Latest / Pharmacy Podcast Network / Why the "SAFE Drugs Act" Isn't Safe for Patients | Essential: The Pharmacy Compounding Podcast

Transcript

Why the "SAFE Drugs Act" Isn't Safe for Patients | Essential: The Pharmacy Compounding Podcast · 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 to Essential Compounding News and analysis from the Alliance
0:29
Speaker 2: for Pharmacy Compounding.
0:31
Speaker 3: I'm your host, Andrew Cantor.
0:33
Speaker 2: As usual, we're going to give you a bit of
0:35
Speaker 2: compounding news before we get to the main event. That's
0:37
Speaker 2: where we'll look at an anti compounding bill now in
0:41
Speaker 2: Congress and how it could hurt patient access to essential
0:45
Speaker 2: get it compounded medications. But first the news. So there
0:52
Speaker 2: has been some news on the peptides front. The FDA
0:55
Speaker 2: is considering a recommendation to add seven peptides to the
0:59
Speaker 2: five three bulks list. And if you don't know what
1:02
Speaker 2: that is, it's a a curated list the FDA is
1:05
Speaker 2: required to maintain of active ingredients that pharmacists are allowed
1:09
Speaker 2: to compound with, even though they aren't used in FDA
1:12
Speaker 2: approved drugs. They don't have a monograph. A group of
1:15
Speaker 2: staff scientists that the FDA recommended that the agency not
1:19
Speaker 2: add those seven peptides to the five H three A
1:22
Speaker 2: bulks list. But the most important recommendation is going to
1:25
Speaker 2: come later this month when the FDA's Pharmacy Compounding Advisory Committee,
1:31
Speaker 2: or PEACACK, meets in considers the same question PCACK. That
1:36
Speaker 2: doesn't sound right like an angry duck PCAC not pakack. Anyway,
1:41
Speaker 2: here's a twist. Peacack's got some new members now, and
1:44
Speaker 2: they are health and wellness professionals who seem to have
1:47
Speaker 2: more patient facing experience than the previous PEACACK panels have.
1:51
Speaker 2: That's actually kind of refreshing, and maybe this new group
1:54
Speaker 2: won't just rubber stamp what the FDA tells it to.
1:57
Speaker 2: They might actually, you know, think about it.
1:59
Speaker 3: See.
2:00
Speaker 2: The thing is, it doesn't make sense to make a
2:02
Speaker 2: blanket rule covering every peptide. They aren't the same. There's nuance,
2:07
Speaker 2: and it'll do the agency good to have some voices
2:09
Speaker 2: that take that into account. We're not going to get
2:11
Speaker 2: into the weeds when it comes to which peptides have
2:14
Speaker 2: safety studies, which are effective, which ones are probably just type.
2:17
Speaker 2: We're well aware that some of these peptides have really
2:20
Speaker 2: limited safety data. And yeah, safety is everyone's priority. Well
2:25
Speaker 2: maybe not everyone's, but yeah. The point is the FDA
2:28
Speaker 2: shouldn't be thinking about this as a binary choice. It's
2:31
Speaker 2: not approve all the peptides versus ban all the peptides nuance.
2:36
Speaker 2: If nothing else, the agency can't ignore the fact that
2:38
Speaker 2: there's already a flourishing gray market out there. It's an
2:42
Speaker 2: entire peptide economy, and it's not safe. And just saying
2:46
Speaker 2: we need more enforcement, which is what the FDA has
2:49
Speaker 2: been doing. That's not a strategy, it's a sound bite.
2:52
Speaker 2: What we need and hopefully what this new peacack will
2:55
Speaker 2: recommend is smart guardrails. We're talking quality expectations, API controls, documentation,
3:02
Speaker 2: all the rules that will allow some peptides to be
3:04
Speaker 2: added safely to the bulks list so patients can get
3:09
Speaker 2: them through legitimate, licensed compounding pharmacies rather than some morando
3:13
Speaker 2: on TikTok or Instagram, because that's what they're doing right now.
3:16
Speaker 2: We need to go from this illicit market for peptides,
3:19
Speaker 2: I mean, talk about the wild West to the opposite
3:23
Speaker 2: of the wild West, a smartly regulated alternative, one that's
3:27
Speaker 2: not a threat to patient safety, not a ban that
3:30
Speaker 2: throws the baby out with the bathwater. The alternative, whether
3:33
Speaker 2: we like it or not, is patients turning to these unregulated, unsafe,
3:37
Speaker 2: fly by night peptides. Are us shops and then crossing
3:41
Speaker 2: their fingers that what they get in the plain brown wrapper,
3:44
Speaker 2: it's not just baking soda and baby powder. Worse, that's
3:48
Speaker 2: not patient safety. PIKAC and the FDA can do better.
3:51
Speaker 2: Here's hoping they do. Last month, the Supreme Court let's
3:57
Speaker 2: stand a ruling from the Fifth Circuit Court of Appeals.
4:00
Speaker 2: It's a ruling that allows drug makers to sue compounders
4:03
Speaker 2: by claiming that compounding violates state deceptive practices laws.
4:08
Speaker 3: Until this happened, it was only the FDA that.
4:11
Speaker 2: Could bring a pharmacy to court if it thought the Food,
4:13
Speaker 2: Drug and Cosmetic Act had been violated. The ruling, or
4:17
Speaker 2: the lack of one, is a problem, and not just because,
4:20
Speaker 2: at least to us, it doesn't quite make sense. It
4:22
Speaker 2: leaves us with what's called a circuit split right now
4:26
Speaker 2: in the Fifth Circuit, and it's Louisiana, Mississippi, and Texas.
4:29
Speaker 2: Private parties, not just the FDA, now can challenge whether
4:33
Speaker 2: a compounded product complies with federal requirements, and they can
4:37
Speaker 2: do it in state court. So a drug maker, a
4:39
Speaker 2: private organization can sue a pharmacy claiming that it's breaking.
4:44
Speaker 3: The FD and C Act. But in the Ninth.
4:47
Speaker 2: Circuit, and that includes all the Western states from Alaska,
4:50
Speaker 2: California down to Hawaii, Idaho. A bunch more in the
4:54
Speaker 2: Ninth Circuit, the Appeals Court there ruled the opposite that
4:58
Speaker 2: only the FDA can inform or federal law the practical outcome,
5:02
Speaker 2: at least until the Supreme Court takes up Another case
5:05
Speaker 2: is that compounders in some states may have to defend
5:08
Speaker 2: themselves against drug makers who use state laws to challenge
5:12
Speaker 2: legal compounding. And that is APC's big concern. If some
5:16
Speaker 2: states can restrict compounding beyond what Congress obviously intended, well,
5:21
Speaker 2: that throws the entire compounding industry into confusion. It's dueling standards,
5:25
Speaker 2: and nobody wins. We've got good news and bad news
5:31
Speaker 2: out of California, where an anti compounding bill AB nineteen
5:35
Speaker 2: ninety passed the state Assembly and is now in the
5:38
Speaker 2: state Senate. After a lot of pressure from APC and
5:41
Speaker 2: the coalition we led, the Assembly sponsor took out just
5:44
Speaker 2: about all the problematic language. But just about isn't the
5:49
Speaker 2: same as all, and there are some serious issues still
5:52
Speaker 2: in the bill. This new version of AB nineteen ninety
5:55
Speaker 2: focuses on how compounders can advertise and promote their products,
5:59
Speaker 2: and that might not seem like a big deal. It's
6:01
Speaker 2: got a couple of problems for starters. For a bill
6:04
Speaker 2: that's supposed to be about patient safety, it doesn't do
6:06
Speaker 2: a thing to protect consumers from the real problem, and
6:09
Speaker 2: that's the counterfeit sellers, the unlicensed clinics, and the places
6:12
Speaker 2: that are selling consumers research grade products.
6:16
Speaker 3: Instead.
6:16
Speaker 2: AB nineteen ninety focuses on legitimate, licensed compounding pharmacies, the
6:22
Speaker 2: places that are already highly regulated by both the FEDS
6:25
Speaker 2: and state law, and it includes some new requirements that
6:29
Speaker 2: are actually illegal or impossible. Here's an example. AB nineteen
6:34
Speaker 2: ninety would require compounding pharmacies to include risk information with
6:38
Speaker 2: their products, risk information that they're supposed to take from
6:42
Speaker 2: the labels of the commercial drugs. But the compounded drug
6:45
Speaker 2: isn't the commercial drug. You can't copy and paste warnings
6:48
Speaker 2: from one to the other. It's not only misleading, it
6:51
Speaker 2: is illegal by federal law.
6:54
Speaker 3: So you see why the bill is a problem.
6:56
Speaker 2: Right now, California Senate is in recess, but come August
6:59
Speaker 2: it's going to or the bill, and that means if
7:01
Speaker 2: you're in California, you do not have a lot of
7:04
Speaker 2: time to reach out to your state senator and explain
7:07
Speaker 2: why AB nineteen ninety is such a problem and it
7:10
Speaker 2: really won't do anything to help patients. Eck, by forcing
7:13
Speaker 2: compounders to choose between obeying state law and obeying federal law,
7:16
Speaker 2: it could cut patients off from their compounded meds completely
7:20
Speaker 2: and force them into the gray market. There's a link
7:24
Speaker 2: in the show notes that makes it easy to send
7:26
Speaker 2: a message to your state senator, so please use it. Finally,
7:33
Speaker 2: back in Washington, there's still these Safeguarding Americans from Fraudulent
7:37
Speaker 2: and Experimental Drugs Act, the Safe Drugs Act, which is
7:41
Speaker 2: gaining some steam, and that's because it's being pushed hard
7:44
Speaker 2: by drug makers. And it would severely limit compounding pharmacists
7:48
Speaker 2: from preparing copies of commercial FDA approved drugs even if
7:53
Speaker 2: those drugs are in shortage. In other words, if a
7:56
Speaker 2: drug goes into shortage, say if there's another pandemic or
8:00
Speaker 2: just another manufacturing hiccup, the Safe Act would only allow
8:03
Speaker 2: compounders to make twenty copies of it for patients each month.
8:08
Speaker 2: That's right, no matter how critical the drug is, how
8:11
Speaker 2: many patients rely on it.
8:12
Speaker 3: The Safe Act.
8:13
Speaker 2: Would put a flat, arbitrary cap on compounding, it completely
8:18
Speaker 2: ignoring that that drug shortage list exists. Now, think about
8:21
Speaker 2: what that would mean for patients, because it's probably the
8:24
Speaker 2: something that drug makers conveniently forgot to mention when they
8:28
Speaker 2: meet with legislators. That's why we've been urging our members
8:31
Speaker 2: to come to Compounders on Capitol Hill. That is our
8:34
Speaker 2: annual event in Washington where we meet face to face
8:37
Speaker 2: with the very legislators who these pharma companies are trying
8:41
Speaker 2: to fool. It is the best way bar none to
8:44
Speaker 2: get our message across and to explain to these representatives
8:47
Speaker 2: and senators why pharmacy compounding means so much to their constituents,
8:52
Speaker 2: especially during a drug shortage. The good thing is, if
8:55
Speaker 2: you come to Compounders on Capitol Hill, you don't need
8:58
Speaker 2: any lobbying experience at all. You're never on your own.
9:02
Speaker 2: We schedule the meetings, we brief you on the issues,
9:05
Speaker 2: and we have lobbyists with you in every office. You
9:08
Speaker 2: go to Compounders on Capitol Hill. It's our most important
9:11
Speaker 2: event of the year. And if you're a compounding pharmacist
9:14
Speaker 2: or a technician, we really hope you'll come to DC
9:17
Speaker 2: on September fourteenth through the sixteenth. Obviously, there's a link
9:21
Speaker 2: in the show notes to get all the information you need.
9:24
Speaker 2: And with that it is time for our deep dive
9:27
Speaker 2: and it is all about this troublesome bill. Today we're
9:37
Speaker 2: going to talk about a bill in Congress that's kind
9:39
Speaker 2: of an anti compounding bill. It's called the Safeguarding Americans
9:44
Speaker 2: from Fraudulent and Experimental Drugs Act, the Safe Act, and
9:49
Speaker 2: it's a bit controversial, to say the least. With me
9:52
Speaker 2: are two people who know all about it and a
9:54
Speaker 2: lot more. First is David Poor. He's an attorney and
9:57
Speaker 2: partner with Hans Scarborough in Washington in d C. And
10:01
Speaker 2: also APC's federal lobbyist. And with David is Amy Shank
10:05
Speaker 2: and she's senior director for Government and Public Affairs at PCCA.
10:10
Speaker 3: Welcome both of.
10:11
Speaker 4: You, Thank you, good morning.
10:12
Speaker 3: We'll start with the.
10:13
Speaker 2: Basics, and I'm going to try to keep everything in
10:16
Speaker 2: clean English. What does this Safe Act actually do? In broadstrokes?
10:21
Speaker 2: I mean, how would it change how a compounding pharmacy
10:25
Speaker 2: operates day to day.
10:27
Speaker 5: Yeah, I'll jump in Andrews, So you know, I think
10:30
Speaker 5: we could start with the title and what the bill
10:32
Speaker 5: does not do, and that is, have anything to do
10:35
Speaker 5: with fraudulent or experimental drugs. So we really, starting with
10:39
Speaker 5: the title, we take issue with a lot in this
10:41
Speaker 5: bill and the way it's being messaged and the way
10:43
Speaker 5: it's being lobbied and described on Capitol Hill. Basically, what
10:49
Speaker 5: the drug would do is change the dynamic around five
10:54
Speaker 5: oh three eight compounding and would effectively override or pre
10:59
Speaker 5: amp the current FDA guidance on compounding drug products that
11:03
Speaker 5: are essentially copies of commercially available drugs. So drug shortage
11:08
Speaker 5: compounding would be dramatically changed because the bill would codify some.
11:14
Speaker 4: New definitions into law of what.
11:17
Speaker 5: Essentially a copy and commercially available mean. And to really
11:22
Speaker 5: cut to the chase, what it would do is remove
11:26
Speaker 5: the current exemption from the definition of commercially available drugs
11:32
Speaker 5: drugs that are on FDA's drug shortage list. And so
11:37
Speaker 5: currently there are two situations when compounding essentially a copy
11:42
Speaker 5: of an FDA approved drug is allowed on one when
11:45
Speaker 5: the drug is in shortage, when FDA is determined that
11:47
Speaker 5: there's a drug shortage and that drug is on FDA
11:50
Speaker 5: shortage list, and two when a significant difference is made
11:55
Speaker 5: to the drug to meet the specific needs of an
11:59
Speaker 5: individual patient, and this could be route of administration, dosage,
12:03
Speaker 5: form strength, these kinds of changes that are needed to
12:09
Speaker 5: make the drug tailored to meet a specific patient's needs.
12:13
Speaker 5: And this bill, along with a few other things, some
12:17
Speaker 5: reporting requirements and some new requirements on five oh three
12:20
Speaker 5: B outsourcing facilities.
12:23
Speaker 4: The most onerous provision.
12:24
Speaker 5: In this bill is ending the ability of five oh
12:28
Speaker 5: three A pharmacies to compound drugs on the drug shortage List,
12:32
Speaker 5: and I can get into some more detail on that
12:34
Speaker 5: as we go along.
12:36
Speaker 2: For those folks listening who don't know the difference between
12:39
Speaker 2: five three A and five or three B compounding and
12:44
Speaker 2: correct me if I'm wrong. Five O three A is
12:47
Speaker 2: you're small, but usually a neighborhood pharmacy. Maybe it's got
12:51
Speaker 2: several locations, but it's it's a small individual pharmacy. They
12:56
Speaker 2: get a prescription for a single patient and fill the
12:59
Speaker 2: perscripure with a compounded medication one on one, whereas five
13:03
Speaker 2: O three b's are the larger outsourcing facilities that compound
13:09
Speaker 2: many more drugs that are then either shipped to five
13:13
Speaker 2: or three a's or to hospitals or in other cases
13:16
Speaker 2: where it's not just a single individual involved, is that right?
13:21
Speaker 4: Yeah, that's right, Andrew.
13:22
Speaker 5: Five O three a's refer to traditional state licensed pharmacies,
13:26
Speaker 5: which you would think of as your neighborhood pharmacy. In
13:29
Speaker 5: a lot of cases, they're required to compound drugs on
13:33
Speaker 5: a patient specific basis pursuant to a patient specific prescription.
13:37
Speaker 5: They do so subject to state laws and state regulatory
13:43
Speaker 5: frameworks over pharmacy, and in almost all cases, states require
13:47
Speaker 5: that those drugs are compound and pursuant to US Pharmacopeia
13:51
Speaker 5: Standards USP standards. Whereas outsourcing facilities are registered with FDA,
13:57
Speaker 5: they are held to a higher cGMP Current Manufacturing Practices
14:02
Speaker 5: standards and are able to compound in larger volumes as
14:06
Speaker 5: you said, without patients specific prescriptions for hospitals, doctors, clinics,
14:11
Speaker 5: or for sale to five O three A pharmacies for dispensing.
14:15
Speaker 4: Yeah, that's great, David.
14:15
Speaker 6: I would just add that the five O three A
14:18
Speaker 6: pharmacies are compounding typically both either non sterile medications so
14:25
Speaker 6: think capsules, creams, and then also the sterile medications such
14:29
Speaker 6: as eye drops or injections, whereas the five O three
14:32
Speaker 6: B outsourcing facilities are required to produce sterile medications, so
14:37
Speaker 6: maybe they might also produce the capsules and the creams,
14:40
Speaker 6: but they're required to produce sterile medications.
14:44
Speaker 2: And what we learned during well the GLP one shortage,
14:49
Speaker 2: semi glue tiders, appetite shortage, was that the five O
14:54
Speaker 2: three a's, the smaller the individual pharmacies stepped in and
14:59
Speaker 2: were able to you provide these drugs. So it was
15:02
Speaker 2: kind of important that they were there during shortages, and
15:05
Speaker 2: certainly during the pandemic.
15:08
Speaker 3: We talked a lot. We've heard a lot about five.
15:10
Speaker 2: Oh three b's during the pandemic, but five O three
15:13
Speaker 2: A pharmacies were also stepping up because drugs were in shortage.
15:18
Speaker 2: And now you're saying the Safe Act is going to
15:21
Speaker 2: not allow them to compounding and drugs.
15:25
Speaker 3: Are in shortage, it seems kind of a big deal.
15:29
Speaker 5: It is a big deal, Andrew, and you know, you
15:33
Speaker 5: just hit the nail on the head. During the pandemic, pharmacies,
15:36
Speaker 5: both five O three BEE pharmacies in some cases outsourcing
15:39
Speaker 5: facilities were compounding shortage drugs. But what we found is
15:44
Speaker 5: that because the outsourcing facilities are subject to cGMP requirements
15:49
Speaker 5: that include testing requirements and compounding of large batches of
15:54
Speaker 5: drugs and kind of a ramp up and ramp down period.
15:57
Speaker 4: They're not as nimble.
15:58
Speaker 5: As the five oh three A pharmacies in responding to
16:00
Speaker 5: drug shortages. That's why the five three a's were able
16:04
Speaker 5: to quickly step in and compound COVID drugs that had
16:07
Speaker 5: gone into shortage, and through an emergency guidance deering COVID,
16:11
Speaker 5: we're actually able to do so.
16:13
Speaker 4: Prior to receipt of a patient's specific prescription.
16:16
Speaker 5: So yes, pharmacies played a critical role in addressing the
16:20
Speaker 5: pandemic when we were going through.
16:22
Speaker 6: That, and it was quite a variety of drugs too,
16:25
Speaker 6: right David. So it was everything from the drugs used
16:28
Speaker 6: to intubate patients that were allowed by the guidance, and
16:32
Speaker 6: then it was also just all shortages are probably unexpected.
16:37
Speaker 6: Most are, but hydroxychloric when went into shortage, and that
16:41
Speaker 6: left many autoimmune patients who'd relied on the therapy sometimes
16:45
Speaker 6: for many many years without their medication and then needing
16:48
Speaker 6: to turn two compounded alternatives when they couldn't they couldn't
16:52
Speaker 6: get it through regular channels. So a lot of different
16:55
Speaker 6: angles to how compounding helped to patients significantly during COVID.
17:03
Speaker 4: Yeah, and that's still the case, Andrew.
17:04
Speaker 5: I mean, at any given time, you've got eighty to
17:06
Speaker 5: ninety drugs on FDA shortage list. They come on and
17:10
Speaker 5: go off as as FDA determines their their availability. But
17:17
Speaker 5: right now you've got you know, a lot of cancer drugs,
17:20
Speaker 5: several hospitals, sterile injectable drugs Lyda kine and other sterile
17:25
Speaker 5: injectibles that hospitals need that are in shortage. So this
17:28
Speaker 5: is a lot broader and a lot a lot more
17:32
Speaker 5: serious than just GLP one drugs.
17:34
Speaker 2: Well, I'll get to gop ones in a second, as
17:37
Speaker 2: I understand, and again correct me if I'm wrong, the
17:40
Speaker 2: impetus for this bill is that, well, in part, big
17:45
Speaker 2: drug big drug makers are saying that there are a
17:49
Speaker 2: lot of adverse event reports with compounded drugs and other
17:55
Speaker 2: kind of issues, but specifically adverse event reports. So someone says,
18:00
Speaker 2: is that compounded drug did something bad to them, Whatever
18:05
Speaker 2: it is, it's an adverse event.
18:06
Speaker 3: It could be big, could be small.
18:09
Speaker 2: But as I understand it, these adverse event reports that
18:14
Speaker 2: the big drug makers point to and have been pushing
18:18
Speaker 2: because been pushing leading to this bill. They're problematic. It's
18:25
Speaker 2: not like this is some kind of detailed official document
18:30
Speaker 2: of issues with compounded mets.
18:33
Speaker 3: Is that right.
18:34
Speaker 2: They're kind of misleading these adverse events reports.
18:39
Speaker 5: Yeah, it's complicated, but basically, yes, these are reports that
18:43
Speaker 5: an adverse event has occurred. Somebody took a compounded drug
18:46
Speaker 5: and called into the FAIR system, a federal adverse event
18:49
Speaker 5: reporting system. But what it lacks is any sort of
18:52
Speaker 5: follow up, any sort of investigation as to causation of
18:56
Speaker 5: the adverse event.
18:57
Speaker 4: So, yes, an adverse.
18:59
Speaker 5: Event got reported after somebody took a drug, but no
19:02
Speaker 5: medical evidence that the adverse event was caused to buy
19:05
Speaker 5: the compounded drug and not perhaps by.
19:10
Speaker 4: Some sort of user error.
19:12
Speaker 5: Maybe the patient took made a mistake in taking the drug,
19:15
Speaker 5: Maybe it was an allergic reaction, maybe it was something
19:19
Speaker 5: entirely different that had nothing to do with the compounded drugs.
19:22
Speaker 5: So it's a little misleading to report adverse events tied
19:26
Speaker 5: to compounded drugs without that evidence of some sort of
19:29
Speaker 5: link to the compounded drug and investigation of causation. And
19:34
Speaker 5: the problem exists on the FDA proof side as well.
19:37
Speaker 5: I mean, the same thing until there's an investigation as
19:40
Speaker 5: to what caused the adverse event.
19:43
Speaker 4: It's misleading to just state the statistics.
19:47
Speaker 5: On the number of reports without knowing whether those are
19:50
Speaker 5: valid reports actually tied to something related to the compounded drug.
19:55
Speaker 2: Well, it also seems that you get adverse events with
19:59
Speaker 2: i'll call them commercial drugs, FDA approved drugs, the big
20:02
Speaker 2: manufacturer drugs, not just compounded versions. Is that the case
20:08
Speaker 2: because no one seems to mention how many adverse events
20:11
Speaker 2: there are with you know, brand name drugs. Is that
20:17
Speaker 2: because there are adverse events?
20:20
Speaker 5: Yes, there are, you know many adverse events reported from
20:23
Speaker 5: FDA approved drugs.
20:24
Speaker 4: In fact, the numbers are comparable when you break it
20:26
Speaker 4: down and you look at it. But again, the same
20:28
Speaker 4: problem exists.
20:29
Speaker 5: We don't know if those adverse event reports on the
20:32
Speaker 5: FDA side are necessarily because of the FDA approved product
20:36
Speaker 5: the patient took. So it's an imperfect system, the reporting system,
20:40
Speaker 5: and really, you know, those those numbers and those statistics
20:43
Speaker 5: can be used to mislead policy makers in the public,
20:46
Speaker 5: and that's that's unfortunate, and that's some of what's going
20:49
Speaker 5: on here.
20:50
Speaker 2: So we know that that compounding is really important during shortages,
20:57
Speaker 2: and this bill is going to severely limit the ability
21:01
Speaker 2: for compounders to supply drugs to patients.
21:04
Speaker 3: The bill comes out of two.
21:07
Speaker 2: Representatives from Indiana and one from each side of the aisle,
21:11
Speaker 2: which is, you know, these days is kind of odd
21:13
Speaker 2: on his face, But why is that happening? Why are
21:16
Speaker 2: they introducing a bill that is gonna well, it's it's
21:21
Speaker 2: gonna hurt patients, it's gonna prevent them from getting drugs that.
21:24
Speaker 3: Are in shortage.
21:25
Speaker 2: What's why do we have this this purple bill for
21:30
Speaker 2: compounded drugs?
21:32
Speaker 4: So, you know, it's interesting.
21:34
Speaker 6: We have always looked at this through the lens of
21:38
Speaker 6: it's about patients and what can we be doing to
21:42
Speaker 6: make sure that patients have access to their medications, and
21:48
Speaker 6: haven't really looked at it so much as a Republican
21:50
Speaker 6: issue or a Democrat issue, because certainly there are patients
21:54
Speaker 6: who are both right, there are Republican patients and there
21:56
Speaker 6: are Democrat patients. So just really focus seeing on patient
22:01
Speaker 6: centered policy is what we've tried to work toward. Yeah,
22:06
Speaker 6: it's interesting.
22:07
Speaker 4: In this year, the second half of the year, there's going.
22:11
Speaker 7: To be probably a full two months when the many
22:14
Speaker 7: of the lawmakers are back in their states, and districts
22:18
Speaker 7: pretty much the most of the month of August and
22:21
Speaker 7: then similarly the month of October.
22:24
Speaker 6: And in terms of an educational drive, certainly it's a
22:29
Speaker 6: helpful time to invite lawmakers to come out and tour
22:33
Speaker 6: a compounding pharmacy.
22:34
Speaker 7: Right, it's really different than a retail setting.
22:38
Speaker 4: It's very different to gun them back, to.
22:41
Speaker 6: Take them back in the lab and to let them
22:45
Speaker 6: see what is there now.
22:46
Speaker 8: I hope that that happens and that we have many
22:49
Speaker 8: compounding pharmacists who are doing that and showing the facility.
22:51
Speaker 8: But what's really key, and what you touched on what
22:54
Speaker 8: we talked about earlier, was the impact on the patients
22:56
Speaker 8: and those site visits.
22:57
Speaker 7: It's really key to have patients there.
23:00
Speaker 6: So the patients can then speak up and explain what
23:05
Speaker 6: type of medicine are they on, why was it prescribed
23:08
Speaker 6: for them, what's their experience been like, and to have
23:11
Speaker 6: that different perspective.
23:13
Speaker 4: Brought into the site.
23:14
Speaker 6: Is it where you can hear from the pharmacist about
23:18
Speaker 6: how these medications are custom made for the patient, you
23:22
Speaker 6: can hear from patient about why they're needed. Because it
23:25
Speaker 6: really is about patient centered policy and we've tried to
23:30
Speaker 6: not really look at this so much as a partisan issue.
23:35
Speaker 4: Yeah, I think that's right, Amy.
23:36
Speaker 5: I mean, we have Republicans and Democrat rats that are
23:39
Speaker 5: very supportive of compounding, pharmacy, compounding, and we've got Republicans
23:42
Speaker 5: and Democrats that are very close to the pharmaceutical industry
23:46
Speaker 5: and really buy.
23:47
Speaker 4: Into some of the patient's safety arguments being made.
23:51
Speaker 5: And that's really where the lobbying on the other side,
23:54
Speaker 5: the lobbying and support of this bill.
23:56
Speaker 4: Has been focused.
23:57
Speaker 5: And you know, I mentioned it at the beginning of
23:59
Speaker 5: the PS that it starts with the name when you
24:02
Speaker 5: put fraudulent, you know, saving Americans from fraudulent and experimental drugs.
24:06
Speaker 5: Who doesn't want to save Americans from fraudulent and experimental drugs?
24:10
Speaker 5: And so when you start with a title like that
24:13
Speaker 5: and you're saying that a member of Congress their constituents
24:16
Speaker 5: are in danger of risky compounding and that this drug
24:20
Speaker 5: is going to this bill is going to somehow improve
24:23
Speaker 5: that situation, that becomes a persuasive argument in getting members
24:27
Speaker 5: of Congress.
24:28
Speaker 4: Especially of those that may not have.
24:30
Speaker 5: Deep policy experience or serve on the committees of jurisdiction,
24:35
Speaker 5: that this type of legislation would go through. You know,
24:37
Speaker 5: normally when you get a healthcare bill dealing with pharmacy
24:41
Speaker 5: or other health care policy, you would take it to
24:43
Speaker 5: a member of the Energy and Commerce Committee, where this
24:47
Speaker 5: type of legislation would go in the House, or a
24:49
Speaker 5: member of the Health Committee in the Senate. The two
24:52
Speaker 5: original sponsors of this bill in the House both come
24:56
Speaker 5: from a state that is where the headquarters of one
25:00
Speaker 5: of the major pharmaceutical companies that manufacture GLP ones are located.
25:05
Speaker 5: And so, you know, what we've seen is persuasive arguments
25:10
Speaker 5: that they're somehow a large patient safety risk out there
25:14
Speaker 5: that makes it necessary to restrict compounding. And in this case,
25:19
Speaker 5: you know, it's very focused on drug shortage compounding, and
25:23
Speaker 5: so the actual substance of the bill doesn't have a
25:26
Speaker 5: lot to do with improving patient safety. It has to
25:29
Speaker 5: do with protecting the market share of the pharmaceutical companies
25:32
Speaker 5: that make the drugs that are going into shortage. And
25:37
Speaker 5: so that's our issue with it. But when you kind
25:39
Speaker 5: of peel those layers back, and as we talk to
25:42
Speaker 5: members of Congress and educate them about the bill, what
25:45
Speaker 5: we're finding is that there's been a lot of misinformation
25:48
Speaker 5: surrounding this bill, and some of the members of Congress,
25:51
Speaker 5: even those that have co sponsored the bill, are unaware
25:55
Speaker 5: that it would codify a definition of commercially available that
25:59
Speaker 5: would radically change the current framework of drug shortages and
26:03
Speaker 5: how we as a country address drug shortages, and part
26:07
Speaker 5: of that system involves compounding.
26:10
Speaker 4: When those drugs are on the FDA shortage list.
26:13
Speaker 5: So it's been interesting to see that there are members
26:16
Speaker 5: of Congress that we're not informed that that's what the
26:19
Speaker 5: bill does, and are being told that it's all about
26:22
Speaker 5: protecting patient safety, but there's.
26:25
Speaker 4: Really you know, what they're leaving out is that if you're.
26:29
Speaker 5: Creating a situation where drugs are in shortage and there's
26:32
Speaker 5: no legal pathway for compounding pharmacies to step in and
26:37
Speaker 5: help address those shortages, you're actually creating a patient safety issue,
26:41
Speaker 5: not addressing one.
26:43
Speaker 4: And that's how we look at this bill.
26:45
Speaker 6: That's right, is lack of access is the patient safety issue.
26:49
Speaker 2: So realistically, if this bill passes, what are patients going
26:54
Speaker 2: to see? Are they can be any benefits to patients,
26:57
Speaker 2: and is what's the kind of thing that your every
27:00
Speaker 2: Joe who needs a compounded medication. What are they going
27:03
Speaker 2: to see and what are patients in general going to
27:07
Speaker 2: see after it passes well.
27:09
Speaker 5: One of the things that concerns us is the hard cap.
27:12
Speaker 5: The bill contains a cap. So once you remove the
27:16
Speaker 5: exemption for drugs on the FDA shortage List from the
27:19
Speaker 5: definition of commercially available, and you codify this prohibition on
27:24
Speaker 5: compounding those drugs, and you put into the statute an
27:27
Speaker 5: arbitrary limit of no more than twenty drugs compounded that
27:33
Speaker 5: are essential copies. What you create is a situation where
27:39
Speaker 5: if a drug is on the shortage list, there's not
27:42
Speaker 5: an outsourcing facility that's able to react quick enough to
27:45
Speaker 5: get those drugs compounded into the providers and patients that
27:49
Speaker 5: need them. Pharmacies will be limited caped at twenty twenty copies.
27:55
Speaker 4: Per month, and so that is a very arbitrary.
27:57
Speaker 5: Cap that kind of removes the current language and the
28:00
Speaker 5: guidance that is much more subjective, much more enforcement discretion based,
28:06
Speaker 5: and is really based on quantities needed to address unanticipated
28:11
Speaker 5: emergency circumstances.
28:13
Speaker 2: So hold on one second, are you saying that this
28:16
Speaker 2: twenty prescriptions a month limit, meaning each pharmacy can say, okay, well,
28:21
Speaker 2: twenty patients I can take care of and give you
28:24
Speaker 2: access to this drug that's in shortage the rest of you.
28:27
Speaker 6: Sorry, yeah, you have to figure out what you're going
28:30
Speaker 6: to say to the twenty first patient or the twenty
28:32
Speaker 6: fifth patient. And you know, in particularly in rural areas,
28:36
Speaker 6: it's your neighbor, a family member, someone that you've helped
28:40
Speaker 6: for a while. How do you choose who gets their
28:42
Speaker 6: medicine and who doesn't get their medicine. It's very troubling,
28:45
Speaker 6: and it's you know, peely and oniony. Further you get
28:48
Speaker 6: into it, the more complicated it becomes. Right, So when
28:52
Speaker 6: the industry started to vet this more thoroughly earlier in
28:56
Speaker 6: the year, it just it became obvious that that it
29:00
Speaker 6: is there's a lot of layers to it, and it's complicated.
29:03
Speaker 6: And the Alliance for Pharmacy Compounding and then also the
29:07
Speaker 6: National Community Pharmacist Association been a letter explaining their concerns
29:14
Speaker 6: with the proposal and strong opposition to members of Congress,
29:17
Speaker 6: and it's a helpful letter. It's on the APC website,
29:21
Speaker 6: but it just really breaks down some of the complicated
29:24
Speaker 6: issues that David has articulated on this podcast today and
29:30
Speaker 6: just cuts to the chase in terms of where the
29:33
Speaker 6: concerns truly lie. So that letter, I think, in addition
29:37
Speaker 6: to the educational outreach, is a terrific tool to really
29:42
Speaker 6: highlight the concerns.
29:43
Speaker 4: And the access gaps that would exist.
29:47
Speaker 3: And we'll have a link to that letter in the
29:50
Speaker 3: show notes.
29:53
Speaker 2: I want to We've been avoiding mostly talking about g
29:56
Speaker 2: LP one drugs and specifically be because this bill is
30:00
Speaker 2: going to affect more than that. But the bill is
30:04
Speaker 2: positioned as being about compounding in general and making it
30:08
Speaker 2: quote unquote safe.
30:10
Speaker 3: As we said, that's not really true.
30:12
Speaker 2: But how much is really about g LP one compounding
30:19
Speaker 2: because that was in the news is still in the
30:22
Speaker 2: news with the shortages of ozembic and zep bound and
30:29
Speaker 2: their kin because it's it's not a coincidence that this
30:32
Speaker 2: bill comes up just as these blockbuster drugs are sort
30:37
Speaker 2: of kind of coming out of shortage.
30:40
Speaker 4: Yeah, and anybody with a television Andrew remembers.
30:44
Speaker 5: You know, and still sees just kind of on a
30:46
Speaker 5: loop the commercials that the heavy heavy marketing for the
30:50
Speaker 5: FDA proof products in this GLP one space and really
30:54
Speaker 5: the kind of the boom the boom and prescriptions as
30:59
Speaker 5: these drugs started to get prescribed for weight loss, and
31:03
Speaker 5: not just other medical indications like diabetes and others. You
31:06
Speaker 5: really saw just aggressive marketing that led to drug shortages.
31:10
Speaker 5: The manufacturers were not able to keep up with the
31:13
Speaker 5: demand those drugs went into shortage.
31:15
Speaker 4: The five O three.
31:16
Speaker 5: Outsourcing five oh three B outsourcing facilities again have their
31:21
Speaker 5: own limitations due to cGMP requirements that make it difficult
31:25
Speaker 5: for them to start and stop drug shortage compounding.
31:29
Speaker 4: They're not nearly as nimble.
31:30
Speaker 5: As the five O three A pharmacies, and so yes,
31:34
Speaker 5: I think the impetus behind the bill was the manufacturers
31:38
Speaker 5: seeing that five O three A pharmacies were able to
31:41
Speaker 5: step into the space compound essential copies that were safe
31:46
Speaker 5: and effective, and in a lot of cases at a
31:49
Speaker 5: much lower cost.
31:51
Speaker 4: And that's not a.
31:54
Speaker 5: Reason that FDA recognizes as a legitimate reason that makes
31:58
Speaker 5: a significant difference for a patient. We could argue about
32:01
Speaker 5: whether pricing should be included in that, but it's not
32:05
Speaker 5: under the current guidance. And so frankly, they didn't like
32:08
Speaker 5: the competition is how I see it, and really have
32:12
Speaker 5: aggressively since.
32:13
Speaker 4: Then gone after pharmacies.
32:16
Speaker 5: Now, another nuance here is the provision in the current
32:20
Speaker 5: guidance that allows for compounding essential copies of FDA approved
32:27
Speaker 5: products if a significant difference is made to the drug
32:31
Speaker 5: product for an individual patient. And so this has led
32:35
Speaker 5: to some pharmacies compounding drugs that are in different dosage
32:40
Speaker 5: forms or routes of administration or strengths to meet individual
32:45
Speaker 5: patient needs. That has led to allegations of copying and
32:51
Speaker 5: pretext use of different dosage forms and things that violate.
32:57
Speaker 4: The spirit of the guidance.
33:00
Speaker 5: So there's a gray area there and room for discussion
33:03
Speaker 5: about what a true significant difference to an individual patient
33:06
Speaker 5: looks like. But right now, the guidance and the framework
33:10
Speaker 5: around drug shortage compounding is working and protecting patient access,
33:15
Speaker 5: whereas this bill would would end that drug shortage and
33:19
Speaker 5: replace drug shortage compounding and replace it with the arbitrary
33:21
Speaker 5: twenty cap.
33:24
Speaker 2: So it just seems to me, you've got this gray area,
33:27
Speaker 2: as you say, and the reaction I mean, for me,
33:34
Speaker 2: if you have a gray area that needs to be
33:36
Speaker 2: quote unquote fixed, you target a bill at that gray area,
33:40
Speaker 2: you tweak existing legislation. But here, I mean, there are
33:44
Speaker 2: bad actors out there, but it seems like this bill
33:47
Speaker 2: is throwing the baby out with the bath water. And
33:52
Speaker 2: painting with broad strokes and potentially hurting a lot of
33:56
Speaker 2: patients when it's trying to solve essentially a small problem.
34:01
Speaker 3: This graat area can't be that big.
34:03
Speaker 5: Yeah, Andrew, I think there would be ways to go
34:05
Speaker 5: in much more surgically and address this idea of what
34:11
Speaker 5: is a true significant difference and maybe building on the
34:15
Speaker 5: existing language and the guidance. But you're absolutely right they're
34:18
Speaker 5: throwing the baby out with the bathwater here by eliminating
34:21
Speaker 5: all compounding of drugs on the drug shortage list subject
34:25
Speaker 5: to the twenty per pharmacy cap per month.
34:30
Speaker 4: And so yeah, it's not.
34:34
Speaker 5: It's not the ideal system, and it's not going to
34:36
Speaker 5: improve patient access.
34:39
Speaker 3: Amy.
34:40
Speaker 6: Yeah, I think that's very well said, is that certainly
34:47
Speaker 6: there's significant access concerns with the proposal. I do point
34:52
Speaker 6: back to the Association letter from April in terms of
34:57
Speaker 6: a very helpful summary of walking through issue by issue
35:03
Speaker 6: where the concerns are. And I hope that you know,
35:06
Speaker 6: we can just keep working with anyone who is interested in,
35:14
Speaker 6: you know, patient centered policies. That's what's really driving us,
35:17
Speaker 6: and just to make sure that patients can get the
35:21
Speaker 6: medicine and need.
35:23
Speaker 2: Right well, thank you. Thank you both for taking the
35:27
Speaker 2: time to join us today. I know you're both really busy,
35:31
Speaker 2: and this is in some senses, it's a complicated issue,
35:35
Speaker 2: but in another sense, it feels like it's pretty straightforward.
35:39
Speaker 2: A lot of people are going to lose access to
35:42
Speaker 2: drugs that are in shortage that could have been given
35:45
Speaker 2: to them via compounding pharmacy if this passes. And you've
35:51
Speaker 2: mentioned a couple of times the letter from NCPA, which
35:55
Speaker 2: we will link to, But this is an issue that's
35:59
Speaker 2: going to affect a lot more people, I think than folks.
36:03
Speaker 3: Certainly folks in Congress realize that's.
36:06
Speaker 4: Right, Andrew.
36:06
Speaker 5: Yeah, And you know right now we're we're not seeing
36:10
Speaker 5: the bill move in this Congress, luckily, but we're really
36:14
Speaker 5: looking ahead to the next Congress and the possibility that
36:17
Speaker 5: it could get some traction, and so we're trying to
36:19
Speaker 5: make the rounds and educate folks about what it does
36:21
Speaker 5: it does not do.
36:23
Speaker 6: I gotta say that's one thing too the APC's done
36:26
Speaker 6: a great job about is just overall engagement and patient
36:32
Speaker 6: engagement as well on their website and on compounding dot
36:36
Speaker 6: com and just you know, pushing out these messages in
36:39
Speaker 6: points of concern I've built remissed without mentioning before we
36:43
Speaker 6: wrap up that their legislative conference, Compounders on Capitol Hill
36:48
Speaker 6: is right around the corner, and it really is a
36:51
Speaker 6: sterrific opportunity for compounding pharmacists to come to Washington and
36:58
Speaker 6: just explained the needs.
37:01
Speaker 8: Of their patients number one and then number two.
37:04
Speaker 6: The concerns about the legislative proposal, and sometimes I like
37:08
Speaker 6: to think of them as the love of unintended consequences. Right.
37:11
Speaker 4: So that's September fourteenth.
37:13
Speaker 6: Through the sixteenth here in Washington, and I think that
37:17
Speaker 6: APC just different registration for that.
37:20
Speaker 5: That's a great club. Amy, thank you so much for
37:22
Speaker 5: that wonderful clug again. And this bill will definitely be
37:24
Speaker 5: one of the top policy issues that we'll be talking
37:27
Speaker 5: about on Capitol Hill.
37:28
Speaker 4: So really encourage everybody listening to sign up and come
37:31
Speaker 4: join us at Compounders on Capitol Hill and we will
37:34
Speaker 4: both be there if.
37:35
Speaker 2: You are a compounding pharmacist or work with them, Yeah,
37:37
Speaker 2: Compounders on Capitol Hill. They'll be linked to that in
37:40
Speaker 2: the show notes also, And if you're a patient and
37:44
Speaker 2: you're getting compounded drugs or a drug you take is
37:48
Speaker 2: in shortage, talk to your pharmacist and talk to your
37:52
Speaker 2: legislator and say, hey, this is going to cut me off,
37:56
Speaker 2: because they don't always know what's happening on the ground
37:59
Speaker 2: with with real patients, especially if they're getting David, as
38:02
Speaker 2: you pointed out, a lot of misinformation from some of
38:06
Speaker 2: the bigger players. So again, thank you, Thank you both
38:08
Speaker 2: for being here. Really appreciate it. And that is it
38:13
Speaker 2: for this episode of Essential But before we hit that
38:17
Speaker 2: outro music, I always point this out if you are
38:20
Speaker 2: a compounding pharmacist or technician, or if you prescribe compounded meds,
38:25
Speaker 2: not only should you come to compounders on Capitol Hill,
38:27
Speaker 2: but remember the APC is here helping you and helping
38:31
Speaker 2: your patients. I won't go through everything that APC does,
38:35
Speaker 2: but we are the biggest and the loudest trade association
38:39
Speaker 2: for the compounding profession.
38:40
Speaker 3: So if you're not a member, we would love you
38:42
Speaker 3: to become one. We are working for you, So come
38:45
Speaker 3: on board.
38:46
Speaker 2: Just to head over to a four PC dot org
38:50
Speaker 2: check out what we're doing. All right, Brady, play that
38:54
Speaker 2: outro music now, Thanks everyone for listening.