Pharmacy Board denies my petition again

Des Moines 20100822 066Here are the events that took place on my petition for marijuana scheduling. First the subcommittee report from November 19, 2014.

Here’s a link to a copy of the subcommittee report.

After the subcommittee report was read, the following conversation took place:

EDWARD MAIER: So, that entire document is what the committee has recommended to the board. I would now open it for discussion or any action that the board would like to take.

SUSAN FREY: Well, I would like to thank the committee for their work. I think it, this document and these recommendations, sum up what we have been trying to do for the last five years that we’ve been looking at this project, or this subject. So, I would be in support of the committee recommendation.

JAMES MILLER: I, too, would like to thank the committee for all its work, and it’s certainly been a worrisome issue since 2009 or before. I think there’s a lot to this document that Ed has just read and we just received it in copy a few minutes ago to review. I would be in favor of tabling this thing until at least until our next meeting so we have time to review it more thoroughly. I’m especially concerned about the last paragraph, that the Iowa Board of Pharmacy making a rule about schedule changes when this is clearly the purview of the federal government. We just went through a situation in Iowa where hydrocodone, one of the most widely prescribed opiate pain relievers in our state, and in the whole country; and we schedule it as a schedule 3 in Iowa until the federal government said, “No, it’s going to be a schedule 2.” We could have a petition saying, “You know what? In Iowa I think we’re just going to leave it in schedule 3.” That was not our ability to do that. The federal government decides what schedule things are in. So, I think we should take our time as far as making any further recommendations. So, I would move that we table this. Give it some more thought.

EDWARD MAIER: Do we have any discussion?

SUSAN FREY: Jim does bring up an interesting point. And, again, we find ourselves in that quandary of we already have the established, the legislative established cannabidiol act. I would certainly be willing to table it and hear more.

EDWARD MAIER: That was the quandary that the committee placed ourselves in. We knew that number one we could have a recommendation straight out against because of the federal class 1. And, then we could look at Iowa law, the act this last year, the cannabidiol act has placed us in a position where Iowa law, it meets all the criteria of for class 2. We’re into the catch-22, so to speak here.

JAMES MILLER: I would say that Iowa legislators are elected representatives of the citizens of Iowa. We are not elected representatives. We have different scope and service to the citizens. The elected body can choose to do whatever they wish. But as an Iowa citizen, I’m a citizen of Iowa, and so I’m subject to Iowa laws. I’m also a citizen of the United States. So, I’m subject to federal laws. I’m not attorney. My recollection is federal law supersedes. So, I think even, regardless of what the Iowa legislature does, as a citizen I have to kind of be thinkin’, “Hmm, I wonder which set of laws are we going to be under?”

EDWARD MAIER: And, I think it’s important that no matter which way this goes, this is simply a recommendation to the legislature and the legislature then would have to take action and the governor would have to sign that. It would have to be, go through the regular channels. And, it’s a difficult, very difficult matter.

JAMES MILLER: I think it’s extremely difficult. But I also think that there’s some credibility here as far as the board and what our role is and that we maintain our diligence as far as the safety of the citizens of Iowa. And, we’ll be looked at to establish the safety of the drug products that we currently take responsibility for. Marijuana wouldn’t fall into that category at all: the standardization of dose; as far as proven efficacy; as far as proven safety. I think that clearly is outside of the bounds of our expertise.

EDWARD MAIER: Any other comments?

EDWARD McKENNA: I agree with Jim, because I think that the marijuana oil that people use for epilepsy, the University of Iowa is monitoring that program. Right? So, I think we need more information that the oil is actually working. That program was just implemented.

January 5, 2015:

Item 3.5 on the Agenda (around 9:30 a.m.)

JAMES MILLER: Item 3.5 is the Olsen versus the Board of Pharmacy petition.

LLOYD JESSEN: I think Meghan might have a little comment for us.

MEGHAN GAVIN: Yes, I’ll give you a little update. This is one of your several judicial reviews right now going through the courts at the moment and time, but the board will remember this was Mr. Olsen’s request that you considered in January of last year about the reclassification of marijuana rescheduling, I should say of marijuana. Judge Ovrom determined after the briefing and oral argument that this board maintains discretion about which particular drug it chooses to make recommendations to the legislature for. She said that your decision on whether or not to recommend can only be overturned for abuse of discretion. She found no abuse of discretion in the year 2014 recommendation. So, she is saying that. This has since been appealed by Mr. Olsen to the Iowa supreme court. The case is not done, but this is the first time that we actually have a judicial decision that directly pertains to what your, this board’s obligation is under the controlled substances act to make recommendations every year. It’s a fairly short decision, so I encourage you all to read it. If you have any questions, just let me know.

JAMES MILLER: Is there any indication of when the supreme court’s going to review it?

MEGHAN GAVIN: Appeals take time and what will happen is once the transcript is sent to the court, they’ll send out a briefing schedule and that usually takes about four to six months for the briefings to be completed and given to the court, at which time Iowa has kind of a unique appellate system, so it will be reviewed by staff attorneys and the supreme court will make a decision on whether or not to keep the case or to give it to the court of appeals. I suspect, because the case is based solely on statutory interpretation, that it will be sent to the court of appeals for adjudication. They then get things pretty quickly before them. So I would imagine next fall. I know, does that seem quick from an outside perspective? But, actually it is fairly quick. So I would imagine next fall they will have it submitted to the court of appeals. Both the court of appeals and the supreme court take short recesses in the summer to work on administrative things, so that’s my best guess. After the court of appeals you have an opportunity to request the supreme court review, but you don’t have a right to that. So, that could keep the case pending for a little while longer.

JAMES MILLER: Any other questions regarding item 3.5?

Item 2.1 on the Agenda (approximately 10:00 a.m.)

The pharmacy board delayed the discussion of my petition (Item 2.1 on the Agenda) until 10:00 a.m. on January 5, 2015.

EDWARD MAIER: We’re ready to proceed and my understanding is that we are at 2.1 on our agenda, the petition to request reclassification of marijuana. And, what we’ve heard on that is that we have some suggestions from the last time around from the subcommittee. And, we voted to table it. And, so I’m going to open it up here to the board for some discussion at this point and see where we want to go from here on that topic.

JAMES MILLER: Well, I think we should limit our discussion to the cannabidiol that was acted on by the Iowa legislature. The Iowa legislature did not, certainly had discussions about reclassifying marijuana, and they did not take any action on that. I think their purview demands that they would, but they did take action as far as addressing cannabidiol. And, so I think we can, we could uphold the act. But as far as the rest of the 400 components of the marijuana plant that are listed, I don’t think we have any purview there.

SUSAN FREY: I guess I would agree with that, simply because as a board our procedure has always been in the past that we name the specific compound or chemical entity. For instance, we don’t just recommend that we reschedule all pain killers, because there’s different levels, they are used for different things. And, so, I would, I think that’s probably been our biggest stumbling block, is just by saying marijuana it’s not specific enough. So, I would simply, we already have legislation that has addressed the cannabidiol oil, and that we recommend reclassification of that product. And, as scientific and medical information comes along for other derivatives, since we already have Marinol that is scheduled, that’s a marijuana derivative or THC product, a chemical entity of marijuana, it’s already scheduled. I think we should address each individual chemical as they become, or entity as they become available. So, that would be, I would second Jim’s recommendation that we address simply the cannabidiol oil to bring us in compliance with the legislation.

MEGHAN GAVIN: Can I interject one second?

SUSAN FREY: Sure.

MEGHAN GAVIN: The board is certainly able to make your recommendation as narrow as you want. The actual petition, however, itself is for the reclassification of marijuana. So, if you’re going to go down the route as has been suggested, you would deny that recommendation in total and make your more specific recommendation. That would be the procedure.

SUSAN FREY: Okay.

JAMES MILLER: I would move that we . . .

EDWARD MAIER: Just a second. I think that we need to have a little more discussion from the members of the the committee who made the recommendation. I’d like to hear if they have any input on what’s just been said.

SHARON MEYER: Well, I think as a pharmacist we all have that scientific viewpoint that if a particular chemical or compound that has some medical effect, it would need to be studied and researched and standardized. And, that’s what we prefer for dosage forms for patients. As a member of the subcommittee I think what we wrestled with is what is currently in the code that has language to the effect that if a substance is currently in schedule 1 is found to have some medical benefit then perhaps it should be considered schedule 2. I think that’s kind of where we as a subcommittee were going is because we were following what’s in the Iowa Code now to make recommendations.

LADONNA GRATIAS: And, also the legislature did pass medical marijuana. It was told to us that it really was a schedule . . .

EDWARD MAIER: That was cannabidiol oil.

JAMES MILLER: Just one component.

LADONNA GRATIAS: Right.

SUSAN FREY: Well, I guess . . .

JAMES MILLER: I would say, there’s a product being tested in the US and UK, it’s being tested in human subjects in a product that has both THC and cannabidiol. It’s been in clinical trials. So there are some standardized products being developed. But to consider the whole marijuana plant I think is way beyond the scope of what . . .

SUSAN FREY: I guess I’m, in retrospect, it makes sense to me that if you can use the analogy of opium, opium is in schedule 1. So, it’s a raw plant. And, so it has medicinal value. It’s in schedule 1. But, yet, we have morphine, which is in schedule 2, which is a direct derivative of that plant. To me, that’s where this should fit. We should keep marijuana in schedule 1, but then the chemical entities that developed from that should go into schedule 2.

EDWARD MAIER: Okay, I guess I agree with Sharon from the perspective of the group. That is what we struggled with. But we also struggled with the fact that I don’t think any of us were completely ready to say we want to jump both feet in and say that we think there should be a medical marijuana program in this state. That’s not, at least from my personal perspective, and I think I recall a conversation that was a part of it, because it is such a broad thing. And, there is such a variance in potencies of the plant. It’s a very hard thing to get your hand on scientifically. We’ve heard some people say there’s some uses for derivatives, but, you know, at this point and time we’re still, we need more research. But schedule 1 and schedule 2 both allow research. One point that I really am, because I’m really, I’m really strong on, because I’ve been here for the last six year and we’ve struggled with this, there are conflicting citations in the code. One place it says its schedule 1 except by rules of the board and one place it says its schedule 2 except by the board. I strongly believe that we need to recommend, or that we need to do something legislatively to clear that mess up, whichever way we go.

JAMES MILLER: There’s a petition to your point and I think the petition itself talks about two places in the Iowa Code. You know, we have a legislature that is charged with writing the code in particular. I don’t think they need any recommendation from us. We’re not attorneys. We’re here to take care of the pharmacy laws and protect the health of our citizens. So, I think that kind of stuff is way beyond our area of expertise. I don’t think we have any business telling them what to do.

EDWARD MAIER: I agree with the part about the fact, probably I feel more comfortable with making a recommendation of cannabidiol than I do on marijuana. Personally, if somebody’s willing to make that recommendation, then I’m willing to go . . . I don’t think we can just deny this request and move away because the legislature’s already said that there is some use for cannabidiol. If we’re allowed to turn aroundthen and make a recommendation for cannabidiol, I’m willing to say we deny the marijuana part of it and we just include the cannabidiol and recommend that the change be made to delete those references to the rules of the board.

MEGHAN GAVIN: Well, your proposal then would be to make clear that the legislature would have to act before marijuana would be rescheduled, then the board would not be committed to establish a marijuana program.

EDWARD MAIER: That’s what I’m thinkin’. Our idea is that we don’t have the power to establish a marijuana program. We can’t write those rules because they’re too broad. But, yet, there’s a suggestion there that we should, and that’s not right. That’s the legislature’s prerogative, not our prerogative. And, those things need to be out of the code.

SUSAN FREY: I agree that if we deny the petition, that we should turn around and do a recommendation for the cannabidiol oil. But, then, perhaps we should move the other part of that as a piece of legislation to be entered in and not part of a suggestion.

EDWARD MAIER: And I’m perfectly agreeable to that. I was thinking to make that change as a part of the whole thing. It’s going to keep coming back to us as rule making and those are those outdated wording that has been there for years. That kind of a program is way too broad for one board. It would be way too broad for the board of medicine, or the board of nursing, or anybody else to write those kinds of rules. So, I guess I would entertain . . . Is there any other discussion? Okay, I would entertain a motion from anybody.

EDWARD MCKENNA: I think we already have a motion.

EDWARD MAIER: Just a second now, we have a comment.

CARL OLSEN: Opium plants are in schedule 2, not schedule 1. And coca plants are in schedule 2, not schedule 1. We don’t have any plants in schedule 1 from which any medicines are derived. So, that was an incorrect statement. If you want to normalize the act, you recommend marijuana be classified like opium poppies and coca plant because that’s where we put plants that are the source material for these derivatives like cannabidiol.

JAMES MILLER: Duly noted. I’ll make a recommendation that we deny the request.

SUSAN FREY: And I will second it.

EDWARD MAIER: Any further discussion? All those in favor, aye.

ALL BOARD MEMBERS: Aye.

EDWARD MAIER: Opposed? Okay, the motion has been denied. Does anyone have any further recommendation they would like to . . .

SUSAN FREY: I move that we recommend to the legislature to reschedule cannabidiol oil to schedule 2.

MAIER: Second. Any further discussion?

EDWARD MCKENNA: The only discussion I have on it is, how broad is that? In other words, if you have morphine scheduled like 15 mg, 30 mg, different things like that? How do we know if there’s other ingredients in that oil? What are we recommending? In other words there are certain companies out there that make that. Are they legitimate companies?

EDWARD MAIER: And, that’s already been said. I think at this point the legislature has recognized the medical use for it and that is our criteria.

EDWARD MCKENNA: Right.

EDWARD MAIER: But, duly noted that there are concerns, a major concern.

JAMES MILLER: Another major concern, according to DEA it’s schedule 1. So, every pharmacy in the state has to have a DEA license and you have to abide by that license. So we would all be breaking the law if we had a cannabidiol product. Its consistent with the legislative act, but nothing else.

MEGHAN GAVIN: I think, I want to say this accurately, the classification of cannabidiol under federal law is a little bit of a gray area at the moment and time. Some people believe it to be part of schedule 1 as marijuana and some people believe it to be unscheduled. There’s no definitive statement. And, to my knowledge I don’t believe DEA has taken a position publicly on it.

EDWARD MAIER: Carl, do you want to . . .

CARL OLSEN: The DEA website clearly classifies cannabidiol as schedule 1.

EDWARD MAIER: So, if we were to go to schedule 2, we would still be . . .

CARL OLSEN: It has a drug control number, 73 something.

JAMES MILLER: But the derivative product being approved, you know, in the approval process, includes the cannabidiol that is in the act.

SHARON MEYER: Just for the sake of discussion, is something that is needed possibly something the legislature needs to address with that? That a substance, cannabidiol is included in this to the legislature? That is is a schedule 1 substance? Is that something that really the legislature needs to address, that there is conflicts in the code? So, I don’t know if we’re recommending that it should go to schedule 2 or that the legislature needs to address that there’s a conflict.

EDWARD MAIER: Your motion, Jim.

SUSAN FREY: It was my motion.

SHARON MEYER: We were also trying to think of other potential derivatives that may come on the scene, that there are active uses for. And, we were going to the conundrum of the scheduling of schedule 1 / schedule 2, the other derivatives, the federal, the state. So, I feel its like as a member of the subcommittee, that’s where we had a tough job because there is conflicting code.

EDWARD MAIER: The code says cannabidiol. So, if we change cannabidiol, we’re following what the legislature did. The subcommittee had already recommended schedule 2 anyway.

JAMES MILLER: It’s totally correct. There’s no product. There’s conflicting code. I think the only thing we’re doing with this recommendation is supporting the cannabidiol legislation that this particular product has some use, possible use in cases of epilepsy.

SUSAN FREY: So, are you offering a friendly amendment?

EDWARD MAIER: No, I just wanted to clarify because of the question she brought up. This is a change.

SUSAN FREY: That’s where I want to see this going. If the existing program, whichever is being developed, we don’t know what that is, the department of public health, whether that’s going to involve, what distribution system, we don’t know. So, I guess, putting it in schedule 2 makes it more readily available if that comes to, once those plans and design is available.

EDWARD MAIER: Any other discussion? We have a motion to reschedule cannabidiol to schedule 2. All those in favor, aye.

ALL BOARD MEMBERS: Aye.

EDWARD MAIER: Opposed? Okay, the motion is carried. And I would commend the subcommittee. And I, when we get to the legislation, we need to talk about what we said. The other thing is that’s going to get lost in this is that we really felt now, twice, bodies of the board have said something about there being a committee of a cross section of people from multiple disciplines that take a look at either cannabidiol oil or marijuana or whatever it is. And, I hope that this doesn’t just get lost in the record that somewhere a committee forms and takes it seriously. With that, we’re going to move on.

TERRY WITKOWSKI: Question. Do you want to go . . . Do you want to have a recommendation that the legislature look at the current language that talks about the board of pharmacy adopting rules for medical? Because neither of these motions really address any kind of a recommendation to them regarding that.

EDWARD MAIER: Susan was talking about that. We look at that as a piece of legislation that goes up. Or would that have to be a recommendation?

TERRY WITKOWSKI: If you want to propose any legislation now, you’d have to get a legislator to do it because we’re beyond the deadline for pre-filing.

SUSAN FREY: Okay.

EDWARD MAIER: I’d like to see a recommendation.

SUSAN FREY: And, refresh my memory, Terry. What is it that we need to review, or to remove from . . .?

TERRY WITKOWSKI: There is a provision in schedule 1 that makes an exception or an exemption for marijuana when pursuant to rules of the board for medical marijuana program. There’s a provision in schedule 2 that, along that same line, that says that marijuana is a schedule 2 substance pursuant to rules of the board. So, it makes an exemption out of schedule 1 and an exception into schedule 2, both of them pursuant to rules of the board for a medical marijuana program. So, your recommendation could simply be to eliminate those two provisions.

EDWARD MAIER: And the reason being that our authority is too narrow to adopt the rules.

MEGHAN GAVIN: You could just remove “pursuant to rules of the board.” That’s all you have to say.

EDWARD MAIER: In both places. Would you like to make a motion to make that recommendation?

SUSAN FREY: Okay, here goes. I move that we send a recommendation to the legislature to remove in schedule 1 concerning marijuana the exemption . . . No, I mean in schedule 1, giving the exemption for a medical marijuana program, I suggest we remove the wording “pursuant to rules of the board of pharmacy,” or, “the board.” Okay, because the board does not have the authority to establish a program. And, I further recommend that the exception of a medical medical marijuana program that we remove the wordage “pursuant to rules of the board” for that same reason, that the board does not have authority to publicate those rules.

EDWARD MAIER: Do we have a second?

JAMES MILLER: Second.

EDWARD MAIER: Discussion? All those in favor, aye.

ALL BOARD MEMBERS: Aye.

EDWARD MAIER: Opposed? Carried.

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