Latest / Pharmacy Podcast Network / Lies and Lawsuits | Essential: Pharmacy Compounding Podcast APC

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Lies and Lawsuits | Essential: Pharmacy Compounding Podcast APC · Pharmacy Podcast Network

0:05
Speaker 1: You are listening to the global network of podcasters dedicated
0:09
Speaker 1: to the pharmacy profession. Welcome to the Pharmacy podcast Network.
0:24
Speaker 2: Welcome to Essential, the Pharmacy compounding podcast with the latest
0:29
Speaker 2: news and analysis from you know It, the Alliance for
0:32
Speaker 2: Pharmacy Compounding, the voice for compounding pharmacy. I'm your host,
0:36
Speaker 2: Andrew Canter, and today we've got a follow up on
0:39
Speaker 2: the desiccated thyroid extract story, what drug maker's battalion of
0:44
Speaker 2: lawyers are up to and why it backfired and more.
0:47
Speaker 2: Then we'll dive into some of the latest court cases
0:49
Speaker 2: against compounders with a lawyer who's kind of an expert
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Speaker 2: at representing compounding pharmacies. But first let's do that news.
1:05
Speaker 2: We want to start with a quick follow up to
1:08
Speaker 2: the big story we covered in our last podcast. That's
1:11
Speaker 2: when we talked about how the FDA is reclassifying desiccated
1:15
Speaker 2: thyroid extract DTE as a biologic and that means it'll
1:19
Speaker 2: be out of bounds for compounding and therefore out of
1:22
Speaker 2: bounds for many many patients, and that's supposed to take
1:25
Speaker 2: effect next to August. Now, last time we talked about
1:28
Speaker 2: why the decision was so wrong on a lot of levels.
1:31
Speaker 2: The biggest issue though, is that it's going to be
1:33
Speaker 2: a real problem for patients. A lot of the people
1:35
Speaker 2: who need thyroid meds just can't take the synthetic stuff,
1:39
Speaker 2: and that means that in a year they're going to
1:40
Speaker 2: be out of luck. APC is obviously concerned about this.
1:44
Speaker 2: Protecting those patients is actually one of our top priorities
1:47
Speaker 2: at the moment. Here's what we're thinking. It's going to
1:50
Speaker 2: take a two pronged approach to get the FDA to
1:52
Speaker 2: change its mind. First, we need to put some pressure
1:56
Speaker 2: on the agency directly. APC is doing that, obviously, Boy
2:00
Speaker 2: would it help if patients and prescribers did too. I mean,
2:03
Speaker 2: at least in theory, these are the people the FDA
2:06
Speaker 2: is there for right. Second, we need to reach out
2:09
Speaker 2: to Congress to get it to intervene.
2:11
Speaker 3: Again.
2:11
Speaker 2: ABC is doing that. We've got lobbyists in Washington. But again,
2:15
Speaker 2: it would help a lot to have patients and prescribers
2:18
Speaker 2: reach out to their senators and representatives.
2:21
Speaker 3: So here's what we did. We created a web page.
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Speaker 2: It's compounding dot com slash thyroid, and that's also in
2:29
Speaker 2: the show notes. On the page, there are four big buttons,
2:32
Speaker 2: two for patients, two for prescribers. One button will let
2:35
Speaker 2: them send a message to the FDA, the other one
2:37
Speaker 2: will let them send a message to their members of Congress.
2:40
Speaker 2: And it really is just about that simple. We've got
2:43
Speaker 2: sample letters, we handle the sending, and there's even a
2:46
Speaker 2: way to leave a written or video testimonial about DTE Anyway,
2:51
Speaker 2: it's all on once again, compounding dot com slash thyroid.
2:55
Speaker 2: The whole point is to ramp up pressure on the
2:58
Speaker 2: FDA and get it to realize it's stake can leave
3:01
Speaker 2: dt alone. All right, let's talk about the newest games
3:06
Speaker 2: drug makers are playing. They really do not like compounding,
3:09
Speaker 2: do they. So their latest tactic spread the idea that
3:13
Speaker 2: somehow poumpounders are using low quality ingredients in their drugs.
3:18
Speaker 2: What they've done is create fake organizations with legitimate sounding names.
3:22
Speaker 2: They're supposed to sound like some independent organization on a
3:26
Speaker 2: mission of righteousness, but it's just a sock puppet stuffed.
3:29
Speaker 3: With drug maker dollars.
3:32
Speaker 2: These sock puppets they send out these fake independent press releases,
3:36
Speaker 2: and those releases just happen to parrot the same lies
3:40
Speaker 2: as the farmer companies can we say lies, Nope, False
3:43
Speaker 2: claims okay, False claims okay. So even if people don't
3:47
Speaker 2: fall for the false claims, the drug makers hope to
3:51
Speaker 2: confuse regulators, confuse the media because the more confusion, the
3:55
Speaker 2: more scared patients will be. But sometimes those plans backfire.
3:59
Speaker 2: At least here's the story through one of those sock
4:02
Speaker 2: puppet groups. A few months ago, drug makers claim that
4:05
Speaker 2: shipments of counterfeit GLP ones came into the US from
4:09
Speaker 2: who knows where, They came in with stickers or whatever
4:12
Speaker 2: that said they were bound for compounding pharmacies.
4:16
Speaker 3: Sure, yeah, we all know there are.
4:17
Speaker 2: Fake drugs and other listed substances coming into the US,
4:20
Speaker 2: and that's a problem. But the notion that these were
4:23
Speaker 2: going to compounding pharmacies, legitimate compounding pharmacies, it's nonsense. First off,
4:28
Speaker 2: who the heck cares what some shady company from across
4:31
Speaker 2: the Pacific puts on its drugs. They could say for
4:34
Speaker 2: delivery to Buffalo, New York. But it doesn't mean Josh
4:36
Speaker 2: Allen is getting into the GLP one business. But the
4:40
Speaker 2: bigger thing is compounding pharmacies don't get their ingredients directly
4:44
Speaker 2: from manufacturers. All right, Yeah, There are some edge cases,
4:47
Speaker 2: but by and large, compounding pharmacies source their ingredients from
4:51
Speaker 2: FDA registered American wholesalers who have gotten them from FDA
4:55
Speaker 2: registered manufacturers, and the wholesalers they analyze the ingredients before
5:00
Speaker 2: before they send them to the pharmacies, and heck, most
5:01
Speaker 2: of them even do independent third party testing. The point is,
5:05
Speaker 2: no licensed compounding pharmacy is buying ingredients off some random
5:10
Speaker 2: ship docked in Los Angeles or wherever it was.
5:13
Speaker 3: But still the drug maker.
5:14
Speaker 2: Sock puppets make a lot of noise and make a
5:17
Speaker 2: lot of false claims without any evidence to back it up.
5:21
Speaker 2: And still it got the attention of some folks in Congress.
5:25
Speaker 2: Not all of them understand how the compounding supply chain
5:27
Speaker 2: actually works. See this is what I was talking about
5:29
Speaker 2: about spreading confusion. So some members of Congress pushed the
5:33
Speaker 2: FDA to do something about this non existent problem. What
5:37
Speaker 2: the FDA did was take its list of legitimate GLP
5:41
Speaker 2: one manufacturers, the ones that knew met all its standards,
5:44
Speaker 2: and named it the Green list APIs from anywhere else.
5:48
Speaker 2: It said, we're going to be confiscated the drug makers.
5:51
Speaker 2: They were hoping this would be some big news story,
5:54
Speaker 2: I don't know, scare people away from compounders.
5:56
Speaker 3: The problem was it didn't affect compounding pharmacies.
5:59
Speaker 2: At all legit ones anyway, because the manufacturers on the
6:02
Speaker 2: green list are exactly the ones the wholesalers were already using.
6:07
Speaker 2: So the story comes out and it doesn't take long
6:10
Speaker 2: for journalists to realize it's pretty much a non story.
6:13
Speaker 2: And yes, APC can't take a little credit for helping
6:16
Speaker 2: explain that if anything, And here's where it kind of backfires.
6:20
Speaker 2: The FDA actually validated that compounding pharmacies were indeed following
6:24
Speaker 2: the rules using the same kinds of high quality ingredients
6:27
Speaker 2: that the big drug makers were the green list to
6:30
Speaker 2: prove it. So who does that green list actually affect?
6:33
Speaker 2: Illegal pop up shops? You know, the ones selling the
6:36
Speaker 2: do it yourself GLP one injections on TikTok or whatever.
6:40
Speaker 2: And honestly, those folks deserve what's coming to them. There's
6:45
Speaker 2: another recent development in the pharmacy world. You've probably heard
6:48
Speaker 2: at least the general story. The FDA was ordered to
6:51
Speaker 2: crack down on misleading claims in direct to consumer drug ads,
6:55
Speaker 2: and that included everyone from big pharma companies to compounders
6:59
Speaker 2: to telehealth platform everyone in between. I'm not going to
7:02
Speaker 2: talk about the letters that went to Eli Lilly or
7:04
Speaker 2: Novo Nordisk or any of those. This is a compounding podcast.
7:07
Speaker 2: The kinds of letters we've heard that were sent to compounders,
7:10
Speaker 2: they definitely raise some eyebrows. Apparently, one of the claims
7:14
Speaker 2: that some compounders made, claims the FDA had a problem with,
7:18
Speaker 2: was that the active ingredient in their compounded GLP one
7:22
Speaker 2: was the same as that in a commercial GLP one.
7:25
Speaker 2: Now FDA says that's deceptive. So think about that for
7:29
Speaker 2: a second. The FDA says it's misleading for compounders to
7:33
Speaker 2: point out that their active ingredient is the same as
7:36
Speaker 2: the one in Zeenpic or zep bound or wick Ov
7:38
Speaker 2: or whatever. But it is the same ingredient. It has
7:41
Speaker 2: to be the same. If it wasn't, they wouldn't be
7:43
Speaker 2: allowed to compound with that. The law is crystal clear
7:46
Speaker 2: about that. But saying so that's misleading. It's like the
7:50
Speaker 2: FDA tripped over its own logic rushing to get those
7:53
Speaker 2: letters out.
7:54
Speaker 3: The National Law Review.
7:56
Speaker 2: Has a great article about the whole mass and the
7:58
Speaker 2: weird penalty flag the FDA has been throwing. There's a
8:02
Speaker 2: link to the article in the show notes. Oh as
8:04
Speaker 2: a side note, by the way, remember that the same
8:07
Speaker 2: FDA crackdown is also affecting the big drug makers. We
8:11
Speaker 2: love the story about Astrozeneca being told to take down
8:14
Speaker 2: an ad because it had teenagers discussing drugs and there
8:18
Speaker 2: wasn't an adult in the room. Sauce for the gander,
8:21
Speaker 2: You might say, all right, enough about GLP ones for
8:26
Speaker 2: a moment. Every now and then, APC releases what we
8:29
Speaker 2: call a best practices document.
8:31
Speaker 3: It's a short guide. It's written by a panel of.
8:34
Speaker 2: Experts, and it covers one of the important issues that's
8:37
Speaker 2: been cropping up with our members. We've got some on
8:40
Speaker 2: specific topics, but our latest is a little different.
8:43
Speaker 3: It's a bit broader.
8:44
Speaker 2: It's called Best Practices for Dispensing Compounded Therapies and it
8:48
Speaker 2: is as broad as that title implies. It pretty much
8:52
Speaker 2: covers all the basics of compounding, packaging, labeling logistics, dealing
8:57
Speaker 2: with adverse reactions, handling recalls, counseling patient. Yeah, I said
9:01
Speaker 2: it was broad, and no, it's not telling you how
9:04
Speaker 2: to do your job. It's like a refresher I mean,
9:07
Speaker 2: let's face it, you do something long enough and it
9:09
Speaker 2: kind of becomes automatic. So we think it's a good
9:11
Speaker 2: idea to take a moment and stop being automatic. Just
9:15
Speaker 2: download the document, it's free. The link is in the
9:17
Speaker 2: show notes. See how what you do compares to the
9:21
Speaker 2: best practices. Chances are you're right on the money, but
9:24
Speaker 2: you never know. And if nothing else, it's a chance
9:27
Speaker 2: to talk to your team about how you all work together.
9:29
Speaker 2: So grab it and while you're there, take a look
9:31
Speaker 2: at the other best practices docs we have. There's good
9:34
Speaker 2: stuff there and some of it is worth copying and
9:36
Speaker 2: pasting into your own pharmacy SOP manual. And now it's
9:42
Speaker 2: time for our deep dive. Today we're going to look
9:44
Speaker 2: at lawsuits, in particular some of the suits that have
9:47
Speaker 2: been filed by the big drug makers against compounding pharmacies
9:51
Speaker 2: and telehealth platforms. They haven't really been terribly successful. Just recently,
9:56
Speaker 2: there was one against Willow Health that got thrown out.
10:00
Speaker 2: There was one against stry Pharmacy in Arizona that was
10:02
Speaker 2: also dismissed. Yeah it was on a technicality, but still dismissed.
10:06
Speaker 2: And there's one still going on against Moshi Health in
10:09
Speaker 2: southern California. But the judge in that case doesn't seem
10:12
Speaker 2: terribly sympathetic toward Eli Lilly. And you know what they say,
10:16
Speaker 2: Mauret's one two rast nice here, rob at the all ball.
10:24
Speaker 2: All right, maybe not out because this is the American
10:27
Speaker 2: legal system and they can refile, but lately at least
10:30
Speaker 2: they've been swinging and missing. So here to discuss them
10:34
Speaker 2: and a few other lawsuits, we have Mark Bosen, one
10:37
Speaker 2: of the founding partners of Boson and Snow Law in Washington, DC.
10:41
Speaker 2: Not only does Mark specialize in pharmacy law, he's actually
10:44
Speaker 2: a practicing pharmacist, and that is not a combination you
10:47
Speaker 2: see a lot of and joining Mark is APC CEO
10:51
Speaker 2: Scott Brunner, who, like anyone with a lawyer as.
10:54
Speaker 3: A captive audience, has a lot of questions. So Scott, Mark,
10:58
Speaker 3: take it away.
11:01
Speaker 4: Lots of questions. Andrew, thank you, and Mark welcome. This
11:06
Speaker 4: is a hot topic and we're looking forward to hearing
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Speaker 4: some of your thoughts about what is truly a slew
11:14
Speaker 4: of litigation. We're not even going to talk about cease
11:17
Speaker 4: and desist letters. Of course, the drugmakers continue to send
11:20
Speaker 4: those out, not only to compounding pharmacies, but also to
11:25
Speaker 4: some prescribers providers, which I think was a bit jarring
11:30
Speaker 4: for some of those. But we're going to talk about litigation,
11:34
Speaker 4: and that trio of lawsuits that Andrew has mentioned is
11:37
Speaker 4: where I'd like to start. It strikes me and I'd
11:42
Speaker 4: be interested in what you think about this. It seems unusual,
11:46
Speaker 4: out of the ordinary, maybe for judges to and this
11:51
Speaker 4: is my word but editorialize the way they have in
11:55
Speaker 4: these three cases Willow, the strife case, and the Motion
11:59
Speaker 4: care the judges have seemed remarkably unsympathetic to some of
12:06
Speaker 4: Lily's claims. In one of those cases, the judge asked
12:09
Speaker 4: one of the Lily lawyers a question. The lawyer answered
12:12
Speaker 4: at length, and the judge responded by saying, what I
12:17
Speaker 4: hear you saying is you don't have anything. How unusual
12:21
Speaker 4: is it for judges to do this, because in each
12:24
Speaker 4: of those three cases, what the judges are saying really
12:28
Speaker 4: validate that compounding pharmacies are working within law and policy
12:33
Speaker 4: to serve patients with compounded gop one drugs.
12:37
Speaker 5: It's a good question, Scott, and it is a little
12:40
Speaker 5: unusual regarding the volume of information that the courts are
12:45
Speaker 5: putting in with their decisions, particularly in a decision that
12:48
Speaker 5: happened in this Drive case the host talked about Andrew
12:52
Speaker 5: talked about, Strive was dismissed on a technicality.
12:55
Speaker 6: What was that technicality?
12:57
Speaker 5: Very simply, the court said, Hey, Delaware isn't the right
13:01
Speaker 5: place to sue this entity. The centite's primary place of
13:04
Speaker 5: businesses in Arizona, and your allegation that they have a website,
13:09
Speaker 5: that they have a non resident pharmacy permit in Delaware,
13:13
Speaker 5: and that people in Delaware buy your products makes it
13:16
Speaker 5: a legitimate venue to utilize the Delaware courts wasn't good enough.
13:20
Speaker 5: Not in twenty twenty five, when every major business has
13:23
Speaker 5: a website and advertises to people all over the country,
13:27
Speaker 5: it doesn't mean that they have what's called personal jurisdiction
13:31
Speaker 5: subject themselves to the courts of the other states. If
13:34
Speaker 5: they don't have any brick and mortar there, they don't
13:36
Speaker 5: have any employees there, they don't have any substantial business there.
13:40
Speaker 6: And that's what the Delaware court did.
13:42
Speaker 5: And it would have been very easy for that judge
13:44
Speaker 5: to simply rule on that personal jurisdiction issue. Does the
13:48
Speaker 5: Delaware court have personal jurisdiction over this entity that is
13:53
Speaker 5: headquartered in Arizona. And it could have been a very
13:56
Speaker 5: very short holding, but it wasn't. It was several pages long.
14:00
Speaker 5: And that narrative, there's a term for it in the
14:03
Speaker 5: legal industry. We call it dicta dicta.
14:07
Speaker 6: Judges have the discretion to.
14:09
Speaker 5: Write dicta and dicta is simply a commentary that has
14:13
Speaker 5: no bearing or no legal precedence on what's next.
14:17
Speaker 6: It's just a way for the judge to say, hey,
14:21
Speaker 6: I did review some of this case.
14:23
Speaker 5: I needed to in order to evaluate personal jurisdiction, and
14:26
Speaker 5: so I do have an opinion about the merits. And
14:29
Speaker 5: although it might be inappropriate for the judge to write
14:32
Speaker 5: about the merits of the case in a dismissal and
14:35
Speaker 5: personal jurisdiction, it's within their discretion to do so, and
14:39
Speaker 5: they usually do that when they have strong opinions about
14:44
Speaker 5: what's happening next. And one of my favorite lines in
14:48
Speaker 5: that decision from that judge in Delaware, and it's the
14:51
Speaker 5: first couple of sentences, and it was very clever, and
14:55
Speaker 5: it read something like, and I'm paraphrasing the federal Court's
14:59
Speaker 5: reward the drug innovation, but it does not reward innovative
15:04
Speaker 5: thoughts about jurisdiction. Eli Lilly's pleading has both, which is, hey,
15:11
Speaker 5: you're a drug innovator. We applaud you for that, but
15:15
Speaker 5: we don't appreciate you trying to be clever and innovate
15:18
Speaker 5: a new theory about personal jurisdiction. And so we're going
15:22
Speaker 5: to send this out of this jurisdiction and.
15:27
Speaker 6: They're free.
15:28
Speaker 5: Lily is free to refile in another jurisdiction. We expect
15:32
Speaker 5: it to be Arizona because that would be the clearest
15:35
Speaker 5: place for them to refile.
15:37
Speaker 6: And so we'll wait and see.
15:39
Speaker 5: But that judge was very critical, as were the Willow judge,
15:42
Speaker 5: as were the Mochi judges in their interrogation.
15:48
Speaker 6: Of the lawyers for Eli Lilly.
15:51
Speaker 5: In Willow, what was remarkable and in Mochi what was
15:55
Speaker 5: remarkable was they did talk about the merits, and the
16:01
Speaker 5: merits are simply this one is was there false misleading advertising?
16:07
Speaker 5: And that's what Andrew was talking about. And there's tremendous
16:11
Speaker 5: skepticism that there was anything false or misleading about the
16:15
Speaker 5: advertising that these defendants are being accused of. But more importantly,
16:21
Speaker 5: even if you have an injustice, even if you're harmed
16:24
Speaker 5: by the legal system.
16:26
Speaker 6: You have to have an injury for the court to fix.
16:29
Speaker 5: So what the judges are all forecasting is, even if
16:33
Speaker 5: I can get you to the point where you've approved,
16:37
Speaker 5: you know you've proved some false or misleading advertising, help
16:41
Speaker 5: me explain what your injury was. And in Mochi's hearing,
16:46
Speaker 5: the judge was very concerned that there was no injury here.
16:50
Speaker 5: In Willow, the judge says, there's no injury here, and
16:53
Speaker 5: that makes sense. You can't simultaneously tell the shareholders of
17:00
Speaker 5: the publicly traded companies that we're selling as much drug
17:04
Speaker 5: as we can, as fast as we can, and especially
17:07
Speaker 5: during a shortage period, we don't have enough to sell.
17:10
Speaker 5: But we were also injured because these compounding pharmacies were
17:14
Speaker 5: supplementing the market with more drug. Which one's the fact,
17:18
Speaker 5: did you have enough drug to sell everybody? Or based
17:24
Speaker 5: upon the information you provided to the FDA and exists
17:28
Speaker 5: in real life that people couldn't find this drug at
17:32
Speaker 5: their pharmacy. What damage did you have if you're selling
17:35
Speaker 5: one hundred percent of the product that's coming off of
17:38
Speaker 5: your assembly line. Help me understand what damage there was,
17:42
Speaker 5: And that's the big hurdle that Eli Lilly's lawyers are
17:46
Speaker 5: just having a tough time explaining.
17:49
Speaker 4: Yeah, it is fascinating. In the Willow case, in particular,
17:55
Speaker 4: the judges and I've learned a new word. Thank you,
17:57
Speaker 4: Mark Dicta. The judge found that personalized supervised compounded prescriptions
18:05
Speaker 4: are indeed lawful, even made a comment that seemed to
18:10
Speaker 4: me to be sort of a swipe against the claims
18:12
Speaker 4: that he lootedly had made that the entity was engaged
18:16
Speaker 4: in mass production mass manufacturing of compounded drugs. And the
18:21
Speaker 4: judge said, basically, in effect, just because something is produced
18:24
Speaker 4: in volume doesn't mean that it is not intended for
18:29
Speaker 4: an end of one for an individual patient in the
18:31
Speaker 4: needs of that individual patient, based.
18:32
Speaker 3: On a prescriber.
18:34
Speaker 4: So let me ask, and of course I'm asking you
18:37
Speaker 4: to speculate, do you see these as indicative of how
18:42
Speaker 4: other courts might react? Again, Lily is able to adjust.
18:50
Speaker 4: I guess it's claims to come back with a different
18:52
Speaker 4: set of claims in these Certainly they're gonna they're likely
18:57
Speaker 4: to pursue the Strive case in a different jurisdiction. Do
19:01
Speaker 4: you do you think there's more of the same or
19:03
Speaker 4: or these just three sympathetic judges that the that Liley
19:09
Speaker 4: happened to draw.
19:10
Speaker 5: I don't think it's three sympathetic judges that Lily accidentally drew.
19:15
Speaker 5: I don't think there's a coincidence here. And why, and
19:19
Speaker 5: this is the basis of why do why do we
19:22
Speaker 5: seek out different courts? Why did Lily go to Delaware
19:24
Speaker 5: in the first place is a question to ask yourself.
19:27
Speaker 5: Eli Lilly itself is in the Southern District of Indiana.
19:31
Speaker 5: That's their home turf. That's where they usually file cases
19:35
Speaker 5: because that's where they employ many many Indianas and they're
19:40
Speaker 5: a big deal there. They might have avoided Arizona because
19:45
Speaker 5: that's where Strive is, And there's a perception we learn
19:48
Speaker 5: in law school that if you can avoid fighting the
19:53
Speaker 5: other side in their home territory, try not to because
19:58
Speaker 5: regardless of the blindfold that's on Lady Justice, there's always
20:04
Speaker 5: a bias of well, this is an employer, these are
20:09
Speaker 5: people that might be friends and neighbors of mine. There's
20:11
Speaker 5: this bias, whether it's conscious or not, that's there. And
20:14
Speaker 5: so you try to find people in a neutral environment.
20:17
Speaker 5: And so Delaware would be neutral to both Eli Lilly
20:21
Speaker 5: and Strive and Delaware is notorious for being a very
20:27
Speaker 5: neutral environment.
20:28
Speaker 6: They have very business friendly laws there.
20:31
Speaker 5: Lots and lots of businesses choose to organize there and
20:34
Speaker 5: choose those courts because those judges are known and have
20:38
Speaker 5: a reputation and it's a proud reputation of being unbiased,
20:43
Speaker 5: very critical, critical thinkers, and they don't choose sides. And
20:49
Speaker 5: so you've got a Delaware judge who not only dismissed
20:52
Speaker 5: the case because he found no jurisdiction, but wrote a
20:55
Speaker 5: tremendous round of dicta supporting Eli supporting Strives position. And
21:01
Speaker 5: then you've got another judge on the other side of
21:04
Speaker 5: the country in Mochi. In the San Francisco Courts, the
21:08
Speaker 5: Ninth Circuit, which is where I live and I practice
21:11
Speaker 5: most is notoriously difficult to predict.
21:16
Speaker 6: And it's because it's such a large district.
21:19
Speaker 5: Geographically, it is the largest district in the United States.
21:23
Speaker 5: So many states, from the most liberal states to the
21:27
Speaker 5: most red states all sit in the Ninth District. And
21:32
Speaker 5: when you see Adelaware and so we always perceive, particularly
21:36
Speaker 5: the San Francisco courts, as to have a much different culture.
21:40
Speaker 5: They tend to be more liberal, they tend to be
21:42
Speaker 5: more activist. They tend to be reviewing things that may
21:48
Speaker 5: not fit neatly withinto statutes and regulations, and we accuse
21:52
Speaker 5: them sometimes of inventing new law. But that judge didn't
21:55
Speaker 5: want to do that there, despite the reputation of her
21:58
Speaker 5: own circuit, of her own city, of her own brethren,
22:02
Speaker 5: she is taking a very very critical view, just like
22:05
Speaker 5: the Delaware judged it. So you've got two very very
22:07
Speaker 5: different cultures of jurists, and then in the Willow case
22:13
Speaker 5: you've got some consistency. It is not a coincidence that
22:19
Speaker 5: they found the three judges that are gonna that that
22:25
Speaker 5: all have taken the position that they have grave concerns
22:30
Speaker 5: about the strength of Eli Lily's case because it is difficult.
22:34
Speaker 5: You talked about it, Andrew talked about when when I
22:39
Speaker 5: said it early on when they filed, when Lily filed
22:43
Speaker 5: its claim against Mochi and Willow, when they started pick
22:47
Speaker 5: on picking on the use of personalization, I said, well,
22:51
Speaker 5: that's the definition of compounding.
22:54
Speaker 6: We're personalizing a dose.
22:56
Speaker 5: And I'm glad you brought up the just because there
22:58
Speaker 5: are hundreds of patients, or thousands of patients, or even
23:02
Speaker 5: ten thousands of patients that need a personalized dose that
23:07
Speaker 5: happens to be the same as the other nine thousand
23:10
Speaker 5: people doesn't mean that it's not personalized. This is a
23:15
Speaker 5: drug that the Kaiser Family Foundation tells us that likely
23:18
Speaker 5: one in eight American adults is on now or has taken.
23:21
Speaker 5: And that's probably a conservative estimate because there's no way
23:24
Speaker 5: for them to count how many compounds are being dispensed,
23:27
Speaker 5: so it's probably a little higher than that. And so
23:30
Speaker 5: you've got tens of millions of people out there, tens
23:33
Speaker 5: of millions of doses that are going out there every
23:37
Speaker 5: year between Novo's drug, Lily's drugs, and the compounder's drugs.
23:43
Speaker 5: And if ten thousand or even one hundred thousand of
23:47
Speaker 5: those millions of doses need to be the same for
23:51
Speaker 5: a handful of people, well that makes sense. You've got
23:54
Speaker 5: a number of patients that share the same need for
23:58
Speaker 5: something that's clinically different provides a substantial benefit to the
24:03
Speaker 5: patient that the FD approved drugs don't do. And my
24:08
Speaker 5: favorite thing to point out in administrative hearings and in
24:11
Speaker 5: court hearings is, but your client only makes two or
24:15
Speaker 5: three formulations, how is it possible that all of their
24:19
Speaker 5: patients only need two or three. And I said, well,
24:22
Speaker 5: it's not possible for the patients that don't benefit from
24:26
Speaker 5: those two or three formulations, they're going other places. Let
24:30
Speaker 5: me point out this pharmacy that makes two or three
24:33
Speaker 5: different kinds of formulations, and they're just as busy as
24:36
Speaker 5: my client. Let's point out this one that makes another
24:39
Speaker 5: two or three. And so, because my clients aren't manufacturers,
24:44
Speaker 5: they can't produce everything for everyone. So if someone comes
24:48
Speaker 5: to them and says I need this particular mixture, this
24:52
Speaker 5: particular formulation, our clients often say, you know what, that's
24:56
Speaker 5: not something that we're set up to do. It's very
24:59
Speaker 5: expensive for us to re evaluate a new formulation. But
25:03
Speaker 5: I happen to have a colleague in another state, in
25:05
Speaker 5: another location that's licensed here that does make that formulation.
25:09
Speaker 6: Those phone calls and those referrals happen every day well.
25:12
Speaker 4: And the other thing that the judge in the Willow
25:15
Speaker 4: case seemed to recognize is that these are based on
25:18
Speaker 4: the judgment of a prescriber. That often gets left out
25:21
Speaker 4: of this conversation. It gets left out in media reporting,
25:24
Speaker 4: it gets left out in what some of the sock
25:26
Speaker 4: puppets say to Congress. There is a prescriber using his
25:31
Speaker 4: or her judgment to determine that an individual patient needs
25:34
Speaker 4: this drug.
25:36
Speaker 6: That's absolutely right, and we lose that.
25:40
Speaker 5: I have to remind administrative agencies and courts all the time.
25:44
Speaker 5: Pharmacies don't get to decide.
25:47
Speaker 4: Yeah, nothing happens in a compounding pharmacy until a script
25:50
Speaker 4: comes in.
25:50
Speaker 5: That's right and our job and I do this not
25:54
Speaker 5: just with compounded medications, but anytime I'm defending a pharmacist
25:57
Speaker 5: related to something they've dispensed.
26:00
Speaker 6: Our job is not to practice medicine.
26:02
Speaker 5: Our job is to practice pharmacy, and that means providing
26:05
Speaker 5: a safety net to potentially dangerous medications, potentially, you know,
26:11
Speaker 5: typographical errors that might lead to something, and helping pay
26:14
Speaker 5: attention to drug drug interactions that the prescriber of record
26:18
Speaker 5: for prescription A.
26:19
Speaker 6: May not know there was a different prescriber or prescription B.
26:22
Speaker 5: Our job is not to veto a prescription, but to
26:25
Speaker 5: provide information to.
26:26
Speaker 6: The prescriber if there are concerns about it.
26:28
Speaker 5: But at the end of the day, the person practicing medicine,
26:32
Speaker 5: which is the prescriber, physician, nurse practitioner PA, they made
26:36
Speaker 5: that decision Yeah, if you're concerned about their medical judgment,
26:40
Speaker 5: then that's a different person to talk to.
26:44
Speaker 4: Yeah, that's a that's a different sort of discussion. I
26:47
Speaker 4: appreciate your thoughts on that. I want to jump to
26:51
Speaker 4: a couple of other areas of litigation. Let's talk briefly
26:56
Speaker 4: about Florida. So back during the early mid days of
27:02
Speaker 4: the shortage, drug makers filed lawsuits against a number of
27:07
Speaker 4: compounding pharmacies, mostly in Texas, Tennessee, and Florida. Several in
27:14
Speaker 4: the state of Florida. In each of those cases, and
27:18
Speaker 4: correct me, Mark if you think I get this wrong.
27:19
Speaker 4: This is my layman's reading of those briefs. You could
27:23
Speaker 4: read those briefs from drug makers and be compelled to
27:27
Speaker 4: think that there was no federal government, that there was
27:30
Speaker 4: no Food, Drug and Cosmetic Attact, that there was no FDA,
27:33
Speaker 4: there were only state deceptive practices laws, and the drug
27:37
Speaker 4: makers were accusing the pharmacies of unauthorized drug manufacturing and
27:43
Speaker 4: deceptive practices. Well in at least three cases, four cases
27:47
Speaker 4: in Florida, the drug makers lost those lawsuits. APC actually
27:53
Speaker 4: filed AMEKAS briefs in a couple of those cases, just
27:57
Speaker 4: trying to make sure that the court understood the proper
28:00
Speaker 4: role of compounding in law and policy. So the compounding
28:04
Speaker 4: pharmacies prevail, and of course the drug makers are now
28:07
Speaker 4: appealing the courts. I think, I don't know that you
28:10
Speaker 4: may teach me another new word like dicta. But the
28:13
Speaker 4: courts have combined those cases, at least three of those
28:16
Speaker 4: cases into one on appeal. There's another one Brooksville, hanging
28:20
Speaker 4: out there that we wonder might be added to that group.
28:25
Speaker 4: And APC will once again be filing amikas brief in
28:30
Speaker 4: those cases. Can you talk a little bit about what's
28:31
Speaker 4: at stake and what's going on there?
28:33
Speaker 3: Just briefly, yes, I can.
28:36
Speaker 5: And what happened in Florida and is happening in Texas
28:41
Speaker 5: as well on a very similar case they almost mirror
28:45
Speaker 5: each other, is the drug companies have found an obscure
28:49
Speaker 5: part of the law in Florida. It exists also in
28:52
Speaker 5: five other states that is found not within the Pharmacy
28:56
Speaker 5: Practice Act, not within the Medical Practice Act, but in
28:59
Speaker 5: a step part of the law that just talks generally
29:01
Speaker 5: about consumer protection, and to oversimplify it, it's a provision
29:06
Speaker 5: that says, hey, as a state, we don't allow entities,
29:12
Speaker 5: whether they be people or businesses, to introduce unapproved drugs
29:16
Speaker 5: into our marketplace. And I know exactly, well, I don't
29:22
Speaker 5: know exactly, but I can speculate with some certainty as
29:25
Speaker 5: to where this comes from. So anybody who knows a
29:27
Speaker 5: little bit about politics knows that you're elected.
29:30
Speaker 6: People come from all walks of life.
29:33
Speaker 5: There are exterminators, there are nurses, there are sometimes doctors.
29:37
Speaker 5: There are very few pharmacists, but God bless the ones
29:40
Speaker 5: that are there. But everybody is responsible for knowing everything.
29:45
Speaker 5: You've got in the legislature committees that write these bills
29:50
Speaker 5: and the Pharmacy Practice Act, the Medical Practice Acts are
29:53
Speaker 5: usually going to be in health committees. There's are going
29:55
Speaker 5: to be people who understand health law, but these consumer
29:58
Speaker 5: protection laws usually end up in different places, different committees
30:01
Speaker 5: where you've got no discussion of health hardly ever. And
30:06
Speaker 5: I can see someone and I see this in my
30:08
Speaker 5: daily life.
30:10
Speaker 6: Well, in order to protect.
30:12
Speaker 5: The consumers, we should make sure that no one sends
30:16
Speaker 5: or tries to sell a drug in our state that's
30:18
Speaker 5: not FDA proof because they're all approved, right, every single
30:21
Speaker 5: one has to be, and the layman just assumes that,
30:24
Speaker 5: and they have no idea. And you know this, and
30:27
Speaker 5: I know this, compounded drugs by definition and an FDA approved.
30:30
Speaker 5: Most of the over the counter medications aren't FDA approved.
30:33
Speaker 5: They're made pursuant to a monograph, which is simply a
30:36
Speaker 5: recipe that exists in the Federal Register, and if you
30:39
Speaker 5: follow the recipe, you're allowed to market it. You've got
30:42
Speaker 5: all of these drugs that were made before nineteen before
30:45
Speaker 5: the food drug and cosmetic active they've been grandfathered.
30:49
Speaker 6: In, but they have never gone bugs FDA approval.
30:51
Speaker 5: So you've got all of these medications out there, over
30:55
Speaker 5: the counter and prescription that have never been FDA approved.
30:58
Speaker 5: But you try to tell a lawmaker who's sitting on
31:01
Speaker 5: the Consumer Protection Committee that, and they would their jobs
31:05
Speaker 5: would drop.
31:06
Speaker 6: And so you've got these obscure laws that clearly.
31:08
Speaker 5: Contradict the Pharmacy Practice Act of the Medical Practice Act
31:12
Speaker 5: in those states. So let's say there was no federal government,
31:16
Speaker 5: even in Florida, I could say, well, this is impossible
31:20
Speaker 5: to do because that the entities that regulate medicine not
31:25
Speaker 5: only allow for this, but they expressly allow for this,
31:30
Speaker 5: which is allowing doctors to write foreign pharmacists to dispense
31:34
Speaker 5: certain unapproved medications and for retailers to market OTC medications,
31:39
Speaker 5: many of which you have never been empty approved. And
31:41
Speaker 5: so even if I just took Florida law, I could
31:44
Speaker 5: dispatch with it. But what the drug makers did was
31:47
Speaker 5: say the Florida law ought to control, or in these
31:51
Speaker 5: other states, the other states laws ought to control. And
31:55
Speaker 5: because the Food Drug and Cosmetic Act is not preemptive,
32:00
Speaker 5: there is no express preemption in the Food Creditor Cosmetic
32:03
Speaker 5: Act that says, hey, no matter what we do, we're
32:07
Speaker 5: going to preempt any state law.
32:09
Speaker 6: That's contradictory to this.
32:11
Speaker 5: But there is a long case history of even though
32:16
Speaker 5: those words might not be in there, they mean what
32:19
Speaker 5: they mean.
32:20
Speaker 4: So and so that's how that's how the courts in
32:22
Speaker 4: these cases ruled in federal preemption, there's no private right
32:26
Speaker 4: of action by a drugmaker to enforce the Food Drug
32:28
Speaker 4: Cosmetic Dact. So so let's fast forward to their appeal.
32:32
Speaker 4: What what what do you on what basis are they
32:36
Speaker 4: are they appealing?
32:37
Speaker 6: Well, I'm a little worried that they're going to appeal
32:40
Speaker 6: based upon a relatively new Fifth Circuit Court of Appeals case.
32:46
Speaker 4: And that's the other one I want to talk with
32:48
Speaker 4: you about, so let's just go right into it. You're
32:50
Speaker 4: talking about the ZI like a right, Yeah.
32:52
Speaker 6: They intermingle.
32:53
Speaker 5: So Zayla is a drug manufacturer, traditional drug manufacturer, and
32:56
Speaker 5: Wells Pharma is a five oh three B outsourcing facility,
33:00
Speaker 5: and we're going to talk about something as boring as
33:03
Speaker 5: into methicine suppositories right now.
33:05
Speaker 6: And what was the case.
33:08
Speaker 5: Xyla makes commercially available into medicine suppositories at fifty milligrams
33:15
Speaker 5: per dose if I'm remembering correctly, and Wells pharmam five
33:20
Speaker 5: oh three B compounds one hundred milligrams suppositories because those
33:25
Speaker 5: are necessary for the patients that at the institutions and
33:30
Speaker 5: at the prescribers' offices and at the five oh three
33:32
Speaker 5: A pharmacies whose doctors have said, hey, this person needs more.
33:37
Speaker 5: And I'm not going to ask the person to insert
33:40
Speaker 5: two suppositories rectilly, I'm going to order one because that's
33:44
Speaker 5: more humane and more friendly, and it's going to cause
33:47
Speaker 5: more compliance. And there's nothing wrong with that. It's not
33:52
Speaker 5: essentially a copy. There's a legitimate medical need you can
33:55
Speaker 5: absolutely substantiate for these patients. I'm presuming that they need
34:00
Speaker 5: to a higher dose than what Zilah is going to support.
34:04
Speaker 5: And Texas Court was asked to review these laws and
34:09
Speaker 5: they came to the same conclusion. The lower court said,
34:12
Speaker 5: now the FDA preempts this. If you've got a problem, Zila,
34:15
Speaker 5: go complain to the FDA. If the five or three
34:18
Speaker 5: b's doing something wrong, that's their job to figure it out.
34:21
Speaker 5: It's not even for us to consider. Sila didn't take
34:24
Speaker 5: that for an answer. They went to the Fifth Circuit
34:26
Speaker 5: Court of Appeals and very briefly, you've got and I
34:33
Speaker 5: wrote it in a brief to the Supreme Court for
34:35
Speaker 5: another client, which was I'm concerned that this judge is
34:39
Speaker 5: using something as low salient as into methican suppositories. You
34:45
Speaker 5: are not going to hear Shannon Bream on Fox News
34:49
Speaker 5: Sunday or Norah O'Donnell talk about an into methician repository case.
34:54
Speaker 4: Although that would be fun if they did, Yes.
34:56
Speaker 5: It would be fun, but I don't think they can
34:58
Speaker 5: even they can't make it entertaining right. And so what
35:04
Speaker 5: the Texas Court wants to do and this is speculation,
35:08
Speaker 5: but I believe it's true Texas. And what's interesting is
35:13
Speaker 5: Texas doesn't have this problem Texas isn't one of these
35:16
Speaker 5: six states.
35:18
Speaker 6: But this is a Texas judge. Judge Hoe.
35:20
Speaker 5: Judge Hoe is a big deal in the Court of Appeals.
35:25
Speaker 5: It is speculated that if President Trump gets another nominee
35:28
Speaker 5: to the Supreme Court, Judge Hoe might be that guy.
35:31
Speaker 5: And so he carries a lot of weight, and he's
35:33
Speaker 5: a good jurist.
35:34
Speaker 6: I admire him. He's a good guy, but.
35:37
Speaker 5: I worry he's got his eyes focused on a different prize,
35:40
Speaker 5: which is bigger states rights issues that are more critical
35:46
Speaker 5: than into methicisin suppositories. Particularly in Texas, you have the
35:50
Speaker 5: Texas Rangers in particular, working with Governor Abbott on trying
35:54
Speaker 5: to enforce immigration laws. Traditionally, that has been a role
35:58
Speaker 5: that the courts have said belong exclusively to the federal
36:00
Speaker 5: police Department, namely Ice and Border Security. And we know
36:04
Speaker 5: this because Arizona tried that during the Obama administration, we
36:08
Speaker 5: would have our law enforcement officers arrest people simply for
36:12
Speaker 5: the crime of entering the country illegally. The Obama administration
36:17
Speaker 5: suit Arizona and the court said, now, that's not for
36:19
Speaker 5: local police to determine, that's federal police, and so you
36:23
Speaker 5: can't do that you can't send your regular agents there.
36:27
Speaker 4: Well, and you got and so you got Texas with
36:30
Speaker 4: an eye toward this border immigration enforcement sort of thing.
36:35
Speaker 4: You've also got. I mean, it is not if a
36:38
Speaker 4: prestone potentially at play in this as well, and so
36:45
Speaker 4: a lawsuit about a suppository suddenly has the potential to
36:49
Speaker 4: become a three ring circus.
36:51
Speaker 5: It does, and that's something I tried to get the
36:53
Speaker 5: Supreme Court alerted to in Wells wants to appeal this
36:58
Speaker 5: Fifth Circuit Court of decision because it's got broad implications
37:02
Speaker 5: on our entire profession. If the Fifth Circuit has said
37:06
Speaker 5: there's a chink in the armor related to the supremacy
37:11
Speaker 5: of the Food, Drug and Cosmetic Act, that's a problem
37:13
Speaker 5: because now you can have states do what they want.
37:15
Speaker 5: And so whether it's something unrelated to pharmacy, like immigration
37:21
Speaker 5: or gun ownership rights, or directly related to pharmacy, which
37:26
Speaker 5: is MiFi pristone already forty six, and whether or not
37:31
Speaker 5: a state can regulate that separately from the FDA, those
37:36
Speaker 5: are big deals and we're already seeing that. Regardless of
37:41
Speaker 5: your position pro life, pro choice, MiFi pristone or not,
37:47
Speaker 5: in my opinion, it's important that the fifty States, the
37:50
Speaker 5: District of Columbia, and the territories all act the same
37:53
Speaker 5: as it relates to our drug supply, and you.
37:55
Speaker 4: Would think in this particular case, FDA is going to
37:58
Speaker 4: want the same thing. FDA is not going to want
38:01
Speaker 4: preemption shot down. So it'll be interesting to watch what
38:04
Speaker 4: they do there. We're about to have to wrap up
38:06
Speaker 4: bring this back. Let's let's go back to Florida. How
38:09
Speaker 4: does ZILA play in Florida again? I see that.
38:14
Speaker 5: My concern is the law has changed since the lower
38:17
Speaker 5: court's reviewed these cases in Florida and threw them out.
38:21
Speaker 5: Now there's a Fifth Circuit decision that is newer, and
38:27
Speaker 5: I believe that's one of the reasons why NOVA wants
38:30
Speaker 5: to take another run at this. Now, what's nice about
38:33
Speaker 5: the Fifth Circuit is it's not in Florida. Florida is
38:38
Speaker 5: the Eleventh Circuit. And even though the Fifth Circuit has
38:42
Speaker 5: a new precedent out there, it's only persuasive in the
38:45
Speaker 5: other districts. It's not binding. And so while Wells fights
38:52
Speaker 5: at the Supreme Court level to remove this precedent, and
38:55
Speaker 5: I hope they win, it's only persuasive in the eleven Circuit,
38:59
Speaker 5: the Eleventh Circuit, and the Ninth Circuit, which is the
39:02
Speaker 5: other side of the country I just talked about, have
39:05
Speaker 5: strong precedent that say no, no, no. The Food, Drug
39:08
Speaker 5: and Cosmetic Act clearly has supreme authority over any state
39:13
Speaker 5: that contradicts it.
39:14
Speaker 6: And I even think if you admit.
39:17
Speaker 5: This this Fifth Circuit Appeal Judge Hoe said, as long
39:22
Speaker 5: as the state's law mirrors the federal law, it's enforceable. Well,
39:27
Speaker 5: I don't necessarily disagree with that, except you've just told
39:30
Speaker 5: me it doesn't mirror federal law.
39:32
Speaker 6: It's different.
39:33
Speaker 5: So where does your mirror analogy come from? And so
39:37
Speaker 5: I think there's a flaw in that argument, And it's
39:42
Speaker 5: going to be what it relates to Florida is there's
39:44
Speaker 5: a new piece of case law that Novo can bring
39:47
Speaker 5: to the table that they didn't have a chance to
39:49
Speaker 5: in the lower court.
39:51
Speaker 4: Well, it's going to be it's going to be interesting
39:53
Speaker 4: to watch that one. Well to watch Asilah and whether Wells,
39:59
Speaker 4: whether Supreme Court or Greece to take the Wells Zyla case,
40:03
Speaker 4: and then what the implications might be for Florida and
40:06
Speaker 4: for other states. We are out of time. We did
40:09
Speaker 4: not get to talk about some of the shenanigans the
40:12
Speaker 4: drug makers have been pulling with state boards of pharmacy,
40:16
Speaker 4: letters to state boards of pharmacy that miss state law
40:18
Speaker 4: and policy. They've been meddling a bit in state attempts
40:22
Speaker 4: to regulate five O three be sourcing to five O
40:24
Speaker 4: three a's, and I think most disturbing to a lot
40:27
Speaker 4: of APC members is the filing of nuisance complaints against
40:32
Speaker 4: particular pharmacies. And we sort of feel like the nuisance
40:35
Speaker 4: complaints that the drug makers, not the pharmacy, is going
40:39
Speaker 4: to be found innocent of those, but they have to
40:41
Speaker 4: law your up to defend themselves against these claims. So
40:44
Speaker 4: maybe we'll have you back sometime to talk about those.
40:48
Speaker 4: And there's plenty more to talk about as well. Thanks
40:51
Speaker 4: Mark for being with us, and thanks for your perspective.
40:54
Speaker 4: We appreciate all you do for the pharmacy compounding industry.
40:58
Speaker 6: I appreciate that. Happy to be back anytime.
41:01
Speaker 4: Andrew back to you.
41:02
Speaker 2: Thank you, Scott, Thank you Mark. We know you're a
41:04
Speaker 2: busy guy. We really appreciate your time. Before we play
41:08
Speaker 2: the end music here, something I want to point out.
41:11
Speaker 2: If you are a compounding pharmacist, or you prescribe compounded medication,
41:15
Speaker 2: APC is almost certainly helping you and helping your patients.
41:19
Speaker 2: I'm not going to go through everything we do, but
41:21
Speaker 2: i will say that APC is the biggest and in
41:25
Speaker 2: a good way, the loudest trade association for the compounding profession.
41:29
Speaker 2: So if you're not a member of APC, you really
41:31
Speaker 2: ought to be. We're working for you. We'd love to
41:34
Speaker 2: have you on board. Just head over to a four
41:37
Speaker 2: pc dot org check us out. All right, now we
41:41
Speaker 2: can play that end music.
41:43
Speaker 3: Thanks for listening.