Latest / Pharmacy Podcast Network / The DTE Mess, Pharmacy Board Shenanigans, and GLP-1 Confusion | Essential: Pharmacy Compounding Podcast APC

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The DTE Mess, Pharmacy Board Shenanigans, and GLP-1 Confusion | 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.
• 0:10
  Speaker 2: Welcome to the Pharmacy Podcast Network.
• 0:25
  Speaker 3: Welcome to Essential, the Pharmacy Compounding podcast with the latest
• 0:29
  Speaker 3: news and analysis from who Better the Alliance for Pharmacy Compounding,
• 0:34
  Speaker 3: the voice for compounding pharmacy.
• 0:36
  Speaker 2: I'm Andrew Canter, and today we've got questions.
• 0:39
  Speaker 3: About GLP one compounding, a problematic word in California, some
• 0:44
  Speaker 3: FDA shenanigans and more. Then we'll dive into one of
• 0:48
  Speaker 3: the biggest issues facing the industry, FDA's out of left
• 0:52
  Speaker 3: field ban on natural thyroid products.
• 0:55
  Speaker 2: But more on that in a little bit. Let's do
• 0:58
  Speaker 2: this thing.
• 1:07
  Speaker 3: We're going to be talking a bunch about GLP one compounding,
• 1:10
  Speaker 3: but there's something I want to mention first because it's important.
• 1:14
  Speaker 3: APC's been hearing this question a lot in the past
• 1:16
  Speaker 3: couple of weeks. Can a five oh three B outsourcing
• 1:20
  Speaker 3: facility prepare compound to drugs using GLP one? APIs now
• 1:25
  Speaker 3: that the shortage is over, The short answer is, let's
• 1:29
  Speaker 3: put it this way. We don't know of any legal
• 1:32
  Speaker 3: way the current situation will allow it unless we're talking
• 1:35
  Speaker 3: about lyric glue tide, which is in shortage, but with
• 1:39
  Speaker 3: semiglutide urzepetide, we don't see any legal way that five
• 1:44
  Speaker 3: oh three B out forced outsourcing facilities can prepare them.
• 1:48
  Speaker 3: But and this is important, we are not lawyers. So
• 1:52
  Speaker 3: if you're at a five o three a pharmacy and
• 1:54
  Speaker 3: someone at a five oh three B says they can
• 1:57
  Speaker 3: supply you with semiglutide or urspite drugs that they prepare,
• 2:02
  Speaker 3: even if your patient has a.
• 2:03
  Speaker 2: Prescription, you should probably talk to a lawyer first.
• 2:09
  Speaker 3: California, your Board of Pharmacy may mean well, but it
• 2:14
  Speaker 3: just has to make things complicated, doesn't it complicated and unclear?
• 2:18
  Speaker 3: It always has to leave pharmacies guessing about what compliance
• 2:22
  Speaker 3: looks like.
• 2:23
  Speaker 2: Here's the latest.
• 2:24
  Speaker 3: California just updated its compounding regulations, and there's one section
• 2:29
  Speaker 3: that kind of mirrors what's in the Federal Food, Drug
• 2:32
  Speaker 3: and Cosmetics Act, and it's all about the term essentially
• 2:35
  Speaker 3: a copy, which is obviously critical to compounding. The federal
• 2:39
  Speaker 3: law says that a drug that is essentially a copy
• 2:44
  Speaker 3: is one that quote produces for that patient a significant
• 2:48
  Speaker 3: difference unquote from the commercial drug. California's new reg uses
• 2:54
  Speaker 3: the phrase quote clinically significant difference unquote, and the Farms
• 3:00
  Speaker 3: has to verify and document that difference. So you've got
• 3:03
  Speaker 3: significant difference in the federal law, clinically significant difference in
• 3:08
  Speaker 3: California's new wrig Does adding the word clinically change things?
• 3:12
  Speaker 3: Maybe it might mean nothing, or it might mean that
• 3:16
  Speaker 3: the California board can jump in overrule the prescriber or the.
• 3:20
  Speaker 2: Patient and the pharmacist. We really don't know.
• 3:23
  Speaker 3: Obviously, we'll be keeping an eye on it, and of
• 3:25
  Speaker 3: course we will let APC members know if California starts
• 3:29
  Speaker 3: doing anything weird with that one word change.
• 3:33
  Speaker 2: And apparently breaking news.
• 3:35
  Speaker 3: There is no FDA ban on GLP one compounding.
• 3:40
  Speaker 2: There isn't and it shouldn't be news. Why is it?
• 3:44
  Speaker 3: Because there are a couple of drug makers out there,
• 3:46
  Speaker 3: and our lawyers don't want us mentioning names along with
• 3:49
  Speaker 3: we'll call them sock puppet groups that they fund that
• 3:53
  Speaker 3: are telling people it's illegal. They're telling patients, they're telling
• 3:56
  Speaker 3: the media, they're telling regulators, they're even telling members of Congress.
• 4:00
  Speaker 3: And you know, it's hard for all those people to
• 4:03
  Speaker 3: believe that a big company, a multinational company, would just
• 4:06
  Speaker 3: outright lie. So when they got a letter or saw
• 4:09
  Speaker 3: a press release, they believed it, and then some of
• 4:12
  Speaker 3: them told their members but it wasn't true.
• 4:16
  Speaker 2: Yeah.
• 4:16
  Speaker 3: Yeah, the GLP one shortage is over, except for lyric gluetide.
• 4:20
  Speaker 2: That's another issue.
• 4:21
  Speaker 3: GLP one shortage is over, and compounders can't just dispense
• 4:25
  Speaker 3: copies of semiglutide or to zepetide anymore, same as any
• 4:29
  Speaker 3: other FDA approved drug that's not in shortage. But just
• 4:33
  Speaker 3: like any other drug, when a patient has a prescription
• 4:36
  Speaker 3: for a legit custom formulation of a GLP one you know,
• 4:41
  Speaker 3: dosage form or a strength or some combo that's not
• 4:44
  Speaker 3: commercially available, then yes, it can legally be compounded. That
• 4:49
  Speaker 3: is literally what the Food, Drug and Cosmetic Act says.
• 4:52
  Speaker 3: It is the prescriber's call. The point is there are
• 4:56
  Speaker 3: some very clear and honestly pretty common scenarios where it's
• 5:00
  Speaker 3: perfectly legal to dispense compounded semiglutide enter zeppetite.
• 5:05
  Speaker 2: So that puts APC in.
• 5:07
  Speaker 3: A strange position of having to tell other professional medical
• 5:10
  Speaker 3: organizations that they're giving their members incorrect information. Now, it's
• 5:15
  Speaker 3: bad enough when a reporter believes the nonsense they're being
• 5:18
  Speaker 3: told by these unnamed pharmaceutical companies. It's worse when legislators
• 5:24
  Speaker 3: and regulators also believe it.
• 5:26
  Speaker 2: If you're an APC.
• 5:27
  Speaker 3: Member, by the way, you understand why we're always asking
• 5:30
  Speaker 3: you to invest in our programs like COMPAC and our
• 5:33
  Speaker 3: Legal Action Fund.
• 5:34
  Speaker 2: And if you're not a member of this is a
• 5:35
  Speaker 2: shameless plug.
• 5:36
  Speaker 3: You ought to become one. A four PC dot org.
• 5:41
  Speaker 3: Here's something we just did. We rented a room on
• 5:43
  Speaker 3: Capitol Hill and we gave a briefing to about twenty
• 5:46
  Speaker 3: five staffers of US senators and representatives. We gave them
• 5:49
  Speaker 3: a primer on compounding. We explained when it's allowed, why
• 5:52
  Speaker 3: it's done. We even brought in a real life compounding
• 5:56
  Speaker 3: pharmacist to talk about what it's like on the front lines,
• 5:58
  Speaker 3: you know, give them a real perspective. It was a
• 6:01
  Speaker 3: ton of work, and it is incredibly frustrating because the
• 6:05
  Speaker 3: only reason we have to do it is because these
• 6:07
  Speaker 3: people are being deliberately misled. But here we are, and
• 6:11
  Speaker 3: we're going to keep teaching and correcting and pushing back.
• 6:16
  Speaker 3: Oh something we absolutely love when a compounding pharmacist invites
• 6:20
  Speaker 3: a congress person or a senator for a pharmacy tour.
• 6:23
  Speaker 2: That is a huge deal. That kind of one on
• 6:26
  Speaker 2: one or one on staff meeting. I mean, that's gold.
• 6:30
  Speaker 3: You cannot beat that kind of educational opportunity. In the
• 6:34
  Speaker 3: last few weeks, we know of at least three compounding
• 6:37
  Speaker 3: pharmacies that have had their local representatives come for a visit,
• 6:41
  Speaker 3: take a tour see the labs. There was a Pencoal
• 6:44
  Speaker 3: Pharmacy in Denver, Acasia Apothecary, a Casa Apothecary in Tucsoon,
• 6:51
  Speaker 3: and Wells Pharmacy in Okaala, Florida. These congress people they
• 6:55
  Speaker 3: walked out knowing a lot more than when they walked in,
• 6:58
  Speaker 3: and that kind of relationship could pay off big time
• 7:01
  Speaker 3: if you.
• 7:01
  Speaker 2: Take a look at our show notes.
• 7:03
  Speaker 3: By the way, there is a link to APC's guide
• 7:05
  Speaker 3: to hosting a legislator. We've got you covered, so all
• 7:10
  Speaker 3: this outreach it works. We've pushed the FDA so often
• 7:14
  Speaker 3: about addressing the confusion around GLP one compounding that you
• 7:18
  Speaker 3: got it. The agency actually sent out a communication a
• 7:21
  Speaker 3: few weeks ago specifically about the subject, and wouldn't you
• 7:24
  Speaker 3: know it, they got it right. They made it clear
• 7:27
  Speaker 3: that GLP one compounding was legal in the usual circumstances,
• 7:31
  Speaker 3: and that compounded drugs may have a higher risk profile,
• 7:34
  Speaker 3: but they're not inherently unsafe. There's a difference between legit
• 7:38
  Speaker 3: compounding those little pop up wellness center sites. You know it,
• 7:42
  Speaker 3: we know it, and now the FDA says they know
• 7:45
  Speaker 3: it too.
• 7:47
  Speaker 2: And then there's the media.
• 7:48
  Speaker 3: We'll be honest when it comes to writing about compounding.
• 7:51
  Speaker 3: They don't always.
• 7:52
  Speaker 2: Get it right.
• 7:53
  Speaker 3: Every time a reporter calls a compounded drug a knockoff
• 7:56
  Speaker 3: where convinced a kitten loses a whisker. The problem is
• 8:00
  Speaker 3: these companies, and you know who they are, they're feeding
• 8:02
  Speaker 3: reporters misinformation in writing in press releases. By the way,
• 8:06
  Speaker 3: we used to call it lies, but these days were
• 8:09
  Speaker 3: more polite. It's misinformation, and of course compounding is complicated,
• 8:13
  Speaker 3: so we try not to get too frustrated, at least
• 8:16
  Speaker 3: not with the reporters. The good thing is, bit by bit,
• 8:19
  Speaker 3: the mainstream media is starting to get the story right.
• 8:21
  Speaker 3: And yes we will brag a little. We've spent a
• 8:24
  Speaker 3: lot of time writing to reporters, writing to editors and
• 8:27
  Speaker 3: telling them what you wrote. It's not exactly what you'd
• 8:31
  Speaker 3: call correct, and they're getting the message and you can
• 8:34
  Speaker 3: always help. You know, if you read an article or
• 8:36
  Speaker 3: you see a news story that just gets it wrong,
• 8:38
  Speaker 3: it's absolutely worth it to reach out to the reporter
• 8:41
  Speaker 3: or to the editor. Let them know, be polite, be friendly,
• 8:45
  Speaker 3: give them the facts. We actually have a section on
• 8:48
  Speaker 3: our website called APC in the News where we link
• 8:51
  Speaker 3: to the stories we've been quoted in, and every one
• 8:54
  Speaker 3: of those could be a reporter who just got a
• 8:56
  Speaker 3: whole new perspective on pharmacy compounding. It is a slow process,
• 9:00
  Speaker 3: but it is working. If only we could stop them
• 9:03
  Speaker 3: from calling compounded drugs knockoffs and copycats, that is a
• 9:07
  Speaker 3: miracle we are still working on. All right, we are
• 9:12
  Speaker 3: going to switch gears now and get to the main
• 9:14
  Speaker 3: topic of today's episode. On August sixth, the FDA did
• 9:18
  Speaker 3: a weird thing. It declared that desiccated thyroid extract DTE
• 9:23
  Speaker 3: was now classified as a biologic and patients had one
• 9:26
  Speaker 3: year to transition to something else. And that's not just
• 9:29
  Speaker 3: drugs with compounded DTE. It's commercial drugs that use DT too,
• 9:35
  Speaker 3: And this is a problem on a lot of levels.
• 9:37
  Speaker 2: The reality is the.
• 9:39
  Speaker 3: FDA has no business just declaring DT a biologic and
• 9:42
  Speaker 3: making it off limits. Well, that's why we've got a
• 9:45
  Speaker 3: couple of folks here who are going to talk about
• 9:47
  Speaker 3: why the ban is just so wrong.
• 9:51
  Speaker 4: DTE or desicated thyroid extract, also known as animal thyroid products,
• 9:56
  Speaker 4: have been around since the late eighteen hundreds, before the
• 10:00
  Speaker 4: formation of the Food and Drug Administration, and have been
• 10:05
  Speaker 4: used by patients to treat hypothyroidism, which is a disease
• 10:09
  Speaker 4: where the body doesn't produce enough thyroid hormone.
• 10:11
  Speaker 1: Since eighteen ninety.
• 10:15
  Speaker 4: So to have these drugs be changed in their classification
• 10:20
  Speaker 4: where they're going to be less available for patients could
• 10:23
  Speaker 4: be hugely problematic.
• 10:25
  Speaker 2: That's to Neil Davis. She is APC's Chief Advocacy Officer.
• 10:31
  Speaker 1: Thanks Andrew. I'm a pharmacist to by trade.
• 10:33
  Speaker 4: Before I came on at APC, I treated patients at
• 10:36
  Speaker 4: a pharmacy for sixteen years and I have a lot
• 10:39
  Speaker 4: of experience dispensing and compounding with these animal thyroid products.
• 10:43
  Speaker 5: I think it's worth pointing out as well that the
• 10:47
  Speaker 5: DT or the ADT, or whichever these abbreviations are getting
• 10:50
  Speaker 5: used depending on the FDA letter that we've seen. Most
• 10:53
  Speaker 5: compounders are probably familiar with this as thyroid USP.
• 10:58
  Speaker 3: That's Matt and Martin as a pharmacist, an APC board
• 11:02
  Speaker 3: member and VP of Clinical Services at PCCA.
• 11:06
  Speaker 1: That's right, Matt.
• 11:07
  Speaker 4: Thyroid USP is made from the dried, ground up thyroid
• 11:12
  Speaker 4: glands of either pigs or cows. In the United States
• 11:15
  Speaker 4: these days, it's primarily a pig or poor sine thyroid
• 11:19
  Speaker 4: hormone that's desiccated or dried in ground up that's being
• 11:24
  Speaker 4: formulated into either compounded capsules or into pressed tablets made
• 11:29
  Speaker 4: by drug manufacturers in certain doses that are standardized for patients.
• 11:35
  Speaker 5: So this was interesting to see FDA take this approach
• 11:38
  Speaker 5: in August, but this isn't the first time that this
• 11:41
  Speaker 5: topic has come up.
• 11:43
  Speaker 6: A few years ago, FDA sent a letter.
• 11:46
  Speaker 5: To NABP, the National Associations of Boards of Pharmacy, with.
• 11:52
  Speaker 6: The same idea that DTS.
• 11:55
  Speaker 5: That was referred to at the time was going to
• 11:58
  Speaker 5: be a biologic and so this is not a typical
• 12:02
  Speaker 5: course of action that I would expect, And there was
• 12:05
  Speaker 5: a lot of feedback, a lot of concern, a lot
• 12:08
  Speaker 5: of uproar about what would happen to the compounding of
• 12:12
  Speaker 5: DTE of thyroid USP at that time, and ultimately UH
• 12:17
  Speaker 5: FDA sent a letter from gailbor Mel, who's the director
• 12:22
  Speaker 5: of the Office of Compounding Quality and Compliance at that time, saying, hey, yeah,
• 12:27
  Speaker 5: we sent this letter to nab P, but you know
• 12:32
  Speaker 5: those products are still available.
• 12:34
  Speaker 6: You know, we're certainly going to do our.
• 12:36
  Speaker 5: Risk based inspections and related things like quality that type
• 12:41
  Speaker 5: of issue.
• 12:42
  Speaker 6: But it kind of dropped the issue.
• 12:44
  Speaker 5: So I think, you know, based on that letter and
• 12:48
  Speaker 5: that series of events, a lot of people would have
• 12:51
  Speaker 5: thought that this issue had been closed.
• 12:53
  Speaker 6: And yet what is old is new again.
• 12:56
  Speaker 3: So what's the normal process if the wants to name
• 13:01
  Speaker 3: to declare something is a biologic and thus can't be
• 13:05
  Speaker 3: compounded with I mean, is it just it makes a
• 13:08
  Speaker 3: statement now it's a biologic. I would assume there's some
• 13:11
  Speaker 3: kind of process involved.
• 13:13
  Speaker 4: Yeah, a biologic has a specific definition from the FDA,
• 13:17
  Speaker 4: where it's a sequence of amino acids greater than forty
• 13:21
  Speaker 4: amino acids in length.
• 13:23
  Speaker 1: And what they're saying.
• 13:24
  Speaker 4: Is that the thyroid usp because it contains an excipient
• 13:30
  Speaker 4: that's naturally present in these animal thyroid glands called thyroglobulin.
• 13:35
  Speaker 4: Thyroglobulin is a large protein. It has more than forty
• 13:39
  Speaker 4: amino acids, so it in itself would be biologic if
• 13:44
  Speaker 4: it was pharmacologically active, which it's not. So thyroglobulin is
• 13:48
  Speaker 4: an excipient or an inactive ingredient that ends up being
• 13:52
  Speaker 4: in thyroid usp. The active ingredients are small small molecule
• 13:57
  Speaker 4: drugs called T three and T four or liyothyronine and levothyroxine.
• 14:02
  Speaker 4: Those are the thyroid hormones, and those are the active
• 14:05
  Speaker 4: ingredients in DTE. So this thyroglobulin, which is a protein,
• 14:12
  Speaker 4: is an inactive ingredient.
• 14:13
  Speaker 1: An FDA has set itself that.
• 14:16
  Speaker 4: The presence of a you know, a protein or a
• 14:19
  Speaker 4: biologic as an inactive ingredient in a substance does not
• 14:23
  Speaker 4: make that substance automatically a biologic.
• 14:26
  Speaker 1: Like human albumin is an example, the FDA.
• 14:29
  Speaker 4: Gives as a biologic product that sometimes exists in pharmaceuticals.
• 14:34
  Speaker 4: That does not make the finished pharmaceutical a biologic instead
• 14:37
  Speaker 4: of a drug.
• 14:38
  Speaker 5: What Neil's referring to was guidance after some changes were
• 14:43
  Speaker 5: made back in twenty twenty. So back then there was
• 14:47
  Speaker 5: a process instituted for FDA to transition several drugs to
• 14:52
  Speaker 5: becoming biologics products.
• 14:56
  Speaker 6: This was based on a law passed a.
• 14:58
  Speaker 5: Number of years before that, and I think the intent
• 15:01
  Speaker 5: of that law, at least when it was passed, was
• 15:03
  Speaker 5: the hopes of making cheaper insulin become a reality, because
• 15:08
  Speaker 5: there's a difference between a generic drug product and a biosimilar,
• 15:14
  Speaker 5: which is kind of like a generic for a biologic
• 15:17
  Speaker 5: drug but has some technical differences that I don't know
• 15:20
  Speaker 5: that they're worth getting into for the purposes of what
• 15:22
  Speaker 5: we're talking about, And I don't know that that, you know,
• 15:25
  Speaker 5: became the reality that there was cheaper insulin. But regardless,
• 15:30
  Speaker 5: this was all stemming from that, And so guidance related
• 15:34
  Speaker 5: to that transition period of drug products to biologics is
• 15:39
  Speaker 5: what to Neil was speaking to, where they said, hey,
• 15:42
  Speaker 5: when the protein is in there, it doesn't make as
• 15:48
  Speaker 5: an inactive ingredient. It doesn't make it.
• 15:50
  Speaker 6: A biologic at that point.
• 15:52
  Speaker 5: So it's a little hairy to step through because we're
• 15:55
  Speaker 5: talking about things that have not really been important to
• 15:58
  Speaker 5: the product. Despite you know, these DTE products having been
• 16:01
  Speaker 5: around for decades and decades, nobody's really spent time talking
• 16:05
  Speaker 5: about thyrol.
• 16:06
  Speaker 6: Globulin until now.
• 16:08
  Speaker 5: It's not something that's listed in the package insert of
• 16:13
  Speaker 5: the product. If you look up the USP monograph. So
• 16:17
  Speaker 5: one of the criterias for the way you can use
• 16:19
  Speaker 5: something as an active ingredient in compound is to say
• 16:21
  Speaker 5: it has a USP monograph.
• 16:23
  Speaker 6: Okay, thyroid has a USP monograph.
• 16:26
  Speaker 5: That's why we talk about thyroid USP, meaning that the
• 16:29
  Speaker 5: United States Pharmacopeia has set standards for that chemical. Standards
• 16:34
  Speaker 5: include tests that have to be performed on that chemical.
• 16:39
  Speaker 5: And there's no test or listing or requirement for the
• 16:44
  Speaker 5: quantity of thyrol globulin. So a substance that's never really
• 16:49
  Speaker 5: been discussed until that first FDA letter a few years ago,
• 16:54
  Speaker 5: and now in the notice that was provided to companies
• 16:58
  Speaker 5: in August, now points to thyroglobulins or the central issue
• 17:03
  Speaker 5: as to why all of a sudden these products need
• 17:06
  Speaker 5: to be biologics instead of drugs.
• 17:10
  Speaker 3: So are there other examples besides thyroglobulin that, by the
• 17:16
  Speaker 3: FDA's new logic, well not new logic, but by what
• 17:21
  Speaker 3: the FDA is saying, that could also be suddenly classified
• 17:25
  Speaker 3: as biologics even if they're inactive ingredients. Has the FDA
• 17:30
  Speaker 3: opened a door to a Pandora's box?
• 17:34
  Speaker 2: If I may mix my metaphors.
• 17:36
  Speaker 3: Of other drugs suddenly being classified as biologics.
• 17:41
  Speaker 1: It's really hard to say.
• 17:43
  Speaker 4: And one of the things that we're also aware of
• 17:45
  Speaker 4: is that this seems to have come from a push
• 17:49
  Speaker 4: from one singular pharmaceutical company. So in twenty twenty four,
• 17:53
  Speaker 4: a pharmaceutical company that manufactures commercially available animal based thyroid
• 17:58
  Speaker 4: tablets sent a citizen petition to the FDA asking the
• 18:02
  Speaker 4: FDA to kind of crack down on unapproved manufactures of
• 18:07
  Speaker 4: animal thyroid products. We have to remember that these have
• 18:10
  Speaker 4: been around since, you know, the late eighteen hundreds. They
• 18:13
  Speaker 4: preceded the formation of the FDA, so they don't have
• 18:16
  Speaker 4: formal FDA approval. They're grandfathered in, so they existed and
• 18:20
  Speaker 4: treated patients.
• 18:21
  Speaker 1: Before the FDA regulated drugs.
• 18:23
  Speaker 4: So this pharmaceutical company submitted a citizen petition basically asking
• 18:28
  Speaker 4: the FDA to crack down on, say, unapproved marketing of
• 18:32
  Speaker 4: these kind of thyroid medications, and the FDA a year later,
• 18:36
  Speaker 4: just this past August, came back and partially granted the
• 18:39
  Speaker 4: citizen petition and partially partially denied it, and basically said
• 18:43
  Speaker 4: that thyroid products were a biologic and that a pharmaceutical
• 18:48
  Speaker 4: company would have to go through the biologic drug approval
• 18:51
  Speaker 4: process to keep these products on the market. So the
• 18:54
  Speaker 4: biologic process is called getting a BLA or a biologics license.
• 18:59
  Speaker 1: Is you going to get FDA formal approval for these products?
• 19:03
  Speaker 4: If this happens, but it's down the biologics pathway instead
• 19:06
  Speaker 4: of the drugs pathway, which is a more complicated FDA
• 19:10
  Speaker 4: approval process, likely what this ends up, what ends up happening,
• 19:15
  Speaker 4: is this one pharmaceutical company will end up the only
• 19:19
  Speaker 4: the only one that is you know, partially down this
• 19:22
  Speaker 4: BLA pathway, and so that at the end of the
• 19:25
  Speaker 4: year when this enforcement period ends, where the FDA is
• 19:30
  Speaker 4: allowing patients to transition to other thyroid products, that they'll
• 19:33
  Speaker 4: be the only manufacturer on the market that has FDA
• 19:37
  Speaker 4: approved animal thyroid drugs. Compounding pharmacies are not allowed to
• 19:42
  Speaker 4: compound with biologics. So this one pharmaceutical company, if this
• 19:45
  Speaker 4: plays out and the way that we think it might,
• 19:48
  Speaker 4: would effectively have a monopoly in the marketplace.
• 19:51
  Speaker 5: So the citizens petition that Tonio brought up. FBA did
• 19:56
  Speaker 5: respond to a citizens petition saying that they weren't to
• 20:00
  Speaker 5: take specific actions relative to the citizens petition and this
• 20:05
  Speaker 5: asks for enforcement that they go through risk based enforcement,
• 20:09
  Speaker 5: which is pretty common type of language that you see
• 20:12
  Speaker 5: from FDA. I will note the individual from FDA that
• 20:18
  Speaker 5: responded to the citizen inspetition is a gentleman named George Tidmarsh. Now,
• 20:24
  Speaker 5: George is an interesting person based on his comment on
• 20:28
  Speaker 5: LinkedIn for from several months preceding this response that he
• 20:34
  Speaker 5: happened to be the signature on because he said, flat
• 20:39
  Speaker 5: out and I quote, the new FDA needs to remove harmful,
• 20:43
  Speaker 5: useless drugs from the market. Let's start with desiccated thyroid
• 20:48
  Speaker 5: extract and unapproved crude pig tissue extract that has proven
• 20:53
  Speaker 5: worse than synthetic thyroid hormone and harmful, working with the
• 20:57
  Speaker 5: new FDA to remove it permanently from the market end quote.
• 21:02
  Speaker 5: So I have no idea what role this individual may
• 21:07
  Speaker 5: or may not have played in the process. I'm just
• 21:10
  Speaker 5: simply noting two things. That they are the person named
• 21:13
  Speaker 5: on the response to the citizens petition, and that was
• 21:17
  Speaker 5: their quote that they would seemingly have been the person
• 21:21
  Speaker 5: that posted on LinkedIn.
• 21:24
  Speaker 2: Is any of that true?
• 21:26
  Speaker 4: Well, animal drug thyroid products are not the first choice
• 21:29
  Speaker 4: to treat patients, so patients with hypothyroidism.
• 21:32
  Speaker 1: The first choice is to.
• 21:34
  Speaker 4: Prescribe synthetic thyroid hormones leabothyroxine and or a liothyronine, but
• 21:40
  Speaker 4: those don't work for all patients.
• 21:42
  Speaker 1: Some patients, even if they.
• 21:44
  Speaker 4: You know, their labs show that their thyroid hormones are
• 21:46
  Speaker 4: at the right level, they just feel crappy and switching
• 21:51
  Speaker 4: them to these animal thyroid products makes a big difference
• 21:54
  Speaker 4: in how they feel.
• 21:55
  Speaker 1: So this is not the first choice.
• 21:57
  Speaker 4: It's not the primary thyroid therapy used by America and patients,
• 22:00
  Speaker 4: but for the small subset that need these medications, they're very,
• 22:05
  Speaker 4: very important, and the patients that take them are desperate
• 22:08
  Speaker 4: to retain access to these medications for their treatment.
• 22:12
  Speaker 5: I think we have to talk about the thyroid products
• 22:15
  Speaker 5: and when he mentions that they are unapproved in that statement,
• 22:20
  Speaker 5: and in some ways that's true and in some ways
• 22:23
  Speaker 5: it's not, and so it's technicality a little bit. So
• 22:27
  Speaker 5: these thyroid products have been around for many, many years,
• 22:31
  Speaker 5: and so they're around prior to nineteen sixty two.
• 22:35
  Speaker 6: Why does that date matter.
• 22:36
  Speaker 5: That's when drugs not only had to be proven effective,
• 22:41
  Speaker 5: but they had to be proven safe. So there have
• 22:43
  Speaker 5: been a handful of drugs that have been grandfathered, so
• 22:47
  Speaker 5: they're known as DESI drugs that were around prior to
• 22:50
  Speaker 5: nineteen sixty two. These thyroid products, the DTE, animal drive
• 22:55
  Speaker 5: thyroid products are all know.
• 22:59
  Speaker 6: This type of drug.
• 23:00
  Speaker 5: And so in the last gosh I do know, ten
• 23:03
  Speaker 5: to fifteen years, it does seem like FDA has gone
• 23:07
  Speaker 5: through some processes and removed some of those products from
• 23:11
  Speaker 5: the market or reviewed some of those other products and
• 23:15
  Speaker 5: found out maybe some of those.
• 23:17
  Speaker 6: Products aren't necessary. So in some ways this is sort
• 23:20
  Speaker 6: of the continuation of that pattern.
• 23:22
  Speaker 5: We can all argue about whether the products are good, bad,
• 23:25
  Speaker 5: or indifferent, but just to say this history exists. So
• 23:29
  Speaker 5: where you look for an FDA approved drug product, the
• 23:33
  Speaker 5: thing that is specifically a drug, not a biologic. FDA
• 23:36
  Speaker 5: has these different color books that are online. I don't
• 23:40
  Speaker 5: know who picked the color scheme, gonna ask me how
• 23:42
  Speaker 5: that works.
• 23:43
  Speaker 6: But the orange book is.
• 23:45
  Speaker 5: Where you find FDA approved drug products. The purple book
• 23:50
  Speaker 5: is for biologic products.
• 23:53
  Speaker 6: And there's a green book too, and that's.
• 23:54
  Speaker 5: For animal drugs. And that's a discussion for another day.
• 23:57
  Speaker 5: But if you go into the fd a Orange book
• 24:01
  Speaker 5: and you search thyroid, which would be the name of
• 24:03
  Speaker 5: the active ingredient. You're not going to return any products.
• 24:08
  Speaker 5: Same thing for the purple book. So there is no
• 24:10
  Speaker 5: fully FDA approved thyroid product on the market. It exists
• 24:16
  Speaker 5: because it's one of these grandfather products that existed prior
• 24:19
  Speaker 5: to this date in the sixties.
• 24:21
  Speaker 3: Now, if the two of you would just for a
• 24:23
  Speaker 3: second put on your pharmacist hats, which I assume you're
• 24:27
  Speaker 3: actually wearing most of the time. Anyway, the question of
• 24:31
  Speaker 3: whether this whether compounded thyroid extract works, George, as you said,
• 24:40
  Speaker 3: indicated that they don't work, they're ineffective.
• 24:42
  Speaker 2: But that's not true, is it.
• 24:44
  Speaker 3: I mean, from your experience to Neil, you mentioned there
• 24:47
  Speaker 3: are some patients where the commercial product didn't work. The
• 24:50
  Speaker 3: compounded version does work, right. I mean, you can't say
• 24:54
  Speaker 3: it's ineffective. You can say it's unapproved, as Matt just explained,
• 24:59
  Speaker 3: but there's no question that this stuff works.
• 25:02
  Speaker 2: These drugs work for patients, is that right?
• 25:04
  Speaker 4: These drugs absolutely work for patients, and it's not just
• 25:07
  Speaker 4: compounded therapies. So these animal drug products, there's commercial manufacturers
• 25:13
  Speaker 4: of these animal drug products that you can get prescriptions
• 25:15
  Speaker 4: filled for these at your corner. You know, retail drug store,
• 25:19
  Speaker 4: but for patients that need customized strengths or excipients or
• 25:24
  Speaker 4: dosage forms, Compounding pharmacies also make specialized or customized formulations
• 25:30
  Speaker 4: of these based on a prescriber's order. I would imagine
• 25:33
  Speaker 4: there's a lot more of the commercial tablets being dispensed
• 25:36
  Speaker 4: than compounded animal drug products. But compounding is, you know,
• 25:40
  Speaker 4: a part a part of this market as.
• 25:42
  Speaker 1: Well, and these absolutely work.
• 25:45
  Speaker 4: There's change dot Org petitions to keep these products on
• 25:49
  Speaker 4: the market. Since patients have got a hold of this
• 25:51
  Speaker 4: issue since the letter came out in August, and you know,
• 25:54
  Speaker 4: patients are absolutely rabid that this therapy not be taken
• 25:58
  Speaker 4: away from them.
• 26:00
  Speaker 5: There is some time where all this is going to
• 26:02
  Speaker 5: play out. This is not These drugs have not been
• 26:05
  Speaker 5: removed from the market as a map, all right. So
• 26:10
  Speaker 5: that August sixth letter, FDA said that they were going
• 26:13
  Speaker 5: to give twelve months of what they called enforcement discretion
• 26:17
  Speaker 5: before they would take issue with anyone for dispensing the
• 26:21
  Speaker 5: manufactured drug products or for having compounded and dispensed the
• 26:26
  Speaker 5: compound of thyroid USP preparations. However, we have had some
• 26:32
  Speaker 5: pharmacists start to report that some of the pharmacies in
• 26:36
  Speaker 5: their area have started to tell patients that will they
• 26:41
  Speaker 5: are no longer carrying and can no longer dispense to
• 26:45
  Speaker 5: them the manufactured products for some of the community pharmacies.
• 26:50
  Speaker 5: So it looks like some people are making decisions to
• 26:53
  Speaker 5: go ahead and just move away from this. So this
• 26:56
  Speaker 5: is going to start to create some access issues, I think,
• 26:59
  Speaker 5: just because the number of places that may be available.
• 27:02
  Speaker 5: There has also been some confusion around this topic, and
• 27:07
  Speaker 5: I think you all have nailed this in the discussion
• 27:09
  Speaker 5: that this is specifically about thyroid usp This is not
• 27:14
  Speaker 5: about levothyroxin and lyiothyronin. I had one pharmacist in particular
• 27:19
  Speaker 5: tell me that they were having some pharmacies who were
• 27:23
  Speaker 5: transferring their levothyroxin and loyothyronine prescriptions to them because they
• 27:31
  Speaker 5: were believing that they could no longer dispense those drugs either.
• 27:36
  Speaker 5: So some people have misunderstood, misread.
• 27:39
  Speaker 6: This whole thing.
• 27:41
  Speaker 5: So hopefully that's a limited number of people, but I
• 27:44
  Speaker 5: want to make sure that we note that so that
• 27:47
  Speaker 5: people are not confused. FDA's logic about having this twelve
• 27:52
  Speaker 5: month enforcement discretion period was so that patients could be
• 27:56
  Speaker 5: transitioned to levothyroxin or le with irocks and inliout therony
• 28:01
  Speaker 5: or whatever might work for those.
• 28:03
  Speaker 6: Patients, or at least let them try some things.
• 28:06
  Speaker 5: Certainly, as to Neil's has stated, some patients just do better.
• 28:11
  Speaker 5: Based on my own personal experience in serving the needs
• 28:15
  Speaker 5: of those patients, some people just seem to do better
• 28:18
  Speaker 5: on thyroid USP products, whether they were manufactured or compounded.
• 28:22
  Speaker 5: It is not necessarily the point that they they seem
• 28:26
  Speaker 5: to do better. I mean, just based on what I observed.
• 28:28
  Speaker 3: So to Neil, I mean, if as Matt says, there's
• 28:32
  Speaker 3: some time before this takes effect, what can people do?
• 28:37
  Speaker 4: Yeah, So for people that may be affected by this,
• 28:40
  Speaker 4: change a resource on our website to help educate them
• 28:43
  Speaker 4: about this issue and then also help with something to
• 28:46
  Speaker 4: do a call to action, So if patients want to
• 28:49
  Speaker 4: visit compounding dot com, slash thyroid or pharmacies can send
• 28:54
  Speaker 4: their patients or prescribers to that page.
• 28:56
  Speaker 1: It'll have information about.
• 28:58
  Speaker 4: This issue, and then also a place for patients to
• 29:01
  Speaker 4: fill out a letter to send to the Administration to
• 29:04
  Speaker 4: ask them to reverse this decision to classify natural thyroid
• 29:08
  Speaker 4: products as the biologic. If the agency reverses this decision,
• 29:13
  Speaker 4: then everything goes back to normal if they want to
• 29:16
  Speaker 4: pursue approval of thyroid products. We are not opposed to
• 29:19
  Speaker 4: FDA approval of animal thyroid products, but we do need
• 29:22
  Speaker 4: it to go down the FDA drug approval pathway, not
• 29:26
  Speaker 4: the biologic approval pathway. So anyway, we're going to have
• 29:29
  Speaker 4: information on the website to explain this issue to patients
• 29:32
  Speaker 4: and then a wait for them to fill out a
• 29:34
  Speaker 4: form to submit information to the Administration to ask them
• 29:37
  Speaker 4: to do the right thing, keep natural thyroid products as
• 29:41
  Speaker 4: a drug not a biologic.
• 29:43
  Speaker 3: Terrific Thank you to Neil, Thank you Matt both for
• 29:46
  Speaker 3: being here and talking about this issue. So that's what's
• 29:50
  Speaker 3: up right now with the whole DTE thyroid situation.
• 29:54
  Speaker 2: Obviously, it's a major priority for APC.
• 29:57
  Speaker 3: In fact, we talked to Congress about it literally face
• 30:00
  Speaker 3: to face at compounders on Capitol Hill on September sixteenth,
• 30:04
  Speaker 3: and as Teil said, though, we need help from the
• 30:07
  Speaker 3: compounding community. If you can, if you're a pharmacist, please
• 30:12
  Speaker 3: tell your patients about compounding dot com slash thyroid. If
• 30:17
  Speaker 3: you're a patient, well that is the place to go
• 30:20
  Speaker 3: to give a testimonial explain how important Thyroid Extract has
• 30:25
  Speaker 3: been for you. That will be linked in the show notes,
• 30:27
  Speaker 3: by the way, in case you didn't write that down.
• 30:30
  Speaker 3: But we're hoping to get as many people as possible
• 30:33
  Speaker 3: to give us testimonials that we can use and we
• 30:35
  Speaker 3: can share and we won't share your personal information, of course,
• 30:39
  Speaker 3: and to write to Congress, and to put pressure on
• 30:42
  Speaker 3: the FDA to make the right decision. So compounding dot
• 30:48
  Speaker 3: com slash thyroid it makes it really easy.
• 30:51
  Speaker 2: To do all these things.
• 30:54
  Speaker 3: And with that now this has been essential from the
• 30:58
  Speaker 3: Alliance for Pharmacy. You can find more information about us,
• 31:02
  Speaker 3: and more importantly join if you aren't already a member
• 31:06
  Speaker 3: at a four PC dot org and we'll see you
• 31:11
  Speaker 3: next time.