Latest / Pharmacy Podcast Network / Peddling a Fantasy: How Drugmakers are Misleading State Lawmakers| Essential: Pharmacy Compounding Podcast APC

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Peddling a Fantasy: How Drugmakers are Misleading State Lawmakers| 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.
• 0:25
  Speaker 2: Welcome back to Essential, the pharmacy compounding podcast with the
• 0:30
  Speaker 2: latest news and analysis from you know who, the Alliance
• 0:34
  Speaker 2: for Pharmacy Compounding, the voice for compounding pharmacy. I'm your host,
• 0:39
  Speaker 2: Andrew Canter, and today we've got something a little different.
• 0:42
  Speaker 2: There are two big stories in the world of pharmacy
• 0:45
  Speaker 2: compounding going on right now, and they're both important enough.
• 0:48
  Speaker 3: That we want to do kind of a double deep dive.
• 0:55
  Speaker 2: The first is a broad effort on the part of
• 0:59
  Speaker 2: a couple of big drug makers to get laws passed
• 1:02
  Speaker 2: that make compounding a lot more difficult, and it is
• 1:05
  Speaker 2: a broad effort. We'll get to that in a sec
• 1:08
  Speaker 2: The other is a public statement by the FDA on
• 1:10
  Speaker 2: February sixth that the agency is looking at restricting semiglutide
• 1:16
  Speaker 2: and to zeppetide as active pharmaceutical ingredients. The statement was
• 1:21
  Speaker 2: kind of cryptic. It wasn't like the agency was announcing
• 1:24
  Speaker 2: a new policy or anything. It was just kind of
• 1:27
  Speaker 2: thinking out loud, so everyone's guessing what might happen next.
• 1:31
  Speaker 2: But before we get to that. Let's go back to
• 1:34
  Speaker 2: talking about what's going on in the States. When I
• 1:40
  Speaker 2: said farmer companies were making a broad effort to restrict
• 1:43
  Speaker 2: the compounding, I mean they've literally authored legislation to do that,
• 1:47
  Speaker 2: to limit compounding, and they've managed to get it introduced
• 1:51
  Speaker 2: in about ten states. To talk about all this and
• 1:54
  Speaker 2: what it means, my guest is APC's CEO, Scott Bruner,
• 1:58
  Speaker 2: who is obviously the chin deep in all these issues.
• 2:02
  Speaker 2: Welcome Scott.
• 2:04
  Speaker 4: It's actually deeper than that, Andrew, I'm pretty sure, so
• 2:06
  Speaker 4: my ten's not that tall, but thanks.
• 2:08
  Speaker 5: I'm glad to be here.
• 2:09
  Speaker 2: So rather than go through every state, since all these
• 2:13
  Speaker 2: bills are pretty similar, let's talk in the general terms.
• 2:17
  Speaker 2: What is the gist of these bills that the pharma
• 2:21
  Speaker 2: companies are introducing and why are the companies pushing for them.
• 2:26
  Speaker 4: Well, it's a coordinated effort across the country. Eli Lilly
• 2:30
  Speaker 4: and Novo Nordesk are pitching legislators on a neat, scary story.
• 2:36
  Speaker 4: They're saying that licensed compounding pharmacies are some sort of
• 2:41
  Speaker 4: shadow supply chain, that compounded golp ones are inherently suspect,
• 2:47
  Speaker 4: and that these sweeping new state level restrictions framed as
• 2:53
  Speaker 4: patient safety or anti counterfeiting measures are the only possible
• 2:58
  Speaker 4: responsible response. And yet that story is a fantasy, and
• 3:04
  Speaker 4: unfortunately in the nine or ten states, too many lawmakers
• 3:08
  Speaker 4: are acting on them without checking the facts. We know
• 3:14
  Speaker 4: that drug makers since last summer. End of last summer,
• 3:19
  Speaker 4: drug makers had been shopping legislation with legislators in various states.
• 3:26
  Speaker 4: We had received copies of drafts, and then shortly after
• 3:29
  Speaker 4: the first of the year its legislative session season across
• 3:34
  Speaker 4: the country and bills began to be introduced.
• 3:38
  Speaker 5: The interesting thing about the legislation is.
• 3:41
  Speaker 4: That they have been pitched to legislators as anti counterfeiting,
• 3:45
  Speaker 4: let's cut out illicit substances coming into the country from offshore.
• 3:50
  Speaker 5: In effect, though the.
• 3:51
  Speaker 4: Bills don't do anything about the black market or the
• 3:55
  Speaker 4: gray market, or counterfeiting or illicit substances. The bills do
• 4:00
  Speaker 4: nothing to make patients safer, and in fact, the bills
• 4:04
  Speaker 4: impose on state licensed compounding pharmacies standards that are very
• 4:10
  Speaker 4: difficult for those pharmacies to meet. They basically impose manufacturer
• 4:16
  Speaker 4: level standards cGMP current and manufacturing practice standards on independent
• 4:23
  Speaker 4: pharmacies that prepare one drug for one patient. The standards,
• 4:28
  Speaker 4: though for cGMP, are for manufacturers of drugs that make
• 4:31
  Speaker 4: millions of doses for millions of patients, and so many
• 4:35
  Speaker 4: of the pharmacies aren't going to be able to adhere
• 4:37
  Speaker 4: to the testing requirements. Those testing requirements, by the way,
• 4:40
  Speaker 4: that have already been done at both the manufacturer and
• 4:42
  Speaker 4: the wholesaler level and documented in a certificate of analysis.
• 4:46
  Speaker 4: And so the result is going to be impede patient
• 4:49
  Speaker 4: access to certain compounded therapies. Some of these bills have
• 4:54
  Speaker 4: been very broad and affect all compounded therapies. Others have
• 4:59
  Speaker 4: been fairly tailored, shall we say, to only restrict GLP
• 5:05
  Speaker 4: one compounding, or the Florida Bill, for instance, would restrict
• 5:09
  Speaker 4: compounding of weight loss drogs, and weight loss is not defined.
• 5:14
  Speaker 4: So that's going to sweep in to those restrictions and
• 5:18
  Speaker 4: requirements well more than just GLP ones.
• 5:21
  Speaker 5: So we have undertaken APC has.
• 5:23
  Speaker 4: Undertaken, with our sister association, the Outsourcing Facilities Association.
• 5:28
  Speaker 5: An effort to push back against this threat.
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  Speaker 4: It's called the Compounding Defense Initiative, and I'll be happy
• 5:34
  Speaker 4: to say more about it.
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  Speaker 2: Okay, let me before we go any further, I just
• 5:38
  Speaker 2: want to rattle off the list of states so that
• 5:41
  Speaker 2: listeners can you know, if they're in one of these states,
• 5:43
  Speaker 2: they'll know it's going to affect them. So far, it's
• 5:47
  Speaker 2: their bills anti compounding bills being introduced in Arizona, Colorado, Florida, Indiana, Mississippi, Virginia,
• 5:54
  Speaker 2: Washington State, Georgia, and possibly Pennsylvania. When I look at
• 5:59
  Speaker 2: this list, I see nothing in common with these states.
• 6:03
  Speaker 2: They're geographically diverse, they're red, they're blue, they're all over
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  Speaker 2: the place. Why have drug makers chosen these states to
• 6:11
  Speaker 2: introduce the bills.
• 6:12
  Speaker 4: It's a great question, and we've been looking for something,
• 6:16
  Speaker 4: some pattern, and there doesn't seem to be one.
• 6:19
  Speaker 5: As you say, I mean, Virginia's.
• 6:21
  Speaker 4: A purple state, Florida is a red state, Mississippi is
• 6:24
  Speaker 4: a red state, Colorado is a blue state. And so
• 6:26
  Speaker 4: we don't think that that flavor of partisanship really has
• 6:30
  Speaker 4: anything to do with it. At the end of the day,
• 6:33
  Speaker 4: I think they have found traction in states where they
• 6:36
  Speaker 4: found a chair or a vice chair of a committee
• 6:40
  Speaker 4: of jurisdiction.
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  Speaker 5: In that particular legislature who is.
• 6:44
  Speaker 4: Willing to introduce the bill for them, and indeed that's
• 6:47
  Speaker 4: their strategy.
• 6:48
  Speaker 5: We are finding that in most.
• 6:49
  Speaker 4: Of these states where it's been introduced the chairman of
• 6:52
  Speaker 4: a committee, in a couple of instances, a vice chairman
• 6:55
  Speaker 4: has introduced the bill, which makes it frankly harder for
• 6:58
  Speaker 4: members of the committee.
• 6:59
  Speaker 5: To push back again if they're opposed.
• 7:01
  Speaker 4: Nobody likes to go up against a chairman, So that
• 7:04
  Speaker 4: seems to be the only the only pattern that we
• 7:07
  Speaker 4: can discern.
• 7:08
  Speaker 2: Okay, now, obviously I mean to be a cynic here.
• 7:13
  Speaker 2: They're the drug companies are doing this to protect their
• 7:15
  Speaker 2: market share.
• 7:16
  Speaker 3: Make their shareholders.
• 7:18
  Speaker 5: Do you think I think a little bit.
• 7:21
  Speaker 3: They're they're trying to make their shareholders happy.
• 7:24
  Speaker 2: And obviously they're not pitching it that way to legislator,
• 7:27
  Speaker 2: as you mentioned that they're saying they are issues with counterfeiting,
• 7:30
  Speaker 2: their issues with gray market drugs.
• 7:34
  Speaker 3: Are those real issues?
• 7:37
  Speaker 2: I mean, it's easy to say they're they're pitching bills
• 7:40
  Speaker 2: to fight something that doesn't exist. But I mean, from
• 7:43
  Speaker 2: what I understand, there is some problem with gray market
• 7:47
  Speaker 2: and counterfeit drugs. But you know how big a problem
• 7:51
  Speaker 2: is it?
• 7:51
  Speaker 3: Really?
• 7:52
  Speaker 4: Well, the counterfeit market and illicit substance is purporting to
• 7:56
  Speaker 4: be GLP ones and a range of other drugs coming
• 7:59
  Speaker 4: into this country is a seriously legitimate problem, and some
• 8:05
  Speaker 4: crackdown on that is absolutely due. We need, we need,
• 8:10
  Speaker 4: we need more enforcement. But that's not what these bills do.
• 8:14
  Speaker 4: And I should assert elicit substances coming into this country
• 8:17
  Speaker 4: are not going to state license compounding pharmacies. I mean
• 8:21
  Speaker 4: a pharmacy that is sourcing API from a non FDA registered, inspected,
• 8:28
  Speaker 4: deemed cGMP compliant manufacturer will not have a pharmacy license
• 8:33
  Speaker 4: for long because state boards of Pharmacy come in with
• 8:37
  Speaker 4: regularity once a year or so and inspect. They're looking
• 8:41
  Speaker 4: at those prescriptions and a pharmacy that's not sourcing appropriately
• 8:45
  Speaker 4: would immediately be written up. They could be fined, they
• 8:47
  Speaker 4: could lose their license. It's a serious infraction. And so
• 8:50
  Speaker 4: as a business strategy that doesn't work for a state
• 8:52
  Speaker 4: licensed pharmacy. These substances coming into the country are going
• 8:55
  Speaker 4: to elicit actors. The National Association of Boards a Pharmacy
• 8:59
  Speaker 4: says that as high as ninety percent of online pharmacies
• 9:04
  Speaker 4: or bogus and it's those entities that are peddling these
• 9:10
  Speaker 4: illicit substances purporting to be something that they may or
• 9:14
  Speaker 4: may not be. And patient too are getting those substances
• 9:18
  Speaker 4: without a prescription, that are getting advice in our a
• 9:21
  Speaker 4: Reddit chat room where somebody tells them they can buy
• 9:24
  Speaker 4: a lack of lized powder and order it from overseas
• 9:27
  Speaker 4: and then hop down to the Walgreens and get some
• 9:30
  Speaker 4: steal water and syringe and inject themselves.
• 9:33
  Speaker 5: Well, I mean, that's a case of meningitis waiting to happen.
• 9:37
  Speaker 2: Are you actually saying, and I want you on the
• 9:39
  Speaker 2: record for this, are you actually saying that if I
• 9:43
  Speaker 2: get medical advice and I buy some random weight loss
• 9:48
  Speaker 2: drug off a link on TikTok, that I'm taking a
• 9:52
  Speaker 2: risk here?
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  Speaker 4: You think, I'm sorry, getting your healthcare advice from TikTok
• 9:57
  Speaker 4: is probably not a good st strategy for survival, shall
• 10:02
  Speaker 4: we say? And so it's seriously I'm being glid, but
• 10:07
  Speaker 4: that is actually happening. I mean, you can go in
• 10:09
  Speaker 4: those chat rooms and get advice for where you can
• 10:11
  Speaker 4: get these substances that don't come from a state licensed pharmacy,
• 10:15
  Speaker 4: that are not from FDA registered manufacturers and wholesalers, And.
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  Speaker 5: So that needs to be addressed. But that's not what
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  Speaker 5: these bills do.
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  Speaker 4: These bills take state licensed pharmacies that operate under the
• 10:29
  Speaker 4: US Food Drum Cosmetic Act and FDA guidance and state
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  Speaker 4: pharmacy law and the standards of the US Pharmacopeia, the
• 10:37
  Speaker 4: Compounding Chapters, which are rigorous standards for preparing one drug
• 10:43
  Speaker 4: for one patient, and imposing on those pharmacies additional standards
• 10:47
  Speaker 4: that they can't meet. And the interesting thing about both
• 10:50
  Speaker 4: the drug maker strategy and I respect state legislators greatly.
• 10:55
  Speaker 4: I think they are serving their constituents, but I find
• 10:59
  Speaker 4: it a bit frustrating that some of them are interested
• 11:02
  Speaker 4: in introducing or voting for these bills and they've not
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  Speaker 4: reached out to the state Board of Pharmacy to ask, hey,
• 11:09
  Speaker 4: you regulators over.
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  Speaker 5: This industry, is this a legitimate problem?
• 11:14
  Speaker 4: Do we really need this overlay of new regulation on
• 11:19
  Speaker 4: state licensed pharmacies? Generally speaking, that has not happened. And
• 11:23
  Speaker 4: so drugmakers are selling to these legislators a problem that
• 11:28
  Speaker 4: doesn't exist with state licensed pharmacies, and yeah, then it's
• 11:32
  Speaker 4: a serious threat.
• 11:33
  Speaker 2: And then they're solving it or purporting to solve it
• 11:36
  Speaker 2: with a sledgehammer.
• 11:39
  Speaker 5: Is this whole strategy is a blunt instrument.
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  Speaker 4: Now, No, Look, I think if you want to have
• 11:47
  Speaker 4: a conversation about opportunism in the GLP one compounding space,
• 11:54
  Speaker 4: that's a conversation we can have and we might find
• 11:57
  Speaker 4: areas of We certainly found areas of disagreement, but we
• 12:00
  Speaker 4: might find.
• 12:01
  Speaker 5: Areas in which we agreed.
• 12:03
  Speaker 4: These bills not a one of them, and they're all
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  Speaker 4: very similar, by the way, there's a Novo version, there's
• 12:08
  Speaker 4: a Lily version.
• 12:09
  Speaker 5: They're very similar. And yet in the nine.
• 12:13
  Speaker 4: States where they've been introduced, not a one of them
• 12:15
  Speaker 4: is exactly the same. But they all are sort of
• 12:22
  Speaker 4: cut from the same cloth, and they don't do anything
• 12:27
  Speaker 4: to even address that problem. And so I think this
• 12:30
  Speaker 4: is a sledgehammer where if anything's needed, it was a scapel.
• 12:35
  Speaker 2: So you mentioned your fighting back through the Compounding Defense
• 12:39
  Speaker 2: Initiative ABC and its partners, and so far, based on
• 12:45
  Speaker 2: my notes, you've won legislative battles already, at least five
• 12:50
  Speaker 2: of them, five different states. You've had the bills. You've
• 12:53
  Speaker 2: been able to get the bills squashed either in committee
• 12:57
  Speaker 2: or subcommittee. But here's a quo, since to speculate, what
• 13:01
  Speaker 2: if one of these bills passed, Pick any of the
• 13:05
  Speaker 2: states that scott one. What would happen for patients? What
• 13:09
  Speaker 2: would happen for pharmacists if the bill passed? As Eli
• 13:14
  Speaker 2: Lilly or Novo Nordisk has written, And as an aside,
• 13:18
  Speaker 2: just the idea that drug companies are writing bills, and
• 13:22
  Speaker 2: as I understand it, they actually are writing these bills
• 13:26
  Speaker 2: and then giving them to state legislators and saying, hey,
• 13:30
  Speaker 2: here's the bill we'd like you to introduce that. I know,
• 13:34
  Speaker 2: it just kind of goes against civics one oh one
• 13:37
  Speaker 2: for me.
• 13:38
  Speaker 4: Well maybe only because you're thinking that way, only because
• 13:40
  Speaker 4: it's corporation.
• 13:41
  Speaker 5: But that happens all the time entities.
• 13:43
  Speaker 4: I mean, we work with Congress and urge members of
• 13:47
  Speaker 4: Congress past legislation that protects patient access to compounded drugs.
• 13:52
  Speaker 4: What's interesting about this strategy by drug makers is that.
• 13:56
  Speaker 5: It is so brazenly protectionist.
• 13:59
  Speaker 4: They are carving out their GLP one drugs and putting
• 14:04
  Speaker 4: extra restrictions on the compounding of the drugs, and so
• 14:08
  Speaker 4: the practical effect, I mean, the drug makers will say
• 14:10
  Speaker 4: all day long, oh, we're not prohibiting compounding of glp ones. Well,
• 14:15
  Speaker 4: in most of these instances, they're putting in place requirements
• 14:21
  Speaker 4: that the pharmacies aren't going to be able to meet.
• 14:24
  Speaker 4: And even those who might be able to meet those
• 14:27
  Speaker 4: additional requirements beyond state license law, beyond beyond USP are
• 14:32
  Speaker 4: going to incur additional cost, which makes the ability of
• 14:35
  Speaker 4: the patient to afford that king have phrase the priceis
• 14:37
  Speaker 4: and so the ability of patient to afford the drug
• 14:41
  Speaker 4: and therefore access the drug is at risk. And some
• 14:44
  Speaker 4: of these patient access will be cut off as a
• 14:47
  Speaker 4: result of these bills. If they were to pass in
• 14:49
  Speaker 4: other states, the access would become much more difficult. And again,
• 14:54
  Speaker 4: I can't say enough how brazen an approach this is.
• 14:58
  Speaker 4: It is try to It's almost like regulatory capture. It's
• 15:02
  Speaker 4: riding into law a protection for your product.
• 15:06
  Speaker 2: So, okay, you've got, as we've said, nine bills introduced.
• 15:11
  Speaker 3: You've won a bunch of them.
• 15:13
  Speaker 2: There are still several that are in various stages of
• 15:17
  Speaker 2: the legislative process. What happens next? Are there more you
• 15:21
  Speaker 2: see being introduced? Have you heard rumors of this? And
• 15:25
  Speaker 2: what is the compounding defense initiative planning next to deal
• 15:30
  Speaker 2: with the issues.
• 15:31
  Speaker 5: Well, it's a great question.
• 15:32
  Speaker 4: So we saw this coming back in the fall, when
• 15:34
  Speaker 4: we began to hear about the drugmaker shopping the bills,
• 15:39
  Speaker 4: we did not know at that point what the scope
• 15:41
  Speaker 4: of the uptake would be. I mean, the fact that
• 15:44
  Speaker 4: we don't have fifty states where these bills are introduced
• 15:47
  Speaker 4: tells me that in many states they couldn't find a
• 15:50
  Speaker 4: drugmaker who was willing to introduce this bad legislation.
• 15:54
  Speaker 3: Whoops, Scott meant to say that they couldn't find lawmakers
• 15:58
  Speaker 3: to introduce these bills, not drug makers.
• 16:01
  Speaker 4: In the nine states where the bills have been introduced,
• 16:03
  Speaker 4: we have been able to either have set aside or
• 16:08
  Speaker 4: to kill the bills. And I mean it's five of them,
• 16:11
  Speaker 4: so you may have to help me, Andrew. Virginia was
• 16:14
  Speaker 4: the first state where the bill was set aside. Two
• 16:17
  Speaker 4: bills in Florida died in committee. Mississippi committee voted to
• 16:24
  Speaker 4: kill the bill Arizona and as of this time we're
• 16:29
  Speaker 4: recording Arizona's the most recent one, and there was a
• 16:32
  Speaker 4: tie vote in the Committee of Jurisdiction, and on a
• 16:35
  Speaker 4: tie vote the bill dies, So that one was a
• 16:37
  Speaker 4: squeaker and worrisome. And then Washington State was just overwhelmingly
• 16:43
  Speaker 4: put down I think that may.
• 16:45
  Speaker 5: Be five states.
• 16:46
  Speaker 4: We still have bills pending in Indiana, Eli Lilly's home state,
• 16:50
  Speaker 4: and the bill in Indiana is right now the bill
• 16:53
  Speaker 4: that has made it the farthest. The Senate basically gutted
• 17:00
  Speaker 4: the original bill and made some changes that would apply.
• 17:06
  Speaker 5: Would put med.
• 17:07
  Speaker 4: Spas and we need to talk about medspots by the way,
• 17:10
  Speaker 4: put medspas within the reach of state boards of pharmacy,
• 17:13
  Speaker 4: and then would incorporate sections five three A and five
• 17:16
  Speaker 4: oh three B of the Food, Drug and Cosmetic Act
• 17:18
  Speaker 4: into Indiana law. It went over to the House, and
• 17:22
  Speaker 4: recently the House has made further significant changes to the bill,
• 17:28
  Speaker 4: most of which this has only just happened in the
• 17:32
  Speaker 4: past twenty four hours. Most of those we think we
• 17:35
  Speaker 4: can live with, we are still reviewing. We do have
• 17:39
  Speaker 4: a bill in Colorado that has not yet had hearing,
• 17:43
  Speaker 4: and we have My concern is that in some of
• 17:48
  Speaker 4: these states we have legislators that are believing the fantasy
• 17:51
  Speaker 4: that the drugmakers have sold them despite not hearing from
• 17:56
  Speaker 4: boards of pharmacy about legitimate concerns.
• 18:00
  Speaker 5: And so you know, I'm a little I'm a little.
• 18:03
  Speaker 4: Concerned about Colorado, and then Georgia is the most recent one,
• 18:07
  Speaker 4: and my suspicion is that we'll be fine in Georgia
• 18:11
  Speaker 4: and the bill will not get out of the house there.
• 18:15
  Speaker 4: We're hearing rumors of the bill to be introduced in Pennsylvania.
• 18:19
  Speaker 4: It may be that by the time this episode airs
• 18:21
  Speaker 4: something will have been introduced there. It's not more states
• 18:25
  Speaker 4: because they couldn't find anybody to introduce it. We have
• 18:28
  Speaker 4: pulled together a coalition the Outsourcing Facilities Association, that's the
• 18:33
  Speaker 4: trade association that represents five O three B outsailities and
• 18:36
  Speaker 4: US and we represent both five oh three A and
• 18:38
  Speaker 4: five oh three B. We are certainly raising money from
• 18:42
  Speaker 4: our members to engage lobbyists in all of these states.
• 18:47
  Speaker 4: We have been very fortunate in several of these states
• 18:51
  Speaker 4: to be able to work collaborate with the state pharmacy associations,
• 18:56
  Speaker 4: and most of these state pharmacy associations have taken a
• 18:59
  Speaker 4: position in opposition to the bill or have been integrally
• 19:03
  Speaker 4: involved in helping improve the legislation. Indiana is a good
• 19:07
  Speaker 4: example of that. Can't say enough good things about the
• 19:09
  Speaker 4: Indiana Pharmacist Association and their work to.
• 19:13
  Speaker 5: Improve the bill.
• 19:14
  Speaker 4: Washington State Pharmacists Association fantastic Arizona, and so we're grateful
• 19:21
  Speaker 4: to sort of have this clunky coalition of folks who
• 19:25
  Speaker 4: are trying to tell legislators the truth about what's going on.
• 19:29
  Speaker 4: I think our track record is pretty good, and I
• 19:32
  Speaker 4: babbled on Your real question was what happens next. We
• 19:36
  Speaker 4: still have some state in which the legislative timeline is
• 19:41
  Speaker 4: such that a bill could be introduced. So there may
• 19:44
  Speaker 4: be a state where we're going to see a bill
• 19:45
  Speaker 4: that we don't yet know about. But for most states,
• 19:49
  Speaker 4: the deadline for introduction of you legislation has passed, and
• 19:53
  Speaker 4: so we begin to look toward next year. We do,
• 19:57
  Speaker 4: by the way, have to be vigilant in watching some
• 20:01
  Speaker 4: of these bills because amendments can be made to other
• 20:05
  Speaker 4: bills that might be judged germane laid in session. And
• 20:09
  Speaker 4: so even though we you know, it looks like we
• 20:12
  Speaker 4: put a bill down in Florida, it may be that
• 20:14
  Speaker 4: somebody could attach the language of the bad legislation to
• 20:19
  Speaker 4: another piece of legislation, and so we're having to keep
• 20:22
  Speaker 4: watching for that as we as we move toward the summer.
• 20:26
  Speaker 4: This is not a one and done. I do not
• 20:28
  Speaker 4: believe drug makers are going to say, oh, well, we
• 20:31
  Speaker 4: tried that in non states, didn't work or it didn't
• 20:34
  Speaker 4: work the way we thought it would. We're we're we're out.
• 20:37
  Speaker 4: They've got infinite resources. They got more money than God,
• 20:39
  Speaker 4: as my grandmother would say. And I believe we will
• 20:43
  Speaker 4: see a return of the strategy next year, and they
• 20:46
  Speaker 4: will have learned from some of the learned some lessons
• 20:50
  Speaker 4: from from from what's occurred this year. I think as
• 20:52
  Speaker 4: an industry, we're going to have to be ready for that,
• 20:54
  Speaker 4: and you will. You will see h a PC preparing
• 20:58
  Speaker 4: for the fight to continue as we as we go forward.
• 21:03
  Speaker 2: Okay, we've been talking about mostly GLP one weight loss
• 21:08
  Speaker 2: diabetes drugs, and that's what most of the legislation seems
• 21:14
  Speaker 2: to be targeting, although in some cases it's a much
• 21:16
  Speaker 2: broader target of compounding in general. But the focus seems
• 21:21
  Speaker 2: to be on GLP one drugs. So I'd like to
• 21:25
  Speaker 2: transition over to the federal level because of that statement
• 21:32
  Speaker 2: that I mentioned earlier from FDA Commissioner McCarry. He's talking
• 21:37
  Speaker 2: in a statement he alluded to limiting or even prohibiting
• 21:42
  Speaker 2: compounding with the active ingredient, the API that's in these
• 21:47
  Speaker 2: GLP one weight loss and diabetes drugs semi glue tide,
• 21:50
  Speaker 2: terzepetite notably right now, and correct me if I'm wrong.
• 21:56
  Speaker 2: As long as a prescriber says that a patient needs
• 21:59
  Speaker 2: a compound version of semiglutide or ze epetide, it's perfectly
• 22:04
  Speaker 2: legal for a compounding pharmacist to use those APIs to
• 22:09
  Speaker 2: make formulations. It's up to the prescriber believes it, then
• 22:14
  Speaker 2: it's legal to do this. So can the FDA just
• 22:18
  Speaker 2: snap its fingers and restrict one or two APIs that
• 22:23
  Speaker 2: are already legal to compound with.
• 22:26
  Speaker 4: Okay, there's a lot wrapped up there, So first of all,
• 22:28
  Speaker 4: I'm going to correct you.
• 22:29
  Speaker 3: Okay.
• 22:30
  Speaker 5: Federal law allows.
• 22:33
  Speaker 4: Prescribing or dispensing of a compounded drug when an FDA
• 22:38
  Speaker 4: approof drug is in shortage. FDA guidance allows compounding pharmacies
• 22:43
  Speaker 4: to make what FDA calls essentially a copy of the
• 22:45
  Speaker 4: FDA approofd drug. That's when the drugs in shortage semi glutide, epetide.
• 22:50
  Speaker 4: FDA has deemed them out of shortage now and so
• 22:54
  Speaker 4: that does not apply. There should be no making of
• 22:57
  Speaker 4: essentially copies of FDA approved G one drugs, right now.
• 23:01
  Speaker 4: On the other hand, the other instance in which compounding
• 23:03
  Speaker 4: is authorized is when a prescriber in her judgment, determines
• 23:09
  Speaker 4: that a specific formulation for an individual patient is needed
• 23:14
  Speaker 4: and there's not an FDA approved drug corollary to that
• 23:17
  Speaker 4: specific formulation. She needs a different dosage form or dosage
• 23:21
  Speaker 4: strength or combination of drugs for that individual patient. And
• 23:26
  Speaker 4: so in that regard, yes, what you said is true.
• 23:32
  Speaker 4: The criteria for substances that can be used in compounding,
• 23:36
  Speaker 4: there's a threefold criteria. One of these three it has
• 23:40
  Speaker 4: to be a component of an FDA approved drug well
• 23:43
  Speaker 4: some of those dieters appetitor components of FDA approved drugs.
• 23:46
  Speaker 4: Or it needs to have a national formulay or USP monograph.
• 23:52
  Speaker 4: Or it needs to be on this curated list that
• 23:54
  Speaker 4: FDA keeps. It has a slightly fancy er title, but
• 23:59
  Speaker 4: it's the five three A bulks list. And so in
• 24:03
  Speaker 4: the environment that they're in right now, prebscriber judges that
• 24:06
  Speaker 4: a custom formulation of some of glue tide or chir
• 24:08
  Speaker 4: zeppetite is appropriate for an individual patient, she can write
• 24:12
  Speaker 4: a prescription for that compounded drug for that patient. Again,
• 24:19
  Speaker 4: compounders can only use active ingredient that comes and this
• 24:23
  Speaker 4: is in the law as well, has to come from
• 24:25
  Speaker 4: FDA registered facility, and generally one would presume that that
• 24:31
  Speaker 4: is FDA inspected and deemed to be cGMP compliant. And indeed,
• 24:35
  Speaker 4: FDA back in the fall created a green list of
• 24:41
  Speaker 4: GLP one manufacturers that it deemed to be cGMP compliant.
• 24:46
  Speaker 4: Some of them had been inspected, they were all FDA registered,
• 24:50
  Speaker 4: but FDA was by putting them on the glreen list
• 24:53
  Speaker 4: deeming them to meet the christ here for compounding. And
• 24:57
  Speaker 4: so as long as the pharmacy is a acquiring the
• 25:01
  Speaker 4: API from one of those, by our reading of.
• 25:04
  Speaker 5: The law, they should be able to do that.
• 25:06
  Speaker 4: And so what was unusual about doctor McCarey's statement was
• 25:10
  Speaker 4: the stridency of it. I think the timing was interesting.
• 25:14
  Speaker 4: It came on the hills of what I would characterize
• 25:17
  Speaker 4: as a provocative move by a telehealth platform, and it
• 25:22
  Speaker 4: makes us wonder exactly what the commissioner has in mind.
• 25:26
  Speaker 4: I don't know that just across the board, FDA has
• 25:31
  Speaker 4: the ability to prohibit the use of an active pharmaceutical
• 25:36
  Speaker 4: ingredient when it is an ingredient that is authorized that
• 25:42
  Speaker 4: meets the criteria in the Food during Cosmetic Act, and
• 25:45
  Speaker 4: FDA has already deemed that it's safe for use in
• 25:49
  Speaker 4: an FDA approved drug. So are they talking about import
• 25:53
  Speaker 4: restrictions on certain manufacturers?
• 25:56
  Speaker 5: Well, that will be interesting.
• 25:58
  Speaker 4: If they've released the green list back in the late
• 26:01
  Speaker 4: summer or fall, and now they're going to put import
• 26:05
  Speaker 4: restrictions on API from some of those manufacturers that they
• 26:12
  Speaker 4: had deemed incompliance back in the fall, that seems to
• 26:16
  Speaker 4: be an odd.
• 26:17
  Speaker 5: Thing to do.
• 26:18
  Speaker 4: Certainly, they could bow to the demands of the drug
• 26:24
  Speaker 4: makers and move to add the GLP one API to
• 26:29
  Speaker 4: the demonstrably Difficult to Compound list. I would argue that
• 26:33
  Speaker 4: the drug makers arguments for doing that are remarkably flimsy,
• 26:38
  Speaker 4: but it doesn't mean FDA could not do it.
• 26:41
  Speaker 5: Even so, adding drugs to the.
• 26:43
  Speaker 4: Demonstrably difficult to compound list a list, by the way,
• 26:46
  Speaker 4: which is not finalized. It technically doesn't exist because the
• 26:50
  Speaker 4: criteria has not been finalized by the agency yet.
• 26:53
  Speaker 5: But let's say they did that.
• 26:54
  Speaker 4: You're going to have to go through a protracted notice
• 26:57
  Speaker 4: and comment rulemaking.
• 26:58
  Speaker 5: Period to do that.
• 27:00
  Speaker 4: So if that's the course they take, I kind of
• 27:03
  Speaker 4: hope they don't.
• 27:04
  Speaker 5: I think the science, as I've said, is flimsy. It's
• 27:06
  Speaker 5: going to take a while to do that.
• 27:08
  Speaker 4: Noticing comment rulemaking is not a quick process, and so
• 27:12
  Speaker 4: all of that is pure speculation. If there are other
• 27:17
  Speaker 4: tools in their books or in their bag of tricks,
• 27:20
  Speaker 4: I guess for restricting GLP one compounding, I'm not quite
• 27:25
  Speaker 4: sure what they are. The other thing that should be noted, though,
• 27:28
  Speaker 4: the Commissioner did say that they intend to restrict compounding
• 27:35
  Speaker 4: with GLP one API. His statements and multiple statements, not
• 27:41
  Speaker 4: just the one that was released on the sixth, but
• 27:44
  Speaker 4: a tweet on the fifth said more about advertising and
• 27:49
  Speaker 4: marketing claims and mass advertising of mass marketing of compounding
• 27:59
  Speaker 4: GLP one drugs. And we we've already got some clues
• 28:03
  Speaker 4: there as to how the agency is handling that they
• 28:05
  Speaker 4: have sent warning letters. In fact, the majority the warning
• 28:08
  Speaker 4: letters have gone to manufacturers of FDA approved drugs for
• 28:12
  Speaker 4: inappropriate claims, but some of those went to telehealth platforms,
• 28:16
  Speaker 4: some of them went to compounding pharmacies. I'll wrap up
• 28:20
  Speaker 4: in a minute, but one little nuance that is interesting
• 28:23
  Speaker 4: to us UH is FDA has sent warning letters UH
• 28:27
  Speaker 4: to compounding pharmacies questioning statements in the Pharmacies marketing of
• 28:36
  Speaker 4: its gl A compound of GLP one drugs stating that
• 28:39
  Speaker 4: the active pharmaceutical ingredient in the drug is the same
• 28:42
  Speaker 4: active ingredients.
• 28:43
  Speaker 5: In the approved drug.
• 28:46
  Speaker 4: Yeah, and and and doctor McCarry seems to be questioning,
• 28:49
  Speaker 4: and the agency and it's in its letters, seemed to
• 28:52
  Speaker 4: be questioning that statement. But I would assert Andrew, that
• 28:55
  Speaker 4: has that has to be a true statement. I mean,
• 28:58
  Speaker 4: if if the API is not a component of the
• 29:01
  Speaker 4: FDA approved drug.
• 29:03
  Speaker 5: You can't be compounding with it in the first place.
• 29:06
  Speaker 4: And so we're trying to figure out what is there
• 29:08
  Speaker 4: something more precise about those claims that FDA is concerned about,
• 29:12
  Speaker 4: because on its face it's a true statement.
• 29:16
  Speaker 2: Yeah, that's something that confused me about that. Part of
• 29:18
  Speaker 2: the statement is that the compounding pharmacists are using the
• 29:25
  Speaker 2: same active ingredients as in the FDA approved drugs. It's semiglutide.
• 29:30
  Speaker 2: It is a molecule that looks like this, It's there's eppetite.
• 29:34
  Speaker 2: It's a molecule that looks like that. It is the
• 29:37
  Speaker 2: same molecule, the same active ingredients. But saying that you
• 29:44
  Speaker 2: can't say that you're using the same active ingredient. I mean,
• 29:49
  Speaker 2: I look at at you know, medication all the time
• 29:51
  Speaker 2: and I'll see it'll say, you know, acetomtafin the same
• 29:55
  Speaker 2: active ingredient as tilanol.
• 29:57
  Speaker 3: But it's it's a generic version. There's no problem there.
• 30:02
  Speaker 4: Well, and it may I mean, I'm speculating, I'm not
• 30:04
  Speaker 4: a lawyer. It may be the use of the trademark term,
• 30:09
  Speaker 4: you know, same active ingredient as in wigov. Maybe that's
• 30:13
  Speaker 4: the concern that it's so specific to the commercial name
• 30:18
  Speaker 4: of the drug. I don't know, but we're we're waiting
• 30:20
  Speaker 4: for the other shoe to drop right, waiting to see
• 30:22
  Speaker 4: what the agency will actually do.
• 30:25
  Speaker 5: Uh in in this regard.
• 30:28
  Speaker 2: So let's let's let's go take a step back and
• 30:31
  Speaker 2: look at the bigger picture. With those statements, why would
• 30:36
  Speaker 2: FDA Commissioner McCurry say stuff like this, Why, I mean,
• 30:42
  Speaker 2: wouldn't the FDA want patients to get the drugs in
• 30:46
  Speaker 2: the formulations that their prescribers say is appropriate. Wouldn't the
• 30:50
  Speaker 2: FDA want patient to get the right drugs whether it
• 30:55
  Speaker 2: comes from it comes with an Eli Lilly brand on it,
• 31:00
  Speaker 2: or it comes from a state licensed compounding pharmacy.
• 31:03
  Speaker 3: Why is the FDA doing this? We're threatening to do this?
• 31:07
  Speaker 4: Yeah, pure speculation, But again some of it came had
• 31:12
  Speaker 4: to do with timing. On February fifth, you had a
• 31:15
  Speaker 4: telehealth platform make a remarkably provocative marketing move, and I
• 31:22
  Speaker 4: would view doctor McCarey's response as a direct response to that.
• 31:30
  Speaker 4: I would suspect that FDA heard immediately from the drug makers. Uh,
• 31:34
  Speaker 4: and we're feeling pressure to to respond to this move
• 31:40
  Speaker 4: by the telehealth platform.
• 31:41
  Speaker 5: And this is.
• 31:43
  Speaker 4: This is how it this is how it came out.
• 31:46
  Speaker 4: I don't know beyond that, but but it has to
• 31:52
  Speaker 4: be tied in one way or the other to the
• 31:55
  Speaker 4: action by the telehealth platform. I just don't see, you
• 31:57
  Speaker 4: know the reason the agency would sort of are pitraily
• 32:00
  Speaker 4: make that sort of announcement.
• 32:04
  Speaker 2: All right, So a lot of big and related issues
• 32:08
  Speaker 2: going on here at the state level with bills that
• 32:12
  Speaker 2: would restrict compounding, specifically in some cases of GLP one drugs.
• 32:17
  Speaker 2: You've got the federal level with insinuations threats, however you
• 32:24
  Speaker 2: want to describe it, against compounding pharmacies for their marketing
• 32:29
  Speaker 2: and for dispensing legally at this point, legally dispensing these drugs.
• 32:36
  Speaker 2: First of all, thank you for taking the time. As
• 32:39
  Speaker 2: I said before, you are you're up to your chin
• 32:41
  Speaker 2: at least in dealing with this. So for the listeners,
• 32:47
  Speaker 2: where can people get more information the state level issues,
• 32:50
  Speaker 2: the FDA issues? Is there an easy place for them
• 32:53
  Speaker 2: to get the updates on what's happening.
• 32:55
  Speaker 4: Yeah, Well, the best thing you can do is join APC.
• 32:58
  Speaker 4: We would love to have more in our community of
• 33:02
  Speaker 4: compounding pharmacies and compunding stakeholders on the multi state legislative threat,
• 33:11
  Speaker 4: Compounding dot Com is your best resource. We have set
• 33:14
  Speaker 4: up individual pages for the landing pages. I guess for
• 33:17
  Speaker 4: the states where this legislation has been introduced, you should
• 33:21
  Speaker 4: be able to find a copy of the bill our
• 33:23
  Speaker 4: analysis of the bill. In some of these states, we've
• 33:26
  Speaker 4: issued calls to action for residents of the state prescribers
• 33:31
  Speaker 4: in the state to reach out to members of their legislatures.
• 33:35
  Speaker 4: So there's a lot there at compounding dot com in
• 33:38
  Speaker 4: terms of FDA statement. I mean again, if you're if
• 33:41
  Speaker 4: you're a member of a PC, you get our weekly
• 33:43
  Speaker 4: newsletter where we're speaking and addressing and this issue and
• 33:48
  Speaker 4: sharing what we know weekly. In that venue, you can
• 33:51
  Speaker 4: also follow us on LinkedIn, Facebook and Instagram and.
• 33:57
  Speaker 5: We should be able to keep you in the note
• 34:00
  Speaker 5: there as well.
• 34:02
  Speaker 2: All right, thank you. That was again Scott Brunner. He
• 34:05
  Speaker 2: is the CEO of the Alliance for Pharmacy Compounding And
• 34:09
  Speaker 2: before we play the outro music, if you are a
• 34:12
  Speaker 2: compounding pharmacist or a technician, or if you prescribe compounding meds.
• 34:16
  Speaker 2: As Scott pointed out, APC is there for you. It's
• 34:20
  Speaker 2: helping you, it's helping your patients. So not to go
• 34:23
  Speaker 2: through everything APC does, but certainly in terms of keeping
• 34:26
  Speaker 2: up with the latest regulations and the threats to compounding,
• 34:32
  Speaker 2: ABC is the biggest, the loudest trade organization, trade association
• 34:37
  Speaker 2: for compounding. So if you're not a member, you should
• 34:40
  Speaker 2: consider becoming one. APC is working for you. You can find
• 34:43
  Speaker 2: out more at a four PC dot org.
• 34:47
  Speaker 3: That's a the number four PC dot org.
• 34:50
  Speaker 2: And as Scott mentioned on compounding dot com and now
• 34:55
  Speaker 2: we can play that outro music.
• 34:57
  Speaker 3: Thanks everybody for listening.