[00:00:01] Speaker 01: Good morning, Your Honors. [00:00:02] Speaker 01: May it please the Court? [00:00:03] Speaker 01: I'm Shane Pennington. [00:00:03] Speaker 01: I represent the petitioners in this case. [00:00:06] Speaker 01: And I'd like to reserve five minutes for rebuttal, if that's all right. [00:00:12] Speaker 01: I'll begin today by addressing the Court's request regarding final agency action in this case. [00:00:18] Speaker 01: As the Court knows, the final agency action standard was articulated by the Supreme Court in Bennett v. Speer. [00:00:25] Speaker 01: There are two prongs. [00:00:26] Speaker 01: The first is whether the agency decision under review [00:00:30] Speaker 01: is the embodiment of the consummation of the agency's decision-making process. [00:00:37] Speaker 01: And that's in contrast to whether it's merely tentative or interlocutory in nature. [00:00:43] Speaker 01: In the prior round of litigation in this case, the sort of aims won, as I'll call it, where this court held that [00:00:53] Speaker 01: A letter responding to a request for advice and assistance from DEA was not final agency action. [00:01:03] Speaker 01: Under the first Bennett prong, the court said, look, this letter is not the consummation of any decision-making process because no decision-making process had begun. [00:01:12] Speaker 01: That conclusion from the court was based on the fact that petitioners in the letter to DEA that prompted the non-final response from DEA had not asked for any waiver or exemption or change to the agency's regulations or any formal decision from the agency. [00:01:34] Speaker 01: As all they asked for was advice and assistance. [00:01:40] Speaker 03: There are two issues here that were asked of the agency. [00:01:47] Speaker 03: They went to some general statement that the RTT, the Right to Try Act, applied and they could go and give his patience. [00:02:07] Speaker 03: drug, and then secondly, they wanted a specific exemption. [00:02:14] Speaker 03: So leave that part out. [00:02:16] Speaker 03: As to the first part, what was being asked of the agency? [00:02:20] Speaker 01: In the first round of litigation, Your Honor? [00:02:21] Speaker 03: Oh, in this round of litigation. [00:02:23] Speaker 01: In this round, there were two requests or [00:02:26] Speaker 03: That's why I just sat there with your request. [00:02:28] Speaker 01: Right. [00:02:28] Speaker 01: I'm not sure that I'm understanding your question. [00:02:30] Speaker 03: What were you asking the agency to do with regard to some declaration of whether the RTT was an exemption from the Controlled Substances Act? [00:02:42] Speaker 03: You were just asking for their legal opinion, basically. [00:02:45] Speaker 01: I know, Your Honor, we asked the agency to make two decisions. [00:02:50] Speaker 01: First, an individualized exception or finding that my client could obtain access to psilocybin, a qualifying investigational drug under the Right to Try Act for this therapeutic use under state and federal law. [00:03:07] Speaker 03: As a legal matter, because you weren't asking the agency to do anything. [00:03:11] Speaker 03: You were just asking them to say, it's OK. [00:03:14] Speaker 01: Right your honor and there's a reason for that because in order to get the drug to be able to provide it to these terminally ill patients in this urgent situation. [00:03:23] Speaker 01: the drug sponsors, the manufacturers, the ones who are the source of the drug who have to agree to provide it, are going, they did want, and the record, sorry, Your Honor. [00:03:34] Speaker 03: As to that first question, not the second issue about whether you would get a waiver for registration and so on, but as to that first request, which is just tell us it's okay. [00:03:45] Speaker 03: Was that the request? [00:03:46] Speaker 03: Tell us it's okay. [00:03:47] Speaker 01: No, Your Honor, it was to do what the agency has done in the past, which is to make [00:03:52] Speaker 01: an individualized accommodation for access to a Schedule I drug outside of the research context for therapy. [00:03:58] Speaker 03: But I thought that's the second request. [00:04:00] Speaker 03: The first request here was just tell us it's OK. [00:04:03] Speaker 03: Don't make a rule. [00:04:05] Speaker 03: Don't do a formal exception. [00:04:07] Speaker 03: Just tell us it's OK. [00:04:10] Speaker 01: In a sense, I mean, functionally, Your Honor, that's true, right? [00:04:13] Speaker 01: Functionally, we just needed to have evidence that it was OK so that we could get. [00:04:18] Speaker 03: So you're just asking for the agency's legal [00:04:21] Speaker 03: opinion and what, leave aside even the first part of Bennett, what legal impact does that have? [00:04:31] Speaker 03: It has none. [00:04:32] Speaker 03: If you then want to go, if, for example, you went ahead and did it and got prosecuted, the fact of what the agency said would be no, never mind, it wouldn't matter. [00:04:40] Speaker 03: You could still defend on the ground of your construction of how the two statues fit together, right? [00:04:48] Speaker 01: I suppose so, but your honor, when a regulated entity goes and asks for permission from an agency to be able to build a pipeline, for example. [00:04:55] Speaker 03: But they can. [00:04:57] Speaker 03: They have ways of giving permission, but saying their legal opinion isn't one of them. [00:05:03] Speaker 03: Suppose you went and asked the NLRB the same question, right? [00:05:06] Speaker 03: Does the CSA allow us to do this? [00:05:10] Speaker 03: And the NLRB said, well, that's really not our problem. [00:05:12] Speaker 03: We don't have any authority over that. [00:05:15] Speaker 03: What difference would that? [00:05:16] Speaker 03: What authority does the agency have over that question? [00:05:21] Speaker 01: Under 21 USC 871B, Congress provided the Drug Enforcement Administration, provided it to the Attorney General, who then delegated to the administrator of DEA authority to make rules, regulations, and procedures. [00:05:35] Speaker 03: That's the second request. [00:05:36] Speaker 03: But the first request was just tell us it's OK. [00:05:42] Speaker 03: That's what we were asking about, whether there's a file decision. [00:05:47] Speaker 00: Can I see if I can? [00:05:49] Speaker 00: I think the same question is slightly differently because I'm wrestling with this too. [00:05:54] Speaker 00: You go to an agency and you say, we just want you to know that you're not going to come after us if we do X. We think X is allowed by the statutes, but we want to know that you're not going to come after us if we do X. So can we essentially get like a legal opinion from you agreeing that we can do X? [00:06:10] Speaker 00: So you're not asking them to do a rule. [00:06:12] Speaker 00: You're not asking them to do anything sort of affirmatively. [00:06:14] Speaker 00: You're just really asking for their view of what the statute says. [00:06:17] Speaker 00: If they say to you, no, you can't do that. [00:06:19] Speaker 00: The statute does not allow it. [00:06:21] Speaker 00: One could argue that under Bennett, [00:06:24] Speaker 00: Your. [00:06:25] Speaker 00: they haven't decided any, there's no legal rights that flow from the agency's decision because if the agency's right that the statute doesn't allow you to do it, if we agree with the agency that you can't do it, then it isn't the agency telling you their view of the statute that binds you, especially now that Chevron's gone, it's our view of what the statute says. [00:06:45] Speaker 00: And so in theory, no legal rights flow from that. [00:06:49] Speaker 00: So why is that final agency action? [00:06:50] Speaker 00: And then let me just follow, if it's not final agency action though, it creates this really weird, [00:06:55] Speaker 00: deal or when you ask for that, and I can understand practically why you're asking for it. [00:06:59] Speaker 00: I totally get that. [00:07:00] Speaker 00: Your other option is to go and just issue prescriptions or whatever for this, which you can't even do because you can't get the message. [00:07:07] Speaker 00: But if you were to, if the agency [00:07:10] Speaker 00: correctly says you can't do it, then in theory, there'd be no final agency action under this way of reasoning, and you would not be able to challenge it. [00:07:19] Speaker 00: And so we would dismiss your petition, right? [00:07:22] Speaker 00: I guess we'd argue. [00:07:23] Speaker 00: But if the agency was wrong, if we conclude the agency wrong, then there was final agency action, because the agency's blocking you from doing something that the statute of lives should do. [00:07:31] Speaker 00: And so there would be jurisdiction. [00:07:33] Speaker 00: So it would be a weird deal where there's no jurisdiction if the answer was the agency was correct in saying you couldn't do it. [00:07:38] Speaker 00: There would be jurisdiction, but maybe that's okay because I'm not sure maybe it doesn't change the outcome. [00:07:43] Speaker 00: Maybe it doesn't matter because [00:07:45] Speaker 00: Either way, you win in one instance and you lose in the other instance. [00:07:48] Speaker 00: It's just whether we deny the petition or whether we dismiss the petition. [00:07:52] Speaker 00: So are you following the sort of challenge? [00:07:54] Speaker 00: Absolutely. [00:07:55] Speaker 01: If I could back up just a little bit, if you put yourself in my client's position, we cast our eyes across DEA precedent. [00:08:02] Speaker 01: DEA has allowed and facilitated a number of requests, sua sponte, sometimes at the request of industries. [00:08:09] Speaker 01: So in the reverse distributor context, for example, that was a request. [00:08:12] Speaker 01: from the industry the industry didn't say promulgate regulations they didn't propose regulations they just said hey we would like to be you know sort of [00:08:21] Speaker 01: accommodated within the actual formal. [00:08:24] Speaker 03: Well, we'll talk about that in a minute. [00:08:26] Speaker 01: Go ahead. [00:08:27] Speaker 01: Sure. [00:08:27] Speaker 01: Thank you, Your Honor. [00:08:28] Speaker 01: So there were many different ways, many different tools. [00:08:31] Speaker 01: They used memorandum of understanding. [00:08:33] Speaker 01: They sometimes used those memorandum of understanding to actually grant registrations. [00:08:37] Speaker 01: Sometimes they passed regulations. [00:08:39] Speaker 01: There were a variety of ways. [00:08:41] Speaker 01: Sometimes there were individualized exceptions, as in the single patient IND with Robert Randall. [00:08:46] Speaker 01: All of these are detailed, and they're different. [00:08:49] Speaker 01: And as the court's aware, there's a certain authority for doing it. [00:08:52] Speaker 00: So it's one thing that says, we have a statute that allows us to grant exceptions, and we're doing that here. [00:08:58] Speaker 00: Then there's a final agency action. [00:09:00] Speaker 00: But if it's just a mere interpretation of the statute and saying we don't [00:09:05] Speaker 00: We don't have, we just don't think we have the authority to do this. [00:09:08] Speaker 00: What do we do with that? [00:09:10] Speaker 00: Because in that instance, in theory, they're just saying, even if there was no agency here, you couldn't do it, right? [00:09:15] Speaker 01: That's the core of the case, Your Honor, because the core of the case is whether DEA has the tools to be able to accommodate this request at all. [00:09:23] Speaker 03: In the end, they didn't say they didn't, they just said they wouldn't. [00:09:26] Speaker 03: But they said they wouldn't because of the classification of psilocybin in Schedule I. But then when they got to the question of whether they were going to grant a waiver of registration, they didn't say they couldn't. [00:09:38] Speaker 03: They just said they wouldn't. [00:09:40] Speaker 01: Well, you're correct, Your Honor. [00:09:41] Speaker 01: They found that it was not in the public interest. [00:09:43] Speaker 01: That was a finding after a decision-making process. [00:09:46] Speaker 01: But if you look at the reasons that they gave for that, the reasons were, it's schedule one. [00:09:50] Speaker 01: Here are the characteristics of a schedule one substance, first of all. [00:09:54] Speaker 01: Second, there are research restrictions on schedule one substances. [00:09:57] Speaker 01: That's just another statement of law. [00:10:01] Speaker 01: And third, to deviate in the way that you're proposing would be too dramatic a departure from current law. [00:10:08] Speaker 03: And thirdly, you never really said exactly what you want us to do. [00:10:12] Speaker 01: That particular piece, Your Honor, is a little bit confusing, because we were under no obligation to say the scope of the rule that we wanted. [00:10:22] Speaker 01: And if you look at our letter to the agency, we said, we're really open. [00:10:28] Speaker 01: to a dialogue with you about how we might do this. [00:10:31] Speaker 01: And again, everything that we were saying was based on the agency's precedent. [00:10:35] Speaker 03: Can I say one other thing just about whether you really had a dilemma? [00:10:39] Speaker 03: I mean, the odd thing here is that you went to the agency and then came to us as a review of the agency decision as to that. [00:10:45] Speaker 03: I mean, it seems to me in most instances what litigants do in this context is you should bring a district court case. [00:10:56] Speaker 03: And you say, we need a clarification of whether we can do this, because we intend to do it. [00:11:04] Speaker 03: And if we do do it, we can get prosecuted. [00:11:07] Speaker 03: And even if you got this letter, and the agency's position is that we can't do it, and we need a determination that we can. [00:11:17] Speaker 03: There are zillions of lawsuits running around like that now. [00:11:21] Speaker 03: And so to do it as a review of an agency decision, which isn't really a decision, and come directly to us with no possibility of the development of a district court record and so on, is an odd way to proceed. [00:11:36] Speaker 01: It may seem that way, Your Honor, but under this statute, 21 U.S.C. [00:11:41] Speaker 01: 877, the Congress routed [00:11:45] Speaker 03: Well, yes, if there's an agency decision. [00:11:47] Speaker 03: But that's why we're asking whether there is one. [00:11:49] Speaker 03: I think you should probably get off this question and go. [00:11:52] Speaker 01: Well, it's obviously a very important jurisdictional. [00:11:54] Speaker 03: Well, it's not, because you still have your second part of the case, which definitely is a final agency decision. [00:12:01] Speaker 01: Yes, Your Honor. [00:12:01] Speaker 01: If I could say one more thing about it. [00:12:03] Speaker 01: In United States Fish and Wildlife Service versus Sierra Club, Inc., a 2021 United States Supreme Court decision that I don't have the sight for off the top of my head, but I can get for you. [00:12:15] Speaker 01: The Supreme Court said that on Bennett's first prong, this consummation piece, if the agency itself says, this is our final determination. [00:12:24] Speaker 01: This is the consummation of our process. [00:12:27] Speaker 01: Well, of course, the agency can't create the jurisdictional. [00:12:30] Speaker 03: But our concern with Bennett is really on their first prong. [00:12:33] Speaker 03: It's on the second one. [00:12:34] Speaker 01: Right. [00:12:34] Speaker 01: So if you go to the second prong, and I will move off of this. [00:12:37] Speaker 01: I just really want to, this is a very important point. [00:12:39] Speaker 01: I want to address the court's questions best I can. [00:12:42] Speaker 01: So in this court's cases, [00:12:44] Speaker 01: The court has repeatedly recognized there's a case called Weight Watchers, Inc. [00:12:48] Speaker 01: versus FTC, which then cites another Ninth Circuit opinion called Clark v. Busey. [00:12:53] Speaker 01: And in both of those cases, the court said that where an agency has a petition in front of it, and it denies that petition, unless there is some really good reason, [00:13:03] Speaker 01: to think that Congress did not intend judicial review of that decision. [00:13:08] Speaker 01: We consider it final, and we exercise judicial review. [00:13:11] Speaker 01: And if I could say one last thing about it, in the case that happened before this one, where there was a petition to reschedule, the court reviewed that decision. [00:13:21] Speaker 01: Of course, it didn't address final agency action, but it was a similar thing. [00:13:24] Speaker 01: We petitioned the agency. [00:13:28] Speaker 03: You know, we got to find out the second one where you're asked to the second issue where you petition the agency to do something. [00:13:33] Speaker 03: You don't have this problem. [00:13:35] Speaker 03: But as to the first one where you did petition them to do anything, you just said, you know, tell us it's OK. [00:13:41] Speaker 03: Tell us your legal opinion that it's OK. [00:13:44] Speaker 03: But really, I think you should get off this. [00:13:47] Speaker 01: OK. [00:13:47] Speaker 01: I will follow your instructions. [00:13:49] Speaker 01: So just moving to the merits, I'd like to make two points. [00:13:53] Speaker 01: And they're very simple. [00:13:54] Speaker 01: This case allows the court hat can rule for petitioners on very narrow grounds. [00:14:00] Speaker 01: There's nothing dramatic here or [00:14:02] Speaker 01: that requires the court to go break new ground. [00:14:05] Speaker 01: Because really what we're faced with is a categorical view of the world from the DEA. [00:14:11] Speaker 01: And that categorical view of the world that there is no path to access to Schedule I substances for therapeutic use. [00:14:18] Speaker 01: The only way that you can access them is through these research protocols. [00:14:22] Speaker 01: That view of the world stands in stark contrast to decades of agency precedent that we pointed out. [00:14:30] Speaker 01: And it also flies in the face of the statute, which is a deregulatory measure designed to remove the FDA from between the patient-doctor relationship in these very limited circumstances. [00:14:42] Speaker 04: Has the DEA ever approved the use of a Schedule I drug outside the research context? [00:14:47] Speaker 01: Yes, Your Honor, it has. [00:14:48] Speaker 01: So we cite in the reply note, I'm sorry, in the opening brief where we're talking about the Robert Randall episode or however you want to refer to it, we included in the record a hearing where Mr. Randall testifies that there was a settlement between himself and the government where [00:15:11] Speaker 01: the government agreed to allow him to have access to Schedule I marijuana for medical purposes, and it was to be given to him by his own treating physician, not in a research protocol. [00:15:24] Speaker 01: And so that is one example. [00:15:27] Speaker 03: And then there are... The agency's account is they tried this for a while, it didn't work, and they decided not to do it anymore. [00:15:37] Speaker 01: That is what the government's council in this case says. [00:15:40] Speaker 01: That's not what DEA said. [00:15:41] Speaker 01: DEA didn't address any of these historical examples, except for the Epidiolex one. [00:15:46] Speaker 01: And it's important in the Epidiolex example as well, just to touch on that. [00:15:51] Speaker 01: They cite the testimony of a DEA official in a congressional hearing. [00:15:55] Speaker 01: And if you read that testimony, you'll see that that official is saying that DEA supports therapeutic use outside of [00:16:05] Speaker 01: Outside of the clinical trial context in the expanded access context and that was a schedule one Marijuana related substance there as well as the expanded access as an FDA That's right [00:16:18] Speaker 01: And it's the exact same thing. [00:16:19] Speaker 01: So DEA is saying, and this is important to understand in this case, they're saying, listen, you can do it in expanded access if you label it research, even though we all know that it's therapeutic. [00:16:28] Speaker 01: And we all acknowledge that, right? [00:16:30] Speaker 01: But if you don't label it research, then you can't do it. [00:16:33] Speaker 01: The problem with that is that the point of the Right to Try Act itself was to distinguish it from expanded access by removing FDA. [00:16:42] Speaker 03: But the Right to Try Act has in it [00:16:47] Speaker 03: a designation of which provisions are being accepted, and the CSA is not one of them. [00:16:55] Speaker 01: That's right, Your Honor. [00:16:56] Speaker 03: The CSA doesn't need- So where do you get the notion that the Right to Try Act was overriding the CSA, or how to be accommodated by the CSA? [00:17:05] Speaker 03: I mean, at this stage of the argument, it's not really an override. [00:17:08] Speaker 03: It should be accommodating. [00:17:10] Speaker 03: But where do you get that from? [00:17:11] Speaker 01: So two places, Your Honor. [00:17:13] Speaker 01: First, we're not saying that the Right to Triact overrides the Controlled Substances Act in any way. [00:17:19] Speaker 01: Any more than RFRA has a provision that says this overrides the Controlled Substances Act. [00:17:23] Speaker 03: But RFRA does not have a provision that, as I understand it, says it overrides any other statute. [00:17:28] Speaker 01: Well, to the extent that I'm wrong about that and I admit I'm not a RFRA expert and I trust you. [00:17:32] Speaker 03: You are wrong. [00:17:32] Speaker 03: RFRA is a funny statute. [00:17:33] Speaker 03: It's an unusual statute that way. [00:17:35] Speaker 01: I trust you, Your Honor. [00:17:36] Speaker 01: So my second reason is that Congress actually, in many cases, we find that Congress hasn't spoken quite as clearly as we would like in many situations. [00:17:45] Speaker 01: But here, in the very early stages, when it first enacted the CSA, in Section 902, it created a rule of construction precisely for this situation, where you have the interplay between the Controlled Substances Act on the one hand and a provision of the Federal Food, Drug, and Cosmetic Act on the other. [00:18:03] Speaker 01: And it said, where there is some sort of a [00:18:05] Speaker 01: interaction between them, DEA and courts may not construe the provisions of the Controlled Substances Act to modify. [00:18:15] Speaker 03: But then you run into the same problem, which is that the RTT doesn't [00:18:22] Speaker 03: say you can do this despite the CSA, so there is no conflict. [00:18:25] Speaker 01: Respectfully, Your Honor, I think there is, because Congress defined eligible investigational drugs broadly, well actually quite narrowly, and then it made a bunch of rifle shot exceptions. [00:18:36] Speaker 01: It did not list schedule on drugs. [00:18:37] Speaker 01: And when you view that in light of the savings clause in section 902, we have to assume that Congress was acting and drafting the right to triage. [00:18:47] Speaker 03: It seems to me that you're stronger [00:18:49] Speaker 03: piece here is the question of whether the agency sufficiently explained it could accommodate if it wanted to. [00:18:59] Speaker 03: I mean, that's your ultimate position. [00:19:01] Speaker 03: It could make an accommodation. [00:19:03] Speaker 01: That's right. [00:19:03] Speaker 03: And whether it explained why it didn't adequately [00:19:06] Speaker 03: seems to me to be the strongest argument. [00:19:08] Speaker 01: I agree, Your Honor. [00:19:09] Speaker 01: And that's why my first point. [00:19:10] Speaker 03: Well, if you thought so, you might have gotten there faster. [00:19:13] Speaker 01: Well, my initial point was to say that you could rule in our favor on very narrow grounds. [00:19:18] Speaker 01: And those are the grounds. [00:19:19] Speaker 01: There simply is no adequate explanation, because the agency didn't grapple with its precedent. [00:19:23] Speaker 01: It didn't come to grips with the problems that we raised in the petition. [00:19:27] Speaker 01: It's precisely the same problem that we had with the rescheduling petition in the Agarwal case before. [00:19:34] Speaker 01: And this is a classic problem. [00:19:36] Speaker 01: This is black letter administrative law. [00:19:38] Speaker 01: When an agency doesn't deal with its own precedent, when it doesn't actually acknowledge and clearly grapple with the problems raised by a petition, the court vacates and remands. [00:19:49] Speaker 04: Because the AP- I think what the agency's concern was, in part, was that the scope of the request was not entirely clear. [00:19:57] Speaker 04: How do you address that point of the agency decision? [00:20:01] Speaker 01: So the agency decision didn't tell us what was not clear. [00:20:04] Speaker 01: And if you look at the government's brief, [00:20:06] Speaker 01: The only thing that it tells us is that we didn't say whether it was Dr. Agarwal who wanted this waiver or the class of physicians who wanted it. [00:20:13] Speaker 01: Obviously, Dr. Agarwal is concerned about his patients and being able to do this himself primarily. [00:20:20] Speaker 01: Nonetheless, when you're requesting a waiver that has to be done by regulation, it's obviously a forward-looking, generally applicable pronouncement, which by definition would apply to other similarly situated patients. [00:20:31] Speaker 03: But that wasn't true in the Randall and marijuana situations. [00:20:34] Speaker 03: They did it one by one, as I understood it. [00:20:36] Speaker 03: That's right, which is why we requested. [00:20:37] Speaker 03: But that's why there's a difference. [00:20:38] Speaker 03: That's why they didn't know which one you were asking for. [00:20:41] Speaker 01: We asked for both, though, Your Honor, and this is why we asked the first thing first. [00:20:44] Speaker 01: We said, listen, you've done this in the Randall situation. [00:20:46] Speaker 01: You've done it through 822D. [00:20:48] Speaker 01: You've done it through MOUs. [00:20:50] Speaker 01: We don't care which tool you want to use. [00:20:53] Speaker 01: Congress gave you all these tools. [00:20:55] Speaker 01: We don't care which one you use. [00:20:56] Speaker 01: We're requesting that you find some way to accommodate this urgently needed access to a therapeutic drug that Congress said that we should have access to. [00:21:05] Speaker 01: And nobody's disputing that it's an eligible investigational drug. [00:21:08] Speaker 03: But once you say that Congress said we should have access to, you're kind of gaming the system. [00:21:15] Speaker 03: Their position is, and at least off the top, maybe you could persuade me otherwise, it doesn't appear that Congress did say that. [00:21:22] Speaker 03: But what you're really saying is that the general zeitgeist of the RTT sort of applies here and you want to accommodate it. [00:21:31] Speaker 01: May I respond? [00:21:32] Speaker 01: I see that I'm past my time. [00:21:33] Speaker 04: Yeah, why don't you respond, and then we'll have you sit down. [00:21:35] Speaker 04: We'll put three minutes on the clock after that. [00:21:37] Speaker 04: But please go ahead and respond. [00:21:38] Speaker 01: Thank you, Your Honor. [00:21:39] Speaker 01: Respectfully again, I don't think it's the general zeitgeist. [00:21:41] Speaker 01: Congress said what an eligible investigational drug is. [00:21:45] Speaker 01: Neither the government nor DEA disputes that if you look at that definition and you just do textualism like you do so well, there's no way to say that it doesn't cover psilocybin. [00:21:53] Speaker 01: This is not something that's ever been disputed in this case. [00:21:56] Speaker 01: And so the question is, does the Schedule I status itself [00:22:01] Speaker 01: somehow, is it a silent exception that Congress didn't write in? [00:22:05] Speaker 01: And we just know that basic tools of statutory construction dictate that that's not how statutory construction works, right? [00:22:14] Speaker 01: Like, if there's going to be an exception... Let me ask you something. [00:22:17] Speaker 03: Does your second request for an accommodation depend on the agency agreeing with that? [00:22:23] Speaker 01: No, Your Honor. [00:22:24] Speaker 01: No. [00:22:25] Speaker 01: It only requires the APA basics of adequate explanation under the APA. [00:22:31] Speaker 01: Thank you, Your Honor. [00:22:32] Speaker 04: Okay. [00:22:32] Speaker 04: Thank you, Mr. Pennington. [00:22:33] Speaker 04: Let's hear from the DEA. [00:22:50] Speaker 02: Good morning, and may it please the court, Thomas Pullman for DEA. [00:22:56] Speaker 02: It seems like the court was more interested in the second part of the request for waiver of rulemaking, so I will start there. [00:23:03] Speaker 03: Well, you might give us your short answer to the final agency action question. [00:23:08] Speaker 02: Certainly. [00:23:10] Speaker 02: So the government's view was that this request, the second letter, differed from the first insofar as it asked for an authorization to do something, not merely guidance or assistance. [00:23:24] Speaker 02: So it seemed somewhat similar to a request for a permit or a license. [00:23:30] Speaker 03: So you just, when think of it as two different requests, you think of it as one request. [00:23:35] Speaker 02: No, I'm sorry, we thought of it as two different requests. [00:23:37] Speaker 02: The first was the request for an authorization under the Right to Try Act, which in their view displaced the registration requirement. [00:23:48] Speaker 02: But however you kind of look at this first request, we agree that the answer is controlled by [00:23:56] Speaker 02: the statute and the agency adheres to the same view of the statute that it articulated in the last case. [00:24:02] Speaker 02: The agency's view was that this was final agency action when it denied the authorization. [00:24:10] Speaker 03: But does it make any difference what the agency thinks about that? [00:24:15] Speaker 02: Only, I think, on the first prong, but as Your Honor said, those aren't what you're focused at. [00:24:22] Speaker 02: However the court looks at it, we agree it's controlled by the statute, and if this means it's not final agency action, the government certainly has no objection and is happy to take the correction. [00:24:33] Speaker 04: I guess I'm, well I don't know how you can, I like your view on it because it's jurisdictional, but I don't see how it's not final agency action under the second prong when they ask for authorization and your position is they don't have it. [00:24:46] Speaker 04: That does change their rights. [00:24:47] Speaker 04: They asked for an authorization, they didn't get it, and so whatever legal consequence that has, I'm not sure, but they believed it was important to ask and they were denied that. [00:24:57] Speaker 02: Well, and that was why the government also thought this was final agency action. [00:25:03] Speaker 02: But as I said before, we think it's ultimately controlled by the statute, whether that means it's not a final agency action because it's just all the consequences flow from the CSA, or whether it's a final agency action because it's a denial of an authorization under that statute, which doesn't exist is basically what the agency said. [00:25:23] Speaker 02: Either way, [00:25:25] Speaker 02: we agree that it's controlled by the statute and have no objection to whichever ground the court decides. [00:25:34] Speaker 02: With respect to the second request for a denial of a rulemaking, this is subject to extremely limited review and given the utmost deference under the APA, all that an agency needs to do is offer a brief statement indicating that it recognized the problem that was being asked about [00:25:55] Speaker 02: and providing a description of why it declined to exercise its discretion to engage in a rulemaking. [00:26:00] Speaker 03: Just to begin, the agency could have granted some kind of waiver by rule here. [00:26:10] Speaker 03: I mean, if the agency had said, well, recognizing the concerns that underlie the RTT and the fact that this is a drug that is under investigation and has been, that we are willing to issue a rule providing for a waiver of registration. [00:26:33] Speaker 03: It could have done that, is that right? [00:26:37] Speaker 02: Yes, the agency never said it lacked authority under the CSA under Section 822D to engage in a rulemaking. [00:26:42] Speaker 03: So that suggests that if it could have done that, that some explanation [00:26:48] Speaker 03: I mean, the explanation here, other than this thing about the scope, which you can address, was just in the words of the statute. [00:26:56] Speaker 03: It just said, we don't think this is a schedule one drug, and we don't think this is in favor of this advances public health. [00:27:06] Speaker 03: And that's it. [00:27:07] Speaker 03: It didn't explain anything about whether accommodating the RTT's scheme, even though it wasn't directly applicable, was a good or a bad idea, or why it wouldn't do it. [00:27:19] Speaker 02: Well, I think it did. [00:27:20] Speaker 02: The agency first noted the features of the substance in question, which is that it has no currently accepted medical use, high potential for abuse, and a lack of accepted safety. [00:27:34] Speaker 03: But those are all the statutory criteria for why it's in Schedule I to begin with. [00:27:37] Speaker 02: Well, that's right. [00:27:38] Speaker 02: And I think it's appropriate for the agency to consider how this request fits with the kind of [00:27:45] Speaker 02: statutory framework, both the reasons for classification and the kind of express restrictions that Congress placed on access to Schedule I substances with respect to dispensing to patients. [00:27:59] Speaker 02: So if I could just provide an example that I think highlights this, another type of rulemaking, or I'm sorry, another [00:28:08] Speaker 02: One regulation that the agency has adopted through this process, this waiver process, was to allow for law enforcement officers to possess controlled substances in the course of their official duties. [00:28:30] Speaker 02: that situation doesn't involve giving this highly dangerous substance to a patient. [00:28:37] Speaker 02: It doesn't as directly implicate the reasons for schedule one placement in the first place. [00:28:44] Speaker 02: And it doesn't kind of implicate the structure of 823F and the limited circumstances in which Congress has said that dispensing is consistent with the statute. [00:28:55] Speaker 02: So I think because this requested waiver [00:28:59] Speaker 02: whatever its scope, which we should talk about, goes kind of directly to the reasons why the substance is classified as Schedule I, and goes directly to the narrow exception of A23F. [00:29:15] Speaker 04: What about the marijuana comparison? [00:29:18] Speaker 02: Yeah, so what the agency said was that all of these examples were consistent with the 823 framework, under which the only time it's appropriate to give, to dispense a substance to a patient is in the context of research. [00:29:32] Speaker 02: And the testimony of Mr. Randall, which the petitioners put in the [00:29:44] Speaker 02: excerpts of record underscores how it's consistent with that framework. [00:29:49] Speaker 02: He mentioned several times how his doctors were licensed to evaluate marijuana's use. [00:29:55] Speaker 02: That's on ER382. [00:29:56] Speaker 02: ER384, he says his personal doctor became the second ophthalmologist licensed by FDA to evaluate marijuana's medical use in the treatment of glaucoma. [00:30:08] Speaker 02: And then on ER 388, he says, my medical condition has been constantly monitored by FDA licensed and approved investigators. [00:30:17] Speaker 02: So this happened kind of repeatedly. [00:30:19] Speaker 04: You're saying these were A23F researchers? [00:30:21] Speaker 04: Is that your position? [00:30:25] Speaker 02: So it's a little unclear. [00:30:29] Speaker 02: It certainly started that way. [00:30:32] Speaker 02: The program kind of, my understanding is, [00:30:38] Speaker 02: the agency became concerned over how it was being implemented. [00:30:42] Speaker 03: The original understanding was... In any event, none of that is in the letter. [00:30:47] Speaker 02: No, but the general reason is, which is that the examples which are provided were consistent with the 823 framework and they involved... You just said you don't actually know whether it was. [00:31:00] Speaker 03: And the Epidiolex one was those people were registered researchers, but you don't know about the marijuana one. [00:31:13] Speaker 02: The agency explained that all of the examples, it said the examples were consistent with the 823 framework. [00:31:20] Speaker 02: The only evidence that's in the record is consistent with the idea that this was initially provided during research. [00:31:27] Speaker 02: And then there is case law, which the court can see. [00:31:31] Speaker 02: We cited one of the cases in our brief explaining that the agency discontinued this program because it was concerned that it wasn't being administered in a lawful manner. [00:31:40] Speaker 02: So I think this explanation, while it could have been [00:31:45] Speaker 02: longer and more detailed does satisfy, does clear what this court has described as the low hurdle for providing a short explanation of why a rulemaking can be appropriately denied. [00:32:02] Speaker 02: And none of this, of course, undermines the agency's threshold ground for denying the request for rulemaking, which was that the petitioners didn't provide the text or even the scope of the regulation that they sought. [00:32:17] Speaker 02: Petitioners waived any challenge to this independent ground, and the court could [00:32:23] Speaker 02: dismissed the petition on that ground alone. [00:32:27] Speaker 02: And the argument they did raise belatedly in their reply brief was just that, well, there was no regulatory requirement for us to provide the text of the requested rule. [00:32:40] Speaker 02: Whether or not that was a requirement in a regulation does not resolve the question of whether this is a reasonable basis to deny the request for a rulemaking. [00:32:51] Speaker 02: And I think it's just kind of a common sense that if you ask an agency to waive a statutory requirement through a rulemaking, you should [00:33:02] Speaker 02: provide the agency with the scope of the waiver that you're requesting. [00:33:06] Speaker 02: They never argued that this wasn't a reasonable ground. [00:33:09] Speaker 02: And so that provides another basis for dismissing the issue. [00:33:17] Speaker 02: I'm happy to answer any other questions the court has. [00:33:25] Speaker 04: Well, it does not appear there are any, Mr. Pullman. [00:33:27] Speaker 04: So Judge Bereson, Judge Van Dyke, any further questions? [00:33:33] Speaker 03: I don't think so. [00:33:35] Speaker 03: I do find your statutory argument singularly unconvincing. [00:33:40] Speaker 03: I'm sorry, which statutory argument? [00:33:43] Speaker 03: The main statutory argument that somehow there is no, that the CSA fits within the RTT scheme or that there's a conflict that should be resolved by the 902. [00:34:00] Speaker 03: I know you're very earnest about it and you keep repeating it, but I just don't see how it works. [00:34:06] Speaker 03: I'm sorry, just to clarify, you don't understand that... You were arguing that somehow because of the 902, if I have the right number, principle of CSA provision about how you... [00:34:25] Speaker 03: apply the CSA that the RTT should essentially be accommodated within a CSA, but I just don't see how that works given the fact that, but we already went over it, so I don't know. [00:34:38] Speaker 02: Well, just to be clear, I believe you might be referring to the petitioner's statutory argument. [00:34:43] Speaker 02: The government's statutory argument is that Section 902 is a kind of standard savings clause that does nothing. [00:34:53] Speaker 02: I could just address one point on that. [00:34:55] Speaker 02: They said, well, it affects the operation of the Right to Try Act, and our view is that it doesn't, because as Your Honor pointed out, the Right to Try Act provides a very limited exemption from parts of the FDCA. [00:35:10] Speaker 03: I don't have anything else. [00:35:11] Speaker 04: Let me ask you quickly before you sit down. [00:35:12] Speaker 04: What is the status of the other remand? [00:35:15] Speaker 04: There was a prior panel that sent back the question of the schedule one versus schedule two rescheduling request. [00:35:23] Speaker 04: Do you know the status of that in the agency? [00:35:25] Speaker 02: That's right. [00:35:25] Speaker 02: It's still before the agency. [00:35:26] Speaker 02: The agency is considering the petition. [00:35:29] Speaker 04: Is there an estimated timetable on that? [00:35:31] Speaker 02: I don't have an estimated timetable. [00:35:36] Speaker 02: I would just point out that, you know, the basis of the remand is that the agency had not, it needed to either provide a more detailed explanation or, you know, take a different disposition. [00:35:49] Speaker 02: So the agency's taking that very seriously and looking at everything to give its considered views. [00:35:57] Speaker 02: And there was also a [00:36:00] Speaker 02: kind of legal change in the interim that the agency needs to consider, which was that the Office of Legal Counsel issued an opinion [00:36:09] Speaker 02: that the DEA's prior test for evaluating a currently accepted medical use was too narrow. [00:36:15] Speaker 02: So this is something new since the remand that the agency also needs to take into account. [00:36:22] Speaker 03: Is there also a pending statute to include the CSA as an exception within the RTG? [00:36:35] Speaker 02: I don't know if you're asking if there's a bill pending in Congress. [00:36:37] Speaker 02: I believe there is. [00:36:38] Speaker 02: I'm just not aware. [00:36:38] Speaker 02: I apologize. [00:36:40] Speaker 02: I didn't see that referenced in the briefs, and I'm not fully aware of everything that happens in Congress. [00:36:46] Speaker 02: It's not in the briefs, but I think there is one. [00:36:47] Speaker 02: I'm sorry. [00:36:47] Speaker 02: I just don't know. [00:36:50] Speaker 02: OK. [00:36:50] Speaker 02: Thank you. [00:36:50] Speaker 02: We would ask that the petition be dismissed. [00:36:53] Speaker 02: Thank you. [00:36:53] Speaker 02: Thank you. [00:36:54] Speaker 02: Or denied. [00:37:01] Speaker 01: Just a couple of points briefly. [00:37:04] Speaker 01: The first one is, this case is actually pretty simple. [00:37:07] Speaker 01: This is just like any case where a party is asking for an exemption from a regulation, asking for permission to take an action under the statute. [00:37:15] Speaker 01: And importantly, the actions that we were asking to take were ones that the DEA had permitted parties to do in the past. [00:37:21] Speaker 01: So it's not like these things were impossible to do. [00:37:23] Speaker 01: The question was, did the agency want to exercise its discretion to do so? [00:37:28] Speaker 01: And the agency said no. [00:37:30] Speaker 01: On the point about the waiver of the 822D argument, [00:37:33] Speaker 01: Throughout the record, both in this case and before, it has been extremely clear, and DEA has repeated it back to us in its letters every single time. [00:37:42] Speaker 01: The government repeats it in its brief. [00:37:43] Speaker 01: What Dr. Agarwal wants is to be able to provide this substance for therapeutic purposes to his patients. [00:37:53] Speaker 01: That is the request. [00:37:55] Speaker 01: As far as the scope of the particular provisions for abuse and diversion that DEA might think are necessary, obviously Dr. Aguilal is a registered physician with DEA. [00:38:07] Speaker 01: So he doesn't, and he's not, [00:38:09] Speaker 04: going to abuse or divert these drugs, he's going to use them in the course of his professional practice. [00:38:24] Speaker 04: or you're asking for a rule that would be generally applicable to medical practitioners who wish to distribute either psilocybin or perhaps all Schedule I drugs, and then if so, what would be the conditions on that? [00:38:36] Speaker 04: And I think that is what the agency likely means by scope of your request. [00:38:43] Speaker 01: It would have been great for them to have told us that, right, and to have spelled that out. [00:38:47] Speaker 04: But isn't it fairly clear? [00:38:48] Speaker 04: I mean, the letter does not indicate much beyond that your client would like to do this. [00:38:53] Speaker 01: On the first point about whether it's just him or a broader class, and again, this was not in DEA's decision, but to address it, [00:39:02] Speaker 01: A rule is generally applicable. [00:39:04] Speaker 01: 822D allows the agency to make these waivers by rule to classes. [00:39:08] Speaker 01: And this is from the government's brief and from the plain text of the statute. [00:39:12] Speaker 01: There's no way that there could be a generally applicable rule that applies only to my client. [00:39:17] Speaker 01: So I think that that part is just by definition. [00:39:20] Speaker 03: But you've just said two contradictory things then. [00:39:22] Speaker 03: So it seems to me they have a legitimate problem. [00:39:24] Speaker 03: You said all Dr. Aguilar wants is to be able to preside [00:39:30] Speaker 03: prescribed for his patients. [00:39:31] Speaker 03: And then you said, but of course, that's going to mean it's going to have to be applicable to everybody. [00:39:37] Speaker 01: Dr. Aguilal is knocking on every door. [00:39:38] Speaker 01: The house has a front door, a side door, a back door. [00:39:41] Speaker 01: He's trying to get through the door any way he can because he has patients who are dying. [00:39:45] Speaker 01: And he wants to be able to give them an eligible investigational drug. [00:39:49] Speaker 01: The Congress acted, President Trump signed this into law in 2018 to remove FDA from the process. [00:39:54] Speaker 01: and now DEA is inserting them back in. [00:39:57] Speaker 01: And one thing that's very important about this is to recognize that DEA would allow this under expanded access because there's a label on it that says research, right? [00:40:05] Speaker 01: But now the exact same thing that it's allowed from the dawn of the CSA forward consistently, it won't allow strictly because Dr. Aguilal won't lie about it and say that he wants to do research because he doesn't. [00:40:18] Speaker 01: There is no registration available under the regulations for this particular [00:40:22] Speaker 01: activity so he asked them to do what they've done in the past. [00:40:25] Speaker 01: Either create that through a regulation or grant him an exemption like you did in these other cases. [00:40:33] Speaker 01: We asked that the court [00:40:34] Speaker 03: Can I just for a moment ask you about, you keep relying on these reverse distributor situations and I don't, as I understand what the agency did with that is it basically said, well, you know, we just realized that this is really happening and so we're going to make a regulation and we're going to, and it's in that context that they, [00:40:56] Speaker 03: said that, so I understood what they were saying was the opposite as to being not necessary to the distribution. [00:41:08] Speaker 03: They said, well, that used to be the case, but at this point it's become very prevalent, so we're gonna make a specific exemption for these people. [00:41:16] Speaker 03: So I don't understand, you keep in your briefs, you go on and on and on about that, usage, and I don't see that [00:41:24] Speaker 03: that they were actually allowing it earlier, that was happening a little, they weren't really noticing it. [00:41:29] Speaker 03: And once they noticed it, they passed a rule. [00:41:34] Speaker 01: The core issue with the reverse distributor and why I think it's so important is because DEA did not act through 822D at first. [00:41:42] Speaker 01: These folks were registered as distributors. [00:41:45] Speaker 01: They were not registered as manufacturers. [00:41:47] Speaker 01: DEA knew they were manufacturing. [00:41:49] Speaker 01: But it didn't require registration. [00:41:50] Speaker 03: I thought they weren't manufacturing. [00:41:51] Speaker 03: They were. [00:41:52] Speaker 01: They were processing. [00:41:53] Speaker 01: And processing falls under the statute. [00:41:55] Speaker 01: That was why it was problematic. [00:41:57] Speaker 01: In the same way, Dr. Agarwal is registered with DEA to do a whole host of things. [00:42:02] Speaker 01: He's been under the regulations and abiding by them. [00:42:05] Speaker 01: Now he wants to do a different activity for which there is no registration classification. [00:42:09] Speaker 01: So it's kind of odd for him to have to ask for a waiver of a registration requirement that doesn't exist. [00:42:14] Speaker 01: He asked for it anyway. [00:42:15] Speaker 01: to the extent that the agency thinks there is one that could apply. [00:42:18] Speaker 01: But the point is, in the past, when confronted with this situation, where there's an activity that the DEA's regulations do not address, the agency has said, well, is it an essential link in the closed distribution system? [00:42:30] Speaker 03: No, I thought they said the opposite. [00:42:32] Speaker 03: They said, well, we thought it wasn't, but it now appears it is, so now we're going to have a regulation. [00:42:37] Speaker 01: You're right, Your Honor, but there were years. [00:42:39] Speaker 01: The first time that they promulgated a rule, that they put a proposed rule, was 1995. [00:42:44] Speaker 01: It was 2003 before they had a final rule. [00:42:47] Speaker 01: During all that time, they used memorandum of understanding to make distributors magically manufacturers. [00:42:53] Speaker 01: Why can't they do that to help these patients get this drug? [00:42:57] Speaker 01: Why can't they do that to facilitate Congress's will here? [00:43:00] Speaker 01: There's no explanation. [00:43:01] Speaker 01: They don't address it. [00:43:02] Speaker 01: And that's why we think it's important. [00:43:04] Speaker 04: I think we've let you go over your time. [00:43:06] Speaker 04: I want to thank you for your argument this morning, Mr. Pennington. [00:43:08] Speaker 04: I want to thank both you and Mr. Poland for the helpful briefing and argument. [00:43:12] Speaker 04: This case is submitted.