[00:00:00] Speaker 05:
Place number 20-5026, Genius Medical Technologies LLC versus United States Food and Drug Administration, a balance.

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Mr. Winnick for the balance, Mr. Farquhar for the FOA.

[00:00:12] Speaker 01:
Mr. Winnick, good morning.

[00:00:14] Speaker 01:
Please proceed.

[00:00:15] Speaker 05:
Good morning, Your Honor.

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May it please the court, Daniel Winnick for the FDA.

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The product at issue here falls within the text of the drug definition in the Food, Drug, and Cosmetic Act.

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And the FDA has consistently treated such products as drugs for 23 years.

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Yet the district court concluded that Congress unambiguously foreclosed the FDA's discretion to treat this product as a drug.

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That was incorrect for two reasons, one that applies to the FDA's regulation of all products and one that applies specifically to its regulation of contrast agents.

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Let me start with the broad reason.

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The district court's rationale was that because the statutory device definition is narrower than the drug definition, it must be read.

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It can only be read as impliedly limiting the drug definition.

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But that assumes Congress could only have meant for the drug and device definitions to be mutually exclusive.

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And in fact, there's no reason to believe that.

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The statute used to contain language excluding devices from the drug definition, but Congress removed that language 30 years ago.

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The current text of the drug definition plainly encompasses the device definition and the statutory structure and purpose provide no basis to read into the drug definition, a limitation not supplied by its text.

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The canons invoked by the district court require either conflicting statutory provisions or superfluity.

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And here there is neither under the FDA's interpretation.

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So it's consistent with the statutes to track regulatory scheme for the FDA to decide which of the two pathways to apply to a product that satisfies both definitions.

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Can we talk about- Mr. Went- Go ahead, Judge Hunter, sorry.

[00:01:57] Speaker 01:
Okay.

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I was just going to ask, your letter,

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says that it appears that this silk solution is a device.

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I have a hard time seeing how it's a device.

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I realize that that's not an issue that you all have raised, but there is

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plenty of precedent for us to consider an issue antecedent to.

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And I'm looking now at the Supreme Court's case in 1992, the US National Bank versus independent insurance agents.

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A court may consider an issue antecedent to and ultimately dispositive of the dispute for it

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even if the parties fail to identify and brief the issue.

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And as I say, I just have a hard time seeing that this oral solution is a device.

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What does it fall under?

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It's not an instrument.

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It's not an implement, a machine, an implant, or in vitro reaction.

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It's not even an apparatus or a contrivance, whatever that means.

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you're left with an article and I realize that every drug is defined in terms of being an article.

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So let me address the question first and then speak to its relevance to this case.

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The clause Your Honor just read, the sort of preparatory clause of the device definition, has been read differently at sort of

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various times.

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The FDA's current view expressed in its guidance is that that language doesn't play much of a limiting role.

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And the reason, frankly, is that there's just such a broad diversity of products that many things that you wouldn't think of as machine contrivance, et cetera, are properly classed as devices.

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So for example, an example given in the FDA's guidance is a solution that is used to clean surgical devices.

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instruments or something like that could be a device, even though you wouldn't think of it as a contrivance implant, et cetera.

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And the FDA has sort of moved past the view it might have held at certain times in the past that that language refers to devices as, quote unquote, things that go clank.

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So the FDA didn't pass on this question here.

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It didn't specifically find that this was a device.

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It merely said, as your honor noted, that even if it is a device,

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the agency would choose to regulate it as a drug.

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I don't think under the Chantry Doctrine it would go to the court to reverse on the ground that actually this is a device that wasn't the issue.

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passed on by the agency.

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But I would say as to what- Then don't we run into the threat of an advisory opinion if we say, well, we'll make the same assumption that this is both a device and a drug when at least I think it doesn't qualify as a device to begin with.

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And so in other words, the question before us is,

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Does the FDA have the discretion when it's both a device and a drug to treat it as a drug?

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And my question to you is, before we even get to your discretion, it's not a device.

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So without being able to state definitively how the FDA would address the question, is it a device?

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I can say that the FDA is highly skeptical of the conclusion that this product doesn't fit the device definition.

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Um, the FDA regards the, you know, it's not, there were a bunch of negatives in there.

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The FDA, the FDA, if the corporate, for example, to remand for the FDA to specifically pass on whether this is a device, I think it's highly likely that the FDA would conclude that this is a device.

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I don't think it is a device.

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that this does fit the device definitely.

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And I mean, I had the same question to some extent as Judge Henderson.

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And the best I could do was to think that this is an accessory to a CT scan or an x-ray, that the barium is part of what

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sets up the scanning technology to actually function.

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And so it could be plausibly a device, but it also led me to be somewhat surprised by

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the FDA's position that the drug definition wholly subsumes the device definition, because it seemed to me with some of the other references in the prefatory phrase of the definition of device, there are gonna be implements, machines, apparati, that because they are so clearly those things,

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would be devices and would not be drugs.

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And that in that, you know, setting aside the

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district court's application and the appellee's application of the specific predominating over the general with respect to the exclusion.

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With respect to the definition of a device, it seems to me more plausible and more straightforward that what is more narrowly explicated in the in the device definition might in fact

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bring things, be decisive of the categorization for at least a number of devices.

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But that's not the FDA's position.

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It is not the FDA's position.

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And I do think as a textual matter, the relevant word in the drug definition is articles.

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And the device definition does specify an error or subset, an instrument, apparatus, et cetera, or other similar or related article.

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But that is a subset of articles.

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And so we return to our broader position here, which is that

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there is no basis to read the device definition as impliedly limiting the broader drug definition.

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Right.

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Unless there is, unless reading, you know, unless declining to do so creates either an irreconcilable conflict or superfluity, which is what the district court believed.

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And that's simply incorrect.

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So on you put on your

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understanding all devices are drugs, correct?

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Correct, Ron.

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And so then let's talk about statutory structure.

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Statutory structure as I understand it is

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All drugs must go through a very elaborate approval process under one part of the statute that's done by one part of FDA.

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And all devices have to go through a very different approval process that's done by a different part of FDA.

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and nobody thinks that some particular article should have to go on both tracks, correct?

[00:09:33] Speaker 05:
That's correct, Your Honor.

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Everybody agrees that the FDA has to identify whether to treat the product as a drug or device, and that's commonplace under the FDCA.

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So the statutory structure is if drug, then you're on track one, but not track two.

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If device, you're on track two, but not track one.

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And the device circle is wholly within the drug circle.

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And yet you acknowledged that this can't be rationally read to require both.

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And then you treat the statutory structure, which says the definition has all of these mandatory consequences associated with that product.

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You read that as saying, well, no, the FDA in fact has unfettered choice to pick whether to treat something as one as opposed to the other.

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So I disagree in a couple of ways, Your Honor.

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First,

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I don't think any of the mandatory consequences your honor referenced follow from the fact that something falls within the broad drug definition.

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I think it follows from the FDA's decision that it is to be regulated as a drug as opposed to a device.

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And again, there's lots of- You don't think the statute is self-executing in saying that no drug may be marketed without FDA approval?

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I think if something satisfies both the definition of a drug and the definition of a device,

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and the FDA exercising the role Congress gave it under section 360 BBB2 determines that the product has to be regulated as a device.

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I don't think under the statute, the drug requirements apply.

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So if something were a cosmetic and also a drug, the FDA would have discretion to put it through the much lighter pre-clearance of or approval process of a cosmetic.

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I believe that's true, Your Honor.

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And it's a great example of the sorts of overlaps that happen all the time under the FDCA.

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It's not just in the drug device context.

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There's also, of course, biologics as well.

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So it is commonplace in this regulatory scheme for products to fall within multiple broad regulatory headings and for the FDA exercising discretion given to it by Congress to decide which pathway to apply.

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So everything that's a tobacco product

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is everything that's a modified risk tobacco product is also a tobacco product kind of by definition.

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So if the FDA wanted to, it could just ignore the modified risk tobacco product more demanding

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pathway and treat all modified risk tobacco products as just ordinary tobacco products?

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It seems quite surprising to me.

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So we don't think, in the context of this case, we don't think it would be remotely open to the FDA to say that it is going to treat as a drug every product that satisfies the device definition.

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And this goes to the second part of Judge Katz's question, which is, is the FDA's discretion here unfettered?

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It isn't remotely unfettered.

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I mean, if the FDA did that, it would clearly be contrary

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to Congress's decision to create true pathways.

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What the FDA has done is exercise that discretion in a very limited number of cases, which is why the issue hasn't arisen to this court in 30 years since the 1990 amendments.

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But the question is what you can do under your interpretive theory.

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And if on the Venn diagram, if the circle for devices is entirely within the larger circle for drugs,

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And your theory is that any article that satisfies both, which is everything in the smaller circle, you have discretion to treat as either.

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What follows from that is you have discretion to treat every device as a drug.

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And that just makes nonsense out of the statutory structure, which is one reticulated scheme for drugs and another for devices.

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But with respect to honor, we don't think we have discretion to do that.

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If FDA treated as a drug every product that satisfies the device definition, it would clearly be contrary to Congress's decision to create two statutory schemes.

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Right.

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And that's really Mr. Farkar's view.

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And I guess to me, maybe we should move to the argument that's actually made, which is not about the predicate clause in the medical device definition, but about the exclusion.

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It seems to me there, even if

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you were more receptive to the questions that we've been asking about the predicate clause, that it in fact specifies some category of things that are devices that don't also fall within the drug definition because of the operation of their additional specificity.

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So because of the operation of the canon that the specific governs,

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the general, even if you accept that, then it seems to me that the district court applied the same reasoning to the exclusionary clause.

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And I'm not sure that it necessarily follows.

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So the exclusionary clause is excluding roughly things that are metabolized or function through a chemical reaction.

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And it says those are not devices.

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And as I understand it, what the district court did was say, okay, if they're not devices, that means they're drugs.

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And that means that something that is not

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That means that that is part of the drug definition and something that does not fall within that exclusion therefore necessarily is not a drug.

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And those further implications seem to me not necessarily to follow from the canon that the specific governs the general.

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And I just wonder, and let me just add one more thing that might make that clearer.

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So the fact that it's not a device might imply that it's a biological or that it is food, not that it is necessarily a drug because it's a multipolar statute, not a bipolar statute.

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And I guess I'm just wondering whether you agree with that.

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It's a narrower way to look at

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your position than the one you've marked out where all devices are also drugs.

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So under our view, if a product falls within the exclusionary clauses of the device definition, but otherwise satisfies the device definition, it is a drug because we regard the drug definition as encompassing

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the device definition.

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Now, biologics are also drugs under the statute, which is, again, another example of an overlap that is just ubiquitous in the FDA and why it's not so strange to have overlapping regulatory categories.

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We agree, of course, that the district court was incorrect to apply the specific governance of the general canon.

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But I think we take that view for a somewhat different reason, which is that under this court's decisions and the Supreme Court's decisions, that canon applies in two and only two scenarios.

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One is where there would otherwise be irreconcilable conflict in the statute.

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So, you know, one provision says no vehicles in the park.

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Another says bicycles can go in the park right that's a classic example.

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The other is where you have

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a broad provision and a specific provision applying side by side so that reading the broad provision as applicable would read out of the statute, the specific provision.

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So for example, in Forco, you had a broad general venue statute and a narrow patent specific venue statute.

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And the Supreme Court said, well, if you could apply the general venue statute in a patent case, there would be no point

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to the patent specific venue statute.

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But again, neither of those is present here.

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There is nothing that creates conflict, nothing that creates superfluity about the FDA's interpretation, which gives full meaning to the exclusionary clauses, which reads the exclusionary clauses to mean, if you work through chemical action or metabolism, you cannot be a device, therefore you can only be regulated as a drug.

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And which doesn't,

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If you operated through, I'm a little bit confused by that.

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If you operated through metabolization, for example, you could be a non-drug.

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You could be a food.

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You could, but you certainly, if you otherwise satisfy the device definition, you would be a drug.

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So if something satisfies the device definition,

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the other parts of the device definition, but works, but achieves its primary intended purposes through chemical action within or on the body or metabolization, then it is a drug.

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It may also be other things as Your Honor has noted, but it is a drug because the drug definition fully encompasses the device definition.

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In other words, it's a drug regardless of whether it satisfies the exclusionary clauses, but if it satisfies the exclusionary clauses, it can only- It's not a device and it's a drug.

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It's not a device and it's a drug, exactly.

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it ultimately decides the question that you say the FDA otherwise has full discretion over.

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So the only non-discretionary sorting as between the category of drugs and devices is that which is accomplished by the exclusionary clauses.

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That's right.

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And I do want to make sure I spell out fully what the FDA regards as the limits on its discretion.

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So it's not just that FDA could not

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take all products satisfying the device definition and decide to treat them as drugs.

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I think it's worth appreciating for a second the sort of rest of the regulatory framework of the device definition.

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So to read Genesis brief, you might think FDA could decide tomorrow it's gonna decide to regulate all band-aids as drugs and not devices, but there are in fact some 2,000 provisions in the code of federal regulations that specify that particular categories of products

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are to be treated as class one, two or three devices.

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The FDA couldn't change any of that without going through notice of comment rulemaking.

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So again, really the FDA, the authority the FDA is asserting here is extremely limited.

[00:20:08] Speaker 02:
But under your view of the statute, you could change those regulations.

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There would have to be a non arbitrary or capricious reason for doing so that did not undermine the broader two track scheme.

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I think if FDA

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exercised its authority in any of the extremely broad ways that have been posited, it would violate the statutory scheme.

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What it is doing here is exercising the authority as to a limited category of products where there are good reasons consistent with the statutory scheme for treating the category of products entirely as drugs.

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You could make a plausible argument in any case you want that

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The article satisfies the definition of drugs.

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Drug regulation is more stringent.

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You care, you rightly care a great deal about safety and efficacy, and you think it's important to have more stringent rather than less stringent regulation for some category of thing about which you have concern.

[00:21:16] Speaker 05:
Respectfully, Your Honor, I don't think that would be consistent with the statutory scheme.

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Congress didn't create these as

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you know, more and less stringent realms.

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And if FDA would reason in that way, I think that would be contrary to the statute.

[00:21:28] Speaker 02:
What is the limiting principle?

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You know, you've taken off the table, the one that Judge Henderson offered you, but what is the limiting principle in terms of your, the extent of your authority to reclassify or to categorize within the

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within that smaller circle.

[00:21:48] Speaker 05:
The limiting principle is that the FDA, the presumption is that something satisfying the device definition is treated as a device.

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And if FDA wants to regulate a product satisfying the device definition as a drug, it has to have a particular reason for doing so.

[00:22:02] Speaker 02:
I'm sorry.

[00:22:02] Speaker 05:
It's not arbitrary.

[00:22:03] Speaker 02:
The presumption in the statute or just how you choose to exercise discretion?

[00:22:08] Speaker 05:
The presumption in agency practice, which I think follows from the statute.

[00:22:12] Speaker 02:
And so if FDA is going to override that presumption, it needs to have- If it follows from the statute, that just sounds like an elliptical way of saying that the reticulated scheme associated with the narrower category is exclusive for the range of things to which it applies.

[00:22:35] Speaker 05:
No, Your Honor, I think it's a way of saying that Congress's decision to create a separate scheme for devices suggests that as a general matter,

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something satisfying a device definition should be treated as a device or else, again, if the FDA treated all devices as drugs, it would override the two track pathway.

[00:22:51] Speaker 03:
I think this is what's difficult for me is that it feels like you're at one time reading

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all the more specific definitions in the lead-in phrase, as if they really just reduced article.

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But then you're circling back and that's sort of for purposes of like your jurisdiction over, you know, which track, your authority to assign them to one track or another.

[00:23:24] Speaker 03:
But then it seems like you're sort of bringing back in those more specific terms as a guide for

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your discretion, in other words, you know, could you take crutches, which are, you know, an implement and say, well, they're a drug because they're an article and they're meant to be, you know, curative or, you know, help people and getting over malady, or can we take x-ray machine and regulate it as a drug and, you know, at some level, it's an article, but so is that right that you're sort of on the one hand,

[00:24:01] Speaker 03:
rejecting that initial language, on the other hand, finding it to still have a bearing on your discretion.

[00:24:09] Speaker 05:
So, Your Honor, the reason crushes, or to use my prior example, band-aids, couldn't willy-nilly be regulated as a drug is not, I think, that it is a thing that goes clank.

[00:24:19] Speaker 05:
It's that there is a regulation in the Code of Regulations that specifies that those things are divisive.

[00:24:27] Speaker 03:
Nothing about the statute.

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Nothing.

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Those terms that really resonate with common sense about devices should just be taken out.

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They're a leftover of another time.

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Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.

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including any component part or accessory.

[00:25:03] Speaker 03:
I mean, Congress spent a lot of time figuring out how to write that, how to write it in a broad way, to encompass a lot of things that don't seem to go clank, like maybe an in vitro reagent, and you're just, they could have just stopped and said article.

[00:25:22] Speaker 05:
So let me try to explain why I'm resisting it, because I realize I am, and I realize sort of why the court made me that,

[00:25:30] Speaker 05:
might be inclined to read that phrase differently.

[00:25:32] Speaker 05:
There's a couple of reasons.

[00:25:33] Speaker 05:
The first is if you look at page JA332, this is the part of the FDA's guidance that talks about that phrase, that similar or related article, and explains why there's just a lot of products that naturally, that ought to be regulated as devices and that aren't sensibly regulated as drugs that don't obviously fall within one of those headings in the preparatory clause.

[00:25:58] Speaker 05:
So for example, it talks about

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gels or powders that are used on the skin as a barrier, or gases used as face fillers, or as I mentioned earlier, liquids used to clean surgical instruments.

[00:26:08] Speaker 05:
The other reason is that there are consequences to being able to call something a drug that have to do with parts of the statutory scheme other than the one we're talking about today.

[00:26:19] Speaker 05:
So to give an example, if someone tomorrow tried to introduce a little metal box with the claim that it cures cancer,

[00:26:29] Speaker 05:
and the FDA wanted to prevent that obviously fraudulent device from being sold to the American public, the typical way in which the FDA would do that under its regulatory authorities is to say that because the box, because the claim is that the box cures cancer, it is a drug and that therefore selling it without authorization violates the unapproved new drug provision of the statute.

[00:26:52] Speaker 05:
And so

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reading the drug definition as narrowed by the specific examples in the preparatory clause of the device definition has implications beyond the context of this case that are troubling to the agency.

[00:27:06] Speaker 05:
And I think for good reason.

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The other thing I just want to make sure I have the opportunity to mention is even if the court is sort of concerned about the implications of FDs and

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across all categories of products.

[00:27:17] Speaker 05:
There's a very good rationale for deciding this case in FDA's favor, specifically with respect to contrast agents, which is that in the 2017 amendments to the statute, Congress legislated in a way that pretty clearly accepted as permissible the FDA's then 20 year old policy of treating all contrast agents as drugs, which is that there was a problem called to Congress's attention by the FDA, that there was a lack of specific authority to approve

[00:27:44] Speaker 05:
a device designed to use a contrast agent in a manner different from the one in the agent's drug labeling.

[00:27:51] Speaker 05:
Congress could have dealt with that problem by telling the FDA to stop treating all contrast agents as drugs, but instead it did the opposite.

[00:27:58] Speaker 05:
It wrote the statute in a way that allows FDA to treat the product as drugs, but creates a pathway for approval of the device as a device.

[00:28:09] Speaker 05:
And that's a pretty good indication as this court has recognized in many cases,

[00:28:13] Speaker 05:
that Congress approved the FDA's interpretation as permissible.

[00:28:16] Speaker 05:
So even if the court is disinclined to reach the broader question, whether FDA can exercise this authority as to other categories of products, it should at the very least reverse the district court's decision as to contrast agents.

[00:28:28] Speaker 05:
And again, this was in the FDA's ruling letter as well, this rationale.

[00:28:34] Speaker 03:
Tell me about the United States pharmacopia and the national formulary and what role

[00:28:43] Speaker 03:
their characterization of, for example, contrast agents as drugs plays if any.

[00:28:53] Speaker 05:
So I may be misunderstanding, but I don't think there is any import to any characterization of contrast agents as drugs by those entities.

[00:29:04] Speaker 05:
The relevance of the 2017 amendments is not simply that they characterize contrast agents as drugs

[00:29:13] Speaker 05:
for the purpose of applying that sort of particular framework for approval created by the 2017 amendments, it's that Congress chose in 2017 to address this problem in a way that accommodated FDA's decision to treat contrast agents as drugs, rather than simply telling the FDA, don't do that anymore, which it could easily have done.

[00:29:36] Speaker 03:
Right, although it may be that those with an interest in this issue simply weren't

[00:29:44] Speaker 03:
at the table?

[00:29:46] Speaker 05:
Well, I don't think that's accurate, Your Honor, because again, Congress wasn't doing this in the vacuum.

[00:29:51] Speaker 05:
And this is clear from the committee before we cite.

[00:29:54] Speaker 05:
It was addressing this problem in close coordination with the FDA because the FDA had called this problem to Congress's attention.

[00:30:00] Speaker 05:
So I think it's pretty improbable that when Congress wrote those provisions in 2017, it didn't know that FDA had for 20 years been treating all contrast agents as drugs.

[00:30:11] Speaker 05:
That was the thing that created the problem.

[00:30:13] Speaker 05:
at least as to contrast agents that also satisfy the device definition and could have been regulated as devices.

[00:30:20] Speaker 01:
All right.

[00:30:21] Speaker 01:
Do my colleagues have any more questions?

[00:30:24] Speaker 02:
All set.

[00:30:24] Speaker 02:
Thank you.

[00:30:25] Speaker 01:
Thank you.

[00:30:26] Speaker 01:
All right.

[00:30:27] Speaker 01:
We'll hear from Mr. Farquhar then.

[00:30:29] Speaker 01:
And we'll give you a couple of minutes, Mr. Winnick, in reply.

[00:30:32] Speaker 05:
Thank you, Your Honor.

[00:30:34] Speaker 00:
Thank you, and good morning, Judge Henderson.

[00:30:36] Speaker 00:
Good morning, Judge Pollard and Judge Katz.

[00:30:38] Speaker 00:
As Doug Fark were representing the appellee, genus medical technologies may please the court.

[00:30:44] Speaker 00:
I'd like to begin actually by addressing the question that Judge Henderson started with, which is how can this device, how can this medical product be a device?

[00:30:55] Speaker 00:
And it will also answer, I think some of Judge Pollard's concerns about whether something could be a food or a cosmetic and a drug.

[00:31:03] Speaker 00:
There is a threshold determination that is made using the intended use portion of the medical device definition and of the drug definition that if the product is intended to be used in this case for the assistance in the diagnosis of a disease, it is a medical product.

[00:31:24] Speaker 00:
So if a product is intended to be used not to treat a disease,

[00:31:30] Speaker 00:
It can be a food.

[00:31:32] Speaker 00:
But if it's intended to be used to diagnose, treat, cure a disease or prevent a disease, then it's a drug.

[00:31:41] Speaker 00:
And a drug or a medical device, depending on the second step of the analysis.

[00:31:49] Speaker 00:
All biologics are drugs.

[00:31:51] Speaker 00:
So there's no separation between those.

[00:31:54] Speaker 00:
Biologics are a subset of drugs.

[00:31:56] Speaker 00:
And that's made clear in the statute and in the regulations.

[00:32:01] Speaker 00:
The second step of the process once a product has been determined to be a medical product is, is it a drug or is it a device?

[00:32:10] Speaker 00:
The device definition, as Judge Katzis was explaining and explicating, is very, very clear.

[00:32:18] Speaker 00:
It is a device if it does not achieve its primary intended purposes through chemical action in or on the body or through metabolic action.

[00:32:28] Speaker 00:
If it does achieve its primary intended purposes through metabolic action or through chemical action, it is a drug.

[00:32:35] Speaker 00:
That's what's left.

[00:32:36] Speaker 00:
There's a universe of medical products.

[00:32:39] Speaker 00:
Some are devices and those that are not devices are drugs.

[00:32:42] Speaker 03:
That's the way the statute read before 1990, but Congress got rid of the exclusion from

[00:32:55] Speaker 03:
the drug definition of everything that's a device.

[00:32:59] Speaker 03:
And I understand that the immediate task there was to open the way for combination products, but that clearly could have been done in a way that excluded devices that are not combination products.

[00:33:15] Speaker 00:
Well, Your Honor, it's more than part, the FDA characterized that as being part of the reason that that clause was excluded.

[00:33:26] Speaker 00:
But if you read the legislative history on that point, it is quite clear in the legislative history, first of all,

[00:33:35] Speaker 00:
the Congress viewed this as being a slight alteration in the definition of drug.

[00:33:41] Speaker 00:
That is in the Senate report, I can give you the site if you'd like, the Senate report on the drug.

[00:33:47] Speaker 00:
It is just before the part, the first time, that Congress says this is a slight alteration of the drug device, which is intended to permit combination products, and combination products have a component of a drug or a device,

[00:34:04] Speaker 00:
to be regulated as a drug if the primary mode of action is that of a drug.

[00:34:09] Speaker 00:
That is, it achieves its primary intended purposes through chemical or metabolic activity.

[00:34:18] Speaker 03:
It just seems puzzling why Congress would have removed that definition.

[00:34:22] Speaker 03:
I mean, you've reminded me that because the choice as between the device track and the drug track is determined by primary mode,

[00:34:35] Speaker 03:
Why is that exclusion even needed if there's a third category that Congress creates and says, if it's combination, we don't automatically include it in device just because it meets that definition, nor do we automatically include a drug because it meets that definition.

[00:34:53] Speaker 03:
Instead, we call an FDA to determine its primary mode.

[00:34:58] Speaker 03:
No need to take away the limitation

[00:35:03] Speaker 03:
on drugs to those that operate through chemical or metabolic functions?

[00:35:10] Speaker 00:
Your Honor, the language that was removed from the drug definition in 1990 by the Safe Medical Devices Act had been in the statute since 1938.

[00:35:21] Speaker 00:
At that point, it was unclear until 1976 after the Bacto-Unidisk case

[00:35:31] Speaker 00:
It was unclear exactly where the line was drawn between drugs and devices.

[00:35:36] Speaker 00:
quite explicitly, the original Medical Device Act in 1976, quite explicitly said we need to, as Congress, we need to set up a clear line between drugs and devices.

[00:35:51] Speaker 00:
They left in that earlier language, but it really almost became surplusage because they said, here's the fence.

[00:36:00] Speaker 00:
If you're chemical action, metabolic action, you're a drug.

[00:36:04] Speaker 00:
if you don't achieve your primary intended purposes through that mode of action, you are a device.

[00:36:13] Speaker 01:
But Mr. Farquhar, the first paragraph of the MDA has the language that you seem to think doesn't have to be

[00:36:23] Speaker 01:
Complied with that is the instrument apparatus implement machine.

[00:36:27] Speaker 01:
What purpose does that serve just to try to describe without being exhaustive some of the more common devices.

[00:36:39] Speaker 00:
Your Honor, originally when that language was in the statute, that was the only definition of what a device is.

[00:36:46] Speaker 00:
And I did want to address very specifically your point, Judge Henderson, about how could this product be a device.

[00:36:54] Speaker 00:
And I would turn to, first of all, the FDA in its current language, the language that's in the briefs, talk about how it appears to meet the definition of a device.

[00:37:07] Speaker 00:
In the district court, the FDA actually admitted that it does fall within the definition of a device.

[00:37:14] Speaker 00:
It said in the Joint Appendix

[00:37:17] Speaker 00:
Let's see, I'm trying to find it.

[00:37:20] Speaker 00:
It's 77 and joint appendix 104.

[00:37:24] Speaker 00:
But even if you go further back, if you go into the citizen petition response in 1997 that was part of the administrative record,

[00:37:37] Speaker 00:
The FDA actually addressed this very specific point with regard to ultrasound agents.

[00:37:43] Speaker 00:
Because Judge Henderson, one of the parties in that matter, put into their citizen petition, how could a contrast agent possibly be a device?

[00:37:55] Speaker 00:
And FDA, correctly in our view, said, because it is an accessory to a diagnostic procedure, it is a device.

[00:38:05] Speaker 00:
Barium sulfate, like those ultrasound products, is an accessory to the diagnostic procedure of taking x-rays or CT scans.

[00:38:17] Speaker 00:
Now, to get back to your question now, why is that language there?

[00:38:25] Speaker 00:
The language is vestigial, but it is quite broad.

[00:38:29] Speaker 00:
If you read it, yes, it talks about device contrivance and so on and so forth, but it also talks about similar or related articles.

[00:38:37] Speaker 00:
Article is actually the same way that drugs are described.

[00:38:40] Speaker 00:
They're articles.

[00:38:41] Speaker 00:
So it's really what the distinction is once you have a medical product.

[00:38:48] Speaker 00:
In other words, once the use is intended to treat, diagnose, cure disease, it is a medical product and then the distinction is either does it

[00:38:59] Speaker 00:
achieve its principal intents and purposes, primary intents and purposes through chemical action.

[00:39:04] Speaker 00:
It's a drug.

[00:39:04] Speaker 00:
If not, it's a device.

[00:39:05] Speaker 00:
And if I could, Mr. Winnick actually, I don't think he did this on purpose, but he said FDA could switch

[00:39:16] Speaker 00:
what's a device and what's not through regulation.

[00:39:19] Speaker 00:
That's not true.

[00:39:20] Speaker 00:
If you look at 21 USC 360C, it specifically says medical devices will be class one, two, or three.

[00:39:29] Speaker 00:
And these are how these, we make the decision, you make the decision, FDA, as to whether it's class one, two, or three.

[00:39:36] Speaker 00:
Well, Mr. Minick might not say, well, that doesn't say all medical devices.

[00:39:42] Speaker 00:
But if you look back at the legislative history,

[00:39:45] Speaker 00:
of the Medical Device Act in 1976 that resulted in this classification system for medical devices, the legislative history, as Judge Boesberg said, says all medical devices fit into one of these three classes.

[00:40:02] Speaker 00:
So you can't excuse a medical device from the class by regulation.

[00:40:06] Speaker 00:
The statute says if it's a medical device, which

[00:40:10] Speaker 00:
it makes perfect sense is because it's a medical device, because it meets the definition of a medical device has to be classed in this particular manner.

[00:40:19] Speaker 00:
So.

[00:40:20] Speaker 03:
I mean, my understanding of FDA's response to that is once they choose to treat it as a statute permits them to as a drug, then it no longer has to fit into one, two or three.

[00:40:33] Speaker 03:
It becomes a drug and only a drug.

[00:40:36] Speaker 00:
That's correct.

[00:40:37] Speaker 00:
I wanted to make sure, though, that it was clear that it's the statute that requires it.

[00:40:41] Speaker 00:
What FDA claims is we have the discretion to regulate, to classify and regulate a medical product as a drug because it meets the intended use portion.

[00:40:52] Speaker 00:
of both of the definitions, the drug and device definition.

[00:41:00] Speaker 00:
But I want to turn now to the reasons that they don't have that discretion.

[00:41:04] Speaker 00:
First of all, they can point to nothing in the statute where Congress said, we want FDA to have that discretion.

[00:41:12] Speaker 00:
The only thing that they point to is the removal of the clause, but does not include devices or their components, accessories, parts, et cetera.

[00:41:20] Speaker 00:
It's a pretty big deal.

[00:41:22] Speaker 00:
On his face, it seems like a pretty big deal, but they did not touch the structure of the definition of what a device is or how a device is required to be regulated and classified.

[00:41:34] Speaker 00:
Also, so if it's ambiguous about what they intended by that, you're permitted to look at the legislative history.

[00:41:45] Speaker 00:
And the legislative history discusses this particular change in two different places in the legislative history.

[00:41:53] Speaker 00:
Both times it says it is intended

[00:41:56] Speaker 00:
to permit combination products to be regulated as drugs under appropriate circumstances.

[00:42:02] Speaker 00:
Combination products.

[00:42:04] Speaker 00:
It's focused on combination products.

[00:42:06] Speaker 00:
And our product is not a combination product.

[00:42:09] Speaker 00:
Then also, again, they say just before that point in the legislative history, this is a slight alteration.

[00:42:18] Speaker 00:
It would make no sense for FDA to make such a massive change

[00:42:26] Speaker 00:
in a scheme, a dual regulatory scheme, as Judge Boasberg described it, that is so important that in 1976, the Congress set forth these very specific rules about how you have to define medical devices and how you have to classify.

[00:42:44] Speaker 00:
Now, Mr. Winnick talked about the Radlax case, and he again misrepresented

[00:42:52] Speaker 00:
the holding in Radlax and the language in Radlax.

[00:42:57] Speaker 00:
In the final brief that FDA filed, it said the narrow versus general or specific versus general canon is restricted to these particular circumstances.

[00:43:07] Speaker 00:
That's actually not what Radlax said.

[00:43:11] Speaker 00:
What Radlak said, what Judge Scalia said in that decision is it is perhaps most frequently applied in those kinds of situations.

[00:43:21] Speaker 00:
But if you look at the other language in Radlak's, it fits quite specifically the situation we have here in terms of narrow versus specific.

[00:43:31] Speaker 00:
In particular, it quotes the Chase decision from 1890.

[00:43:35] Speaker 00:
And even in 1890, this is what the Supreme Court said about it.

[00:43:40] Speaker 00:
It is an old and familiar rule that where there is in the same statute a particular enactment and a general one, which in the most comprehensive sense would include what is embraced in the former, the particular enactment must be operative.

[00:43:55] Speaker 00:
this language is still valid.

[00:43:58] Speaker 00:
It was recently cited, I think it was in the Eagle case, if I remember right, or in the Eddie Rondack case.

[00:44:04] Speaker 00:
It is still operated that when, especially when, and this is what Judge Scalia said and what has been repeated in more recent cases, where, especially in the same enactment,

[00:44:18] Speaker 00:
Here, G, subsection G, subsection H1, same enactment, right next to each other, where there is a specific definition or a specific provision, and then there's a general provision, when the conduct at issue falls within the scope of both provisions, the specific presumptively governs whether or not the specific provision also applies to some conduct that falls outside the general.

[00:44:48] Speaker 00:
So it's clear that the narrow or specific versus general canon is not restricted to the circumstances that Mr. Winnick has argued.

[00:45:01] Speaker 00:
I would like to go back to in terms of the device definition and why it is such a clear line that's drawn by the statute, a line that still remains.

[00:45:18] Speaker 00:
And the reason is because, as I say, it's a universe of products that are medical products.

[00:45:24] Speaker 00:
Medical devices are specifically defined.

[00:45:27] Speaker 00:
What is not a medical device by default is a drug.

[00:45:32] Speaker 00:
makes perfect sense.

[00:45:34] Speaker 00:
It's implicit.

[00:45:35] Speaker 00:
But as was held in the eagle decision, implicit, if I can say, just quote that case, if the text clearly requires a particular outcome, then the mere fact that it does so implicitly rather than expressly does not mean that it is silent in the Chevron sense.

[00:45:58] Speaker 00:
I see my time is up.

[00:46:00] Speaker 00:
I did want to mention just a couple of other things, if I might, Your Honors.

[00:46:05] Speaker 00:
Go ahead.

[00:46:06] Speaker 00:
Thank you, Judge Anderson.

[00:46:10] Speaker 00:
One of the things that you may need to get to if you don't believe that this case is resolvable on Chevron step one is whether the decision that Mr. Winnick is advocating for here, the decision that our product can be regulated as a drug

[00:46:27] Speaker 00:
was an arbitrary and capricious decision.

[00:46:31] Speaker 00:
And I would like to point out that that decision relies on two.

[00:46:52] Speaker 00:
The other case is the Bracco decision that came out of the district court.

[00:46:57] Speaker 00:
response to the citizen petitions, as well as the government's view of that case now, distorts what the holding in that case actually was.

[00:47:07] Speaker 00:
Of course, it wouldn't be controlling on this court anyway.

[00:47:10] Speaker 00:
But what the holding in that case was, there were two holdings really.

[00:47:14] Speaker 00:
The first is you have to treat similar products in a similar fashion.

[00:47:18] Speaker 00:
That is a holding I've actually argued on.

[00:47:21] Speaker 00:
It's a correct holding.

[00:47:23] Speaker 00:
I've cited that case many times for that proposition.

[00:47:26] Speaker 00:
But then what it said is, these appear similar to me, Judge Friedman said.

[00:47:32] Speaker 00:
It is likely that FDA has the discretion to regulate these products, either as a drug or device.

[00:47:40] Speaker 00:
And that is not a decision, it's likely.

[00:47:43] Speaker 00:
What he actually decided was and instructed FDA to do was either treat these products the same or explain, give me a rational, give me the reason why you're not treating them the same.

[00:47:56] Speaker 00:
So it's not the holding that there was this discretion.

[00:48:01] Speaker 00:
I don't think any court has ever recognized that there's discretion for FDA to classify a product that meets the definition of a device as a drug.

[00:48:17] Speaker 00:
And it would be contrary to the structure, the text, the purpose, and the history of the statute.

[00:48:24] Speaker 00:
I'd be happy to answer any other questions.

[00:48:27] Speaker 00:
I have a question on H1.

[00:48:32] Speaker 01:
And how is a device recognized in either the formulary or the pharmacopoeia?

[00:48:40] Speaker 01:
What does the recognition involve?

[00:48:44] Speaker 00:
Yes, Your Honor, I will try to answer that.

[00:48:48] Speaker 00:
There actually is, the United States Pharmacopeia historically is a non-governmental institution that has monographs for particular drugs and particular devices.

[00:49:04] Speaker 00:
And what the statute has said, and this is because

[00:49:09] Speaker 00:
This has been historically in the statute forever.

[00:49:13] Speaker 00:
Because back in 1938, the US Pharmacopeia and the National Formulary, which is part of USP, were the Bible in terms of what was a drug and what was a device and whether it had to meet these particular requirements and specifications in order to qualify for listing in the USP or for using the USP label.

[00:49:37] Speaker 00:
These products, that is not an issue here.

[00:49:41] Speaker 00:
This particular product, barium sulfate, used as a contrast agent for radiological health would be, in fact, superseded by the statutory definition anyway.

[00:49:55] Speaker 00:
But I'm confident that if it had been listed in USP as one or the other, one of the parties who's before you would have recognized that and brought it to your attention.

[00:50:03] Speaker 01:
So is it recognized or not?

[00:50:05] Speaker 00:
I'm not sure, Your Honor.

[00:50:06] Speaker 00:
I don't know the answer to that question.

[00:50:08] Speaker 01:
But it's supposed to be.

[00:50:11] Speaker 00:
No, Your Honor.

[00:50:13] Speaker 00:
I'm sorry.

[00:50:14] Speaker 00:
It's an alternative.

[00:50:15] Speaker 01:
Oh, it's an alternative.

[00:50:16] Speaker 01:
Well, now wait a minute.

[00:50:17] Speaker 01:
It says one recognized or two intended for use or intended to affect.

[00:50:23] Speaker 01:
So how do you read the or comes after H2?

[00:50:28] Speaker 00:
That's correct.

[00:50:29] Speaker 00:
But if you look at the way that the statute is indented and so forth, and I'm looking at the version that's in the government's original.

[00:50:39] Speaker 00:
Right.

[00:50:39] Speaker 00:
So they won.

[00:50:40] Speaker 00:
The way it's indented, it's one, two, or three.

[00:50:44] Speaker 00:
In other words, you don't have to put war after one.

[00:50:46] Speaker 01:
I see.

[00:50:47] Speaker 01:
I see.

[00:50:48] Speaker 00:
OK.

[00:50:49] Speaker 01:
Thank you.

[00:50:50] Speaker 01:
Any more questions?

[00:50:52] Speaker 01:
All right.

[00:50:54] Speaker 01:
Mr. Winnick, why don't you take two minutes.

[00:50:58] Speaker 03:
Oh, go ahead, Judge Pillard.

[00:51:00] Speaker 03:
I just I think you answered this, Mr. Farquhar, but I just wanted to confirm it.

[00:51:04] Speaker 03:
I heard Mr. Winnick to say

[00:51:08] Speaker 03:
that he's not attracted to the suggestion that the prefatory language that you described as somewhat vestigial is actually playing any role in distinguishing devices from drugs.

[00:51:25] Speaker 03:
And I thought I heard you to say more or less the same thing.

[00:51:28] Speaker 03:
That you wouldn't see that as operative

[00:51:35] Speaker 03:
in addition to, in your view, or in contradistinction to, in Mr. Winnick's view, the metabolic and or chemical action exclusion, you both think that the lead-in language doesn't really play an operative role anymore.

[00:51:55] Speaker 00:
I'm glad you asked that question, Your Honor.

[00:51:58] Speaker 00:
And if I might give just a couple of examples, I think it would help the court understand.

[00:52:04] Speaker 00:
We both agree that that language in terms of articles in the drug definition

[00:52:11] Speaker 00:
and instrument apparatus, implement machine, contrivance implant, blah, blah, blah, is very, very broad language.

[00:52:18] Speaker 00:
It is the intended use of the product that makes it a medical product, and it is the chemical action that we contend, in this case, makes it a device.

[00:52:29] Speaker 00:
Now, it seems sort of counterintuitive that something that you swallow would not be a drug.

[00:52:36] Speaker 00:
And that's precisely why this explanation or why this definition is in here

[00:52:41] Speaker 00:
on chemical action, setting up the fence.

[00:52:43] Speaker 00:
So for example, we mentioned in our brief, there is a device that you swallow that is an alternative to a colonoscopy that passes through your system and takes pictures of your GI tract as it's working its way through.

[00:52:58] Speaker 00:
The fact that our product is swallowed, the fact that it's liquid does not make it necessarily a drug.

[00:53:04] Speaker 00:
It is a device because it is not achieving its primary intended purposes through chemical action within or on the body of man,

[00:53:13] Speaker 00:
or being metabolized.

[00:53:15] Speaker 00:
It is inert.

[00:53:17] Speaker 00:
It does not chemically interact with anything.

[00:53:20] Speaker 00:
It passes through your system.

[00:53:22] Speaker 00:
It's excreted.

[00:53:24] Speaker 00:
If I may take just a quick second, I actually, my daughter is a pediatrician and I was talking to her about this argument the other day.

[00:53:30] Speaker 00:
And she said, oh, we just used barium sulfate today.

[00:53:33] Speaker 00:
We had a child.

[00:53:34] Speaker 00:
They wanted to check motility in the child's digestive tract.

[00:53:37] Speaker 00:
So they gave the child scrambled eggs with barium sulfate in it.

[00:53:40] Speaker 00:
And then they watched through the x-ray as it passes through the system.

[00:53:44] Speaker 00:
So that's not a drug-like effect.

[00:53:46] Speaker 00:
That is a device-like effect, as it goes through the tissue, showing whether there's deformities in the tissue and showing how it tracks through the system.

[00:53:56] Speaker 00:
I appreciate your

[00:53:59] Speaker 00:
allowing me to divert into that little anecdote.

[00:54:02] Speaker 01:
I don't see why it isn't a drug-like effect if both of them are used for diagnosis.

[00:54:08] Speaker 01:
Barium sulfate, what you just described, was diagnostic.

[00:54:13] Speaker 00:
That's correct, and devices specifically.

[00:54:17] Speaker 01:
Which is what a drug

[00:54:20] Speaker 00:
No, Your Honor.

[00:54:21] Speaker 00:
No, Your Honor.

[00:54:22] Speaker 00:
I would disagree with that because it is, if you look at the number two, it's intended for use in the diagnosis of disease or other conditions.

[00:54:36] Speaker 00:
This is, I'm sorry, H2 under device.

[00:54:38] Speaker 00:
Devices can be used and frequently are used, mostly are used probably.

[00:54:43] Speaker 00:
in terms of helping to diagnose diseases.

[00:54:45] Speaker 03:
And in fact, the same term about diagnosis applies in both the drug and device definition.

[00:54:50] Speaker 03:
That's the more fundamental.

[00:54:52] Speaker 01:
Right.

[00:54:53] Speaker 01:
That's what I was saying, was just because it's diagnostic doesn't mean it's not a drug.

[00:55:02] Speaker 00:
That's correct.

[00:55:03] Speaker 00:
It's the fact that it does not achieve its primary intended purposes through chemical action.

[00:55:08] Speaker 00:
Thank you very much.

[00:55:09] Speaker 03:
Which relies on the exclusionary clause.

[00:55:11] Speaker 00:
which isn't included in the definition of drug.

[00:55:13] Speaker 00:
But OK.

[00:55:14] Speaker 00:
That's right.

[00:55:15] Speaker 00:
But again, the corollary of that clause is that the things that do achieve chemical action, their primary intended purposes through chemical action, and that are medical products, they are drugs.

[00:55:29] Speaker 00:
That's what's left.

[00:55:32] Speaker 00:
Thank you.

[00:55:32] Speaker 00:
We would ask that you affirm the district court decision.

[00:55:37] Speaker 00:
All right.

[00:55:38] Speaker 00:
Mr. Winnick.

[00:55:39] Speaker 05:
Thank you, Your Honor.

[00:55:40] Speaker 05:
Five points which I promise are quick.

[00:55:42] Speaker 05:
First, as I noted at the beginning, Chevron deference applies under Mylan.

[00:55:46] Speaker 05:
So the FDA wins unless its interpretation is unambiguously foreclosed or unreasonable, and it's neither of those things.

[00:55:54] Speaker 03:
But I thought you relied only on clear language and didn't rely on any exercise of discretion in this case.

[00:56:01] Speaker 05:
So we think the FDA properly exercises discretion to treat this product as a drug.

[00:56:07] Speaker 03:
But in the reading of the statute, you think it's clear?

[00:56:10] Speaker 05:
We think the statute leaves it open to the FDA to treat a product satisfying the device definition as drugs that Congress hasn't clearly required the FDA to do otherwise.

[00:56:23] Speaker 05:
Second, as to Radlax, we don't mischaracterize that decision.

[00:56:26] Speaker 05:
The decision says the canon is most frequently applied to avoid a contradiction, but it is also properly applied to avoid superfluity.

[00:56:35] Speaker 05:
Our point is that here there is neither a contradiction nor superfluity.

[00:56:39] Speaker 05:
Third, the question before the court isn't what Congress had in mind in 1990.

[00:56:43] Speaker 05:
The question is whether there is a basis to read into the text of the drug definition, a limitation that isn't in its text.

[00:56:50] Speaker 05:
And the relevance of what happened in 1990 is simply

[00:56:53] Speaker 05:
all the more incorrect to do that, where Congress expressly removed the limitation 30 years ago.

[00:56:59] Speaker 03:
I think this is proof, oh, go ahead.

[00:57:02] Speaker 03:
No, I'm sorry.

[00:57:02] Speaker 03:
Get your file out and I'll ask you the question.

[00:57:04] Speaker 05:
I'll remember it.

[00:57:05] Speaker 05:
Okay, fourth aside, even if this court weren't to rule on a basis specific to contrast agents under the 2017 amendments, it should have no concern that if the FDA were in the future to apply the authority it's claiming here more broadly than it has done in 30 years,

[00:57:22] Speaker 05:
the court won't be able to confront that.

[00:57:23] Speaker 05:
Manufacturers can easily bring APA challenges to any future decisions that go beyond the narrow terms the FDA is defending today.

[00:57:32] Speaker 05:
Finally, I don't think it's open under Chenery for the court to decide this case based on the preparatory clause, but the FDA would regard that as highly disruptive to its regulatory

[00:57:43] Speaker 05:
So to sum up the district's decision is wrong because it reads into the statute exactly the language Congress removed 30 years ago without any compelling rationale in the statutory structure or purpose and in a way that upsets 23 years of settled industry expectations.

[00:57:58] Speaker 05:
I'm sorry, Judge Pillard.

[00:58:02] Speaker 03:
I said I would remember.

[00:58:06] Speaker 03:
You said there's no concern here about superfluity, but I think the questioning that you heard from the bench in your argument in chief was why is your reading not rendering the device definition superfluous insofar as everything that's a device is also a drug?

[00:58:31] Speaker 05:
And our answer is that the FDA might do that if it were just deciding to treat every device as a drug, but it's not doing that or even close, and it's not asserting the authority to do that.

[00:58:42] Speaker 05:
What it's asserting the authority to do.

[00:58:43] Speaker 03:
I guess the question is, what's the frame for superfluity?

[00:58:46] Speaker 03:
Is it in the scheme that Congress is mapping, or is it in the world as the FDA

[00:58:58] Speaker 03:
exercises its power.

[00:58:59] Speaker 03:
And I thought that it was the former, that the superfluity should be identifiable from just reading the statute without knowing how the FDA is going to act.

[00:59:16] Speaker 03:
But maybe your view is, no, we have an option.

[00:59:18] Speaker 03:
And so it's not superfluous because it's giving us an option.

[00:59:22] Speaker 05:
I think superfluids is a fairly formal analysis.

[00:59:26] Speaker 05:
Is the language in the statute given full effect?

[00:59:29] Speaker 05:
Our point is that the exclusionary clauses of the device definition as a whole is given full effect in FDA's interpretation because it specifies what the FDA

[00:59:40] Speaker 05:
cannot regulate as a device.

[00:59:42] Speaker 05:
If something falls within the exclusionary clauses, it must be regulated as a drug and not a device.

[00:59:48] Speaker 03:
What's your best answer to Mr. Farquhar's point that this was something that Congress thought of as a small change.

[00:59:57] Speaker 03:
And indeed, if it had intended to throw a lot of discretion into FDA's court, wouldn't you expect that there would be some discussion of

[01:00:10] Speaker 03:
what guides that discretion.

[01:00:12] Speaker 05:
So I think a few points.

[01:00:15] Speaker 05:
One, it has been a relatively small change.

[01:00:19] Speaker 05:
Again, this hasn't come to the court in 30 years because the FDA asserts this authority very rarely.

[01:00:24] Speaker 05:
Second, Congress did put in the statute a means for the FDA to exercise discretion in classifying

[01:00:31] Speaker 05:
Products as to which it's unclear whether they should be treated as drugs or devices that's section 360 BBB two and third you know I find it instructive to sort of pretend for a second that 1990 had never happened pretend the statue had always read exactly as it does today.

[01:00:48] Speaker 05:
In that world, it would be just as true as in this world that it would be improper to read into the drug definition a limitation that isn't supplied by its text.

[01:00:57] Speaker 05:
So the only additional point that 1990 gets us is that it would be even more unwarranted to do that where Congress removed the same limitation when it was expressed in the statute.

[01:01:08] Speaker 05:
So to all of Mr. Farquhar's points about what the legislative history does or doesn't suggest, even if you think Congress might not have meant to do this,

[01:01:18] Speaker 05:
The only the only effect that would have is that you put less weight on that additional reason we win.

[01:01:22] Speaker 05:
It doesn't go to any of our more fundamental points about the propriety of reading into the drug definition a limitation that simply isn't in its text, and that is not necessarily implied by the structure of purpose of the statute.

[01:01:37] Speaker 03:
You mentioned that the, I mean, I find, I do find it notable that it's been 30 years and this is the first time this issue has come before us.

[01:01:50] Speaker 03:
It makes it seem like it isn't a dramatic change.

[01:01:53] Speaker 03:
But then when you say the FDA asserts this authority very rarely, I almost find that to be an incomprehensible sentence in view of the way you read the authority because

[01:02:04] Speaker 03:
Every time it regulates a device as a device, it exercises this authority in your view.

[01:02:11] Speaker 03:
Well, except that in practical terms- Because there's no statutory meaningful distinction other than the biochemical or the chemical and metabolic carve out.

[01:02:22] Speaker 05:
So the way I see it, Your Honor, is this.

[01:02:25] Speaker 05:
From Mr. Farquhar's telling, you would think that every time a manufacturer goes to create a new product, a Band-Aid or a crutch or whatever else,

[01:02:33] Speaker 05:
they are sitting there in a state of uncertainty about what FDA is going to do.

[01:02:38] Speaker 05:
But the reality is that for the overwhelming majority of products, it is specified in the CFR what device class the product falls into if it's a device.

[01:02:50] Speaker 05:
So the authority the FDA is defending comes into play only in a narrow, limited number of cases where there's not some regulation on point where

[01:02:59] Speaker 05:
you know, as historical matter, there's been some ambiguity in how the product is to be treated.

[01:03:03] Speaker 05:
We've identified sunscreens, contrast agents is one, but this is not some large list of things.

[01:03:10] Speaker 05:
And, you know, even as to products in this category, again, it's, I think rings hollow to suggest that even contrast agent manufacturers, you know, are sort of hurt by some uncertainty about this.

[01:03:21] Speaker 05:
When, as this Gizkit Amicus brief points out, it's been perfectly clear to contrast agent manufacturers since 1997, how they were going to be regulated.

[01:03:29] Speaker 05:
And what genus is seeking here is an exception to that consistent long-standing and perfectly clear policy, which for the reasons we argue is sensible and should be upheld for those.

[01:03:40] Speaker 03:
And you resist the... So I had thought that there was a distinction between

[01:03:51] Speaker 03:
what's included in the device definition, which distinguishes it from the drug definition in terms of machines and implements versus what's excluded from the device definition, which isn't necessarily included in the drug definition.

[01:04:09] Speaker 03:
But I think I had been operating under what may be an incorrect view of a multipolar FDA regulatory regime

[01:04:22] Speaker 03:
that something could be a drug or a biological, but now that I've been corrected that all biologicals are drugs.

[01:04:28] Speaker 03:
And where you're talking about a cosmetic, the statute's explicit about how to deal with the overlap.

[01:04:33] Speaker 03:
And in fact, so if something that's excluded from the device definition isn't thereby defined as a drug, why not as a practical matter?

[01:04:47] Speaker 03:
Does that make sense?

[01:04:47] Speaker 03:
I know that's a little bit of a jumbled question.

[01:04:49] Speaker 05:
No, that's right.

[01:04:50] Speaker 05:
I mean, so I think if you were to regard the device definition in the abstract, the thing that makes it a drug is not that it is excluded from the device definition.

[01:04:59] Speaker 05:
The thing that makes it a drug is it falls in the drug definition.

[01:05:03] Speaker 05:
And whereas it might otherwise overlap with the device definition, there is no such overlap if it's in the exclusionary clauses.

[01:05:13] Speaker 05:
Does that make any sense?

[01:05:13] Speaker 03:
Yeah.

[01:05:14] Speaker 03:
But doesn't that just reinforce the district court's reasoning?

[01:05:20] Speaker 03:
I mean, you're saying no, because everything that's in the device definition is in the drug definition.

[01:05:26] Speaker 03:
And therefore, the fact that it is not excluded doesn't mean it is exclusively a device, right?

[01:05:32] Speaker 05:
Yeah, that's right.

[01:05:33] Speaker 05:
I mean, the core of the district court's reasoning, to boil it down, is Congress could only have intended for these to be mutually exclusive categories.

[01:05:40] Speaker 05:
They have to be mutually exclusive categories.

[01:05:42] Speaker 05:
And our point is, that's not right.

[01:05:44] Speaker 05:
It's certainly true that if FDA treated every device as a drug, it would eviscerate the two track scheme and that would be impermissible, but there's nothing at all inconsistent with the statute or frankly unusual in the context of the FDCA for the FDA occasionally to decide that something satisfies both definitions should be treated under one track or the other.

[01:06:06] Speaker 02:
Can I just try one more time?

[01:06:09] Speaker 02:
tell me what is the legal principle in the statute that limits your asserted power to reclassify such that you could not treat every device as a drug in the statute.

[01:06:31] Speaker 05:
The FDA has to have a good reason for treating as a drug a product satisfying the device definition.

[01:06:39] Speaker 05:
And it has to be consistent with the statutory scheme.

[01:06:42] Speaker 05:
And it would be inconsistent with the statutory scheme if the FDA exercised that authority as to every product satisfying the definition of a device.

[01:06:49] Speaker 05:
Because as Rana has noted, Congress clearly envisioned that there would be two distinct tracks.

[01:06:55] Speaker 05:
And if any manufacturer in a future case thinks that FDA has exercised that authority impermissibly

[01:07:01] Speaker 05:
it can easily bring an APA challenge and this court can, you know, set limits on the FDA's discretion.

[01:07:07] Speaker 01:
Thank you.

[01:07:07] Speaker 01:
All right.

[01:07:09] Speaker 01:
Your case is submitted.

[01:07:10] Speaker 01:
Thank you.