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House | April 16, 2015 | Committee Room | Health

Full MP3 Audio File

And the quorum was we will start this meeting. Ladies and gentlemen this time I ask committee on health will come to order. Our sergeant at Arms today are Young Bay, Bill Mars, Jim Moran. Thank you gentlemen. Members we have two bills on our agenda, we have a proposed committee substitute for both. The first item will be house bill 647 APPNs and all child serving businesses, representative McGrady. Again this a PCS without objection. We, ll hear PCS the house bill 647 representative McGrady you are recognized to present your bill. Thank you Mr. Chairman and I'm glad to be joined by representative Avler who is one of the core sponsors serve of the bill. The bill summary you've got before you and I want to put this just in perspective to the extend that you may remember last we talk about Bill dealing epinevan[sp?] and auto injectors, but that was actually amended Bill that required the epineva[sp?] or oral injectors to be provided in a schools settings, but really scary needed to be required in a school setting why wouldn't be commissive  in other areas. These  FNF and auto injectors typically require prescription, they're hard to get, and as a former owner of  Summer Camp where the whole population was kids, I had a very clear sense that I wanted to have epinevan[sp?] available, but frankly it was very hard to get, and so in a simple way I'd explain this bill as an effort to address that, if the caption of the bill is n all child serving businesses but I would tell you that the bill is, they are not going to discriminate in terms of who gets the epinephrine a restaurant is among the various entities that potentially could use this bill to acquire the epinephrine, and yes the epinephrine auto injectors could be used on more than just children, I don't know whether I need to ought to go through the bill in great detail, but basically in the first page of part B, it speaks of how to prescribe the auto-injector who is the authorized entities permitted to maintain the supply of the epinephrine it had comes down, has a training regime there, and again. Mr. Chairman some experience. Representative Riddel, are you? I've had all my questions answered [xx] to make the motion Would other members in the committee appreciate further discussion or if I can only say that I'm not aware of any opposition, we work with a very broad group of people on this. Alright, representative Riddel I will be ready with your motion, I see Representative Arcot has her hand up, so Representative Arcot you're recognized for a question Thank you Mr. Chair, I actually think the intent of this bill is really good, and I just have some questions. Right now, as a prescribe myself prescribe of  to an individual and you prescribe based by a diagnosis so by prescribing to an entity you prescribing first of all to an organization of some type whether it restaurant or camp rather than an individual you are not prescribing based on diagnosis, so that my first question as we think about that, how does that work and I realize the board of pharmacy special developer wrote about this, another question is about and again [xx] with slow thinker lets take the first question then we go to the second and I'm going representative [xx] I think I can best answer your question by explaining that I ran out of my office and forgot to bring my showering towel I live with an Appan[sp?] and the reason I do is because one evening I was under doctor's care and I was taking a couple to three

different types of medication, they were trying to find the best combination that would work for me and I followed the doctor's orders and took the medication  and fortunately, at the time we were close to a hospital because I needed one in a very short period of time. I went into Anaphylaxis and it is scary, I made it to the hospital and got just in time to be sitting on the gunny in the emergency room when I passed out, because my throat had swelled up and I could not breath. So as far as prescribing for an individual, it is a [xx] that is a preloaded, I don't care who you give it to, whether it's me 90 year old or whatever, it's the same dose of delivery and it's simply a medication that will allow you to begin to breath again in a very short period of time, so I think those concerns are not something we should be worried about because it is the same type of pin when it's given standardized pin. Senator Bankok  make a follow up. Yes thank you. Representative Avra that's a scarly experience that you went through in July and we need open for you need it right now and the motive delivery is the same, but there is a different doze for children as there is for adults in the injection actors of different pediatric versus adult I have a great deal respect to the amount of work that's going into this bill. In the bill I will add further response is we give authority to the, I don't know what the agency is but the pharmaceutical agency in  state to develop regulations in the area, so if there are, the needs to further direction the appropriate state agencies are authorized to fill in the gaps. You had a second question, I believe. Representative Maycock. I appreciate that clarification and I think that's a good plan just to have the border pharmacy direct the rules. When I read the bill the first time I thought it was all about kids and I see in the bill of summary that they'll also have restaurants and places out of them where children are in addition to children, and I notice that you folks are going to be satisfied to have  training but it's not always easy to diagnose anaphylaxis and to know what's going on with someone and so it's cures should explain that a little more? There is a training regime that set forth here and they're very, again we're not trying to be overly prescriptive here, so physician, physician assistants, nationally recognized organization, NAD approved, experience in training lay persons and NAE approved by the department of health and human services so my hope would be and all I can speak to here is my, really my own experience, but as someone that ran a large camp with lots of kids frankly I trained everybody to both understand what was happening if they misdiagnosed what is happening and there could be bad ramifications but also how to use the epinepherine injector itself, so again we've tried not to be overly prescriptive in terms of this is only the way it's going to be trained, but hope that the agencies involved and the entities that are involved will be using common sense in in terms of what sort of training they're doing here, but  training is required and in the back there is some immunity from liability for somebody that is in an emergency has to make that quick decision, and may use an epinephrine as allowed by the bill. Representative Zaka,   Thank you Mr. Chair, I'm in support of this bill but I did have a question in training and the immunity part, and I I don't want to read the bill earlier, I didn't see it in here but in business A can do training today and have this ample and in their premises and never do it again, so it's just a camera so I don't see there is major requirement of C- or something like that and then the kind of Page 2 was talking about immunity, on line 39 an individual or any

of the instead it conducts the training mandated by Subsection either section. If they don't repeat training, business no matter what they are, could get in some type of an issue if they haven't kept the training up, and then the example is Representative Grady a restaurant might choose to do this, while Servers come and go frequently, and I've been in situations in my life where medical  emergencies happen, and the focuses on what the emergency is, If you have a new server there, they might say go get the [xx] he administers, he pretty hasn't had the training. I'm I'm not trying complicate this, can you just talk to someone concerned. With respect to the letter issue, I will presume that everybody will be trained like you do it at a summer camp, but I would presume that there would be some person or people trained. The immunity only relates to that the people that have been trained here, so in the restaurant situation, I'm sure this funny and turn over and waitresses but presumably they are in that sort of turnover everywhere and if people are inside they'll be able to use it, it was like the day.  The other question related to, Training and frequency training. Training and frequency training I can't I'm willing to work on that surprisingly with the working group that we have come together, they did back into that issue, if I get a bill out with you and others, to make sure we address that issues, its similar to the issue representative Adcock has raised I will work with both of you on it. Representative Bishop. Thank Mr chairman, I was going to ask question of representative Adcook talked about what could be the consequences if there is a misapplication of an EPI10, but I think rather than do that I guess the hard part of out this is I have concern about that, I guess so if you have to choose one of the other I think I would rather make the things available and as I understand that risk, and I guess that's consistent to what the bill sponsors are saying, but I wonder, and the thing is and I'll guess to me I hear about defibrillators place is I got them in our church nd so forth. And I've never heard of those being misused. Maybe that's a question I'll leave with the bill it's a veteling and for this if someone is in position, hopefully have been trying but do not exactly they are not maybe proffessionals and they are going to administer ethic hand what is the range advice consequences that could result? How severe could that be. Representative McGrady? Well I was just going to say, maybe Representative Adcock can speak to that, you've got more of a medical background than I do, if you're willing to jump in and and answer that question. As I looked around the room, other than maybe the chairman, she seems to be the only person who might draw on that. Both my country were doctors but I don't think that gets me anywhere. DNA doesn't do it. Representative Arcot.  Thank you, I'll be happy to answer that here the effect of epinephrine are fairly short term but include rapid heart rate and an elevation in blood pressure, so if you miss diagnose the first one and what they have as there's a problem with their heart rate getting high and their blood pressure is already elevated, there could be some cardiovascular consequences. Now on the other hand, I think when diagnostor[sp?] and luckily, Representative Adler was in a health care standing for they knew what to do in the perfect setting for something terrible like that to happen, in a restaurant [xx] knowing maybe the person is actually chocking, and you think what they're having is an anaphylactic reaction, because when it first starts, your meal is broken down rush, you don't have highs and all that but you come in you say I don't feel right. And maybe you can't even speak because your throat's closing up but what you're really doing, is you're choking versus your having antifoluxis[sp?]. I think the training is an excellent part of the bill and I think the frequency of training the question you asked Representative Saks because it's a once and a life time dangerous life just being trained in anything it's not no one so much time, but the other the ocubation methods consequences of course, not trading it it could be a verses Rim. Representative McGrady. If I could refer upon there is risk in them being misused, but I would suggest to just hear that there's a hell of a lot more risk in not having them available. And unlike the setting that Representative Adler[sp?] set towards, I've heard them occur in the field.

And I've seen a 19 year old who I've known the entire life come within a very short period of time and having another 18 year old know to use that happy pin, apply it and this young adult comeback. And so, it's a bouncing arrest, that's why they are prescribed. [xx] Can you follow Representative Bishop. Just a question, and that's very useful to me and I get the sentiment and I think it's probably right but I'm curious what Representative Adcock balance is. As you balance that would you rather given the risk that you've have discussed and the Bill sponsor has discussed, do you still consider to be a good Bill? Representative Adcock[sp?]   Thank you Mr Chairman. What typically if we knew administering that depends in I keeps you some Representative Adler's example because she gave her a good one. She knows that she's allergic when she starts having symptoms similar, she knows that's the thing to do with the person with her meds there. In this situations where you don't know whats going on with the person you probably can't hurt them, and you possibly could help them. But indeed there's some risk there but I think is represented McGrady said you have to balancing that with what's the best thing you can do and what's the worst thing you can do. Doing nothing is probably the worst thing you can do. Representative Dobson. Friend form Mecroberg Representative Bishop had the same line of questions I had so I'm good. Thinking alike. Chairman Brown. Thank you Mr. Chairman, I'll be brief and speak in a dodally[sp?] concerning we continue to use the food service establish as kind of the beacon point here. I think the only member of this body who owns food service establishments will anebitally address that. It would be it would just not be full zeron to train everyone single member of your team within a restaurant setting, to know what to do or to administer these items we would train our management team, we would train our bar attendants, we would train our high level food service staff. Actually this is anonymous problem, within the food service setting right now from the statistics or stand point you have much more of a chance of going into anaphylactic shock and you do from shocking, there are so many allegies out there right now, from a food perspective that this is quite a critical piece that I think it could certainly save someone's life particular in the food service setting and I certainly recommend it. Representative Villalba. I guess someone in the back of the liability in the other and that if that this creates an expectation and then if a business does not get an happy pound and has a death on the premises as a result, does it create a liability for everybody that doesn't go through this procedure? It's a very good question and sort of relates to social laws on standards of care. This doesn't create a standard of care, the law, the bill does not create a standard of care. I can't tell you 20 years from now that that may become the standard. What this does simply is make important drug available for an increasingly common occurrence and may be at some point in the future there will be a standard of care that some Jury or some future General Assembly will establish. But we are not trying to go there, this is not a mandate bill in any respect, this is a bill where business owners make their own decisions, determine where the risks are and determine the cost. So great question I'd be interested to be here 20 years from now and figure out whether epipens[sp?] are now the standard of caring wherever. They are all in my business, my summer camp I don't you will find a summer camp that is no longer routinely making epinephrine injectors available because of these things and peanut butter and also all sorts of things Represents the overall follow up. What I going to comment on all lines my wife has allergies and we have heavy pills on the boats and then in different areas where we be a right in the house, so it is but a normal thing. Seeing no further hands for discussion, or debate representative Wadia[sp?] you are recognized for motion. Thank you Mr. Chair and I apologize to the chair for thinking there was not a good discussion on this, I think it is a good bill bill. Therefore I move that we give favorable report to the house bill 647 unfavorable

to the original. Representative wardia[sp?] moves for favorable report to the house committee substitute, the house feel 647 unfavorable to the original, all those in favor signify by saying Aye, Opposed no, the I's have it congratulations. We'll get to house bill 652, right to tri act, representative Black Will, you are recognised to present your bill. Thank you Mr. Chairman, I acknowledged that representative [xx] and representative [xx], two of the Co- sponsors are hear and representative [xx], who is the 4th primary sponsor on the bill, wanted to be here, but he had to go home for a funeral of a friend that was this afternoon later, so they wouldn't have had time to come, but wanted to express his continued support and urge the committee to support the bill. Let me give you just a little bit of background or history, I will try not to take too long and leave time if there are questions going to other things, right to trial legislation has now become law to 13 States and that may be growing [xx] one is that there are several bills that are along that process in other legislatures and in every if the 12 states where it went through a legislated process, it passed through their legislators with overwhelming Mac Partisan support in almost unanimously in the [xx]. In the 13th State which was Arizona, it was adopted as a ballot measure and was unanimously with 80% of the vote, that doesn't mean we have to do it, it just means that a lot of folks have taken a look at this substantially  the same legislation and it founded, it was something desirable. Let me talk of briefly about why that might be a case and I may read just to an extent from some of my notes. This primarily, or exclusively, I guess I could say about dealing with terminal patients who've exhausted all of the conventional treatment options, and they're trying to determine if there is any other potentially life saving treatment medication deice that might be available, the patient can attempt to get into a clinical trial, but generally the sickest people don't qualify for these clinical trials. In fact my information that only about 3% of these patients that are in these terminal conditions are enrolled in clinical trials. Their only hope therefore is to get approved by the FDA for special permission. Let me tell what happens there, and this is largely why we're doing this, is because of delays at the FDA level. Only about 1, 000 people make it through the FDA's compassionate use application process each year. It's complicated, time consuming, expensive, the first step in the process requires a doctor to complete an application that the FDA estimates takes 100 hours. After the doctor submits the application, the manufacturer must also submit lengthy documentation, FDA then has a month to review the submission and either grant or deny the request, but if there are any questions the one month clock starts over. After the FDA approves a request, a separate committee not affiliated with the FDA called the an institutional review also must approve the patient's use of the drag, and that sometimes can take up to a month to reach a decision. You can perhaps imagine while this lengthy process is going on, and you're dealing with these patients who are looking for their last shot, that it's just not as for solution, so what we are trying to do with this bill is at the state level, so long as the FTI leave us the 3 ways to remove some of various and is in tip in this bill to allow eligible patients which would find in the bill, to have access to this FTA they are generally processes medication devices that have been through, I think, it's called phase one is that right there are sought of check out there, the drug is generally thought be safe to use in some respects and it expands the opportunity for them to try to do that and under right to try, if they

could qualify there are sought of basic safety testing that has gone on with a biologic medication device in that phase one process, and there is an informed consent requirement that the patient needs to have all of this explained to him. It's put into writting he is supposed to be taught realistically what can happen in result of participating and taking this experimental medication under the circumstances, when the patient is fully informed consistently in  writing, is taught what the risk are and everybody has agreed nothing else has worked, there's nothing else to try, then you go to the manufacturers, the people who have these things and in order to get their participation there are some protections from liability for their allowing these people to have the use of this investigational productions. It's not protection from medical malpractice but they can be charged with a legal liability just because they gave somebody something that hadn't gone through the full FDA process. There's no requirement that any manufacturer to participate in this, we are not forcing anybody to do anything, this is entirely permissive, if all of the T's are crossed in the I's are dotted. There are obviously other details in the bill and I will be glad to come in on anything that somebody is got a specific question about that I either said or maybe in the bill. Representative Dopson. Thank you Mr. Chairman more coming and I have two friends right now who are fighting for their lives and they are about my age, and this is no respecter of age, race anything so this one is kind of personal to me, and I'm very much in support of this bill, and I appreciate you bringing it forward because we have all the people are in this situation young kids whatever with the desire to live, then we need to try and do whatever we can to give them that opportunity so at the right time, Mr. Chairman I make a move Mr. Chairman if I might say frankly I want the privilege is at serving in the legislature just having the opportunity to do something like this. Representative Dollar? I just have some couple of questions. First of all is sort of fair to say that this bill is maybe sort of broader in a sense than what you may remember Representative Mackelruff[sp?] championed that last condition session That canvass related but don't say can. Yeah, hers was I think was limited to that one product and this is sort of broadening I think. Yes. Okay. As I recall her bill. So it's along that same walk. The other question I would see if I had another question, I can't remember what it is, but another question I do have is, and while you're a lawyer and no disrespect to lawyers married to one. Good choice. Thank you. For a lot of reasons. But should not should this bill take a dip in the Jay Committee? The reason why I ask is that I know there are liability sections in here? Right That deal with liability and I notice it just has the referral here, obviously no intent that your bill make crossover or that anybody would be trying to slow it down, but I'm just wondering if maybe it would take a dip and a Jay[sp?] committee. I ask you that as an attorney I don't have any objection to that and it certainly is not inappropriate. The only consideration would be time issues and with J4 Committee's I don't know that that's impractical to do. The speaker is also a lawyer and his office didn't choose to give the cereal refer, but I don't have any problem with that at all.  But it's the rules chairman that, I think it's the in right. Representative Dora. Thank you Mr. Chairman I'm sorry I'm being a little more casual, but which cheque committee are you on?  J4 well do you think being I think J4 will be willing to hear it I would since I anticipate the chairman is going to recognize representative Dopson

at the appropriate time, I would make that as a suggestion as he considers his, considers his motion and the only other thing and I think I've already answered this and that is particular with the PCs all the major stake holder are in good shape, in other word there's no major stake holder out there that has a burning issue with this or is that fair to say it, it's not fair to say. It's fair to say that I'm not aware of it and I don't have a check list that I went down and said have we heard from these people. I did make an effort to distribute coffees to some thugs and to check with [xx] and I've gotten some feedback from some people, but nobody has had any opposition. I have one fellow I don't know whether he is still here or not he is Mr Taylor back there who saw me earlier in the day and was concerned the bill would require some of the manufacturers to produce products so that it would be available and he was making the point that it is very expensive and that it could, and some of this are small companies and it could run him out of business if they had to produce it and didn't get adequately compensated for it and I explained to him and I think the staff confirmed that the bill is wordings in such a way that there is no obligation on the part of the manufactures, whether it's pharmaceutical company or biologic bcompany or whatever to actually participate by providing the investigational product. Representative Dollar. I apologise but last one and so following on that there is nothing in this bill that anyone has staff for anyone else is determined within any way be in [xx] with FDA rules of practice. It's my understanding I did talk with with the staff that the FDA could run on a parade by making it clear like an assault their ability is the Federal Government to say, you don't care what you pay us in state but this point it's a believe that this would be allowed. We have tried to look at it from the stand point of insurance companies, the state health plan, hospitals. Representative [xx] at this is my eyes on that one and we got stuff in here that is designed in opinion to sought of protect house space, by making it clear, somebody decides there going to try to live, by participating in this. That may mean that, if they were in hostage and that under the hostage rules generally if your trying to continue to stay alive, I think they don't take you at hospital until is in under life situation. So I'm hoping  if somebody can identify a problem still, there is no [xx] we try to cover those basis, and this language is based substantially maybe almost, maybe correct me, it's there for particularly state provision and registration that is going to this other state with such unanimity of opinion so the stakeholders. in those other state have currently have not identified things in this relatively marble registration that they will concern and so hopefully, most of those kids will walk out. Thank you. Thank you. Representative Conie[sp?] Thank you Mr. Chairman my question was about Hospsen and he calendared it. Thank you. Okay. Seeing representative Bishop. Mr. Chairman to follow up on Representative Dollar's question, Representative Blackwel has sperck[sp?] considered or you considered whether or not I guess the true or food drug after whatever was that to pre empty the field of pre emptied, I guess not all of [xx] state have done it but I'm curious whether there is any got it on that. I discuss that in general with Ms Johnson and the staffs and my understanding was that as I was attempting to say to Representative Mrs Dollar the potential for them, come passing a rule which specifically negate our ability to do this is out there, but we think there is room for this registration and add knowledge and ambition [xx] and Jason can correct me or head to but honestly it's been a relegation in this writer track that we will suggest that it is in consistent with existing [xx] of law [xx] I guess my concern about that is, if it is an unknown, then if you pass this two equip

people with liability to trying, if it should turn out this its invalid by virtue of Federal prehension then those persons will be at risk so even without FEA taking some action to pass another rule or to litigate it can speak just go [xx] of the law.  Representative Backley do you have comment I may ask Miss Johnson to respond to that after I over my two sense worth on it I'm not clear, I'm no expert on the FDA law on regs, but I would think that If it would determine that some aspect of this is invalid valid it is the piece that would permit the manufactures to dispense, or utilise this things and the prescription of it but I don't know whether the provisions of the bill that protect people from liability for doing these things get listed in our state codes with necessarily being invalidated even if other aspects where, but may be Miss Johnson can offer Do you recognise it Miss johnson? I would agreed in early with you representative Black Well that the pieces that would be at play with regards to the FDA is whether the manufacturer can even give drive certainly the FDA have been given federal authority in dominion over the area, prescription medication particularly [xx] that's why the bill is heard today the legislation is extremely new in this states that we have not seen any court challenges, nor has there been any specific guidance from the FDA to the contrary of the states statues, what has been done by the FDA is as these states are passing the rights to try bill, as you've mentioned 13, the FDA has started to take look at their own procedures for their compassionate use program, and is attempting to speed that a long as well. So it's hard to say whether or not would be preempted or not, there is no authority or guidance on that at this time. Representative Blackwell? Not to drag it out too much longer but the fact again that were doing this doesn't mean that a particular manufacturer or a particular position might not be advised by their attorney, I don't think you ought to get involved with this. This is permissive and we're hoping it works and as McJohnson alluded to and maybe I said it earlier, the effect of state passing this law does seem to be having the salutary[Sp?] effect on the FDA that they're actually moving towards trying to speed up their processes for dealing with these new drugs an getting these approvals out. Representative [xx]. If I could just make one comment, thank you Mr. Chairman many times in the past you probably had a situations of family and loved ones that actually gone to other countries to actually get these drugs because these were not allowed to be used in this country because they were still under these protocols and it takes time and I think one of the biggest criticisms that they have days that take so long to take from concept, invention and then into a patient trow[sp?] and that is something that is trying to speed up, you'll also hear many times that when they go to a foreign country, because we are, these are people that are literally that are on the yesterday and turned every rock over to try to find the solution to the medical condition and nothings worked, this is the last day therefore to try to find something. You'll often here when I do that that it works and I think that's what this is trying to is give them that last hope for products that're emerging and at some point will be on the market but they are not quite there because the link it takes to get to all the FDF approval and all the things that we see has dad and teeth cross. Vendors are typically willing to provide this product because they ultimately want to be able sale these products in the market place and they won't have as much evidence and data as they can to show that they do work so I actually do think it's a very small number of patient I think they will find this attractive, but I I think it again helps those as Representative Dobson said that are on their last days to give them some hope and many times they will work. For recognizing Representative Dobson for motion, chair we'd just like to observe and commend the bills sponsors for this bill I was about to follow the same bill when you did and so it's encouraging to see that life man collegue thought this was a good loss so thank you very much with that, Representative Dobson pursuing to the

conversation from Representative Dollar and the bill sponsor would you like to recommend or forth to [xx] solve it, the committee can do, we can recommend all for then would you like to do that.  Thank you Mr. Chairman. That would be fine. Do you recognize for your motion.  Mr Chairman I would like to make a favorable report for the oppose committee substitute for house bill 652, unfavorable to the original whether you recommended referred to the judiciary forward. Unfavorable to the original representative Gipson, moves for favorable report to the house committee substitute for house bill 652 with a recommended refer legit share[sp?] forward, unfavorable to the original bill, all those in favor signify by say hi, and oppose say no . The hi's have it. Congratulation with your process, no further business before this committee, we extend adjourn