conventional pills. i am encouraged by the addition of abuse s deterring drugs into the marketplace. and while it is not a -- not a silver or magic bullet, and completely stopping prescription drug abuse, it seems to be a tool that can greatly help. some medications have been reformulated to be extremely difficultdissolve. these are abuse deterrent drugs. new additions to the prescription drug marketplace and have not yet been widely adopted. but things are moving in the right direction. question, how do you think abuse, deterrent formulations will have an impact on reducing opiate abuse and how do we ensure that those who are addicted do not just switch to a new drug, such as phenetol or heroin? >> i think that, the abuse, well, first of all, we are very supportive of abuse assistance formulations. we think that is the future that

will curb drug abuse. abuse resistant formulations tend to stop drug abusers from, ingesting the, the, the drug in certain matters. for instance -- injection. or, or, snorting the drug. when, when they need to, they take it orally. and in abuse resistant medicati medication, does not affect how you take it orally. what we are seeing in the field. they're taking the drug orally with an agent that will give it a synergistic property. for a drug like oxycodone. or a muscle relaxant to enhance the effects of the product. >> thank you. i yield back. >> thank you, mr. butterfield. mr. harper you are recognized for five minutes. >> thank you, madam chair. if i could, mr. ronazizzi. itch i could a

if i could ask you a few questions. what reg laotilationship does d to have manufacturers avoid drug diversion? >> for starters, pharmacists are held pretty much to the same standard that doctors are under 1306.04. 1306.04 says a prescription is not valid unless issued for legitimate medical purpose unusual course of medical practice. it goes on to say a corresponding responsibility exists with the pharmacist to ensure the prescription is valid. the manufacturer is under 1301.71 and 1301.74 have to maintain a system that -- that stops diversion. or the diversion of controlled substances into other than a legitimate marketplace. it also goes on to say that you also have a, have to maintain a system of suspicious ordering

monitoring. and -- they leave it up to the manufacturers and distributors to determine how to set up that, that system, of suspicious ordering, monitoring. >> right. you know, i know, dea has ability to see unusual ordering patterns. are there certain thresh holds or levels that you pass on to the distributors to, to look for? are you giving them guidelines to, that, you pass on? >> no, i think with distributors have to do is look at their customers, they know their customers. i don't know all their customers. they do. if they've went on site and looked at their customers they could make a determination of what thresh holds should be maintained for registrant customers. the problem is, i don't believe that the distributors, wholesalers are looking at their customers as closely as they should. if you have customers that on the average purchase, i don't know, 70,000 oxycodone tablets a

year and customers, purchasing well in excess of a million a year. i think that would trigger something where you should go on site and find out why. that's the issue. >> does the dea have those volume parameters that it uses but are not shared with manufacturers? or distributors? >> no. we, no. we don't share, we don't give them volume parameters that's up to them. it's their system they're setting up. the, what guidance has dea provided to the manufacturers -- distributors, pharmacies, whatever. on the specific steps that they should be taking to i didn't tie fraudulent prescriptions? what advice are you giving them to look for or, or suggestions? >> well, there is certain red flags. for instance, a pharmacy. if you are sitting in, let's say ports.

mout -- portsmouth, ohio and all your customers are coming from 80, 100 miles away and the doctor you are filling for is 100 miles the opposite way, and it is all cash transactions, and you are seeing this over and over again. the you know, i'm not the smartest guy, red flags pop up unmy mi in my mind. those are typical red flags. the attorney general, i'm sure, one of the distinguished gentlemen could tell they're seeing the same thing that i am seeing. so, over and over again, we see these red flags. the pharmacist should see them too. >> would you favor under the controlled substances act to create a stricter requirement -- legal requirement for the most problematic drugs? i think the requirements in place now for these drugs are fine if -- if the individuals within the supply chain and

health care delivery system would follow them. the problem is -- that, the doctors continue not, all doctors, 99% of the doctors are perfect. it's that small percentage of doctors that just don't want to fulfill their obligation. what they do is prescribe for illegitimate purposes or don't make a medical determination. they go with patient directed prescribing which is just wrong. i think if everybody within that supply chain would just police each other. we wouldn't have the problem that we have right now. >> thank each of the witnesses for being here today and your insight. with that i yield back. >> thank you, mr. harper, mr. mckinley, you are recognized for five minutes. >> thank you again. let's go back to florida, or maybe, kentucky. let's start with florida. when you have your program, your pdmp, do you have identification system, is that how it, in part, included in it? >> we -- as i'm sure you are

aware, we had some very difficult problems getting our pdmp in place, prescription drug monitoring program. it was in 48 states have a pdmp. many weren't up and running. and ours was one of them. we received some resistance. what we have done now is -- that, it's up and running. we had some issues with getting it funded. seeing who came forward. >> that's not what i am asking -- stow when someone comes in, do they, do they enter their name or something into? >> yes. >> into a file? >> yes. >> enter their name. available for everyone in the state of florida. >> absolutely. used to be 15-day reporting noucht now we have limited that to seven day reporting. we shortened the reporting period. >> if it works in your state why wouldn't that work nationally? >> this is, like i said, brand new in our state because the it had never been funded. now funded by for fit chefiture

from our sheriff. >> in kentucky, do you have a database of names? >> we have a database. what happens in kentucky, first in the country to bring up pdmp online. our doctors will go in to see the patient name to see if the patient is doctor shopping. in kentucky. a pretty good system. only 25% of the doctors are using it. it is not mandatory, that e.r. docs for example. >> all right. what concerns me some its you have done a great job in florida. just chased into another state. that's what i am hearing from the other testimony here. what i am hearing around the conentco country you did a great job. it happens in law enforcement when you start performing your duties, they transfer to another state. i am looking to see how we can capture them nationally. >> we still have a long way to go in florida. but i think what we are doing is we are working together.

and as long as i can tell you the two of us are still alive -- we're going to put, put these guys out of business. i mean, we work together constantly, we share ideas. we share thoughts. and we frankly in florida we work great with the dea. we, you have to work as the a team. i don't know if you were here earlier for that part of it. but you have to bring state, local and federal authorities, and now, wrap all of our states into this. because this is a national crisis. we are in a war with drugs. just the drug has changed. >> if i may address that point, congressman. not to take up too much of your time. kentucky borders seven states. the pharmacists when they fill a script. enter the data into a system doctors later check. the problem for us has been that, the docs feel like it is too time consuming. the docs don't want few to be fd to do this. they don't have a system, user friendly. type in. takes 30 second. tells you in eastern kentucky whether this patient has been to

west virginia, ohio, virginia, tennessee. and really a state like kentucky can't get where we need to be, can't get 50 states with a good system operable. >> in kentucky, do you have the names, with your program, names, individuals, we know what prescription drug they're acquiring? >> we do. we do congressman. our program has been up and running for many years as well. just as kentucky's has the. >> you see a problem with that going nationally? >> i don't. one of the necessary tools that we're going to need. >> how do you deal with the privacy matter. that is the hang up. confidentiality of people accessing. how did you get around that for the state of ohio? >> it is very protected by our, ohio state pharmacy board houses the program. they're protective over the information and who it goes to. and how it is distributed. and, and that's how they get around it. they make sure it is protected. but it is, a necessary tool. in this battle as we move

forward. >> some states. three states. you all have that. you are doing something along the line. >> the information is protected. the doctor will see it. designate the case we can ask g for the data. we have that problem in kentucky. >> that is the same issue in ohio congressman. it is a great tool. underutilized by our physicians. house bill 93 required physicians treating pain management to utilize it. but as the, as the, exactly as you have alluded to as we have success in law enforcement. we are squeezing the balloon. people are moving to other states. and what's happened, the, the three states represented here today have all worked wonderfully together to tackle this issue. and to share that information and investigations. >> in deference to time. i think you are great models. i just want to see it replicated in all 50 states. can't have you operating independently. thank you, yield back my time. >> thank you, doctor, you are

roitsz ed recognized for five minutes. >> thank you, madam chair. first, mike ross and i, hr 4095, stop online pharmacy safety act which attempts to -- close down or at least prevent the publicizing of the rogue pharmacie pharmacies. so, hopefully we'll get co-sponsors on this. secondly, mr. ronazzi. man, with the databases y'all have, if we gave them to google. i have no doubt that google knows what color dress my daughter has on today. so it seems like data mining could really go a long way to pinpointing these problems for a specific intervention. i'm fold by industry that y'all have lots of data forward feud yfeud -- forwarded to you regularly. my question is why not?

>> i think the data they're referring to is our arco system under 2827-d they're required to send all narcotic substance transactions to us to be put p in a database. we do have that information. quite frankly we use that information to, to, assist us in investigations. however that information is proprietary. protected information. i can't release that information to industry. they have asked before. >> but you could release tight local law enforcement. >> if enforcement is involved in an investigation and they request the information, yes. >> as i go through the testimony you, have rank ordered states in which there is highest prescription per capita of controlled substances, to over 65, how many on medicare part d are getting x amount per in a certain region, other statistics you speak about three, four physicians moving from one state to another. physician level, and sure you also have, a pharmacy level.

it just seems, again if google had that, or some other data miner had that. we could have a specific, and boom, there, there. it seems like there is missed opportunities, what am i missing on this? >> i don't believe there is missed opportunities. the data that we have its very narrow. it's for the narcotic controlled substances. for instance, i'm dealing with a pharmacy or group of pharmacies, manufacture manufacturers, distributors, selling a drug or drugs like that. i have no way to track it. it is not entered in the system. >> if we took those which are narcotics -- probably, there is going to be a correlation between somebody getting an illegal prescription for, adavan as well as illegal prescription for oxycontin. not sawing you have to do the breadth. if you have reported narcotics, oxycontin. knowing just from here have a

heck of a lot of data. why aren't we doing every week another intervention at another pharmacy. it seems like it is a target rich environment. >> we are. we have active investigation as cross the country based on complaints and our arcos data. some times the arcos data it might show up with a pharmacy that is indeed a legitimate pharmacy that has the a high volume. the reason they have a high volume or next to a hospital, oncology. >> i can imagine a cross tab. the variables we find aassociate yalted with, you know, again, google with analagy rhythm would data mind, are you formally data mining. >> we look at arcos data on a regular basis. we look at the top 50, top 100 in different areas of the country. we make sure we do background. make sure that those pharmaciep, wholesalers are operating within

the confines of the law. and if we have further information on it we open investigations. yes, that's what arcos is for. it is a targeting tool. >> how active investigations do y'all have right now? >> i would have to get back with you. i don't want to throw out. >> ballpark, 50, 100, 1,000. >> we have a lot. many more than 1,000. >> okay. now, i kind of recurring theme from the folks is that people go from one state, go to another. i live lane lin louisiana, pain tell me, illegitimate patients go from houston to louisiana and back again. federal legislation mandating standard so texas, louisiana, mississippi, arkansas, kentucky with every state bordering it would be in some sort of interchangeable information? >> i think -- my personal opinion is yes, i would love to see that. because the i think doctors need that additional tool. i think as a practitioner, you

would agree i want to know what my patient is doing, who my patient is seeing, kentucky, ohio, or four states over. the problem is interconnectivity. a lot of status have different state laws. and different laws regarding -- the information and how it could be distributed. i don't think it's -- i think the problem lies within the states. have to work it out. not a federal government system. we support the states. want the states to get that interconnectivity. a question better asked to the states. >> if i may have -- i will say that after hurricane katrina, and all my patients were displaced to other states, i found that those, there was something that happened, a switch was turned. and a doctor in oklahoma, could find out the drugs i was prescribing for my patients in louisiana. and so -- it does seem as if that interoperability could occur in a fair low straight forward fashion if we had, you know, a little direction.

>> yeah. i remember that. state board are working extremely well together. i don't know how that information was passioned. we don't have dispensing information. i do know. >> through e-scripts. there was something like that. >> state boards came together and did a fine job getting everybody. >> there is a chance. we need the folks to talk to their state board. okay. thank y'all. i yield back. >> thank you, doctor. the chair recognizes ms. blackburn for five minutes. >> thank you so much. i want to thank you all for your patience. today as you know we have had other hearings downstairs, the secretary looking at the budget. that is there. i know that those of you at the state level are quite concerned about the obamacare impact coming to a state near you very quickly. mr. ronazzizi. close enough, huh? >> perfect. on the ryan/haight, how many

pharmacies have registered under the act, how is that built out? >> currently we have no registered pharmacies under the act. we have -- i think four or five applications pending, no farmlies have been registered. remember there are a lot of provisions in the fact that allow you to do certain things on line that, that you don't -- the act was written so it would prevent the rogue pharmacies from jumping online and continuing practice. it has done that. there is no domestic pharmacies currently, operational, that are under -- >> let me ask you this another way. how many enforcement actions has dea taken against online pharmacies or rogue pharmacies under the act? >> i have to get back to you. very few. because the act pretty much shut down the domestic online pharmacy problem. and -- the problem moved overseas. >> okay.

are you having difficulty in -- in sorting and finding out which are the rogue foreign based farm sees or -- or -- -- i would liko visit with you more about that. i think that it is an issue that is a concern to us and being able to see where we have these online pharmacies find out who is registering or not, that would be helpful and instructive to us. so let's look at that a little bit and then if you could quantify the kind of actions that have been taken against some of these rogue pharmacies. it allows us to do a little bit of due diligence and see if decisions we're making are working or having an impact or not, so i would appreciate having that time with you.

i want to talk with you for just a little bit, and if you can answer this within the allotted time that's great. and if you need to get back to me, that would be great. i'm no cheerleader for the fda, but i understand their fill philosophy and approach in that an agency as it applies to controlled substances seems much more measured than that of the dea at times. and my understanding is i want to talk about this post inspection feedback in the form of what's known as the fda form 483 inspection report. and my understanding on this fda form 83 is it sets out with specificity the agency's concerns and the parties have the opportunity to meet with the fda and discuss any issues that may be before them, that

companies are given the opportunity to address issues and solve problems in a collaborative dialogue. and if the company were to choose not to address the issues, the agency then typically takes further action in the form of a warning letter. and proceeds with proosecution its decrease as appropriate. i think that fda-type approach is different from the dea approach when there are problems which is just enforcement and not the opportunity to address concerns. so it seems like dea there is no post inspection give and take or dialogue that may be there and no information sharing or the opportunity to address issues that are out there.

so my question to you is this, and you mentioned tennessee as one of the states with the pill mills. we all are concerned about patients that are in pain, that need medication, that companies that are trying to meet those needs and, here again want companies to do the right thing, want them to spend the money wisely, want individuals to be safe, want there to be pr protections that are in place. so my question is, is there a more surgical approach? should we be thinking of a more surgical approach to addressing the issue of prescription drug abuse rather than just looking at suspension of licenses? you though, where is the right balance in a vetting process? is there a more proportionate

approach rather than a more immediate suspension? >> yeah, i would love to answer that question. first of all the fda deals with drugs and they do have manufacturing processes, but the vast majority of their authority is over drugs and prescription drugs making sure that labeling is correct, putting the drug through the appropriate validation process. my responsibility under the act is to ensure there's no diversion of highly addictive medications into illicit marketplace. we do give chances to companies -- if you look at our history, we went on site on many companies we've taken actions against and explained what their obligations were. we sat down and talked to them what their obligations were. >> okay. so your response then would be you all are carrying out that dialogue? >> yes.

>> okay. all right. >> i look at florida and the millions tablets that are going into the illicit marketplace not from the pharmacies but the doctors and i think we have to hold the line somewhere. these are drugs that are killing people. it's not amoxicillin and we have to take a stand. >> okay. do any of the others of you want to make a response to that? no? okay. madam chairman, i'll yield whack. >> thank you, and i'm going to recognize myself for five minutes for a second round and any other member who wants to ask a second round, i will yield to you for your own five and then we'll move to the third panel. first of all, my comment on what dr. cassidy had to say, i think you brought up a good point and i think it's fair to ask if the dea data mining capabilities are as robust and clever as you suspect google's are and perhaps we can visit that in the days ahead. but this is sort of a general question to each of you.

and thank you, mr. rannazzisi, for mentioning my support of your takeback days, but 995,000 pounds of drugs in three days. the question i want to ask each of you if you care to comment or weigh in, who is paying for those pills? are we paying for them in the form of health care premiums? are we paying for them through diversion out of medicare part "d" and medicaid? who is paying for all of those pills? why are there 995,000 pounds of extra pills being turned back in? what is the overall toll in health care in our country just from this problem? anybody? >> i can tell you from are our local takeback days, these are good, solid citizens who are coming in with brown paper bags filled with prescriptions that they've had and they're concerned because they know you cannot flush prescription drugs down your toilet and they don't know what to do with them and they don't want their grandkids

to get hold of them. when i speak to people i say no one ever wants to believe it's their kids so i say your kids' friends can get into your medicine cabinets. so people -- it's our citizens and a lot of them are getting them from the doctor, the dentist, taking one or two of them and just stockpiling them because they don't know what to do with them. but we have had remarkable results with good citizens turning them in. >> the question is, why are there so many left over in the medicine chest turned back in? what is the cost? you mentioned this as an american tragedy and i couldn't agree with you more, there's no question our doctors are working too hard and ultimate hadly this comes out of their patient visit. they're scrambling because health care is squeezed more and more and more and this is a part of the problem but $148 million out of medicare "d" in 2008 alone. so are we really, general

conway, do you want to weigh in? >> i don't know if i can quantify the cost. my experience is similar to general bondi. it's a concerned mother who doesn't want her can kid or saw something on tv and what she got for a broken arm has expired. the cost comes in crime. people are committing thefts to getting accesses to buy pills. the theft comes in cash. when you have health care companies trying to get more efficient and mandating 90 day supplies of mail order, a 90 day supply of objectiony condone, it's hitting the streets. that's something that we need to quanti quantify. and certainly medicare and medicaid are paying some of that. >> and i think what you're saying, if you go in for routine dental surgery, why do you need 60 oxycodone pills?

you don't. >> thank you. you suggest that maybe they have a tiered approach into needing the drugs. do you want to speak about your beliefs on this, too? >> absolutely madam chairman. what we see in ohio, to answer your original question, the taxpayers at some level is pay ing for the problem no matter how you look at it, when you boil it down to the common denominator whether it's medicaid costs in ohio, especially in southern ohio which is economically depressed it borders eastern kentucky, as we've heard attorney general conway allude to as an economically depressed area. it's a huge burden on the medicaid system there. as you move across the state of ohio it goes all through all the way from the middle class up to the upper class. whether it's a