[00:00:00] Speaker 04:
case number 20 that's 5341 maybe in a tour a balance versus Food and Drug Administration at L. Mr. Stamens for the balance.

[00:00:12] Speaker 03:
Mr. Sam is good morning before you start.

[00:00:15] Speaker 03:
We've had some difficulties with our connections.

[00:00:21] Speaker 03:
Judge Wilkins can hear, but we can't get him on the video.

[00:00:27] Speaker 03:
But it looked like we did for just a second.

[00:00:30] Speaker 03:
So if you would proceed with your argument.

[00:00:34] Speaker 01:
Thank you, Your Honor, and may it please the court.

[00:00:37] Speaker 01:
I'm David Salmons on behalf of Medinatura.

[00:00:40] Speaker 01:
This appeal from the denial of a preliminary injunction concerns FDA's recent dramatic change in policy governing the importation and marketing of homeopathic drugs.

[00:00:51] Speaker 01:
Before turning specifically to the court's question about the Cook case, I'd like to focus for a short moment on the nature of this policy change, which I think helps answer the court's question.

[00:01:03] Speaker 01:
For decades, CPG 400-400 made clear that homeopathic drugs

[00:01:07] Speaker 01:
that reflected recognized or customary homeopathic practices and complied with manufacturing and labeling requirements specified in the guidance may be marketed in the US without first going through a new drug application process.

[00:01:23] Speaker 01:
Remember that applications are only required for new drugs, which are defined by statute as ones not generally recognized as safe and effective by qualified experts, sometimes referred to as the grassy standard.

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Remember also that FDA's position for decades was that its existing grassy protocols were developed for pharmaceutical drugs and were poorly suited for the uniqueness of homeopathic medicine.

[00:01:49] Speaker 01:
So FDA indicated it would eventually develop a homeopathic specific protocol for determining new drug status.

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In the meantime, 400-400 effectively treated homeopathic drugs that complied with its standards as if they were not new drugs

[00:02:05] Speaker 01:
but were instead at least potentially generally accepted as safe and effective.

[00:02:10] Speaker 01:
Now through its withdrawal of 400-400 and its import alert, FDA seeks not only to impose the existing grassy process on traditional homeopathic drugs for the first time, but to suddenly declare unsafe and block from importation

[00:02:26] Speaker 01:
any homeopathic drug that cannot show it has already gone through the approval process that FDA until recently declared was neither required nor appropriate for these products.

[00:02:35] Speaker 04:
So I understand your point about requiring tests that take time to perform, but I want to be clear.

[00:02:47] Speaker 04:
You're not saying, are you, that FDA couldn't change the standards

[00:02:55] Speaker 04:
and require a new drug application, are you, for these homeopathic drugs?

[00:03:02] Speaker 01:
Assuming that the FDA follows the normal APA process and comes to a conclusion that's supportable, of course it has the authority to do that.

[00:03:10] Speaker 04:
Okay, so the only concern, as I understand it, you have, or the main concern, is that the alert was final agency action.

[00:03:23] Speaker 01:
Well, that is certainly one of the grounds on which we're seeking review.

[00:03:28] Speaker 01:
The other is that the withdrawal of 400-400, the district court below concluded it was final agency action as well, and that the prior policy had given rise to legitimate reliance interest under the Supreme Court's decision in regents.

[00:03:45] Speaker 01:
But then the court erroneously concluded in our view that the FDA had

[00:03:50] Speaker 01:
although cursorily in the court's view, adequately analyzed whether there were reliance interests, whether they were substantial, and properly weighed them against the reliance interest at issue.

[00:04:08] Speaker 01:
And we think the court there was fundamentally wrong that by the reasoning of the district court itself,

[00:04:14] Speaker 01:
FDA made legal errors at each one of those steps.

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It determined that there were no legitimate reliance interests, that there was no possibility of legitimate reliance interest because it characterized its prior policy in an inappropriate and inaccurate way.

[00:04:33] Speaker 01:
And therefore, it never determined that there was a substantial reliance interest, and it didn't meaningfully weigh them against the agency's stated reasons.

[00:04:43] Speaker 01:
agency merely declared these are our reasons and they justify our action.

[00:04:47] Speaker 01:
That's the case.

[00:04:49] Speaker 01:
An agency has to do that in any challenge to satisfy the APA's arbitrary.

[00:04:54] Speaker 00:
I'd really counsel, I'd really like for you to get to

[00:04:59] Speaker 00:
the issue of Cook and the letter that's at supplemental appendix 53, the letter of February 19th from Ms.

[00:05:11] Speaker 00:
Begley, I'm sorry, to Ms.

[00:05:12] Speaker 00:
Begley from the FDA and specifically redressability.

[00:05:22] Speaker 01:
Certainly, your honor.

[00:05:24] Speaker 00:
So with regard to Cook, I think a few things- Let me just say this, is that just to make clear what the concern is that I think that I have, which is that there's a final agency action here now that says that it has found these injectable homeopathic drug products

[00:05:47] Speaker 00:
To be not generally recognized as safe and effective under the food, drug and cosmetic act.

[00:05:55] Speaker 00:
Now that that finding has been made.

[00:06:01] Speaker 00:
Doesn't cook say stand for the proposition that the agency is bound by it.

[00:06:08] Speaker 00:
in that regardless of whether we were to say that the import alert in the withdrawal of the guidance were error, you can't get around this finding in the mandatory language of the statute.

[00:06:32] Speaker 00:
So you're still not going to be able to import

[00:06:35] Speaker 00:
these drugs.

[00:06:38] Speaker 00:
So that's what I want you to deal with specifically, please.

[00:06:41] Speaker 01:
Yes, Your Honor.

[00:06:42] Speaker 01:
I'm very happy to.

[00:06:44] Speaker 01:
And I have several points to make with regard to that.

[00:06:46] Speaker 01:
The first is that I think the one thing that I think you could take away from the Cook case is that it is clear, as we've argued all along, that the issuance of the import alert itself that declares that it appears our products

[00:07:04] Speaker 01:
or unapproved new drugs was final agency action.

[00:07:09] Speaker 01:
The government's argument against that all along has been that it's merely an advisory statement and that the local field office staff can decide whether or not to follow it.

[00:07:23] Speaker 01:
And I think all the authorities we cited for that proposition already defeated that view, but Cook destroys it.

[00:07:30] Speaker 01:
Cook makes clear that once the agency has made a determination

[00:07:34] Speaker 01:
that it appears that there is an unapproved drug or some other drug that's not admissible, that it's mandatory to block it.

[00:07:44] Speaker 01:
And so that just underscores our view that from the very beginning, the import alert was final agency action.

[00:07:52] Speaker 01:
With regard to Article III, I don't think Cooke is relevant, Your Honor.

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Of course, it itself is not an Article III case.

[00:08:00] Speaker 01:
It concluded that certain enforcement

[00:08:04] Speaker 01:
discretion that was claimed by the agency in that case was not, in fact, within the agents committed to agency discretion by law, but in fact was mandated by the statute.

[00:08:18] Speaker 01:
But, but that case, the agency was attempting to write on a blank slate in the terms of regions that case was about in agencies that

[00:08:29] Speaker 01:
failure to take actions required by the statute.

[00:08:32] Speaker 01:
In this case, we have we're not riding on a blank slate.

[00:08:35] Speaker 01:
There's long standing policy that treated our products as if they were

[00:08:41] Speaker 01:
not new drugs and that authorized them.

[00:08:44] Speaker 01:
It was an affirmative grant of the ability to market in the United States.

[00:08:48] Speaker 01:
It wasn't even just a deference of enforcement authority much like the DACA memo in the Regents case.

[00:08:56] Speaker 00:
What I'm trying to get at counsel is that I understand Cook wasn't a standing case.

[00:09:03] Speaker 00:
It seems to me that Cook has significant ramifications as to whether there is redressability.

[00:09:12] Speaker 00:
So let's suppose for a moment that we completely vacate the import alert and we tell the agency that it has to reinstate the former guidance.

[00:09:29] Speaker 00:
You still are stuck with this letter at SA 53.

[00:09:35] Speaker 00:
And I don't see, given that, in the finding of the agency that these don't meet the Grasse standard, how you would be redressed at all.

[00:09:54] Speaker 00:
Can you explain that, please?

[00:09:55] Speaker 01:
Yes, absolutely, Your Honor.

[00:09:57] Speaker 01:
So first of all,

[00:10:00] Speaker 01:
If the agency is required, as we think they should be, to reinstate the policy of 400-400, at least until they have demonstrated an appropriate consideration of the reliance interest engendered by their product, I don't think there's any plausible argument.

[00:10:19] Speaker 01:
I know the court below concluded this, but I think it's just clearly wrong.

[00:10:23] Speaker 01:
that the agency would continue to be able to detain Medinatura's products or exclude Medinatura's products.

[00:10:31] Speaker 01:
And you don't have to take my word for the fact that this enforcement priority that was reflected in the import alert is inconsistent with the policy that was established in 400-400.

[00:10:43] Speaker 01:
The agency itself declared that when it suddenly withdrew that policy after having promised

[00:10:52] Speaker 01:
initially to leave it in place until it was formally replaced with a new guidance.

[00:10:59] Speaker 00:
The agency, you know, as you recall in 2019... That was before the agency issued a finding that these

[00:11:07] Speaker 00:
Drugs are not generally recognized as safe and effective.

[00:11:12] Speaker 00:
And if the statute is to be construed as the court did in Cook, then the FDA has no choice but to bar future importation of these drugs.

[00:11:25] Speaker 01:
Yeah, I think that's where I think your honor is mistaken with regard to the implication of Cook.

[00:11:29] Speaker 01:
And I think the important thing is you have to reconcile however you may be reading Cook with what the Supreme Court said in Regents, for example.

[00:11:39] Speaker 01:
The Supreme Court in Regents was very clear that it was beside the point for purposes of reliance, interest, and remedy

[00:11:46] Speaker 01:
whether or not the prior policy was lawful.

[00:11:52] Speaker 01:
You know, the primary reason it was withdrawn, a stated reason by the acting attorney general, was that it was an unlawful policy.

[00:11:59] Speaker 01:
The dissent in regents made the point that, in fact, from Justice Thomas's dissent, so long as the agency's determination of illegality is sound, our review should be at an end.

[00:12:12] Speaker 01:
But the Supreme Court,

[00:12:14] Speaker 01:
majority rejected that and said it's beside the point whether it was in fact lawful policy or not.

[00:12:21] Speaker 01:
And I'll just read this part from the opinion, your honor.

[00:12:25] Speaker 01:
It says that the decision is correct that DACA was rescinded because the attorney general's illegality determination, but nothing about that determination foreclosed or even addressed the options of retaining forbearance or accommodating particular reliance interest

[00:12:42] Speaker 01:
the acting director should have considered those matters but did not and that failure was arbitrary and capricious and violated to the APA.

[00:12:50] Speaker 01:
So the fact that either before or now they think that our products are illegal does not determine whether we are entitled to have reliance interest considered and whether or not it was arbitrary and capricious on the part of the agency who refused to consider it.

[00:13:09] Speaker 01:
I think that

[00:13:11] Speaker 01:
the extent you're reading Cook and I'm not even sure Cook supports that proposition.

[00:13:17] Speaker 03:
Let me ask you this with respect to Cook and I'll wait to hear Ms.

[00:13:24] Speaker 03:
Dixon's interpretation, but I find Cook irrelevant because it has to do with an unregistered

[00:13:31] Speaker 03:
establishment and you all are registered and the language from Judge Ginsburg about or otherwise is plainly dicta.

[00:13:42] Speaker 01:
Well, I think that is correct, Your Honor.

[00:13:45] Speaker 01:
I think also, you know, it's very clear if you read the holding and cook, it said, you know, our reading of 381 does not require the FDA to inspect

[00:13:56] Speaker 01:
21 million articles, only those that it's obligated to do so because they were manufactured at an unregistered facility.

[00:14:04] Speaker 01:
All of our products were manufactured in a registered facility.

[00:14:08] Speaker 01:
This is part of the framework of 400-400.

[00:14:10] Speaker 01:
All of our products were registered, or excuse me, were manufactured

[00:14:14] Speaker 01:
in registered facilities and the FDA routinely inspected those facilities to ensure compliance with those guidelines.

[00:14:21] Speaker 01:
Fundamentally, what we have here is a policy change on the part of the agency that said previously, because of their unique nature,

[00:14:29] Speaker 01:
And because we have not yet developed a grassy, a formal grassy determination process that is suited to the homeopathic drugs, we have adopted this policy guidance that makes clear that if it's part of the ordinary and customary homeopathic practice, and you comply with the manufacturing requirements set out here and the labeling requirements, there's no dispute Mennonatura did all of that.

[00:14:58] Speaker 01:
then you may market in the United States.

[00:15:01] Speaker 01:
And it's the import alert itself, not even the actions that followed, that for the first time and finally impose the obligation on homeopathic drugs to satisfy the agency's current GRAS-E standards in order to import their drugs.

[00:15:20] Speaker 01:
It's the withdrawal of 400-400, and it's the imposition of the import alert

[00:15:26] Speaker 01:
that has that effect.

[00:15:28] Speaker 01:
And even if you put aside that dramatic policy change, the import alert itself seized Medintur's products.

[00:15:36] Speaker 01:
It itself was a final agency action.

[00:15:39] Speaker 01:
Even if it's the case that additional agency actions that may be final and challengeable have occurred, that doesn't change the fact that the fundamental policy was finally determined at the time the import alert was issued with regard

[00:15:53] Speaker 01:
And I would point the court to cases like Safari Club and Hawks.

[00:16:03] Speaker 01:
and others that make clear that even where there's some agency action that may continue, and even where it's possible the agency might ultimately change its mind, when you have an action that is so, you know, fundamentally affects rights, as this action did, it changed the status of our products, it seized our products.

[00:16:24] Speaker 03:
All right, Mr. Sammons, we have your argument, you're way over your time.

[00:16:27] Speaker 03:
We'll give you some time in reply, and let's hear from Ms.

[00:16:30] Speaker 03:
Dixon now.

[00:16:33] Speaker 02:
Good morning and may it please the court Courtney Dixon for the government.

[00:16:37] Speaker 02:
I'll start with this question about cook.

[00:16:40] Speaker 02:
Judge Henderson, we agree with you that cook is not relevant here because as your honor noted cook dealt with the agency's obligations when it's sampling from unregistered facilities.

[00:16:51] Speaker 02:
This is a registered facility cook was

[00:16:55] Speaker 02:
clear in its opinion that it wasn't, as it stated, exploring all of the, quote, oases of discretion that the agency might otherwise have.

[00:17:03] Speaker 02:
And we don't think the court needs to certainly weigh in on any of those questions here.

[00:17:08] Speaker 02:
Cook is doubly irrelevant here, I would say, as well, because Cook dealt with, in the unregistered facility context, the agency's obligation at the end, after it had made a final determination that the drug was unlawful,

[00:17:21] Speaker 02:
whether it needed to refuse admission or whether it might have discretion.

[00:17:24] Speaker 02:
Here, after the agency finished its process and made the final determination that miniaturist drugs are not generally recognized as safe and effective, the agency issued refusal notices.

[00:17:34] Speaker 02:
And so the court's not confronted here with the question of what discretion FDA may have.

[00:17:39] Speaker 02:
And I don't think, again, that the court should address that, given that, again, Cook itself was careful not to wade into these questions that weren't presented there.

[00:17:49] Speaker 02:
That said, Judge Wilkins, I do agree with perhaps maybe the instinct behind your question, which is that there is a mismatch here between what plaintiff is seeking and its preliminary injunction and the, in terms, and that the irreparable harm that it's alleging here.

[00:18:05] Speaker 02:
And we think that mismatch existed even as plaintiffs before the agency had reached a final decision because plaintiffs are challenging an import alert, which is,

[00:18:15] Speaker 02:
an advisory notice to FDA field staff about this interlocutory decision about determining which drugs to detain.

[00:18:22] Speaker 02:
And of course, detention is the beginning of the administrative process and not the end.

[00:18:27] Speaker 02:
The agency has now completed that process.

[00:18:30] Speaker 02:
It's made a determination as the plaintiff's drugs and the proper path forward is for plaintiff to amend its complaint to put those final decisions before the district court where the full administrative record underlying the agency's decision can be produced.

[00:18:42] Speaker 02:
And plaintiffs can challenge the agency's determination that its drugs are not generally recognized as safe and effective.

[00:18:48] Speaker 02:
We think that's the reason that plaintiffs aren't entitled to a preliminary injunction, maybe not an issue of standing, given that at the time that plaintiffs filed their complaint, you know, they had standing.

[00:18:59] Speaker 02:
But certainly, as we explained in our brief, both with respect to the guidance and with respect to the import alert, you know, to the extent that places are claiming that they're irreparably harmed because they can't presently market and sell their drugs.

[00:19:13] Speaker 02:
An import alert merely directed, or sorry, a preliminary injunction merely directed to the import alert or the withdrawal of FDA's guidance isn't going to allow a plaintiff to immediately begin selling and marketing its drugs as it would like.

[00:19:26] Speaker 02:
Again, plaintiff should amend its complaint, which it has not done.

[00:19:29] Speaker 00:
It won't allow them to, vacating the preliminary injunction won't have an effect because why?

[00:19:38] Speaker 02:
So, Your Honor, I mean, the import alert, as I noted, it's an advisory instruction to field staff about this interlocutory determination of which drugs do we detain pending administrative review.

[00:19:52] Speaker 02:
The agency has now reached a final decision.

[00:19:53] Speaker 02:
So adding and removing plaintiff's drugs to the import alert, you know,

[00:19:58] Speaker 02:
That could have an effect maybe that would if plaintiff's drugs were not on the import alert, you know, that's a that's a mechanism that FDA uses to communicate with its field staff.

[00:20:06] Speaker 02:
So arguably a future shipment of plaintiff's product, plaintiff's drugs wasn't on the import alert.

[00:20:11] Speaker 02:
It might increase the likelihood that a drug could fall through the cracks in the future.

[00:20:17] Speaker 02:
But again, that's so maybe the Article 3 standing could be satisfied.

[00:20:22] Speaker 02:
But in terms of the legal status of plaintiff's drugs and FDA's determination, the import alert, removing its products from the import alert isn't going to change that.

[00:20:30] Speaker 02:
Nor will it change the fact that FDA has now made final decisions about plaintiff's products here and that FDA can continue to detain future shipments of plaintiff's products and could continue to refuse admission to those products.

[00:20:41] Speaker 02:
I begin because the import alert is guidance to FDA field staff about this preliminary decision about which drugs to detain.

[00:20:47] Speaker 02:
It's not a final determination about the legal status of plaintiff's drugs because again, the import alert is preliminary even to a decision whether to detain the drugs and the detention is the start of the administrative process and not the end.

[00:21:04] Speaker 02:
With respect to the guidance, your honor, as the district court noted the agency evaluated reliance interests.

[00:21:13] Speaker 02:
It explained that

[00:21:14] Speaker 02:
It had reason to withdraw its outdated 30-year-old guidance, which no longer reflected the agency's current enforcement priorities in light of recent significant safety concerns and the tremendous growth of the homeopathic drug industry in the last several decades.

[00:21:31] Speaker 02:
The agency explicitly acknowledged reliance interests, and it explained why those were outweighed.

[00:21:36] Speaker 02:
plaintiffs don't dispute, of course, that the agency can change its mind about an enforcement policy that it had in place.

[00:21:44] Speaker 02:
The agency explained its reasons for doing so.

[00:21:46] Speaker 02:
Those reasons were well stated, they were well reasoned, and certainly satisfy the APA here.

[00:21:54] Speaker 04:
So in a hypothetical situation, much as is argued here, this person's drugs

[00:22:07] Speaker 04:
were safe so far as anyone knew.

[00:22:11] Speaker 04:
They were part of a class, but there was no evidence of danger to human health.

[00:22:26] Speaker 04:
That, I gather, is not a requirement when an alert is put on, even though an alert

[00:22:37] Speaker 04:
basically can shut down your business.

[00:22:40] Speaker 02:
Is that right?

[00:22:42] Speaker 02:
So it's not a requirement that the drug be found to be particularly dangerous?

[00:22:46] Speaker 02:
Is that your honor's question before?

[00:22:47] Speaker 04:
So it doesn't matter.

[00:22:49] Speaker 04:
Even if a class of drugs is generally dangerous, but a particular supplier has a drug that is not dangerous, can he be swept up?

[00:23:06] Speaker 02:
So, Your Honor, I guess there's a few ways of answering that question.

[00:23:12] Speaker 02:
Maybe the first being, you know, the import alert at issue here, there's a lot of different import alerts.

[00:23:17] Speaker 02:
The specific import alert at issue here, 6641, is drugs that are suspected of being unapproved new drugs.

[00:23:24] Speaker 04:
Well, we know it's unapproved, all right, in the sense it's not a new drug.

[00:23:29] Speaker 04:
But is there any, it's dangerous.

[00:23:32] Speaker 04:
That's what I'm trying to understand, since that seems to be the standard.

[00:23:36] Speaker 02:
The drug doesn't have to be, sorry, we know that FDA has not approved plaintiff's drug, but a drug doesn't require FDA approval if it's generally recognized as safe and effective among experts qualified to recognize the safety and efficacy of drugs.

[00:23:52] Speaker 02:
So it's not simply that.

[00:23:53] Speaker 04:
So was there evidence here that the plaintiff's drugs were not safe?

[00:23:59] Speaker 04:
I just want to be clear.

[00:24:01] Speaker 02:
So the FDA has,

[00:24:05] Speaker 02:
pursuant to its risk-based approach to enforcement that it's put in place, it has proceeded to enforce the FTCAs requirements against homeopathic drugs that fall into particularly risky categories.

[00:24:16] Speaker 04:
That includes- Is this a risky, particularly risky category?

[00:24:20] Speaker 02:
Yes, Your Honor, because plaintiff's drugs are injectable, which means they're injected directly into the bloodstream and potentially bypass some of the body's natural defenses.

[00:24:30] Speaker 02:
And because of the

[00:24:31] Speaker 02:
ingredients that they are labeled to contain here, potentially toxic ingredients.

[00:24:36] Speaker 02:
So clearly when you have that combination, potentially toxic ingredients inject directly into the bloodstream, it does present a heightened

[00:24:43] Speaker 02:
a heightened risk.

[00:24:45] Speaker 02:
And of course, FDA added plaintiff's drugs to the import alert only when it had enough evidence to have a suspicion that, hey, these drugs, we can justify detention, and that starts the administrative process.

[00:24:56] Speaker 02:
In the administrative process, plaintiffs had the opportunity and did submit evidence to try and say, hey, our drugs are generally recognized as safe and effective among experts qualified to recognize the safety and efficacy of drugs, and that they're not new drugs.

[00:25:10] Speaker 02:
Of course, the FDA has now disagreed with that and plaintiffs may disagree with that conclusion.

[00:25:16] Speaker 02:
But again, the proper course is for plaintiff to amend their complaint to put FDA's final decision before the district court.

[00:25:21] Speaker 02:
The full administrative record can be introduced.

[00:25:24] Speaker 02:
So all of the evidence and arguments that plaintiff presented the evidence and arguments plaintiff or sorry, the FDA.

[00:25:30] Speaker 02:
relied on, all of that can be put before the district court.

[00:25:34] Speaker 02:
And again, now that FDA has reached its final decision, that's the most appropriate path forward rather than seeking a preliminary injunction against this preliminary advisory import alert and then FDA's withdrawal of its guidance.

[00:25:48] Speaker 03:
Let me direct your attention to the guidance.

[00:25:53] Speaker 03:
The close issue that I see is the reliance issue interests.

[00:25:59] Speaker 03:
And the notice in the Federal Register doesn't even mention it.

[00:26:05] Speaker 03:
And it's a pretty weighty consideration after the amount of time the guidance has been in effect.

[00:26:15] Speaker 03:
What is your best authority for answering the reliance interests coming from this citizens petition, from a different document?

[00:26:29] Speaker 02:
Sure.

[00:26:29] Speaker 02:
So first, you know, the agency first announced in 2015 that it was reconsidering its guidance and it solicited public input at that time.

[00:26:38] Speaker 02:
The agency received public input.

[00:26:41] Speaker 02:
And as part of, you know, this, all of this consideration of its, its guidance, it received a citizen petition from the Americans for homeopathic choice that said, Hey, don't rescind your guidance.

[00:26:50] Speaker 02:
In fact, you should make some, they had suggested as they call it modifications, but the agency said they were quite drastic changes.

[00:26:57] Speaker 02:
The Americans for homeopathic choice wanted the agency to to make these modifications and then codify its guidance as a regulation and the agency again in the course of.

[00:27:09] Speaker 02:
making this decision about its guidance, it responded to the citizen petition and said, no, we're not going to maintain our guidance.

[00:27:16] Speaker 02:
We, in fact, are going to withdraw the guidance at this time.

[00:27:19] Speaker 02:
And the agency acknowledged that the citizens petition had explicitly invoked the long standing nature of the guidance and reliance interests and the agency said, you know,

[00:27:30] Speaker 02:
You've asserted these reliance interests both on behalf of industry professionals and consumers.

[00:27:36] Speaker 02:
But the fact that the agency has determined that this guidance no longer reflects its current priorities because the homeopathic drug industry has grown significantly to a billion dollar industry, which has led to an increased consumer exposures to these drugs.

[00:27:50] Speaker 02:
And that has come with a corresponding increase in safety concerns, some of which are quite significant, including infant deaths and seizures,

[00:27:58] Speaker 02:
and in the case of one homeopathic cold medicine, loss of the sense of smell.

[00:28:03] Speaker 02:
The agency recognized that its prior guidance didn't reflect its current thinking, and it wanted to move towards a more specified risk-based approach to enforcement.

[00:28:12] Speaker 02:
And so it said the agency's interest in withdrawing, again, this outdated guidance document that didn't reflect current facts before the agency

[00:28:22] Speaker 02:
didn't or sorry those the FDA's interest in doing so in the interest of public health outweighed the asserted reliance interests.

[00:28:30] Speaker 02:
And with respect to the federal register notice, the agency essentially said all of those same reasons in the federal register notice the next day.

[00:28:37] Speaker 02:
It didn't explicitly say the words reliance interests in that federal register notice.

[00:28:43] Speaker 02:
But again, the same underlying points were there and the agency again had responded to those reliance interests specifically where they had been invoked in the citizen petition response.

[00:28:53] Speaker 03:
Is it basically your argument that the FDA's announcement that it was going to a risk-based approach answers the reliance interests?

[00:29:05] Speaker 02:
I would say that the agency answered the reliance interests at the time it made its decision, and that set forth in the citizen petition.

[00:29:12] Speaker 02:
The Federal Register noticed the next day states essentially the same thing, but doesn't explicitly invoke reliance interests.

[00:29:19] Speaker 02:
But I think that that's also, again, the same reasoning is set forth there.

[00:29:25] Speaker 02:
And plaintiff suggests that, you know, looking at the citizen petition response, even though the words reliance interest weren't specifically included in the Federal Register notice is, you know, similar to a post hoc rationalization of government counsel, but the concern there is that when the agency hasn't had any discussion about something you don't want to, you know,

[00:29:45] Speaker 02:
take my word for it and speculate about what the agency might have been thinking.

[00:29:49] Speaker 02:
I mean, here, that's certainly not the case.

[00:29:52] Speaker 02:
We know what the agency was thinking at the time.

[00:29:54] Speaker 02:
It said it explicitly in its citizen petition response, which was a day before it published the Federal Register notice.

[00:30:01] Speaker 02:
And again, these are the words of the agency articulated at the time.

[00:30:04] Speaker 02:
So

[00:30:04] Speaker 02:
You don't have to take the words of government counsel or potentially speculate about what the agency was thinking.

[00:30:09] Speaker 02:
We know what the agency was thinking, and it set forth its reasonings clearly in the context of considering this exact question, whether it should withdraw or maintain its guidance.

[00:30:19] Speaker 03:
All right.

[00:30:21] Speaker 03:
Do my colleagues have any questions of Ms.

[00:30:23] Speaker 03:
Dixon?

[00:30:25] Speaker 03:
All right, then Mr. Sammons, why don't you take a couple, take two minutes.

[00:30:31] Speaker 01:
Thank you, Your Honor.

[00:30:31] Speaker 01:
I'll try to be very brief.

[00:30:33] Speaker 01:
I have just three quick points.

[00:30:34] Speaker 01:
The first with regard to the import alert and the characterization that it's only advisory and doesn't have any meaningful effects.

[00:30:41] Speaker 01:
I refer the court to the Bolerno and the smoking everywhere cases and to the court case itself, which makes clear that that's simply not true.

[00:30:50] Speaker 01:
The import alert expressly says that it's not subject to normal discretion judgments by the local staff.

[00:30:58] Speaker 01:
And it's not merely advisory.

[00:31:01] Speaker 01:
With regard to the causal connection between the withdrawal of 400-400 and the issuance of the import alert and all that's followed, and to the extent that has any connection here with the remedy we're entitled to, I think it is clear on this record

[00:31:15] Speaker 01:
that the agency itself said we cannot pursue our new enforcement priorities while 400-400 is in place, which is the very reason it gave for why it had to withdraw it immediately.

[00:31:28] Speaker 01:
And then it, of course, immediately follows up with the import alert.

[00:31:32] Speaker 01:
To say now that those two things have no connection to one another is not plausible.

[00:31:36] Speaker 01:
If that policy is reinstated, the import alert goes down.

[00:31:40] Speaker 01:
There's no other way around it.

[00:31:41] Speaker 01:
The only basis for it was that we hadn't complied

[00:31:44] Speaker 01:
with the grassy determination for for pharmaceutical drugs which of course 400 400 says we don't have to do and you can't have it both ways your honor if the two things are unconnected then they had not considered reliance interest with regard to the import alert they need the two to be connected because the only discussion of reliance interest is in the citizen petition

[00:32:08] Speaker 01:
That they claim is connected sufficiently to the withdrawal of 400 400 so they can't have it both ways.

[00:32:14] Speaker 01:
These two things are connected.

[00:32:15] Speaker 01:
And if one if we win that 400 400 has to be reinstated in

[00:32:20] Speaker 01:
That gives us the relief we need.

[00:32:22] Speaker 01:
And then with regard to reliance, I think the Regents case is exactly on point here.

[00:32:29] Speaker 01:
What the agency says they did, what the Supreme Court required is that they assess whether there were reliance interests, determine whether they were significant, and weigh any such interest against competing policy.

[00:32:42] Speaker 01:
You look at the language that the government points to.

[00:32:45] Speaker 01:
And throughout this litigation, it's taken the position that there are no legitimate reliance interests.

[00:32:49] Speaker 01:
So therefore, there's no way they properly did the balancing that was required.

[00:32:54] Speaker 01:
And they never considered alternatives.

[00:32:56] Speaker 01:
The Supreme Court makes clear that even if the underlying policy is illegal, which you would think would give strong interests in favor of withdrawing it, that doesn't preclude them from considering forbearance, which wasn't required here, or the alternative of actually providing the homeopathic-specific

[00:33:13] Speaker 01:
um uh grassy standard that they promised all along the agency says it doesn't have it's barred by the statute now from doing that even though for decades they said they had the authority and they promised to do it by changing another policy that can't solve the reliance interest uh that the supreme court sought to protect in regents all right thank you counsel um madam clerk if you would call the next case