[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. but the researchers to do research with the proper regulation guidance. that is what we will be working with a coalition. but there is one from working and getting it done. and then to be able some of

the new producers in order to evaluate the diversity. and also on the mississippi farm. and the only place that could be provided with the research and knowledge. >> thank you madam chair. >> the gentlewoman yields back it's a pleasure to recognize the gentleman from indiana. there is another hearing going on i have been going back and forth. your testimony is important to us and across the aisle there has been frustration because i think as members of congress we are trying to find out specifically what we need to be doing to help accelerate

medical research. that is the top priority of this committee. and with that hearing testimony and knowing friends who have suffered from tremendous pain of those of cancer on pain therapy. i have very mixed feelings around the issues around marijuana with a criminal defense attorney. and as a former united states attorney working with the dea to disrupt trafficking organizations and drug trafficking to ruin neighborhoods and communities. to have a number of friends

that have suffered tremendously and those that help them with their pain or end-of-life. so where are we conflicted? we have a lot of issues trying to figure out how to break through to move the ball forward because it has taken years and we are so behind. what barriers remain to study the new therapy around pain and how cannabis can help or even addiction therapy? can you share what are the barriers that is relative to pain? to make we are prioritizing to cannabis research and the potential value for the treatment of pain addiction and also hiv and the

anti-inflammatory drug. so we would like to have more investigators and that's where the whole discussion has been going back and forth. those that have that support structure to shy away from schedule one. >> are these private-sector investigators are university investigators? what type of investigators do we need quick. >> one of the areas that is the problem that is developed going into the market. and then to facilitate those interactions.

and then to facilitate the research by the private sector. are there significant pieces of research completed? and with a long period of time of adolescents and children and i appreciate but what are the numbers of years that you are typically looking for in relative to research quick. >> it's depends on what you are aiming for. we have to follow brain development that could be ten or 15 years if you're looking at what extent it could have effect for patients for low back pain. maybe that's a study you could complete a three or four years. it depends very much of the aim or what the study will be doing. >> approximately how many

studies are funded now focused specifically on pain management quick. >> $39 million for cannabis. i don't know what percent for pain. >> off the top of your head are there any significant negative results. >> a pleasure to recognize the gentlewoman from illinois. in my state of illinois was 11 state to develop on - - approve cannabis and with that said i'm interested in hearing

the research that exist particularly for the vulnerable populations program the chair of the congressional black caucus in the network of my colleagues to create legislative policy solutions to reduce health disparity and promote good health and all communities. doctor your testimony discusses adverse health effects with prenatal and adolescent development. based on the science of thc in pregnancy with the outcome. but the can-am annoyed receptors can-am annoyed receptors at shows how they

are moving and connecting. this is something that needs to be taken with caution. we know that in adolescence so it shows those situational outcomes. and of those larger samples and through the study that has shown those social environments have a negative effect to identify the consequences so if you come from that environment you will have a much lower development with the environment that enriches your experience. those that have a greater negative impact. so marijuana is not a good

thing for the developing brain. >>. >> and with the background of economic opportunities and multiple factors of that development. >> doctor in your testimony the act line - - the actively broke in to look at the safety of the products in among the list to affect the population such as the elderly children adolescent pregnant and lactating women can you elaborate? >> the best data we have available comes from the controlled trials to approve the product for disorders. it was conducted in young

children so we simply don't have randomized controlled trials of those populations. we all acknowledge it is important. when we approved that we also posted what we do know about the demographics of response so go on to the drug trial snapshot it will show you the safety and effectiveness broken down by sex and gender and age and ethnicity. you can see for yourself what we know and we need to have a lot more information to expand that to understand the pregnant and lactating women. so they haven't had that opportunity yet. but this is something we recognize to fill as quickly as we can.

>> that we get more diversity. >> going back and forth away feel about recreational marijuana. takes me back to college in the seventies but i read in the paper how the emergency room visits have gone up. and even places that treat dogs they are careless with the edibles and more dogs are getting sick. so what do we need to do to educate the public because that just has become legal? or increased emergency room visits. >> one of the aspects so that

is what affects young people one of the greatest concern but it just so happens that is not the case those places are associated by the content of the thc. so to have the highest rate with the consumption of thc then this is not just explained that there is something about high content thc that triggers psychosis and we need to recognize it.

>> your time is expired. it's a pleasure to recognize the gentle man from montana. spirit to understand the full consequences of marijuana individuals we should be concerned of the lack of federal research because when we consider such a drastic change we must ensure that it is based on sound science of the focus today is appropriate. in november joining with 16 other members of congress asking attorney general bar of the societal impacts for recreational purposes as we start to see preliminary data like colorado and oregon is important to fully evaluate their experiments before making federal policy.

they should continue to investigate. and how greater access to recreational marijuana impacts the users. however expanding access to marijuana without the benefit and guidance of the facts of science is of grave concern. this is concerning this is an additional crisis in my home state of montana as the opioids devastate communities and tear apart families. accounting for 86 percent of drugs trafficked in montana in the past five years. and then through drug treatment courts they help them get clean and get back on their feet while staying engaged in their communities

at a fraction of the cost of incarceration. without adequate research it is a misplaced priority when the addiction continues to ravage the country instead we should focus on combating with a bipartisan work and the success of the support act we must support those that face addictions rather than making marijuana easier to access if we don't the full effect. so to ensure access to mental health services is the priority of mine but montana has the highest suicide rate in the country. i introduce the national suicide hotline that makes 988 national suicide hotline number this bill will protect

emergency access to care with a health crisis especially in the rural areas that lack access to mental health professionals. in your testimony you state serious mental illness and suicide is on the rise and multiple factors contribute to the rise and with that exposure to cannabis is one of them. does this draw a connection between marijuana use for suicide or mental health? >> there have been some larger studies that have noted an increase for suicide with users of thc. but the evidence is not bad as extensive. of which it is contributing so

it is been noted through larger studies. >> do we fully understand the connection between marijuana and mental health and suicide? >> marijuana high content thc will make them paranoid and extremely anxious and very afraid if not psychotic. that can explain why in those circumstances they feel threatened and attack someone else or themselves. and so with that syndrome we don't have the sufficient knowledge of standing in with a very short psychotic episode like the use of marijuana we

do not know that yet. >> but just to summarize i appreciate your expert opinion but it is possible that cannabis in one dish could increase suicide rates? >> the epi logical data has some evidence. but i want to be cautious. but what we have been criticizing with marijuana they say you are exaggerating. and that puts them at risk so how do you know? >> so we just have to do the research. i yelled back. >> the gentle man yields back.

's i thank you madam chair for this hearing and thank you for the witnesses. many of my colleagues we are going over time because there are so many questions that we have. it really is a multitude of issues to protect and enhance public health and provide economic opportunities in a just way and with criminal justice and public safety and at the end of comprehensive legislation though social justice aspects. even a minor criminal record can lead to barriers of employment and housing and education also a significant drain on the national economy. that's why i have introduced bipartisan legislation of the clean slate act with individuals federal record for

nonviolent or simple possession offenses progress congress evaluates the approach let us continue to include criminal justice reform is a critical part of the conversation. doctor, the fda has approved one cannabis derived product for medical treatment. which is used to treat rare pediatric seizures. so how can the fda come to approve it? >> we have a process we have laid down in a variety of different ways including small business assistance that gives a roadmap one - - a roadmap to drug developers with conversations to say i want to develop a drug for the following and this is where i think i might get my drug.

walking through a series of meetings if successful that we could do. >> you have a roadmap we could get a copy? >> absolutely. and also what you learned through the clinical trials as well. since the 2018 farm bill we have seen a massive expansion of cbd product one - - products including toothpaste many have wellness benefits like reduced levels of anxiety are better sleep for i want to continue on the fda has stated many products are marketed with unsubstantiated therapeutic claims. could you talk about what the fda does ask what actions do i take for these bad actors?

what are you doing quick. >> we are happy to follow the details fundamentally if somebody makes a claim their product treats diagnoses to prevent a disease, they are a drug and if they do that without approval from the fda , they are not approved it is subject to our enforcement actions. and then don't have substantiated evidence for the enforcement strategy that focuses on high risk. the really egregious claims to give us examples. so we took in action and sent 15 warning letters out to identify specific products to make those claims that violated the cosmetic fact. to stop the violation that they were committing. and then gave them steps they

needed to take. >> so the warning letter went to the person who was the bad acto actor? and how was the public informed? to make those letters are public to see the series of warning letters. this is the third time we have done this. and we have a follow-up plan for those companies to make sure they come into compliance. >> when i ran through all of those intersections i want to say that's another big area i know if i go into a store then i'm more likely to go on your website if this is dangerous or not. so we need to follow up looking at research and how to best protect the consumer. thank you so much for this very important hearing i look forward to the next one and i

yelled back. >> a pleasure to recognize the only pharmacist in congress. [laughter] from georgia. so to ask earlier in the hearing about taking the drug from one schedule to another. i want to ask you that it could be initiated in a number of different ways. what initiated the change? >> from a doctor. that started in the early 19 nineties arguably the academy was 2006 but it took you through 2014 to initiate?

>> so we believe that came in. >> why did you have to wait on a petition? >> we don't have to wait on a petition. >> then why is it better to take the dea through 2014 to reschedule hydrocodone from c-3 at sea to? >> when that acquisition came in i would argue a lot of folks were concerned about access to opioids so the petition to reschedule marijuana despite the potential for abuse and the actual abuse ran contrary to some of those other products. >> you and i have worked together for many years and i have great admiration for your work. you were asked earlier if

marijuana is a gateway drug , you gave a very scientific response. is that a gateway drug? you understand. we have panels who have lost one's to opioid addiction have all said it started with experimenting with marijuana. so those that is marijuana. and to say why it is a gateway drug. meant to have that vulnerability. and then to go to other drugs.

so i would stay based on stories not epidemiology. and then to be more sensitive to other drugs. >> that has been proven time and time again. >> so what have we done with nicotine quick. >> if you want to see time fly wait until you get appear for five minutes but cut to the chase. everyone appear as expressed the same concern. we need more research tell us what we need to do. what do you need do you need schedule one a? that's fine with me i will create it.

tell me what it will take. please. 150 percent increase researchers in the united states in the last five years we are making progress doing more for sure. what do we need in terms of improving access to research? and then to work collaboratively on a proposal to do just that. >> make sure we get a copy of that. we want to do the right thing. recently said the use of research was prescribed when it was legalized for medicinal

used as a practicing pharmacist have always said the only thing worse filling a prescription for someone that doesn't need it is for someone that does if marijuana does have medicinal benefits i want to use it i'm adamantly opposed i think it is a gateway drug but if there are benefits i want it to be used. everyone has expressed the same throughout the whole hearing. tell us so we can get the research done and how we can find out it is the epitome that the federal government has a schedule one drug in 11 states that approved it recreationally. embarrassing thank you and i yield back. >> thank you very much.

too often we talk about cannabis as a criminal justice issue and that research would have shown as to peer mental health outcomes later on in life. although not incarcerated children and adolescents were more one dish for more than one year or three times more likely to have functional limitations to have symptoms of depression two times more likely to have suicidal effects into adulthood for god not talking about the use of cannabis by incarceration.

let me make that clear. 75 percent of all the people arrested for cannabis -related offenses under the age of 30. one quarter are under the age of 18. a quarter of a million teenagers arrested each year in the united states of america. being arrested from possession leading to incarceration with adverse health consequences to establish add a minimum created health consequences that are negative so then it turns to balancing these concerns. but also the conviction for a controlled substance makes it difficult for job prospects leading to both unemployment and underemployment that has adverse public health consequences. similarly a drug conviction means a college student receiving federal student loan many would have financial

assistance terminated. this could harm future employment, earnings of the youth. examining the public health harm of the criminalization is a type of research that could be conducted without having to expand the research supply. it's important to understand calling cannabis a gateway drug in the anecdotal fashion is unfair to the american people and not a proper dialogue that policymakers or researchers or medical experts should be having. the reason i say that is because if we are going to have that discussion, it should be is alcohol is a gateway product or substance. is nicotine a gateway product or substance?

category one to what should not be the subject of dialogue with true policymaking coming to real honest research not anecdotal answers and questions. i think one of the main things we need to understand as policymakers is the inception of the united states congress calling cannabis class one drug i would encourage everyone in this room and in this country to look at the footage on the floor of the united states congress and the nonresearch derogatory statements being made about a specific 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 it is unfortunate we have that staying on the united states congress and so far we don't have the will to correct it. the united states congress made a mistake in every congress since has not had honest hearings or dialogues and has not truly allowed the researchers in this great country to do the true research that needs to be done and as a result millions of individuals and those i outlined earlier subjected with incarceration and criminal record and then to be

a better life to be the taxpayers to get this right. and then to get it right in the research done and and this anecdotal discussions to have a real discussion about the facts. are you back. >>. >> at least in the hearing room. and then to be fairly brief

are you familiar of what came out of psychiatry with the drug-induced psycho is so sis with schizophrenia? can you comment? and to summarize that report. >> this is consistent with christ - - with chronic psychosis and to go away with the use so this is the use of

marijuana and that positioning in that psychotic episode. mental illness and mental health. and if people do stuff as they medicate through drugs and we may have had personal experiences for friends and neighbors that evolve into the trap. and that is the early drug years provided in early years.

talk about the vaping and thc and the vitamin e acetate issue. so is it possible for scientists to conduct research with these vaping products quick. >> that is what is consumed illegally crack spirit by creating thc extract collects. >> i think that is the direction. yes sir. >> the challenge with that is they want access to that material. under controlled substances act they have to obtain a

controlled substance this is what they have mentioned a failure to do so might impact the ability to keep federal funding for their program. so some have expressed concern about that. >> would you say the scheduling status makes it challenging for the testing of the vaping products quick. >> yes it is. with the emergency room admissions. and then to with the accounting. and with those federal agencies like our. >>.

>> i appreciate the gentleman very much the applicants that are already in place those 33 applicants to grow marijuana for research are out there if they could amend their petition and you said we did this before. we refunded their money. that want their money refunded but not have to go back and start all over with their application. couldn't we just amend their application quick. >> what i meant was in prior to passage of the farm bill some of these applicants may have applied that they are no longer controlled under the cfa to give them opportunity to withdraw their application but those that have applied are in the queue and then to

adjudicate everything. >> i appreciate the clarification. >>. >> the gentle man from illinois. there are not many members left and it's my understanding votes will be called shortly. i think we will be on time. >> thank you for holding this hearing and with around marijuana.

[inaudible] but we prioritize research but we also run the risk of marijuana. earlier madame chairman what is known about how and when marijuana can be harmful. and with the medicinal and recreational use.

and those that supported. and the revenues from increased marijuana sales. to help correct those military issues. and then to ask a question and for those citizens and those that are exhibiting and then

to be more engaged and then wide exist in my state and across the nation. >> they actually call the changing belief without the evidence of the deep state. and then out there with the benefits they were not excluded but it is clear.

and then that emergency department this is happening. to create a sense otherwise they would not have because they don't want to do anything illicit. meant to see adverse success. and at the same time it is quite amazing that perception with the fear among the public. and then to create the balance of evidence of what marijuana can do for those individuals

with the positives and the negatives and they don't do it blindly. >>. >> and with that reference it is okay. is there a difference between marijuana or ingested marijuana to have a lower enforcement issue that leads to mass incarceration.

is buick and with that incarceration of individuals it clearly shows it does not in any way benefit or protect anyone that makes them much more vulnerable with other adverse consequences to have the adverse effect for those who suffer. >> we protect the gentleman. weight. we are waiting? now we go for five minutes of questioning so you are at

bat. thank you all for being here and to have that informative information is pretty powerful. to hear from congressman griffith it is the story that is the most impactful. when i was very young my father had parkinson's pretty much all my life. i would see him in pain and my mom would say i don't care if it is legal or not if there's anything we can do for his pain. and firmly in that same boat to make sure we are providing things like marijuana for medical purposes for those

that have access to give comfort and there is no reason people have to be suffering. 's story was pretty compelling. if anybody on the panel supports any of the legislation before us today? anybody want to comment on any support for any of the bills? >> actually more specifically i said the advancing of science to help us accelerate research. but it is more on the side of you to create these are the

three bills i would support that would be beneficial. and that to be working is that creation and allowed to do that research. >> not just that but the research and with that process. >> and it is very specific. >> and any other bill to help with obviously. so whatever the vehicle that

is digested and in particular from the fda perspective the outcome needs to keep in mind for drug development and appropriate scientific study. >> none of these bills have been reviewed by the administration so there is no official position for the any of those proposals and we mutually agreed upon to have the access to the data with that decision-making whether legislative or the executive branch to pass legislation. >> but on the issue of sickle-cell and from african-americans in some states they have a list

medical marijuana usage. i have talked to patients i have seen what sickle-cell has done and the pain they have suffered and many sickle-cell patients use marijuana to address acute pain that is a symptom of the disease in some of these currently have medical marijuana laws but choose not to because of those conditions that would qualify them to receive the medication. is there a way we can assure that states allow for medical marijuana for those that would qualify for the medication so those that would potentially benefit are not excluded quick. >>. >> which medications are you talking about quick. >> use of marijuana. >> those that i would advocate

for. but those medications we can and do work with providers to make certain. >> that was not the question. the question was those that provide the list and how that is included. >> i'm happy to talk with you off-line those states do that without federal input. >> it is a pleasure to act - - recognize the gentleman from california. >> thank you for being here. you say in your written testimony cbd is ubiquitous impossible to purchase as well as cosmetics and other cbd

containing products that are marketed with health and wellness claims. it's also worth noting that while the more than 30 states allow for comprehensive medical use and the fda has approved some related cannabis drug products it does not have the fda approval for any indication. what can be used to treat certain elements such as seizure disorders that are re- factoring to other treatments and a stimulant to receive human therapy as an adjunct to other therapies which is a particular interest during the current opioid epidemic. multiple sclerosis also evident shows chronic use is not without consequence. cannabinoid syndrome of the chronic at domino all pain and

those among teens who use marijuana regularly these behavioral changes can even be seen on the brain mri and they could be permanent so that bipolar disorder for young users of marijuana it is clear what research needs to be done to better understand the risks and benefits. doctor, it seems the fda has therapeutic value for those compounds but limited for uses can you discuss which factors went into approving these drugs for medical use for specific populations quick. >> it began with the basic science and supporting the research that we support to identify compounds and

therapeutic targets of interest to suggest from animal models or other places that they had used in those areas. and then translational science needs to happen which is a drug manufacturer or developer picks up that idea and comes to talk to us to say we believe this is a product we can turn into a drug but what do we need to do? what are the next steps? from clinical studies or nonclinical studies and the results of the new drug application shows in the therapeutic area and the individual company choosing to invest in infectious diseases with a particular product our job is to make sure that assessment occurs quickly and efficiently. and the approval of a drug with the understanding.

>> based on the approval process can you extrapolate the safety to other products? >>. >> and bad effectiveness doing it in very limited spaces something we could talk about.