Transcripts For CSPAN3 Key Capitol Hill Hearings 20151021

To access. These affect to these effective medications resulting in a significant Addiction Treatment gap in our country. This is without question a chronic neurobiological disorder that starts with a genetic risk, is informed by the environment, and is solidified by the culture surrounding it. Not unlike diabetes or hypertension, we can effectively manage the disease but stopping that treatment prematurely costs us lives. Were here today to provide recommendations on how best to respond to the epidemic of prescription opioid and heroin misuse, addiction and related Overdose Deaths. According to the centers for disease control, we have reached epidemic levels in our country. Weve all seen the data and heard the shocking statistics. But whats not said or heard enough is that the 2. 3 Million People who need treatment for opioid addiction have a chronic disease of the brain. While we need to prevent other americans from developing addiction, these 2. 3 Million People need treatment now. There are currently three medications that are fda approved to treat opioid addiction. Methadone which has been used in highly regulated Opioid Treatment Program since the 1960s. Its been used since 2002 by physicians who complete a special training in their offices and now trexone that can be administered by any licenses prescriber. All of these medications have proven tore clinically effective. A 2013 review of the scientific literature found substantial broad and conclusive evidence for the effectiveness of all three medications. And for methadone in particular. Notably the literature on efficacy of these medications is not new. There are now eight largescale rigorously conducted reviews of the literature on these medications since the early 80s. All fda medications have been shown to reduce mortality. Finally, we have a clear and comprehensive guideline for how to use these medications effectively in the Clinical Care of persons with addiction. However, despite the strong Evidence Base use of these medications and the clinical guidance available, very few eligible patients are offered medication to help treat their disease. Less than 30 of treatment programs offer medications in less than half of eligible patients in those programs receive medications. Indeed a study published this last week in the journal of the American Medical Association found that 80 of americans with opioid addiction dont receive treatment. This treatment gap is attributable to many factors, many some more complex than others. Research has demonstrated significant access barriers to methadone including waiting lists for treatment entry, limited geographic kovrm, limited insurance coverage, and the requirement that many patiented receive methadone daily. Data 2000 was intended to expand access to Addiction Treatment across geographies and populations by integrating it into the general medical setting. In recent months, my practice has had to turn away patients a due to the 100patient limit. And this includes pregnant patients as well as the children of my friends and has resulted in at least two Overdose Deaths that we can track. If i am out of town or unavailable, my fphysician assistants due to the restriction on pas and Nurse Practitioners writing it which exists even if they are under the guidance of a physician who is Board Certified in addiction. It is important to note that the entire purpose of data 2000 was to make opioid Addiction Treatment available outside an otp. And traditional physicians offices both to increase access in areas where otps may be physically inaccessible and to reduce the stigma and burden visiting for treatment on a daily basis. Still, because diversion and quality of care remain legitimate concerns, asam has proposed a gradual and limited lifting of the data 2,000 limits. But coupling with increased training requirements and accountability for those physicians treating large numbers of patients, we feel we can expand access while also ensuring a certain quality of care. Still, this single strategy should be just one part of a broader federal effort to ensure safe prescribing of opioids for pain, alternative pain therapy options and early identification and treatment of addiction. Pain and addiction education should be required curriculum in medical school and encouraged as continuing education throughout a physicians career. Communities should have the resources to educate their citizens about these issues and the outreach and surveillance resources necessary to better understand the unique issues and needs. Thank you again for the opportunity to present here today. Asam and myself look forward to a continued collaboration on this and other addictionrelated issues. The chair thanks the gentleman, now recognizes dr. Katz, five minutes for your summary. Epidemic confronting this nation has exploded in recent years due to the accessibility of cheaply made massproduced deadly synthetic drugs. As a physician on the front line, i have witnessed how these dangerous compounds have directly led to violence, hospitalizations and deaths. For example, in both the adult and pediatric expensive care units in allentown, pennsylvania, this spring, i spent countless hours at the bedside caring for patients suffering from synthetic marijuana which ripped through eastern pennsylvania leaving in its wake multiple patients in Emergency Departments, hospitals and unfortunately morgues. Mr. Chairman and members of the subcommittee, my name is dr. Kenneth katz and i am Board Certified in internal medicine. Thank you for allowing me to testify today on behalf of the American College of Emergency Physicians to discuss the dangers posed by synthetic drugs and to advocate for an act of hr 5353, the synthetic drug control act of 2015. In every Community Across the nation my colleagues and i are treating more and more patients of drug toxicity or poisoning. Its important to understand that the term synthetic drugs were using here today describes substances that are primarily manufactured in clandestine chinese laboratories and actually represents chemical combinations that are designed to mimic the effects of illegal chemicals with stimulant depressant or hallucinogenic properties. They are not organic, unsafe recreational drugs that produce psycho active or mindaltering effects. Many of these substances are markets as incense, plant fertilizer or air freshener and then sold in gas stations or online. Because of their commercial availability, many users presume they must be safe. However, the public should not be fooled. Even though these products may be hiding in plain sight, they are colorfully packaged poison. Unlike most illicit drugs, they contain chemicals with varying potency. For example, synthetic marijuana can contain compounds more powerful than thc. The only goal is to alter the compound to technically create a new compound allowing them to circumvent legislative and regulatory bans. This modification process poses increasing risk to users who are unaware of the reactions the new formulation may cause. It is not until these substances are ingested or inhealed that some can occur, high blood pressure, severe and uncontrollable agitation, seizures and ultimately death. At that point it may be too late for my colleagues or even me as a medical toxicologist to save them. While there is an increasing array of drugs manufactured, high use of synthetic marijuana whether its the data from sam d. E. A. s National Forensic laboratory or poison control centers, it is clear synthetic marijuana use has increased exponentially since it first appeared in the United States a few years ago. For example, according to nflas, there were 21 reports in 2009. By 2012, that number grew to more than 29,000, an increase of more than 1400 . Through the First Six Months of 2014, there were already close to 20,000 synthetic marijuana drug reports. My home state of pennsylvania has been especially hit hard by the increase of use of synthetic marijuana, trailing only new york, mississippi and texas in the number of reported exposures this year. Currently all 50 states have banned some cannabinoids with the majority doing so through legislation. Since synthetic compounds are easily manipulated, many states have passed laws targeting entire class of substances or used broad language to describe the prohibited drugs. Federal statutes must also be updated to meet this constantly evolving challenge. Synthetic drug control act of 2015 would amend the act so that substance can be treated as an analog if it is chemically similar or produces a similar clinical effect. In addition, the bill would add more than 200 known synthetic drugs to schedule 1 of the csa. This legislation is targeted to the manufacturers and distributors of synthetic drugs, not the end users. Hr3537 would amend the analog so that it would only apply to the sale, manufacture, import and distribution of drugs, not simple possession. The easy access to and thoughtless use of synthetic drugs by those who are unaware of their dangerous toxicities not only places their health and lives at risk but can have a profound impact upon my ability to care for all my patients. When users of synthetic drugs need emergency medical attention, theyre utilizing precious resources such as ambulances, Emergency Department beds, hospital personnel, and limited health care dollars. It is both my opinion and that of the American College of Emergency Physicians that this critical issue must be addressed with the enactment of hr 3537 and supplemented by a National Campaign to educate americans about the dangers of using synthetic drugs. Thank you. The chair thanks the gentleman and now recognizes dr. Anderson. Five minutes for your summary. Good afternoon. I am dr. Alan anderson, Orthopedic Surgeon specializing in Sports Medicine. Im also the president of the American Orthopedic Society for Sports Medicine or aosm. Its a Nonprofit Organization made up of 3,400 Orthopedic Surgeons specializing in the care of athletic injuries at every level of competition. 80 of asom meshes are Team Physicians and 60 of our members take care of highcontact collision sports where serious injury can occur. A Team Physician has unique responsibilities and qualificatio qualifications. He or she must have fundamental knowledge of onfield Emergency Care and treatment of musculoskeletal injuries and medical conditions. Today i will discuss the need for a Team Physician to be able to carry controlled substances when traveling with the team and the problems with current law. The fact that workarounds are not practical and why hr3014 the medical control substances transportation act will enable Team Physicians to provide the best quality medical care to our injured athletes. In emergencies or disasters where there is significant trauma, it is critical that a physician have immediate access to controlled substances. There are times such as during air travel or on a bus when the Team Physician is the only medical person available. There are documented cases of players having seizures after concussions on a flight home. And in such situations controlled substances are needed to stop the seizure and perhaps save the athletes life. Additionally, it is humane care to allow a player to take a pain pill if he or she has a broken bone, dislocated shoulder or torn acl. As you watch your Favorite Team on saturdays, one or more athletes is significantly injured in almost every game. These players are your constituents from every state. The Team Physician who is probably a member of asom is there on the sideline to render aid and take responsibility for the athletes wellbeing. This aid is being severely restricted by current law. The current law prohibits the transportation and storage of controlled substances away from the site of storage that is registered with the d. E. A. This makes it illegal for team doctors to transport a limited quantity of critical medications that are needed for pain control or emergency management. This is highly problematic for athletic Team Physicians who need the ability to maintain a limited supply of controlled substances if a player is injured in an away game. The current law also precludes controlled substances from being transported within the same state or across state lines. The current workarounds are problematic. Current options include predispensing medications to every member of the team prior to travel. That would be 80 members on a football team. This would create a logistical nightmare. Delegating the dispensing controlled substances to the whole medical staff and the state of entry, this is also a problem. The opposing Team Physicians can provide medications, but they have to independently examine the patient, and they have limited time due to demands to treat their own team. This would also create malpractice concerns for that physician of prescribing medications and not following that patient. There are also privacy concerns. A local physician is generally caring for the competing team. This would be unacceptable for the Coaching Staff to enter the training room. Hr3014 would address these concerns. It allows the physician who is traveling with the team the ability to appropriately manage the injury in a similar fashion to when in their home facilities. It does not diminish the need or requirement for controlled substances to be monitored at the current level. Records of controlled substances dispensed or maintained and subject to inspection by the d. E. A. At any time. The Team Physician will be responsible for the security of the controlled substances throughout the entire time the team will be traveling and the duration of transport is limited to 72 hours. Military flight surgeons and rural large animal veterinarians have an exemption to carry these medications. Contact sports can be much more perilous than noncombat military maneuvers. It is also hard for me to believe that horses and potentially cows could get better medical treatment than our athletes. This legislation would also benefit patients and physicians who donate their time and declared disaster areas in their states or other states. Therefore, we urge you to support hr3014, the medical controlled substances transportation act, so that we can provide the highest level of care for our injured athletes. Thank you for giving me this opportunity to testify, and im happy to take questions. The chair thanks the gentleman. That concludes the Opening Statements of our second panel. I have a uc request. Id like to submit the following documents for the record. Statements from the college on problems of drug dependence. The National Association of convenience stores. Dr. Cooper, head Team Physician of the dallas cowboys. The from terminatefraternal ord the American College of Emergency Physicians, center for lawful access and abuse deterrence, the American Academy of physician assistants, and the National Association of chain drugstores. Without objection, so ordered. Ill begin the questioning. I recognize myself five minutes for that purpose. Dr. Halverson and dr. Sledge and waller, you can respond here, too. Do you all agree that patients addicted to opioids should receive treatment based on their individual clinical needs . Dr. Halverson . Yes, sir. Dr. Sledge . Absolutely. Dr. Waller . Yes. How would you each advise hhs to take this principle into account when considering how to responsibly implement secretary burwells recent announcement to expand the use of medicationassisted therapy . Dr. Halverson . Since im not a physician, id like to defer to my colleagues here. Go ahead. All right. Dr. Sledge . And i think that prescribing physicians should be trained in all modalities of medicationassisted therapy as well as other options particularly psychosocial treatment with abstinence as an option. Dr. Waller . So weve looked at this very closely in the area that i treat im in charge of a sevencounty area. With patients in figuring out how to treat that sevencounty area. Weve been able to delineate two separate groups of patients which we have good data for, those that started very early in life and started earlier in their adolescence which have a different brain disease than started later in life. Those groups of patients actually separate us out a little bit as far as how treatment works. I have many patients in my clinic that are physicians, pilots and lawyers who i dont give any medication to because generally its not indicated, and we have wonderful outcomes without any medicationassisted treatment with those groups because of many other factors. My groups which are 92 of my patients which are medicated patients or those without insurance, i find that it is a perilous journey to try to treat them without medicine and the data back thats up with a high mortality rate associated with this group of patients specifically. And so dr. Sledge and i are saying the same thing. It is absolutely the right treatment for the right patient at the right time. And making sure that we allow for an expansion of use of these medications that save lives in the hands of those people who are trained best to use them. All right. Youve touched on this, but expand a little bit more on how should differences in certain types of patients and treatment settings and Therapeutic Options be addressed . Well, currently we have guidelines that directly do address the utilization of the medications. Theres are the first these are the first guidelines that look at all three of the fdaapproved medications and it does speak to the may have and psychosocial therapies without medications within there. Generally the medication treatment has been done in a cohort of patients that do not represent a physician or a pilot or a lawyer which, in general, we have programs within states that surround them that are different than the general programmatic treatment pathways. And so utilizing the guidelines that we have delineated with the appropriate education to back that up would be the way that i would say. Dr. Sledge . An overarching principle identified by the institute of medicine for successful treatment included patient selfdetermination, and i think that that hr2872, the opioid Addiction Treatment modernization act, brings patient selfdetermination back to the equation. And in your opinion, what are the most significant obstacles at the present time preventing more individuals with opioid use disorders from receiving the most effective treatments . I think that onesizefitsall treatment is very detrimental to addressing the Opioid Epidemic. I think that an assessment of each individual patient with recommendation and referral based on their individual needs is essential for successful treatment. Any other significant obstacles, dr. Waller . I think the legal obstacles to be able to obtain the appropriate medications for patients if we deem its the right medication for them such as specifically bupinophine, i treat all of the pregnant patients in that sevencounty area, and im out of space. And so i have to turn people away to areas that are either less than optimal for them or, you know, try our best with what we can do. But unfortunately that doesnt turn out very well. Can each of you comment on the role Nurse Practitioners and physician assistants play in providing officebased opioid treatment . I am not a provider of officebased opioid treatment so ill defer to dr. Waller. Dr. Waller . Without the utilization of my physician assistants, my office doesnt run. We have the capability to see patients in volume because we have welltrained physician assistants and Nurse Practitioners that work directly with boardcertified people, and there are other specialties, whether this is a neurosurgeon or Orthopedic Surgeon or addictions specialist. In this case an addiction specialty, coupling my physician assistants along with behavioral therapists with my patients works out really well. And we have great outcomes from this. And this is a model thats been adopted in the medical home model of care and is relatively standardized throughout medicine. And so to eliminate this as a possibility for this specific disease, does it make sense from a monetary statement nor a patient delivery standpoint. Im out of time, but dr. Katz, you talked about synthetic drugs and with the Movement Towards legalization of medical marijuana. Is synthetic marijuana considered medical marijuana, or are the advocates trying to include that in medical marijuana . Not aim aware of. No i think were talking about two different things. Yes, its completely synthetic. Yes. Thats what i thought. Thank you. At this time the chair recognizes the gentleman from maryland, mr. Sarbanes, filling in for Ranking Member green. Thank you, mr. Chairman. Before i ask my question, id ask unanimous consent to enter a letter from Purdue University college of pharmacy, dr. Nichols, which provides some additional perspective on this issue of adding certain synthetic drugs to the schedule icsa and the implications of that for scientific research. Without objection, so ordered. Thank you. I appreciate the testimony,. Everybody. The first question i wanted to ask and maybe dr. Halverson there your sort of Public Health perspective and dr. Waller but others as well, the word epidemic is getting used a lot to describe this. I, frankly, myself didnt appreciate that by the cdc definition of epidemic, weve actually gotten to that point. Can you comment on because, you know, epidemic, thats kind of used in the vernacular to just describe something thats sort of out and hand and serious. You know, if you talk about epidemic where it could be, you know, analogous to sars or ebola, thats to a different degree, and if you could to speak to that. Epidemic is used in large part because of the fact that we dont see an easily controllable end, that we experience the phenomenon, whatever it might be, an epidemic of flu or an epidemic related to any disease where the disease is raging beyond our ability to control it. And the disease has the potential to have a profound impact. And so under those definitions, we certainly have seen an epidemic of opioid abuse, of deaths, and the reality is is that we do have an idea of how to address the epidemic, but at our current point in time, we havent reached the point where we can actually say it is controlled. Any other perspectives . On that . So the two components of an epidemic is susceptibility of something and then to be able to come in contact with that something and have it spread. Weve seen exactly that pattern with heroin. If it shows up in a community, those people that have susceptibility from a genetic predisposition and have already been started on opioids or in the case of many areas, young people, this is the first drug they touch in some cases in early high school, and then they have access and genetic risk, it grows just like the disease that we look at on outbreak where it just covers the map. And thats what were seeing. It kills more people in my state than anything else. And its all people, you know, that are young and healthy as compared to other diseases that affect a whole different population of people. So lets say tomorrow you were appointed the opioid addiction czar in the same way that we had an ebola czar. I accept. Okay. And you could take whatever steps you thought were necessary. Describe what the first two or three things would be, both ones that would require additional resources, would be resource dependent as well it seems ones that maybe are not resource dependent like lifting some of the caps on the number of patients that can be treated and so forth. What would your steps be . I think the first step would be a reeducation of the population about what the disease of addiction is. That this is a chronic neurobiological disorder that has more data about the brain disease aspect than any other Mental Health disease in the history that weve ever looked at. So is that psas . What is that . Is that how do you get that word out . This is, you know, a Surgeon Generals report. This is public messaging. This is rebranding of a disease that has been maligned in the face, and we have been treating this with an emotional context rather than a science context for years. So that has to be the first place. Okay. The second piece is access to all treatments. And the third place is to build a structure around those treatments so that they are delivered with high fidelity and low risk. Okay. Thank you. Im interested because ive got a piece of legislation on this topic of this idea of encouraging coprescribing of maloxone at the time that a physician is prescribing a certain kind of opioid. You know, there would be some demonstration projects around this to test the potential of this and to look at the particular circumstances under which that would be appropriate, the kind of patient you know, their particular vulnerabilities and the likelihood of a potential overdose, et cetera. Can you just speak to your perspective on whether that would be a useful step . Well, first, congressman sarbanes, i appreciate that piece of legislation. It is very impactful. I carry maloxone in my backpack. Its something that we can do it is an antideath serum. And so to have this available in a coprescribing way to family members and to patients alike and to make sure that they are trained in the utilization of this is no different than having an automatic defibrillator on a wall in a gym. I mean, this is something that should be publicly available, and this is a great step toward that. We definitely support that. I personally support this as well as with asam as well. I think the Biggest Issue with this, we need to make sure and dispel the myth that somehow adding an antidote changes a patients behavior to use more often. That has been found to not be true. In the areas in which we have allowed this to be legalized and given to Police Officers and Community Members and made it available to patients, we have seen nothing but a decrease in mortality. We have not seen an increase in utilization. We have not seen an increase in amount of utilization per time. That is just not true. And when you reverse somebody, thats one more time that theyre not dead. And two, we have an opportunity to get them into treatment. So you have to bring all the other measures to bear and view that as kind of a first step back to that opportunity. Absolutely. Thank you very much. I yield back. The chair thanks the gentleman. Recognizes the chairman. First, i know you got up here early. I saw you on the airplane i believe coming out of nashville this morning. I appreciate and im also working with not your organization but people that practice in your area not just for opioids that youre talking about being able to carry but also a friend of mine is an Emergency Room Physician in auburn, so we traveled to kentucky last thursday night with the auburn tigers to watch over the team while theyre playing our beloved wildcats. And theres a licensing issue, too, back and forth about a physician license in alabama and to travel with the team into kentucky. We need to fix that as well. Thats something were looking forward to doing. The second thing, a lot of my good friends back in the legislature in kentucky, former colleagues of mine, were very aggressive on oxycontin and Prescription Drugs and put forth Prescription Drug ways to manage Prescription Drug abuse and it seemed to be very successful with it. Some of the physicians were really having to manage it very closely. And we thought, wow, we really are getting a big handle on the supply of the problem, which supply is still a problem. Youve got to tax supply and all of a sudden heroin became a big component in kentucky. I had lunch yesterday with one of our Drug Task Force leaders. He said its easier to get heroin now than Prescription Drugs in kentucky. I mean, illegal Prescription Drugs, use of Prescription Drugs. So we have to attack the demand for it as well and what you guys do. So one of the questions i have for those of you who have practiced in this area, dr. Halverson, you said youre not an m. D. I know there are caps on what practices can use for bupinorphine. My question is do you think the current cap should be lifted, and if not, why . And if so, how . So any of you that practice in this area, feel free to answer that question. So i can address it initially. The short answer is yes. But safely. Weve identified that this medication is diverted. And in some cases abused. I have patients that i treat for bupinorphine abuse. They show up and i treat them for that. Now that we have the deterrence, utilization through snorting or injection has significantly declined to the point where we generally dont use the mono drug by itself at all in my clinic. Do the caps put limits that you look at and say wow, i could treat more people if i didnt have this cap . I have a sevenmonth waiting list and its purely waiting on slots. Because of the cap. Because of the cap. And no i have no one else in my community of 1. 3 Million People that has any space on their cap that is a specialist in this area. Both of you practice in this area, i believe as well . Dr. Sledge, do you have the same issues with the caps . Well, and again, i dont practice in that area . Officebased opioid treatment. There certainly is not a cap involved with extended release and ultrexone. And again, with the issue of diversion and abuse, i do think that there needs to be diversion protection in whatever measures are taken to dress. Let me ask you a question, dr. Sledge. In your comments earlier, you talked about psychosocial should be added you just cant treat. Why is that important . Why is that important . I wanted to state the obvious but i want you to state for the record why thats important. Absolutely. And i think just prescribing the medication is not going to effect much in the course of this chronic disease. Its a chronic brain disease that affects not only with biological manifestations but psychiatric, psychological, spiritual and social manifestations, and all of those areas have to be addressed for ongoing recovery. I think that medication is unidimensional when its used alone. It addresses the biological manifestations of the disease, but the disease is multifaceted, and all of those areas must be addressed for therapy. I have one more question. If anybody wants to add to that, thanks for doing that. I guess also this is for the record, too, because i think a lot of us understand this, but aside from the Chronic Health impacts of addiction and deaths from overdose, what other health or social impacts are associated in indiana and nationally in your role, i know you see this nationally with opioid use disorders. Right. So one of the things that we experienced in indiana with the Overdose Patients were related to infections that occurred as a result of intravenous drug use. So again, part of the issue is people overdose on drugs for a number of different reasons. They frequently will also be affected by infections as well as actual other diseases that werent intended as part of the effect that they were trying to get from the medication. But additionally, there are a number of other issues that are related to the communitys Overall Health and the ability for the community to be resilient around this kind of disease is important to take into consideration in part, there is, i think, a general lack of understanding around drug abuse in particular. I think one of the questions that was asked earlier was related to what would you do to address the Community Awareness . Part of that is helping people to understand the Science Basis of this disease. It is indeed a chronic disease, and we need to begin to treat it in that manner and approach it from a scientific perspective. There still are a number of people unfortunately that believe that people ought to just quit that. They just ought to stop this. And they dont recognize the fact that this is a disease that has to be treated. We have to also make sure that people have access to treatment, which in our state as well as others, there is a problem. Im over time. I appreciate your answer. I know im over my time but i appreciate your answer. Thank you. I yield back. The chair thanks the gentleman. I recognize mr. Pollone. Five minutes for questions. Thank you, mr. Chairman. My questions are of dr. Waller. You mentioned there are three medications for opioid dependence, methadone, upenaphrine and now trexone. Could you briefly describe how methadone is used to treat individuals with opioid dependence, and are there special requirements to treat individuals with methadone in the Substance Abuse context . Yes, sir. So methadone is a full agonyist medication which means it resembles oxycodone and hydrocodone, morphine in that way. For patients who have traditionally a heroin addiction and specifically injecting heroin, we have great data that states that utelizing this medication in a fully inclusive biopsychosocial environment, not just the medication itself but then specifically adding the biopsychosocial aspects with that, significantly decreases craving for a drug. And by doing that allows them to continue to show up and have a very high retention and treatment rate. So about 75 of patients will be retained in treatment on methadone as compared to bupinorphine where youll retain at 65 . That number hasnt been fully vetted. But when we look at i guess what im trying to find out is why bupinorphine should not be regulated by methadone. Thats what im trying to get you the regulations around methadone are significant. And for a primary care physician to onboard the regulations, it would be a minimum of about 150,000 immediately with the paperwork, the accreditation through the joint commission, the accreditation through carf. At that point, you have to actually dlai actually there are specific issues where you have to par with Mental Health with requests for proposals, which requires a hearing. It almost completely negates the capability for a primary care doctor to deliver this medication at all. Again, i think you were getting at it, but i still dont understand, what are the medical reasons to justify why methadone comes with different requirements than the other two drugs. Well, one, those are historic because thats how it was started. And its been very regulated since it was initially utilized since the 60s. Two, it does have a higher potential for abuse. Three, it has a higher overdose risk. And so all of those are much lower which is why its schedule iii and able to be utilized in an otp. Okay. One of the bills that were discussing today, hr2872 proposes bringing the regulations for physicians who prescribe bupinorphine. How would this affect patients access or how would this proposal affect like pregnant women who are opioid dependent . I would have 200 people without treatment immediately. In my clinic. We would shut down any extension or expansion of this pathway given the amount of money that it takes to get into the pathway and then the amount of regulation surrounding it. So i think that it would be not just me, this is pretty well understood that if that happened, it would be catastrophic and the mortality rate would skyrocket. Isk baally it would profoundly affect our ability to respond to the current Opioid Crisis, in your opinion . Unfortunately, yes. All right. Now, another major access to well, the patients already face a number of barriers in accessing medicationassisted treatment or m. A. T. , and one major bare yes to access m. A. T. Appears to be cultural social stigma surrounding the use of these medications. Although theres strong evidence supporting the use of m. A. T. S, many people even within the treatment field condition to believe that using m. A. T. S is replacing one addiction with another. Can you comment on this perception in are patients on m. A. T. S merely replacing one addiction with another . The short answer is no. But specifically, if we look at what were trying to do the part of the brain that has been injured is the area that released a specific chemical called de called dopamine. We can stabilize that for long term. Unfortunately, we have found that some patients who have used this for an extended period of time, opioids and alcohol and at very high doses, they injure that part of the brain permanently. And that they may require stabilization of those chemicals for a very long time. And sometimes lifetime. We find that we dont we dont keep all of our patients in my clinic on this. We are able to wean a good number of them but it takes time and the data is clear that at minimum its 18 months to 2 years before the brain begins to heal in that setting. Thanks a lot. Thanks, mr. Chairman. The chair thanks the gentleman and now recognizes the chair, mr. Bucshon. Thank you, mr. Chairman and to all the witnesses. This is a very big obviously all of us want to help solve. I was a cardiovascular surgeon prior to coming to congress. Were talking today primarily about treatment. We all know we also have to probably address this on the front end with training of physicians beginning in medical school and residency. I can tell you the amount of training that i had even as a surgeon, specifically on Pain Management and the use of narcotics to manage pain was really minimal. Essentially onthejob training during residency. And i think we need to address that. Moving forward. I had a nice conversation with michael botocelli about an hour ago. As you probably know, the officer of the drug control policy. And i guess president obama will be commenting on this specific subject in West Virginia tomorrow. And ill be looking forward to his comments and what theyre planning to do to help all of us address this situation. I also want to comment on what mr. Sarbanes said about no lock zone. I think it is important that especially First Responders and Law Enforcement and probably family members of people who have these issues as well as maybe the people themselves have access with the appropriate training. Ive used it myself many times primarily in intensive care units when we felt patients were overarcatized. I really agree with what mr. Sarbanes said. The other thing is i think we need to recognize this goes across age groups. For example, in 2013, the most commonly prescribed drug under Medicare Part d was the generic version of vicodin. Not an antibiotic but a narcotic. So with that said, you though, i really appreciate all of your comments today. And i agree with the team doctor, dr. Anderson also, we need to address that situation going forward. Dr. Sledge, can you expand on your experience treating this problem with the available current medications that are out there . I mean, you obviously use other methods other than medical treatment medication treatment, but your experience at cumberland also using those options also . Sure. And i appreciate the question. Touch the button on your microphone. Okay. During the assessment process, its you know, we offer options, patients come in very clear with the course of treatment that we would recommend at the time of the assessment. There are a myriad of referents in the nashville area if they choose to utilize a different approach. But we use bupinorphine typically to detox to get them opioid free. And with a sufficient period of time which is difficult to achieve in an outpatient setting but in a residential setting with a sufficient period of time of abstinence, we can begin to use an opioid blocker if you will and administer that in an extended release formulation that lasts for 30 days in conjunction. Dr. Waller, i was interested in your comments about 2872 since im one of the ones thats working on it. Thank you. Were still working through this, trying to make sure actually we expand access to treatment for patients. And we have a process were going through that we need to continually work on. The one thing, though, i do maybe slightly disagree on is that we should consider history and we should consider money as part of the reason why to do or not to do things as it relates to drug treatment. I understand the practical aspects of that. So, i mean, what might you suggest . What would your suggestions be to expand really access to outpatient treatment for these problems . Because clearly, as you know, what we have now, we have methadone, bupinorphine and i keep confusing the two. You know what im talking about. I do, yes. Vivitrol. I mean, were trying to expand access. If you dont think that we should make sure that everyone is able to offer all of the options for treatment medically, what should we do . No, i think that i may have misspoke or been misunderstood. I think all three should be available for sure. I use all three on a regular basis. I have a number of patients on longacting altrexone. We use it at the time in which its right for the patient. For some people its right at the beginning. For my population in general, its toward the end of treatment as weve stabilized them on these other medications and let the psychosocial aspects really start to work. The biggest thing that i think we have to do is make sure that those of us who have access and knowledge and extra training and board certification in this area many like you did in your training, you wouldnt want a general surgeon doing cardio authorize attic surgery. Just like we want to be able to help our colleagues in primary care by stabilizing these complex patients and helping them to maintain them over a period of time and then in that fashion. So i think bolstering the capability for the people who are Board Certified and trained and focus on this illness to be able to deliver services to a higher number of people with all of the medications is of the utmost importance. Okay. Thank you. I yield back. The chair thanks the gentleman, recognizes the gentle lady from indiana, mrs. Brooks, five minutes for questions. Thank you, mr. Chairman, for holding this hearing and thank you all of the witnesses for coming today. I specifically would like to thank dr. Halverson for being here. Welcome to washington. Its an honor to have you before the panel and always nice to have a fellow hoosier in the nations capital. And i have to admit, your experience, state health director, cdc, now at Iu Fairbanks School of Public Health, were very fortunate to have you in indiana. And in fact, i want to thank you because dr. Halverson convened a roundtable at iupui with prescribers, pharmacists, members of hhs and v. A. , and we discussed the challenges indiana was facing then. As unfortunately one of the states leading the country in prescription opioid and heroin drug abuse. And we had quite a discussion that day. And we actually also had someone from the med school who attended, and we appreciated his participation. But one thing that ondcp, they released a report in 2011 that cited their intent to encourage medical and Health Professional schools such as fairbanks to continue expanding the continuing Education Programs for prescribers. More instruction on measuring pain and prescribing to treat it. Now, that was four years ago. I think were still really struggling in the country with getting our medical schools and our continuing medical Education Programs embracing this concept. And could you please discuss not only your efforts but id be curious from the panel what are we doing wrong . Why can we not get our med schools and our continuing medical education and other Health Educators to focus on the prescribing practices . Dr. Halverson, would you please start in because this is not a new issue. Ondcp said it in 2011. So what challenges, obstacles, what do we need to do to get our prescribers on board with this . Thank you, representative brooks. We appreciate your interest specifically in this matter. I would also say that the need is clear. It is my understanding, as we look at were constantly looking at curriculum. And this is an important issue. Ive had conversations with our medical school dean about this issue. But i also know that there are a whole lot of other issues that are also in competition for that time. But i also dont think theres any question about the importance of this education. Certainly as we look at indiana around issues of continuing education and the need to inform all of the prescribers around this issue, continuing education is not in dispute. I think really its been in the implementation, particularly as it relates to reimbursement and just the logistics around getting it in place. I dont think theres any di disagreement around the importance of the education. Well, ive been involved in Higher Education before coming to congress, and i understand the curriculum committees, theres a lot of discussion and a lot of work that goes into providing curriculum. However, when our med schools are saying they get three to five hours possibly in med school on pain, its just simply not enough. And at this point, to come up with one set curriculum i think is a problem. Lets do more. And so what more and im curious, do we need to be need . Does it need to be mandatory . Should there be certain hours that all prescribers are required to take a year . Im a lawyer. We have continuing Legal Education credits that were required to have every year. There are some what do the other panelists think . This is very troublesome for me not just for physicians, but nurses, dentists, others who are prescribers. What should we be doing . Any ideas . What can we do to fix this problem because weve been talking about it far too long and our educators havent resolved the issue . Two very practical possible solutions and one is to cons consolidate the efforts based on the governing body of medical schools. This curriculum has been developed by samsa as well as c ma c cms. This is curriculum. It is not. I dont know what is mandated. Are there other parts in medical education that are mandated, or is it all left up to each individual med school . Im certain there are mandatory curriculum items. Can you give us some examples . Every medical student has to rotate through the core curriculum. It hasnt changed in 100 years almost. It is internal medicine. It is general surgery, and then it is the connections between all of those, pediatrics. Then you rotate through the critical care, the inpatient care, and then the outpatient care. Until you mandate as part of the curricul curriculum, there is no way for them to glean from a book how hard it is too ta talk to these patients that have had a horrible life. Theres somebody who is Board Certified in pain or addiction to do this. Im sorry. My friends are not going to like me for this. But i think physicians who prescribe controlled substances should be mandated to have ongoing ce. My time is up. Mr. Chairman, if i could just ask the panel, i would be curious if anyone on the panel disagrees with that notion . No. No, absolutely not. Sir . I dont disdisagree. Thank you. With that, i yield back. The gentleman, mr. Tonko, member of the full committee, is recognized for five minutes. Thank you for the thoughtful discussion by the panelists and many in the room who make it their passion to end this epidem epidemic. I understand the drug act was passed to expand access to Addiction Treatment across geographic boundaries and populations by integrating it into the general medical setting. So for dr. Waller, can you describe how data expanded access to Addiction Treatment services in the United States . Yes, sir. Again, congressman tonko, thank you for all your hard work in this area. It is greatly appreciated. We have good partners. It has allowed for clinics such as mine, which i work for a medical system. Were able to open our doors and see patients based on referral and then deliver the highest quality of care. So it allows a specialist like me to work in a regular setting. From a primary care aspect, it does allow them to treat in place especially in our rural areas, there are no methadone clinics. There are no inpatient treatment facilities. We have an Upper Peninsula that is devoid of treatment. They dont have an buprenorphine in the entire Upper Peninsula now. This is a large portion of the population that is left without. Being able to not make this feel like a criminal act to write this medication for patients, not be fearful of the dea walking into your office while youre seeing a patient for hypertension to write a prescription for buprenorphine and then the availability for the medication to prescribe in a thoughtful way is key. We still have a lot to go. In terms of expanding it, the law expanded access to buprenorphine in some ways, but the law did set certain limits. And its clear from the current Opioid Crisis that we have outgrown those rules. As you know in 2012 96 of our states and d. C. Had opioid use. Im concerned the Opioid Crisis has outgrown those rules. Can you explain how the current cap of 100 patients, dr. Waller, has limited us to respond to the current Opioid Epidemic . One is the first year you can only see 30. You take your eight hours of education and make sure you finish the test and then you get your certification to see 30 patients. Next year you can apply for 100. Those of us who are specialty trained cap out at 100 pretty quickly because the vast majority of patients funnel to us, so we cap very early within our areas. In primary care we have a large percentage of doctors who have chosen not to write for this medication. It looks like we have a large amount of capacity. We have 423 primary care doctors in my medical group. It is very specific. Its consistent. They dont feel like they have the training. They dont feel like they have the support to evaluate and initiate treatment in patients and then stabilize them. They feel comfortable with the maintenance as long as they know they have backup, but the reason that we dont see a lot of primary care doctors seeing up to 100 patients or seeing the 30 is because they dont feel like they have the appropriate knowledge or backup. When weve offered that, they do a really good job with this. Once they learn about this disease, their ability to treat it is really good. Therefore raising the cap for people who do this as a specialty would allow us to hand some of our cases off to primary care. Do you have an opinion on the current prohibition of certain other professionals that might assist your prohibition on nonphysician providers prescribing buprenorphine . Does that limit Patient Access . It absolutely does. I have two physician assistants in my office who are the backbone of my patient evaluation. Theyre seeing patients as im sitting here, but were limited in what they can do. If i had an urgent intake, theyre frozen. I cant pick up a phone. They dont have the legal right to write that prescription. So starting this in a way that is appropriately supervised so they have someone to go to for the difficult patients is very important, but the access for them to be able to write these from a practical standpoint really just has to happen. They are really moving forward the biggest part of our health care system. Thank you very much. That concludes the questions of the members who are present. There will be other members who have questions and followups that well send you in writing. Wed ask that youd please respond promptly. Members should submit their questions by the close of business on tuesday, november 3rd. So members have ten Business Days to submit the questions for the record. Very informative and important issues were dealing with. Thank you for your expert testimony. It will help us as we proceed to move the legislation that was the subject of the hearing. I want to thank each of you for coming and presenting the expert testimony today. Without objection, the subcommittee is adjourned. Cspan this week presents coverage of former secretary of state Hillary Clinton as she testifies before the House Select Committee on benghazi. Our coverage begins tonight at 8 00 eastern. Live coverage begins thursday morning during washington journal with reporter interviews and early scenes from capitol hill. Tune in to cspan 3 starting at 10 00 a. M. Coverage. Cspan 2 will reair it in its entirety starting at 8 00 p. M. Eastern. Coming up tonight on cspan 3, a hearing on road and Vehicle Safety legislation. Then the Brooking Institution hosts the panel on Birth Control and family planning. Automotive industry executives and regulators and consumer advocates testified before a house subcommittee on improving vehicle and roadway safety. This hearing is two hours and 40 minutes. If everyone will take their seats, committee will come to order. Good morning. I want to welcome everyone to our hearing today on examining ways to improve vehicle and roadway safety. I will recognize myself for five minutes for the purpose of an Opening Statement. Certainly lives dependent on the safety of cars, safety of trucks, and on the roads themselves in the United States. And on the whole the data is good around the decrease in fatalities against miles driven. But the hearings over the last two years have certainly underlined the severity of problems that do exist, and theres no room for going slow when it comes to safety and certainly deception cannot and will not be tolerated. It is incumbent upon us, the national highway Traffic Safety administration, and others to assure absolutely compliance with Vehicle Safety standards and processes. Lives the depend on it. It is also our responsibility to revisit the adequate si of Safety Standards and processes that determine whether they provide sufficient protection to our nations motorists. This past year i think it has been clear to many of us on the committee and certainly clear to me that this is not always the case and that there is room for improvement. To that end, the discussion draft that we will examine today includes modifications to certain federal motor Vehicle Safety standards and their processes that will enhance Safety Practices amongst automakers at the National Traffic Highway Safety administration itself and provide more information to consumers about Vehicle Safety and foster the development of new Automotive Technologies that will save lives. Some of these modifications include updating how the national highway Traffic Safety administration makes Information Available to consumers. The discussion draft will before publicizing recall notices to consumers as well. These changes are intended to improve overall recall awareness by providing drivers were more complete information about a safety recall and giving them the means to take immediate action to get their vehicles fixed once the defect notice is received. The discussion draft also contains proposaled intended to improve how the national Traffic Safety administration collects and analyzes Vehicle Safety information. To increase accountability and improve Safety Practices amongst vehicle manufacturers, the discussion draft extends their remedy and their obligations under recalls and increases the time they must maintain safety records to facilitate the identification of potential defects and institutes safety incentives that encourage investment into next generations Safety Technologies. After a record year for recalls, the draft we will examine today also discusses roadway safety, Vehicle Safety, and is a continuation of this subcommittees efforts to restore confidence in american motorists that the cars that they drive are safe, that the recall process works, and that automakers and the national highway Traffic Safety administration are capable of keeping pace with the technology and the complexity of cars in the future. I certainly want to thank all of our witnesses for their testimonies. I look forward to an engaging and lively discussion on these issues as we seek to improve auto safety, save more lives, and ultimately benefit the driving public. With that, i will yield back the balance of my time and recognize the Ranking Member. Thank you, mr. Chairman, for holding todays hearing on a legislative effort to enhance auto safety and improve the recall process. I think it is a mistake to hold this hearing without a nongovernment Data Security witness. This draft legislation includes provisions related to privacy and Data Protection and it would benefit all of us to better understand the implication of those provisions. It has been plenty months since the initial gm recall and you think this committee would have acted sooner. As we see again today with the toyota recall of 6. 5 million vehicles, these safety issues arent going away. As a sponsor of legislation, im happy were finally having a legislative hearing. Unfr unfortunately, i believe were having it on the wrong bill. The Vehicle Safety improvement act, the bill i introduced with Ranking Member pallone and five other members of the subcommittee in march. Nhtsa needs to improve rear crashworthiness and every automaker as a executive responsible for certifying the accuracy and completeness relating to safety investigations. Im glad those provisions were included, but it would have been much better and more useful for the majority to engage in a bipartisan discussion during this bill. Had that dialogue taken place, many of the weaknesses in the bill could have been addressed prior to this hearing. It includes several provisions that would enhance safety and improve the efficacy of recalls, none of which are included in this draft legislation. The vsia would more than double nhtsas funding for Vehicle Safety programs. This bill provides no explicit additional funding for the agency. The vsia would increase the quality of information shared. While there is a nod to those priorities in this draft legislation, theres little meaningful change from the status quo. The bill would require manufacturers to fix all recalled vehicles free of charge rather than just those that were purchased within the past ten years. This discussion draft would not. Under vsia, nhtsa would have authority to expedite recalls. Neither of those changes are part of this discussion draft. Beyond those missteps, the republican draft legislation takes egregious steps in the wrong direction. The bill would give automakers a break from health based Carbon Emissions requirements. In the wake of volkswagens cheating, it makes no sense we would give carmakers a free pass to pollute beyond standards needed to maintain Public Health. This provision is a big win for the volkswagens of the world but does nothing to help the public. I urge my colleagues to engage in a bipartisan legislative process that will yield a stronger and more comprehensive bill. Im anxious to participate in that kind of dialogue. We still have an opportunity to do that. Unless there is someone else who would want some time, i yield back my time. Chair recognizes mr. Upton. Five minutes for an Opening Statement, please. Thank you, mr. Chairman. A car isnt just how you get around when youre from michigan. Its a neighbors job. Its the backbone of our states my. We take great pride in the industrys inventiveness, resilience, and creativity. Its helped the industry become a global leader. But over the past couple of years, weve seen the best of what the Auto Industry has to offer. Its no secret that im an optimist and believe that the future is bright for t Auto Industry for michigan and for the country, but unfortunately we have seen safety shortcomings and flat out dishonesty along the way. Were in the midst of an exciting time of automotive. What was once Science Fiction is now becoming reality. This innovation is to be applauded not only because it will revolutionize driving, but because of what it means for Vehicle Safety, the environment, and most importantly save lives. The staff discussion draft that were going to review today is a starting point to achieve those ends. It includes proposals intended to foster greater vehicle and roadway safety. Some pieces like having a corporate officer responsible for Safety Compliance certainly isnt new opposi. Other ideas may need to evolve. Theres good talk about forming a working group to address cybersecurity best practices. The draft seeks to address concerns around recall awareness and incentivizes automakers to invest in technologies that will indeed save more lives. This is a lifesaving endeavor. I look forward to a thoughtful and engaging dialogue on the merits of each proposal. While we have a ton of witnesses today, i want to invite everyone with an interest to give us feedback on how we can improve the legislation. Our work continues to improve safety for drivers and i yield my time to marsha blackburn. Thank you, mr. Chairman. I want to thank our witnesses for being here today. Chairman burgess, i want to thank you for this hearing. I think you have chosen a great day. It is october 21st, 2015. Remember the significance of that date and hear we are talking about interconnectedness of cars and using tablets, so perfect day to have this discussion. Chairman burgess, i thank you for the draft that you have brought forward. My constituents are truly interested in this issue whether they work with toyota or gm or nissan or in the after market auto parts industry with autozone. When you look at the stats that were going to have a quarter billion interconnected cars on the roadway by 2020, by 2020, and the significance of that, as automobiles have become more computerized, its important for us to look at these technological advances such as the vehicle to vehicle communication. Theres a lot of curiosity about that. We look forward to getting some answers as to how this is going to work, and i thank the gentleman from texas for initiating the conversation and yield back. Chair, thanks the gentlelady. The chairman recognizes mr. Pallone five minutes for an Opening Statement, please. The title of todays hearing refers to vehicle and roadway safety, but its clear from the draft before us that safety is not the focus. Instead of improving au auto safety, this draft weakens consumer and environmental protections. Traffic fatalities group in the u. S. By injuries are also up. Medically related Motor Vehicle injuries grew by 33 since 2014. Earlier this year we introduced the Vehicle Safety improvement act of 2015 with an eye towards comprehensive auto safety legislation. T it gets nhtsa the information, resources, and authorities needed to protect consumers and also empowers consumers with more information and ensures used cars are refixed before resold. This draft would give automakers credits towards Greenhouse Gas emissions. Even though theres no apparent link between these technologies and lower emissions. Manufacturers would get credits for things they are already doing, not as an incentive to improve safety. Nhtsa has already released its proposal to require vtov enabled cars. Many crash avoidance technologies are part of a prominent safety rating from the Insurance Institute for Highway Safety. Automakers have considerable incentive to add those features to cars. Im alarmed that congress would consider giving automakers a way around environmental regulations. Auto companies would receive a pass on pollution because they install Communications Devices in their vehicles. Communication devices will not prevent Greenhouse Gases. Im also concerned about the privacy and cybersecurity provisions in this draft. As more hightech Vehicle Safety equipment is integrated into cars, strong Consumer Privacy and Data Protections are more important than ever. But instead of improving privacy and Data Protections, this giving automakers liability protection. Because my time is limited, i want to turn to process for a moment. Im disappointed by the unilateral approach taken by the majority in drafting this legislation. For months, we have been trying to work with our republican colleagues to draft auto safety legislation that would meaningfully reduce deaths. But instead of pursuing a bipartisan approach, the majority chose to prepare this legislation behind closed doors. Regardless, if the majority wants to open up the clean air act, then this bill must be the subject of a hearing. Mr. Chairman, this draft in my opinion fails to increase auto safety. It harms the environment. This is a weak bill that i cant support. Yet again i can only express my hope that in the near future we can Work Together to make Real Progress towards improving auto safety. I yield back. This concludes Opening Statements. The chair would like to remind members pursuant to Committee Rules all members Opening Statements will be made part of the record. Beg again, we want to thank our witnesses for being here today taking time to testify before the subcommittee. Todays hearing will consist of two panels. Each will have the opportunity to give an Opening Statement followed by a round of questions. Once we conclude with questions on the first panel, well take a brief recess to set up for the second panel. Our first Witness Panel for todays hearing is to include dr. Mark rosekind, the administrator of the national highway Traffic Safety administration and mrs. Maneesha mithal, the associate director of the division of privacy and Identity Protection at the federal trade commission. We appreciate both of you being here today and sharing your time with us. Well begin the panel with you, dr. Rosekind, and you are recognized for five minutes for an Opening Statement. Its a privilege to rep the men and women of the national highway traffic and safety administration. Our mission is focused on saving the 32,719 lives lost, prechting the 2. 1 million injuries, and reducing the 5. 4 million crashes that occurred on american roadways in 2013. In just the last ten months, the agency has done the following. Strengthened our oversight and enforcement on Vehicle Safety, issuing penalties for recall and safety reporting failures and making innovative orders to improve safety performance in the Auto Industry. Weve embraced secretary foxs call to accelerate technologies that can save lives. Accelerating proposed rule making on vehicle to vehicle technology. Were taking view of our regulatory structure. Announcing our intent to add automatic emergency braking to our auto system. And we have answered the call of this committee and the American Public to improve our own performance in identifying safety defects. To these efforts are underscore nhtsas commitment to safety. Whatever decisions this committee or the congress will make, nhtsa will seek to do all we can. With your help, we can do everyoeven more. In the grow america act, secretary fox proposed significant enhancements to nhtsas safety authorities, including imminent hazard authorities similarly held by other safety regulators, criminal penalties for vehicle hacking, and significantly enhance Civil Penalty Authority to provide meaningful deterrence against violations of the Vehicle Safety act. This would provide significant funding to enhance our office of defects investigation and to address emerging issues such as cybersecurity. These proposals are essential to enhance our safety mission. And as i told your Senate Colleagues in june, failure to address gaps in our available authority, personnel, and resources are a known risk to safety. Nhtsa has been only able to spend a few days on this legislative proposal that was released late last week. I would like to thank the Committee Members and staff with their engagement with nhtsa and hope productive conversations can continue. The discussion draft proposal includes a provision that would provide fuel economy to automakers for deploying advanced crash technologies. I would raise two general points here. First, there should not be a tradeoff between safety and Public Health. The American Public expects vehicles that address both safety concerns and Public Health and Environmental Concerns. Second, the automakers already have ample incentive to deploy Safety Technologies. The lives they can save and the injuries they can prevent. State agencies are one potential touch point for owners, especially second or third owners of used vehicles. The technology is not yet in place, which is why grow america proposed a Pilot Program to work through these issues. Under the draft proposal, states that do not meet the requirement would be kicked out of the National Driver register, that identifies traffic offenders and ensures that commercial drivers have clean records. The current proposals may have the opposite of their intended effect. By providing regulated entities majority reputation on committees to establish appropriate practices and standards and th standar standards, the proposals could undermine nhtsas ability to set safety. The draft proposal would require nhtsa to prepare recall notices with the manufacturer. This proposal would require nhtsa to withhold safety defect information from the public and give the manufacturers responsible for the defect control over the timeline and release of nhtsa initiated recall actions. This proposal weakens the agencys Enforcement Authority as in direct conflict with other congressional legislation. The best response to recent events to auto safety is to achieve its mission by working together to address gaps in our authorities and resources. Discussion of these and other issues is essential to our shared goal of greater safety on americas roads. I thank you. Chair thanks the gentleman. Gentleman, yields back. Dr. Burgess, Ranking Member, and members of the subcommittee, im maneesha mithal. I appreciate the opportunity to present the commissions testimony on the privacy and security related provisions of the discussion draft to provide greater transparency, accountability, and safety for nhtsa. We are the primary federal Agency Charged with protecting the people with safety and privacy. In addition to enforcing a wide range of privacy and security laws, the ftc educates consumers and businesses. The next conference will take place on november 5th in austin, texas. On the policy front we conducted a workshop on the internet of things where we specifically hosted a panel on connected cars. We released a report on the workshop earlier this year. With this background were pleased to offer our views on title 3 of the discussion draft. We have serious concerns about the privacy, hacking, and security provisions of title 3. First as to privacy, were concerned that the safe harbor from ftc action is too broad. A manufacturer who submits a Privacy Policy that meets requirements but does not follow them may not be subject to any enforcement mechanisms. Even though the Privacy Policy is only required to describe privacy protections for vehicle data, the commission could be proincluded from bringing a section 5 action on the manufacturers website, even if the misrepresentation is unrelated to vehicle data. Security researchers, however, have uncovered security vulnerabilities in connected cars by accesses such systems. Responsible researchers often Contact Companies to inform them of these vulnerabilities so the companies can voluntarily make their cars safer. By prohibiting such access even for research purposes, this provision would likely discourage such research to the debtriment of consumers privacy and safety. The bill creates an Advisory Council to develop best practices. Manufacturers that implement these best practices will have a safe harbor. However, the current draft may not result in best practices robust enough to protect consumers for several reasons. First, at least 50 of the councils membership must consist of representatives of automobile manufacturers because any best practices approved by the council will be by a simple majority of members, manufacturers alone could decide what best practices would be adopted. Second, the discussion draft contains eight areas the best practices may but not must cover. In this respect, the draft does not create a minimum standard for best practices. Third, theres no requirement to update practices in light of emerging risks in technologies. Fourth, but creating a clear evidence standard, the bill gives nhtsa too little discretion and would likely result in the approval of plans that meet the bare minimum best practices on paper. Finally, the proposed safe harbor is so broad it would immunize manufacturers from liability, even as to deceptive statements. For example, false claims on a manufacturers website about its use of firewalls would not be actionable if these subjects were covered by the best practices. In sum, the commission understands the desire to provide businesses with certainty and incentives to implement best practices. However, the security provisions of the discussion draft would allow manufacturers to receive substantial Liability Protections in exchange for weak best practices by a council they control. T thank you for the opportunity to provide the commissions views on the discussion draft. We lo gentlelady yields back. We will move to the question and answer portion of the hearing. To begin, ill recognize myself for five minutes. Ms. Mithal, let me ask you to clarify. You mentioned there would be one of your start with security business initiatives in austin, texas. Is thats correct . Thats correct. Whats the date you gave for that . November 5th. I wanted to repeat that because although my Congressional District is a little north of austin it obviously will Effect People in my state. Dr. Rosekind, thank you for being here. Thank you for always being very generous with your time and very forthcoming whenever they are questions. Thank you for opening up the doors of the national highway Traffic Safety administration to come and visit with you and see the good work that you and the men and women employed there the good work that youre doing. I have a copy of the Inspector Generals report. This was issued in june of this year. Can you take just a moment and go through which recommendations have been implemented . Certainly. Just as context, ill be clear that one of the things we did was actually commit to fulfilling all 17 recommendations within a year of which the Inspector General made sure i understood thats never done, to actually make that kind of commitment, and we actually gave a schedule. I mention that because the first one has been completed two weeks ahead of schedule. Very well. Can you briefly describe the operations for the council of Vehicle Electronics, Vehicle Software, and emerging technologies, that council thats being set up at nhtsa . The current sorry. Just trying to clarify. Is there a council for Vehicle Electronics at nhtsa . We have an office. An office. Right. Okay. In fact, and im just trying to get my bearings there. In 2015, i actually and we can send it to you, we published vehicle and cybersecurity. It actually describes how over the last few years starting in 2012 we reorganized our offices to have a specific office that addresses that with people vehicle looking at that. Is there a separate office for Vehicle Software . Thats in that and we have seven people in d. C. And three at our ohio Vehicle Research and Testing Center thats there. And who leads that office of that council . Well, right now the associate administrator is the technical lead on that. And that also includes the center for emerging technologies at nhtsa . Correct. Is there a Mission Statement that has been published for that office or that council . I dont know if theres a specific Mission Statement for that office, but all of that would be in the 2015 nhtsa and vehicle cybersecurity that well send you. If you were to give us a thumbnail of what the mission of that office is, could you do that . Sure. You know, in 2012, i think this was trying to look ahead. Whats been interesting for me is everyone saying this is an issue now. This has been on us for at least three years, starting with a structural change to the agency that would have at least focused people looking at this. And theyre looking at policy, testing, research, and having continual interactions in the industry. Let me just ask you does federal trade commission currently coordinate with the national highway Traffic Safety administration on data privacy and security . We do, yes. For example, weve had several meetings with nhtsa staff. We also commented on their report on vehicle to Vehicle Communications last year. Let me just take a minute, dr. Rosekind. This may not be entirely within your area, but youre aware another subcommittee held a hearing on the volkswagen emission issue. Do you know what are the standard allowable nitrous oxide emissions are . Can you give me a figure in grams or liters of what is allowable under nitrous oxide emission . I can make sure we send you a Technical Report so i can give you a specific number. That would be great. And i would like to know what that was in calendar year 2000 as a reference point. Would that be possible . You bet. I will yield back. Thank you. Id actually like the victims or their families of the gm switch failure to raise your hands. I want to thank you very much for coming today. I know this is of great interest to you. I have a question for dr. Rosekind. So this draft would require nhtsa to coordinate with au auto manufacturers before publishing any notice of vehicle defect or compliance concern. It seems as though a manufacturer could obstruct the notification process at least temporarily by failing to submit the vehicle identification numbers. How would requiring nhtsa to coordinate with manufacturers before publishing a notice of a defect present a risk to nhtsas ability to issue recalls when necessary . And id like to handle this actually from two angles. One is what youre highlighting. This actually addresses nhtsa initiated actions. Why thats important. Because many of the recalls that occur are initiated by the automakers. They identify something and they move forward. A nhtsa initiated recall is because they have denied the need to do that and weve had to have the action. The concern is the timeline and control of that would be basically under the control of the person who created the defect. But i think the other part really has to do withholding the safety information. Its really frustrating to put the information out and not have the supply of parts. But i cant imagine any of us si sitting here and nowing that we had Vehicle Safety information, holding that back, and have someone lose their life. If people have they information, they get to choose what theyd like to do, including park their car or get a rental. One has to do with the control in timeline, that would be the manufacturer. The other is for us to think about the potential delay in providing information, which clearly wed rather do as soon as we have it. Thank you. Its clear the ability to move quickly in situations in which a vehicle defect poses a series Public Safety risk, even the life of someone, is essential, but nhtsa has no authority to take emergency action. Thats why in the legislation mr. Pallone and i have introduced the Vehicle Safety improvement act includes Imminent Hazard Authority, which gives the administration the ability to step in and issue a recall in cases where defects substantially increases the likelihood of serious injury or death. So how would this Imminent Hazard Authority be helpful to nhtsa in carrying out its mission to reduce deaths, injuries, and Economic Loss resulting from Motor Vehicle crashes . Thank you, congressman, for identifying. We dont want to go from withholding information. We think we need to be in the other direction, which is what you have talked about. That authority, which others already have, is not available currently to nhtsa. Some of my colleagues have noted today traffic deaths rose by 14 in the First Six Months of 2015. Injuries have risen by 30 since 2013. Im concerned this draft bill would put more strain on nhtsa without actually improving safety. According to one estimate, the number of vehicles on u. S. Roads grew by nearly 4 million vehicles from 2013 to 2014. Meanwhile nhtsas budget has remained relatively flat over the past few years. Appropriations for fiscal year 2016 continue that trend. Coming in more than 70 million short of nhtsas request. Do you believe that stagnant funding for nhtsa has made it harder for the administration to do its job of keeping unsafe vehicles off the road . Theres no question. Last time i appeared before you i made the comment give us more resources, well give you more safety. The equation is very straightforward. If you give us more requirements at the same resources, you will get less safety. This draft calls on nhtsa to conduct at least eight new reports and studies without providing any additional funding. Would you expect that additional reports and studies to require a diversion of resources from other nhtsa programs . Absolutely. We need the technical and other resources to produce these kinds of reports. Thank you. I yield back. Chair thanks the gentlelady. Chair recognizes the vice chair of the subcommittee, mr. Lance, for five minutes for questions, please. Thank you, mr. Chairman. Good morning to you both. The state and Motor Vehicle agency in new jersey has contacted me, and i think this is a concern of various state agencies. There is a section directing Motor Vehicle agencies to notify drivers of open recalls on their vehicles when they are renewing registration and in new jersey thats once a year and i presume thats true in other states as well. And there is some concern at the state level that this would put an undue burden on the various states. I understand the benefit of increasing notification and remedy recall rates, but i do share some of the concerns of the agency in new jersey. Could you please, dr. Rosekind, comment on the feasibility of your agencys coordinating with state agencies to ensure they are able to have the information necessary to inform drivers of recalls . Congressman you just used the word, which is feasibility. Nhtsa held a retooli ining reca event. How do we get remedies . Youve hit on the concern. Theres no technology. Nobody knows the cost. Nobody knows the procedures to use dmvs to get this information out. Its a great concept. Theyre a super touch point to get to people. The question is how to do it. For grow america, the question was for a pilot study to figure it out. I presume the pilot study would be with one or several of the various jurisdictions. Some of that is outlined in grow america. It involves two states. Just the things that i mentioned, which is we need to figure out the technology, what would be the procedures, what would be the cost. You do a pilot in a couple studies. Obviously with your view to how you would scale it for the whole country. Is it typical in the states that vehicle registration is once a year or are there multiyear registrations in some of the states . I believe its annual. If theres an exception, i can find that out for you. Thank you very much. Under the legislation, automakers would be required to take reasonable steps to ensure that other entities adhere to the automakers privacy policies. And the automakers privacy policies as applied to automakers would not be subject to ftc jurisdiction. What about the privacy policies of other agencies that would have to adhere to the automakers privacy policies . I request any comments you might have on that. It appears that the safe harbor action would apply to the manufacturers. Thank you very much. I yield back the balance of my time, mr. Chairman. Chair recognizes the gentleman from new jersey, mr. Pallone. Thank you, mr. Chairman. Hightech Vehicle Safety technologies are expected to save thousands of lives per year once they are in broad use. Two types of vtov technology could prevent more than 3,000 crashes. Title 5 of this bill is based on a false trade off, Vehicle Safety instead of environmental safety. Sections 5. 02 and 5. 03 would exchange credits. Particularly in light of the shocking emission fraud scandal surrounding volkswagen, im worried that automakers will comply with environmental regulations. Yes. Two things. One is secretary fox has asked us to accelerate anything that is a new lifesaving technology. The new vehicle proposed rule will get out at the end of the year. Yes, i think we need to acknowledge ten manufacturers came forward and made a commitment to make automatic emergency braking standard on all of their vehicles. The proposed rule you mentioned would require all manufacturers to make all their vehicles vtov enabled . Correct. And that you said by the end of the year . The proposal would be out by the end of the year. Are there other incentives such as revising end cap that youre considering to get these technologies deployed to all cars and not just the luxury cars . There are three tools. We like to use all of them. Rule making is one. End cap is under review right now. More to talk about that in the near future, but alim also highlighting these ten auto manufacturers to do this on their own. These are three different tools. I really have been pushing collaboration and the opportunity to expedite and expand safety beyond the minimums we get from rule making. Again, vtov be installed on every new vehicle is already in the pipeline. You said the Insurance Institute for Highway Safety requires the vehicle to be equipped with certain Safety Technologies . Thats correct. Then you said you worked with iihs to get certain commitments on technologies from manufacturers. Correct. In january, we announced that automatic emergency braking is being added to end cap and there are further changes that are coming soon. Okay. I think most consumers would like to have a car that is both fuel efficient and safe. I mean, that makes sense. Do you support giving automakers credits for installing Automotive Technologies . I think the general principles that i stated are pretty important here. The American Public expects both safety and Public Health. And the second part is i really hope that the manufacturers have enough incentive for lifesaving technologies. Those are going to be the lives say save and injuries they prevent. Do you want to give me an opinion on whether you like or support this idea of giving the automakers the cafe credits because they install these advanced auto technologies . We dont think there should be a compromise. You should be able to get safety and Public Health and Environmental Concerns addressed. I think the incentives are already there. All right. I appreciate that. What impact would the corporate average fuel economy or cafe credit provision in this draft have on vehicle fuel economy and how might that affect consumers that buy these new cars . In other words, what impact would the cafe credit provision have on fuel economy . The credit . Yeah. Im not sure it would change the actual the levels of what are actually covered under fuel efficiency. Its more of the incentivizing thats part of that proposal. So do you want to venture a guess as to how it would affect consumers that buy these new cars . These are very good questions, but id like to get a little more detailed before taking a position on it. Thanks. The chair recognizes the gentleman from kentucky, mr. Guthrie, five minutes for your questions, please. Thank you, mr. Chairman. Did nhtsa or the department of transportation participate in the development of the Cybersecurity Framework and will it participate in future iterations of that framework . We have ongoing interactions with all kinds of government agencies. We are always involved pretty much in participating as well as having them participate in our activities. Are there ways nhtsa could participate to develop best practices for Automotive Cybersecurity . Yes. In fact, if you look at the model of having the ten manufacturers come together to work on aeb as standard, it is a model to be applied across all kinds of issues, including cybe. Everybody has already read the secretary is planning on having a meeting with the ceos about the safety concerns weve been reading about. He has specifically identified safety and cybersecurity to talk to the ceos about it. The other question, nhtsa and the Auto Industry spoke about how to apply the framework to the development of automotive security . The discussions have begun. Ms. Mithal, what standard if auto manufacturers tested the security of cars appropriately before putting them on the market . Sure. Our standard is section 5 of the act which prohibited deceptive practices. If a Company Makes a misrepresentation, we can take action. An unfair practice is one that causes or is likely to cause consumer injury, not outweighed by the benefits to competition and not reasonably avoidable by consumers. Its a cost benefit analysis. Theres no such thing as perfect security, but what we require is reasonable security. Thank you. In your testimony, you discussed the ftcs start with security. Quote, a business initiative. Can you discuss how that should be applied to Car Companies and others involved in the connected car space . Sure. I can give a couple of examples. One example we give in the security business guidance is companies should test products before they launch them. Opposed to launching the products first and seeing about problems later. Something we Call Security by design. Another thing we talk about in our start with security guidance is having a vehicle to accept vulnerability reports. Companies can know of Security Research thats out there and evolving threats and emerging issues in their devices. Thank you. Including cars. Appreciate it. Thats all i have, mr. Chairman. I yield back. Chair thanks the gentleman. Gentleman yields back. The chair recognizes the gentleman from massachusetts. Five minutes. Thank you very much to the panel and the chairman. I want to thank the chairman for calling the hearing. Many of the cars contain navigation and event data recording systems, among others, that all have the ability to record driving history information. Auto manufacturers, other third parties l aly ies also have acc wealth of information. Its concerning to me, candidly, and im sure it concerns a number of other consumers, as well. People want to know their data is safe and being kept private, at least when it is being used with their consent. Dr. Rosekind, i was hoping that you might be able to start the discussion. Data privacy provision in this discussion draft would require Car Companies submit privacy policies to nhtsa, but it does not give nhtsa any change for acceptable policies. Is that how you read it, as well . Yes. Do you think consumers could be or should be concerned that theres no ability for nhtsa to recommend any changes . I think the public expects and wants nhtsa both to regulate and set guidelines for the standards that protect them, the traveling public. Ms. Mithal . Yes. I think there are concerns that, although the bill prescribes requirements to be placed in privacy policies, it may not require companies to follow them, or may not have enforcement mechanisms. Its my understanding under the draft bill, the auto maker will receive protection from Civil Penalties and enforcements by providing nhtsa with the Privacy Policy that addresses the items in the draft. Such as whether or not the auto maker collects, uses or shares data, and if the consumer has any choice of the use or collection. It will not matter how a Given Company chooses to address the items though. As i read section 301, a car maker can hypothetically submit a Privacy Policy to nhtsa, violate the policy and still be protected from enforcement. A car maker can make promises to consumers about collecting the data and suffer no consequences under the act if they break that. Ms. Mithal, is that your understanding of how this system is set up under the draft legislation . That is our understanding, and its a concern. Do you think the bill provides sufficient senses for the auto makers to adhere to the provisions for consumers . Unfortunately, no. If we have a situation where a car Company Claims to have expansive privacy policies to Product Consumer data andpolici that a deceptive practice . Yes. It would strip the authority. Thank you. I have additional questions about the antihacking provision, which would create a civil penalty from gaining authorized access to the data in the system. Wed like to prevent bad actors from accessing the car systems, some observers expressed conc n concerns about penalizing the white house hackers to draw attention to the hackers. These have been covering volkswagen and controlling a jeep remotely via an internet. We heard from repair shops that they think they could be precluded from accessing Important Information they needed to repair cars. They suggest nonauto dealers repair up to 80 cars that are still not under warrant. Ms. Mithal, do you have any thoughts on the provision, from your expertise in reviewing Data Security cases . Could you envision a scenario where information could be siloed so repair shops could get information to repair cars but not fiddle with, say, emergency brakes . Let me be clear. We agree that there should be Civil Penalties for malicious hackers, but we are concerned this bill would disincentivized Security Researchers who Contact Companies, suggest they fix the vulnerabilities, and Companies Fix that to help consumers. We believe the bill would create an impediment to that. On the auto repairs, i have deference on that issue. You mention thirddegreeed t bit. Can you talk about the importance of the researchers to the Data Security work . Its very important. Its the white hat hackers and researchers bringing these problems to the attention of both the Car Manufacturers and regulators like the ftc. Do you have any idea how to make that distinction, between white hat and black hat . It will require careful drafting and we look forward to working with the subcommittee on that. Yield back. Gentleman yields back. The chair recognizes the lady from tennessee, ms. Blackburn. Thank you, mr. Chairman. Lets stay with the regulation issue. One of our concerns is dual regulation. As you all may or may not be aware, we have kind of grappled with this. Ms. Mithal, i know that you are with privacy in the internet space with the fcc, trying to get in on top of the ftc jurisdiction. That has caused a tremendous amount of confusion. Let me go where mr. Kennedy was, and lets talk about the way youve got a manufacture that can get the safe harbor, and then a void that section 5 enforcement, if the manufacturer is meeting those requirements that are listed. Now, nhtsa already handles the issue of privacy and auto motive space. What we want to do is avoid this confusion and this dual regulation. So is the ftc going to honor the recognition that nhtsa has this lead, and are they going to honor the Safe Harbor Provision and act in good faith when they are reviewing these manufacturers privacy policies and making certain that they meet those requirements . So if i could make two points in response to your question . Sure. First, concern is that the safe harbor is too broad in many respects. One example is the Privacy Policy requirements only apply to vehicle Data Collected from owners, renters or lessees. For example, if a manufacturer makes a misrepresentation on a website, that applies to shoppers about how theyre collecting shoppers data, that wouldnt be covered by the Privacy Policy, but the ftc couldnt bring action. We have concerns about the breadth of the safe harbor. We work very well with nhtsa. We support the goal of avoiding overlapping and duplicative requirements. At the same time, nhtsa and the ftc have different focuses. For example, nhtsa does recalls and is very we defer to their expertise in car safety issues. At the same time, we have the ability to get exwquitable reli in the form of, for example, implementing a security program, getting outside audits, in some cases, redress. We think that both agencies bring particular expertise and can bring different remedies to the issues. You are committed to making certain that we draw the lines here so we dont end up with a dual regulation or with confusion . Exactly. You all have born the brunt of this, if you will. Thats exactly right. Consumers have been confused about the reach of the fcc and the ftc and is it diminishing your jurisdiction. As we look at this issue, and knowing cars are going to be more inter connected, not less, more computerized, not less, youre going to have more data and people will say, what are you doing with the data . How do you turn that into usable information . This is something that should be cleaned up and handled appropriately on the front end. Administrator rosekind, i want to go to you. How is nhtsa addressing the Data Collection practices of auto