - >> why did you have to wait on a petition? >> we don't have to wait on a petition. >> being as bad as it is did it take the dea until 2014 to reschedule hydrocodone from c-3-c2. >> when that position came and i would argue a lot of folks in the medical community turned access to opioids. a petition for marijuana despite its potential for

abuse, to the medical. >> we worked together for many years, i have great admiration for your work, great respect. you are asked earlier, if marijuana is a gateway drug, you gave a very scientific response. is there a gateway drug in your opinion? you understand, in this subcommittee, we have parents, loved ones who lost loved ones to opioid addiction, who have all said that it started with experimenting with marijuana. >> most of the epidemiological studies show with other big arguments for saying why it is a gateway drug.

a counter argument that if you have drug taking, it is more likely that you will encounter marijuana than heroin and go into other - and overall, where if you expose them early on -- >> would you agree that psychological effects of extremity with marijuana lead other people to experiment with other drugs which leads to more addiction? that has been proven time and time again. but the same goes with nicotine. with limitations on it. >> if you want to see time fly, i want to cut to the chase.

>> we need more research. tell us what you need to do. what do you need? do you need schedule one ava doesn't have anything in it except marijuana? fine with me. i will legislate that but tell me what it is going to take. >> two things. we have seen a 150% increase in the number of researchers in the united states for the last five years. we are making progress to do more for sure. what do we need in terms of improving access to research? i feel this interagency group of folks have worked collaboratively on a proposal that would do just that. >> you mentioned earlier about fentanyl. >> correct. >> let's get a copy of that. i want to see it.

we invite your input. i saw an article recently, there is actually the use of new research opioids prescribed less often in states where marijuana had been legalized for medicinal recreational use. as a practicing pharmacist for many years i said the only thing worse for me is filling a prescription for someone who doesn't need it is not filling a prescription for someone who does need it. if marijuana truly does have medicinal benefits i want to use it. i'm adamantly opposed to the recreational use of it. i think it is a gateway drug and it should not be used recreationally but if there are benefits i wanted to be used, everyone has expressed the same thing throughout the whole hearing. tell us how we can get this research done and how we can

find out, and it is a schedule one drug and 11 states of approved it recreationally. thank you and i yield back. >> the gentleman from california, mister cardin for five minutes of questioning. >> thank you for having this important hearing in this committee, that belongs to help the subcommittee and commerce committee. we talk about cannabis as a criminal justice issue or medical issue. the reality is we cannot pull them apart. research has shown use in particular incarceration is tied to poor physical and mental health outcomes later on in life. compared to those not incarcerated children and adolescents in the system for more than a year or three times more likely to have functional

limitations, four times more likely to have symptoms of depression and two times more likely to have suicidal effect into adulthood. i'm not talking about the use of cannabis but incarceration. let me make that clear. 75% of all the people arrested for cannabis related offenses, one in four under the age of 18, a quarter of 1 million teenagers arrested for these types of offenses each year in the united states of america. given that we now being arrested for possession growing or selling cannabis can lead to incarceration, incarceration had adverse health consequences, we could establish at a minimum cannabis criminalization, perhaps negative health consequences, so this turns to health concerns. we know that conviction for controlled substance can lead

to difficulty with job prospects which could lead to both unemployment and underemployment which has potentially adverse public health consequences similarly drug conviction means currently enrolled college student receiving federal student loan money would have their financial assistance terminated. this can harm the future employment, earnings and health prospects of that youth. examining the public health harms created by, location of cannabis is a type of research that could be conducted without having to expand the research. it is important for us to understand calling cannabis a gateway drug in anecdotal fashion is unfair to the american people and is not a proper dialogue policymakers and researchers and or medical experts should be having and the reason i say that is

because if we are going to have that discussion we should have the discussion and question is alcohol a gateway product or substance? is nicotine a gateway product or substance? to think that cannabis is in and of itself a category one evildoer is something that should not be the subject of dialogue when it comes to policymaking and real honest research, not anecdotal answers to questions. i think one of the things we need to understand as policymakers the inception of the united states congress calling cannabis a class one drug, i encourage everybody in this room and everybody in this country to look at the footage

on the floor of the united states congress and the nonresearch derogatory statements that were being made specifically about a certain community and how using cannabis would lead to rape and murder of women and citizens of this country. i'm cleaning it up a little bit because i think it is unfortunate that we have that stain on the united states congress and so far we haven't had the will to correct it. the united states congress made a mistake and every congress since is not had honest hearings and honest dialogue and has not allowed truly allowed the researchers in this great country to do the true research that needs to be done

for us to properly categorize cannabis in this country. as a result of that, we have millions of individuals in this country as i outlined earlier who have been subjected to incarceration and a criminal record that otherwise they would have a much more productive and better life and society would be much better off including the taxpayers if we were to get this right. hopefully we will have the opportunity to do that in future hearings of the united states congress so we can get it right and get the research done and end this anecdotal discussion and have a real discussion about the facts. with that i yield back. >> the gentleman yields back. the gentleman from illinois, mister shimkus, partner in all things nine one one.

>> thank you for being here. it is a long day for all of you and i didn't have to sit through all of it at least in the hearing room so i appreciate you had to do that. i will try to be fairly brief and this one is are you familiar with the most recent article that came out of the land of psychiatry about the risk of drug-induced psychosis converting to full schizophrenia. >> correct. >> can you tell me, i mean, that report, and comment on your observations of that? >> this report is consistent with the concern that the use of marijuana particularly with chronic psychosis, and the use

- that by itself will go away. with those individuals that went into an emergency department for acute psychotic episode associated with the use of canaries were much more likely to subsequently going to chronic psychosis. the use of marijuana not just with good psychosis but provides evidence, with transitioning into chronic psychotic episode as is the case of schizophrenia. >> mental health, early use, when they, a lot of people self medicate based on psychosis and i think a lot of us may have had personal experiences with family members or friends or neighbors that have fallen into this trap and part of it is

early drug use at an early age. let me go to this other subject we have been dealing with and this should be back to you, doctor volkow, and to mister strait, dealing with they thing --vaping and the vitamin e acetate issue. is it possible for scientists to conduct federally funded research in these vaping product? >> are we talking about stuff that is being consumed illegally? as opposed to creating thc extract that could somehow be

tested? >> that is the direction. >> as we said earlier the challenge is we understand researchers want access to that material under the controlled substances act. researchers generally have to obtain a controlled substance from another dea registrant. this is something doctor volkow has mentioned, failure to do so might impact their ability to keep their federal funding for their program so some have expressed some concern about that. >> let me follow up. with the cdc the scheduling status of cannabis makes it challenging for epidemiological testing of these vaping products. you are shaking her head yes. >> it did. when you start to see emergency room admissions in these communities, you would like to

be able for researchers to go in and try to understand the products accounting for the rise in these cases and that is not possible if you want to use funding for federal agencies. >> i want to yield my last minute to morgan. >> earlier, we were talking about the applicants that were already in place, 33 applicants who grow marijuana for research changed the rules. i asked if they could amend their petition and you said we did this before, we refund their money. i don't think they want their money refunded, they want to not have to go back and start all over again with their applications. can they amend their application? that make sense? >> thank you for giving me the opportunity to clarify. what i meant and said, before the applications had come in prior to passage of the farm bill some of these applicants

may have applied to produce things that are no longer controlled under the csa. we gave them an opportunity to withdraw the application for purposes of no longer needing it. those that have applied are in the queue and they will not have to reapply. we will be re-adjudicating every application. >> i appreciate that. that makes more sense from what i thought i heard. appreciate the clarification. >> the gentleman yields back. the chair recognizes the gentleman from illinois for his five minutes of questions. we don't have many members left. my understanding is they will be called shortly but it will be on time. >> for holding this hearing, it is timely rather.

and -- around marijuana. and and in january when this was here. not only this but also on risk of marijuana. very little is known about when and how marijuana can be harmful, frequently long-term use.

it seems to me many of these things including mine are stampeding to legalize medicinal and recreational use of cannabis but with those crises, they are confronting it. the revenues from increased marijuana sales and legalized marijuana particularly recreational to help correct budgetary issues they are facing and i want to ask doctor

volkow a question. will you expand on the possible health risk and implementation for citizens of these states which are exhibiting what i call a mob marijuana mentality and who are engaged in what i would refer to as marijuana mania that really exists in my state and other situated states across the nation? >> i like the way you call it marijuana mania because it is a change in belief about the fact there hasn't been evidence to make people think it is safe. i don't want to negate the possibility that in some instances the cannabis can have benefits but we cannot deny the fact that there are some

untoward effects. that does not mean we can come up with indications that it can be used safely for therapeutic purposes. these things are not exclusive but it is clear the evidence is clear the use of marijuana associated with negative affect, we are already seeing it by the significant increase in emergency department admissions being observed in states that are legalizing marijuana and hospital admissions. this happening. by changing the culture, legalizing it, more people are being exposed to it and as a result of that, otherwise they wouldn't have because they wouldn't want to do something illicit. the more people get exposed, the greater the likelihood that we will see adverse effects which is what we are observing. the data is clear that we can have adverse effects and at the

same time, we are leading us country is how rapidly the perception of risk has disappeared and we need to actually create the balance that brings evidence of what marijuana can do so individual that want to take it now the positive and negatives and don't do it blindly which is what we are observing happening. >> reporter: i'm very concerned about along with this mania that exists, the excuse of expungement of records. because of those records as meaning noise. is there a nexus between marijuana, effects of marijuana

and just marijuana and aberrant social behavior that creates a law enforcement issue which has led to mass incarceration? i don't know, can you make that connection? >> the deck of incarceration and incarceration of individuals with substance abuse disorder, it has showed that not only it does not in any way benefit or perfect anyone, it makes them much more vulnerable to relapsing and other adverse consequences so incarceration has an adverse effect on those that are suffering it. >> thank you. >> the gentleman's time is expired. a pleasure to recognize the

gentlewoman from -- no, no, no. i see. you are waiving on. we are going to go to miss barragan for five minutes of questioning and we have two members waiting on to the committee and i hope to take your five minutes of questions as well. miss barragan. five minutes. >> thank you for being here today and providing informative information. pretty powerful, the most powerful was to hear from congressman griffith and his 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 i would ask is there anything that could be done for him whether it is

legal or not and it was more of a sense of seeing your parents suffer and you want to give them something to make the pain go away and so i'm in the same boat of supporting efforts to make sure we are providing things like marijuana for medical purposes, having access to give some comfort especially near the end of their life. there is no reason people need to be suffering. his story was pretty compelling for me. i wonder if anybody on the panel supports any of the bills, any of the legislation before us today. does anybody want to comment on any support on any of the bills? >> i was asked more specifically which when i favor

and i favor the advance of science and the ability to do things in a way that can help us accelerate research but specifically which is the best deal. that is more on the side of the ones creating it. that may put them on the spot. >> i'm not asking for the best bill. the three bills i would support that i think would be helpful, but beneficial. >> we have been working with the fda, the creation of something that would allow research expeditiously. >> not just for marijuana but in general so researchers for the obstacles of the process. and it is what we try to

achieve. >> any particular bill you want us to help you with. the goal needs to be kept in mind, that are suggested in those legislations. we think about the goals in mind in particular the fda perspective. with appropriate scientific study. >> there is no official position in terms of any of the proposals. as we talk about today, the key is science is having access to the data. and in the executive branch

with legislation. >> on the issue of sickle-cell, in some states, i have talked to patients. i have seen what it has done to patients in pain when they suffered, they used marijuana to address acute pain that is a symptom of the disease, some of the states have medical marijuana. the list of conditions the qualifier patient to receive the medication. doctor throckmorton, is there way to assure states that allow for medical marijuana with a comprehensive list of conditions that would qualify for the medication so that those who potentially benefit from its effects are not

excluded? >> which medications are you talking about? >> we are talking about the use of marijuana. >> the medications for sickle-cell disease that i would advocate for in recent years. and those medications can and do work to understand there - >> the states that provide the list where people can use medical marijuana for the disease that is included. >> this addresses federal input. >> i yield back. >> the gentlewoman yields back. the gentleman from california recognized for five minutes of

questions. >> doctor volkow, using your testimony that cbd is ubiquitous, and cosmetics and other cbd-containing products which are marketed with health and wellness claims not backed by science. it is worth noting that more than 30 states allow competent medical use of cannabis, and cannabis related products, the fda approval for any indication. you see cannabis treated certain elements. they are refractory to other treatments for aids or receiving chemotherapy. for the treatment of chronic pain syndromes which is of particular interest during the opioid epidemic.

pain and specificity, evidence shows chronic use is not without consequence, with cyclic intractable abdominal pain and processing speed who use marijuana regularly. these changes are seen on brain mris, these changes can be permanent. with schizophrenia and bipolar old disorders, it is clear more research needs to be done to better understand the risks and benefits. doctor throckmorton, it seems the fda has found therapeutic value and marijuana related

compounds for limited specific uses. can you discuss what factors went into approving these drugs for medical use for these specific populations? >> it began with the basic science works -- it began with supporting the kinds of research night a supports to identify compounds and targets therapeutic targets of interest suggesting from animal models or other places that the drugs had use in those areas and something called translational science needs to happen which is the drug manufacturer, a developer picks up that idea and comes and talks to us and says we believe this is a product we can turn into a drug. what do we need to do? what are the next steps? and non-traditional studies and the new drug application shows in therapeutic area chosen by individual company, they are choosing to invest in pain, or

to invest in, i don't know, infectious diseases or whatever else it is with a particular product. our job is to make sure the assessment occurs and occurs quickly and efficiently, scientifically driven and results if data are what they need to be with a specific condition with safety and effectiveness. >> with his approval process, can fda extrapolate the safety of cbd for other products? >> extrapolation for effectiveness is very hard to do. we have done it in limited spaces. we can talk in more detail off-line. something that we are able to do more readily is safety. a drug in a class that has an adverse effect, does that seem adverse effect occurring in other drugs in the class. we discovered over the years but very small differences in molecules have very large

impacts in terms of effectiveness. thc and cbd are close to one another on the molecular level and restored the different patterns of use. >> your comments earlier said that cbd doesn't come without its risk. your testimony on some of these risks, can you elaborate what you know about cbd and what questions the agency may still have related to other uses? >> are you talking safety or effectiveness? >> safety and other uses. >> safety, my testimony outlines several buckets was one of the adverse effects we observed in clinical trials leading to the approval, two unknowns, things we believe we need to have additional information about, i would put in that category particularly certain things. >> i would like to make an important statement. as you conduct your data

collections you have got to ensure a diverse sample of populations, too many researches done on men and non-hispanics and non-african-americans in the medical world and in all categories of research you need more women and more people of color. thank you. >> the chair now recognizes mrs. schakowsky of illinois. >> i am a proud original cosponsor of representative jeffers of marijuana, freedom of opportunity act.

and to remove cannabis from regulatory controlled substance act and as criminal justice and mass incarceration is an aggressive issue we have been perpetually backing. .. 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 faced 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 h.r. 3797, medical marijuana research act of 2019. the bill would streamline the cannabis research process to ensure that our academic institutions remain at the cutting edge, et cetera. how can we establish a process by which researchers and estate like illinois where recreational marijuana has been legalized in several different strains of cannabis are now widely available, how could illinois

acquire the research supply through local dispensaries? >> this is this is a question te been discussing it and dea is one that's on the process of identifying additional sources of marijuana so researchers can investigate marijuana from different dispensaries. so that is ongoing and, but that's regulated by the dea. >> can we look forward it to some 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 controlled substances act to procure that substance for another dea registered researcher. so none of these dispensaries

are applying for 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 have to do on what is being sold right now. millions and millions of dollars being spent on it and many, many users. >> certainly, that's your discretion and congresses discretion as one way to solve that issue here i don't know at the end of the day with this administration would come down on that approach. >> is that the only were? >> no. i think there's other legislative means by which congress propose to change that specific requirement. but if you believe that it would require some legislative changes to the controlled substance act.

>> i did want to say about that piece of legislation, h.r. 3797, that i do have a concern that doj would have the ability to deny medical marijuana licenses based on even minor past drug convictions, and hope that we can also remedy that. though i know that we don't all agree on deregulation and d scheduling, we, i think 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 30 minute in the the statf illinois and many other states. i yield back. >> gentlewoman yields back. vote seven called and i recognize the gentlewoman from the state of washington, this

mcmorris rodgers 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 here i get asked about this a lot in washington state. we legalized recreational and medicinal marijuana the same year as colorado. i believe we were the first two states. i and a cosponsor of blumenauer research act because i believe we need more research. i also represent washington state university in the same situation as the university around wanting to do more research around the issue. since we legalized marijuana, the number of cannabis products available in the marketplace has exploded over the years. so have the marketing tactics that promise cannabis is 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 are not yet backed by scientific research or clinical trials. i'm concerned that manufacturers who are ignoring all the unknowns of cannabis and spending health promises to fuel an industry that is projected to be nearly $2 billion by 2022. i do believe this industry, like with the fda approved cbd oral solution for epilepsy, and others have mentioned this, is on the verge of major breakthroughs that can improve peoples life. 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 consumer safety issue. those priorities should be at the forefront as we unlock the mysteries of cannabis. doctor throckmorton, i wanted to ask, and others have on this topic also, as i i mentioned earlier, the fda has approved only one cbd product, a prescription drug product to trt 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. so what is the solution to this? how should it be handled? >> so not one solution, that shouldn't be a surprise, right? i personally believe one really important element is to encourage the development of a mature industry using these products. industry used in manufacturing

standards, industry used to packaging standards, labeling standards, an industry of the kind that you see when you go into walmart and costco places like that. those products are being manufactured to a standard as you said which i think is very valuable. i hope that by the recent increase in interest in doing research using these products, behind that will be a growth of an industry that wants to do the right thing, that once to be signed driven, appropriately labeled, manufacturing to a high. that's one important element. among other things i think it's jumping board that we laid out the pathway for nondrug products containing compounds from hemp to find a way for as far as developing this product and making them a properly available. >> do you see that happening at the state level in any of the states where marijuana has been

legalized? >> i do. >> for the industry or the nondrug products. >> we have really benefited from talking with the states. i would say your state has been particularly hopeful to us as we talked to them about their experiences. you had to do with all these things. the states are all taking different approaches but any of them come at us including your state, i know are grappling with these issues around labeling and dosing in manufacturing quality of 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, around the use of these products. and we seen some pretty dramatic increase in numbers around accidents. at the very time we are working here diligently to make our roads safer as and also the number of the town of the accident that involved 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 -- one of the unknowns. we studied it and children we never did this kind of studies because children don't drive but we understand we need to understand the effects of cbd on driving impairment. we need to have those data as soon as we can. >> okay. there's a lot more to explore here. thank you all for being here. thank you, madam chair. >> the gentlewoman yields back, and we thank her for participating in our hearing. so let me, i'm half of all of the members of the subcommittee, thank our witnesses. this is a long hearing. i might add it is the very first hearing on cannabis in the history of the energy and commerce committee, which is the oldest committee in the congress. so it's been a long hearing, but i think a highly, excuse the

expression, instructive one, because of the participation of all of the members. and we will have another hearing from other stakeholders that are nonagency stakeholders. so thank you again to each one of the witnesses. where you were not instructive, it was instructed 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 so many of our undertakings. i want to submit the following statement for the record, and i also want to remind members, of course they are not you, the pursuit 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. i request unanimous consent to enter into the record the following documents, a statement from greenwich biosciences, the statement from the american college of occupational and environmental medicine, statement from the national safety council, a letter from the national consumers league, a statement from doctors for cannabis regulation, testimony of erin smith, executive director of the national cannabis industry association, a letter from over 100 organizations in support of h.r. 3884, a letter from five organizations representing state legal cannabis businesses, a

statement from the california cannabis industry association, the testimony of congressman hakeem jeffries in support of 2843, statement from chris crean, resident of the number four and the word front interest, statement from america's first safe access. adapting a regulatory framework for the emerging cannabis industry. statement from the american property-casualty insurance association. testimony of the deputy director of the national organization for the reform of marijuana laws. our response letter from fda/nih, senator schatz. a letter from the minority requesting a hearing on cannabis. and here we are. a letter from the american

academy of neurology in support of h.r. 171. a letter from the american academy of neurology in support of 601, a bloomberg news article entitled pot imports grew as u.s. stalls on medical research. quite timely. a a collection of six letters fm organizational supporters of h.r. 3797. a statement from the biopharmaceutical research company. a letter from smart approaches to marijuana. a letter from the michael j fox foundation in support of hr6 are one. statement from the consumer brands association, a letter from the dea in replying to an application to grow marijuana research, to grow marijuana for research purposes, and slides created by nih entitled effects of cannabis on the human brain.

without objection, so ordered. does the ranking member have anything? >> i would not do anything to prolong the hearing. >> on that happy note, thank you to each one of our witnesses again. to anyone who remained in the hearing room, thank you for your attendance, and to the reporters, the press, thank you for your interest. at this time the subcommittee is adjourned. [inaudible conversations] [inaudible conversations]

[inaudible conversations] [inaudible conversations] >> senators, in conformity with your notice for the purpose of enjoying with you for the trial of president of the united states. i am now prepared to take the oath. >> while you place your left hand on the bible and raise your right hand. do you solemnly swear that in all things appertaining to the trial of the impeachment of donald john trump, president of

the united states now pending, you will do impartial justice according to the constitution and the laws, so help you god? >> i do. >> at this time i will administer the oath to all senators in the chamber in conformance with article one section three clause six of the constitution, and the senate impeachment rules here will all senators now stand or remain standing and raise their right hand. do you solemnly swear that in all things appertaining to the trial of the impeachment of donald john trump, president of the united states, now pending, you will do impartial justice according to the constitution and laws, so help you god? >> we do. >> for the third time in history a president is on trial in the u.s. senate. watch live tuesday when the