 It's 10 after what we start getting going here. Good evening, I'm Mike Smith, Secretary of Human Services of the Agency of Human Services. To my far left is Nancy Hobe, who's the Director of Pharmacy Services at Diva. She's a pharmacist. And to my immediate left is Kerry Phillips, a pharmacist from the Office of Professional Regulation at the Secretary of State's office. And to my right is Inabakis, the Director of Healthcare Reform at the Agency of Human Services. Thank you for coming to share your perspective, not only about the rules that we'll be talking about, but about prescription drug importation in general. Today we would like to hear from you generally regarding prescription drug importation from Canada to Vermont. We are also inviting your input on the Notice of Proposed Rulemaking issued by the Federal Department of Health and Human Services and the Food and Drug Administration that would allow states to legally import drugs from Canada. We'll submit comments on this rule by Monday, March 9th, 2020, so your input is valuable. In terms of us submitting those comments. This is a listening session for us and I will encourage us to listen to the things that you have to say about this rule or about drug importation. I will also ask Inabakis to briefly describe Vermont's proposed importation efforts as well as the Notice of Proposed Rulemaking Framework, which would enable states to submit applications for approval of drug importation from Canada. So, Ina, would you just take it from there and give us a short sort of snapshot of what we've done and what this rule, what the rule allows us to do. Thank you. Thank you all for coming. Vermont law via Act 133 of 2018 permits the importation of drugs from Canada subject to federal approval. Vermont was the first state in the nation to pass this kind of and enact this kind of legislation. In November of 2019, Vermont submitted a concept paper to the Health and Human Services Department and to the White House, which described our approach or a contemplated approach to a program of prescription drug importation from Canada and the ways that the program would guarantee the safety of the drugs imported from Canada as well as guarantee savings to consumers. Vermont's proposal envisions importation that would be a program where commercial insurers would participate to start with the possibility of phasing in participation by public payers after the launch of the program. This program design is based on savings analysis completed both by Medicaid program as well as participating commercial payers in the state of Vermont. And it was determined that the savings would be substantial to consumers or could be substantial to consumers through commercial purchase of drugs imported from Canada. Whereas with the Medicaid program at this time, that savings opportunity is not as significant. The state of Florida has proposed a program that is only for Medicaid beneficiaries and it differs from Vermont. We selected early analysis, our first analysis, which was submitted along with a report to the legislature at the end of 2018 included information provided by two participating commercial health insurers in Vermont and estimated in the first analysis between one and five million in savings if drugs from Canada were available to their customers. New estimates show that the savings could be at least three times this much. Canadian wholesalers would, the program looks at Canadian wholesalers selling to United States wholesalers who would make prescription drugs available to participating Vermont pharmacies. Vermont has proposed new categories of licensure for these wholesalers. In addition to following the necessary tracking and tracing procedures, safety measure protocol would include that the manufacturers of the drugs would need to be FDA approved. The systems would be required for verification and handling of suspect or illegitimate product. Drugs subject to FDA would be subject to FDA examination at the border and licensure again would be required for eligible participants. The federal government issued on December 18th a notice of proposed rulemaking, making a pathway available for states to pursue importation programs for the first time since the federal government allowed the potential importation of prescription drugs from Canada via section 804 of the Food, Drug and Cosmetic Act. This rulemaking, notice of proposed rulemaking as Secretary Smith said, requires that any comments be submitted by March 9th of 2020. I will now describe briefly the framework that the notice of proposed rulemaking lays out for states or for entities that would be pursuing prescription drug importation. Section 804 of the Federal Food, Drug and Cosmetic Act allows HHS to promulgate regulations that would allow pharmacies and wholesalers to import certain FDA approved prescription drug products from Canada if certified by the HHS secretary. According to the notice of proposed rulemaking, section 804 would be implemented through time limited section 804 importation programs which HHS are referring to as SIPs. Each importation program would be authorized by the FDA in two-year increments and would likely be managed by states. Importation programs may request extensions or additional four additional two-year periods. A state may submit a proposal independently or with a cosponsor and must demonstrate how the program poses no additional risk to the public's health and safety and would result in significant reduction in the cost to the American consumer. The proposal must identify the foreign seller in Canada that will export the drugs to the state as well as the importer in the state that will be responsible for distributing eligible prescription drugs. The FDA would decide whether to authorize a proposal and per the notice of rulemaking, the FDA may not necessarily approve all proposals that meet certification requirements, depending on the FDA's capacity to conduct oversight of programs. I would welcome any comments on drug importation in general or about this specific program or about the rule that notice of proposed rulemaking framework that we have. And I should have mentioned that in the packets available at the door, you will find the rule itself, a summary of the rule by the state of Colorado as well as Vermont's concept paper for importation. Can I share a quote or is that? Do what? We don't have a lot of people here. Do what you want to do. I thought this was interesting in terms of putting sort of context to it. A medical society in the state of New York, 1818, a uniform system of preparing and compounding medicines throughout the United States would contribute much to the satisfaction of the practitioner. The traveler finds different preparations under the same name and almost every village, town, or city. For so multi-ferrarious are the names of medicines. I love the big word factor. That a name which is common in one town may be unknown in another. Or what is worse, be applied to a very different medicine. Therefore, resolve that it is expedient that a pharmacopia should be formed for the use of the United States. Anderson L and Higby G.J., the spirit of volunteerism, it came out of a quote on medicine. And I thought it was very interesting because it got packed sort of way back then what this rule is trying to maintain, which is we need our medicines, but we also need safe medicines. So in reading the rule, I came across an executive summary, Part B summary of the major provisions that propose rule, FDA proposes approved by Health Canada's Health Products and Food Branch, HPFB, eligible drugs could be sold in Canada or the United States with appropriate labeling. My question would be does the labeling tell, or my comment, does the labeling tell the consumer the info that is needed as to it is from Canada, approved by Canada, and lets the consumer know if quality control is as good as it was approved by the FDA. So there would be an education of the consumer that this actually does work and they can have confidence in it. Paragraph 567 mentions relighting of the drug and concerns what consumer relevant information is on the label at the time of purchase when you start talking about relighting. Under Section A, purpose is stated, purpose of rule is to lower prices and reduce our pocket costs for American patients. In additional language, that the quality is as good as also important. I think the two have to stay together in terms of how it's described to the consumer. I'm taking the whole thing from a point of view of what does the consumer see when he's there at the counter or she and buying what they're buying. Unreceived legal authority does the state certified to Congress, pose no additional risk to public health and safety, results in significant reduction in cost of covered products to the American consumer. That is one of the goals, if I'm trying to paraphrase as I go along. Clarify what is significant reduction. And I think you started to get to that in your comment because there could only be a few drugs, there could be several drugs. When you get a savings or a fork, you want the savings, but the quality is there. But the consumer will ask the question, can I afford it? That's a very common question the consumer will ask it. So what is significant reduction to whoever these companies are? And what is the significant reduction to the consumer? There is also a question. How do we get the info for the cost and benefits when I get to that section? We need estimates at the very least possible market effects, even if just a list of benefits adverse effects. I came across that section that sort of said, we don't know anything. And that's where that comes from. And I'm thinking, okay, then you go out and you find the information. We still plow ahead with this consumer opinion. We go out and we work it. The second paragraph strongly suggests administration or operational costs. That sounds a little bit like ADCO. Do you keep the operational costs within 2% or executive fees, wherever it is, administrative? I think we actually do know that one. You have to watch and make sure that that is a meeting of your savings. Let's see. Reference is made to importation will not, yes. It actually said importation will not create better costs to the consumer. And I simply comment, was that a biased statement? That was within that section of it. 79% of the drugs would be found unreasonable in costs. And I'll simply say, okay, I read it. I'm not sure exactly why he was giving me this information. Thank you very much. I'm still not intimidated. It was in there. I just don't know exactly what it was trying to get at. And the background information, you also find a positive attitude. This may work through state implementation. And I think that is a strong point, state implementation. What is the cost of the work that needs to be done? How long will it take? And how do we test the process as we go? Those seem like very relevant questions in terms of where we do go. I will simply add, in 2003, I was immigrating to Colbert, Canada, or to Canada. I actually have been visiting hospitals up there. I heard a little bit of the conversation on the other side of the border. What was very intriguing is they said they were never allowed to talk to the United States because the drug companies would penalize them in terms of the costs of their drugs. So to go from that to we have gotten to this, wow, you've already made great strides going forward compared to conversations as you were in back in 2003. That's it. That's all I have for comment. Thank you. And I do have to apologize. I have to catch a bus, so I have to go. Thank you. Anybody else have any comments on the rule or drug? For some reason, in 2005, when I had this issue, before I called it re-importation, I'm trying to train myself importation. Any other comments? We, the state of Vermont, do need to gather further information to understand that and to understand the universe of willing distributor partners on both sides of the border. Wholesalers and distributors, or wholesaler distributors. Anything else? I'm expecting. You've heard our comment before, it's just that we want to work better the fault by health. Speaking on behalf of the fault by health news, we just want some additional details on how it interacts with that program. We understand that it's not going to impress us down below that, and they're expected to operate in parallel. And also there's the challenge of not being able to participate in other group purchasing schemes where I think we're going to be providers. So it was just a question of how the money flows work if that chunk got knocked out. I trust that it was part of the analysis of this incident. It was just questions on the details of how it works. We're doing more work to gather information about the interaction of a program of this kind and the 340B program. Any other comments, questions? This has got to be the shortest public hearing I've ever done that. Okay, going. Do you have all statements that are expressed in the interest on either side of the border? Not yet, and we haven't reached out to be honest. We haven't reached out to either side of the border. I will say that I think the Canadian government is starting to get interested in what is going on here. In fact, they have reached out to us to find out what this program would look like in terms of what's going on. I think they want to just stay abreast of what's happening. I don't know if I'm supposed to be saying that, but that's what it is. It's good to hear. Yeah, I don't know if that's good or bad, by the way. Well, to the top of this. Yeah. Anywhere in the legislative wording, would it be important? It does. The federal law section 804 that allows HHS to approve any state for an importation program in that law. There are limitations on the types of drugs that can be imported, and those limitations include control substances, biologics, infused drugs, IV drugs, drugs that are inhaled during surgery. I believe that's the list. Yeah. So, for example, a subcutaneous drug in the district? Unless it's a biologic. A lot of them are biologics. Unless it's a biologic. Yeah. It has to depend on how. Anything else for where you just walked in? We're just taking comments sort of ad hoc, and we're pretty much down to you. Okay. Hello there. My name is Catherine Fulton. I'm the executive director of the Vermont Program for Quality and Health Care. And it would be, of course, an area of interest from a quality perspective, because folks go without their meds due to cost, access, location, geography, all kinds of different reasons. Anything that can improve access both geographically and financially would be, I think, an advantage to Vermonters. So I would follow the issue and the actions from a quality perspective in those terms. Thank you. Anything else before we wrap up? Thanks for doing this. Oh, thank you for coming. You're welcome. I apologize there's not more to listen in, but, you know, generally we had this, we had one this afternoon. There was general support for this, and we'll put our comments together for March 9 and go from there. I think there's a lot of work that has to be done both with the comments sections that we're going to do, the rules, the final application that we make in terms of our plan in July, I think it is, that we'll have to do. And as I said, I think the Canadian government will want to be talking with us. Matter of fact, I know they want to be talking with us, and we'll also look at other states and see where they are and what they're doing as well and try to be coordinated with this. Any comments come to anyone's mind after the hearing. You're welcome to email me, ENA.BACKUS at Vermont.gov. We'll take your written comments into consideration as well. Well, I'll conclude this public hearing, and thank you so much for coming out. I hope the weather doesn't turn on you as you go home, but it's not looking good as it starts to get these warnings that we're getting here. Oh, it's Wednesday night. I'm sorry. I think tonight's Wednesday night. We're good tonight. Okay. Okay, thank you.