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U.S. Supreme Court and Generic Drugs | TWIRx · Pharmacy Podcast Network

• 0:05
  Speaker 1: You are listening to the global network of podcasters dedicated
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  Speaker 1: to the pharmacy profession. Welcome to the Pharmacy Podcast Network.
• 0:22
  Speaker 2: Hey, welcome to This Week in Pharmacy. My name is Todd.
• 0:27
  Speaker 2: You're a founder of the Pharmacy Podcast Network seventeen and
• 0:32
  Speaker 2: a half years agoing this profession is in flux, it's changing,
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  Speaker 2: have a wonderful show today. I cannot wait to get
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  Speaker 2: in to some of the material. We're going to go through.
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  Speaker 2: Cassian a transformative digital patient journey. Cassian is in the
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  Speaker 2: specialty pharmacy space. Their team is made up of some
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  Speaker 2: passionate pharmacists. I began working with him. We're going to
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  Speaker 2: our hometown and how special specialty pharmacy is out of Pittsburgh.
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  Speaker 2: So shout out to Cassian and everything that you're doing.
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  Speaker 2: Can't wait for the three part series to come out.
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  Speaker 2: This is twerks. Let's go. Hey, Welcome to this Week
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  Speaker 2: in pharmacy. This This has been a recovery week for me.
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  Speaker 2: I got back from the Assembia twenty twenty six conference.
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  Speaker 2: I picked up a little cold, as you can probably
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  Speaker 2: hear in my voice, and Hey, we all have to
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  Speaker 2: of that. You may have seen the first of the
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  Speaker 2: three part series that came out this week in Pharmacy,
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  Speaker 2: one of six. It was a record setting gathering of
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  Speaker 2: specialty pharmacy experts, and our coverage was record setting as well,
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  Speaker 2: and you're not going to want to miss that. Hey,
• 3:42
  Speaker 2: on Twerk's News Up first, wanted to note the first
• 3:48
  Speaker 2: stories out of Pharmacy Times just today This Week in
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  Speaker 2: Pharmacy featuring doctor Meghan Morony, and she discusses the antidepressants
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  Speaker 2: use and withdraw, describe deep prescribing, and the pharmacists role
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  Speaker 2: in patient education around mental health and the main point
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  Speaker 2: and the concerns about anti depressants should be addressed through
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  Speaker 2: evidence based conversations and certainly not fear you get on TikTok.
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  Speaker 2: You see so many things of people talking about one
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  Speaker 2: side or the other. I don't like that, Like when
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  Speaker 2: pharmacists and physicians enter the chat. There's a lot of
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  Speaker 2: them out there, lots of TikTokers out there who are pharmacists,
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  Speaker 2: very proud of you, and I'd say ninety five percent
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  Speaker 2: of you are evidence based and put up some good information.
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  Speaker 2: There's that five percent outliers that are disappointing and sometimes
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  Speaker 2: they're drifting and they want they want to sell stuff.
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  Speaker 2: But patients should never stop antidepressants abruptly. They should speak
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  Speaker 2: with their pharmacists, their prescriber, a care team about side
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  Speaker 2: effects and tapering off from long use. And doctor Moroney
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  Speaker 2: emphasizes the clinicians need more training on safety discontinuing antidepressants
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  Speaker 2: and not just starting them. She recommends shared decision making
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  Speaker 2: using brand framework b R a n framework benefits risk
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  Speaker 2: alternatives and doing nothing and just understanding how both decisions
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  Speaker 2: can affect a patient, letting them know what the issues
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  Speaker 2: could be, and just flagging it. Education's everything. The article
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  Speaker 2: also notes that lifestyle strategies, especially exercise, Wow, they always
• 5:42
  Speaker 2: want this American culture especially, they always want to just
• 5:47
  Speaker 2: pop a pill and go on their married way and
• 5:50
  Speaker 2: expect it to just solve everything and have no idea.
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  Speaker 2: And I'm a hypocrite and saying that I'm not on
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  Speaker 2: a consistent regimen of exercise. I'm on and off, on
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  Speaker 2: and off. I'll do great for six months and then
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  Speaker 2: crappy for three months and then get back on it.
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  Speaker 2: But always trying to come back to the importance of
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  Speaker 2: exercise on how that can support depression care, particularly for
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  Speaker 2: mild symptoms as part of a broader treatment plan. We'd
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  Speaker 2: love to have you on twerks. If you are a pharmacist,
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  Speaker 2: you're listening, you're curious about mental health, or you want
• 6:25
  Speaker 2: to dig deeper into a specific disease date that you've
• 6:29
  Speaker 2: been involved with, please reach out to us. We would
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  Speaker 2: love to have you join us on twerks. A next
• 6:38
  Speaker 2: article up AMI AMIA Amplify Poster session first data Bank
• 6:46
  Speaker 2: pharmacists show patients specific medication guidance that can reduce pharmacy
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  Speaker 2: alerts by seventy percent. This is huge, and the reason
• 6:58
  Speaker 2: is is because you're working hard, you're on your system
• 7:03
  Speaker 2: and the disruption of the dings and the pings on
• 7:08
  Speaker 2: your pharmacy system. FDB research presented for the twenty twenty
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  Speaker 2: six AMIA Amplify Informatics Conference found that patients specific risk
• 7:19
  Speaker 2: based medication guidance can reduce pharmacy alert volume by seventy
• 7:24
  Speaker 2: percent in a high volume community pharmacy setting. The approach
• 7:28
  Speaker 2: consolidates multiple safety alerts into one actionable message tied to
• 7:35
  Speaker 2: the patient's most relevant clinical risk, helping reduce alert fatigue
• 7:41
  Speaker 2: and improve pharmacist workflow. Pharmacists accepted recommended next best actions
• 7:48
  Speaker 2: more than seventy five percent of the time and reported
• 7:50
  Speaker 2: more time for patient interaction. I mean that is what
• 7:56
  Speaker 2: technology is supposed to do. It's supposed to open up
• 8:00
  Speaker 2: more opportunities for pharmacists to spend time with their patients.
• 8:07
  Speaker 2: And I love this. We're going to be working more
• 8:09
  Speaker 2: with FDB, hoping to be partnering with them for the
• 8:15
  Speaker 2: NACDS Total Store Expo, as well as possibly the NASP
• 8:19
  Speaker 2: the National Association of Specialty Pharmacy twenty twenty six. So
• 8:25
  Speaker 2: stay tuned for more from FDB on the Pharmacy Podcast Network. Hey,
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  Speaker 2: next up, this is interesting, definitely about compounding pharmacy. I
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  Speaker 2: know the team at Empower Pharmacy and how dedicated to
• 8:44
  Speaker 2: safety and how dedicated to patient choice and patient empowerment.
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  Speaker 2: Thus the name and Power Pharmacy and the article headline
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  Speaker 2: that comes from MSN says. Judge dismisses part of Eli
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  Speaker 2: Lilly's GLP one lawsuit against Houston's Empower Pharmacy. I think
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  Speaker 2: you all know, just being in the industry reading between
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  Speaker 2: the lines, that the pharma company would like to control
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  Speaker 2: everything about a product and the compounders out there have
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  Speaker 2: targets on their back from a positioning of revenue and
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  Speaker 2: not necessarily what's best or convenient or accessible medication from
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  Speaker 2: the patient's perspective of Federal Judge dismissed key parts of
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  Speaker 2: Eli Lilly's lawsuit against Houston based Empower Pharmacy over compounded
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  Speaker 2: trizepetide versions of Manjaro and zep bound. The judge throughout
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  Speaker 2: Lily's federal trademark and Texas unfair competition claims, saying Lily
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  Speaker 2: had not shown lost sales or irrepar will harm, but
• 10:01
  Speaker 2: allowed unfair competition claims in other states to continue. In
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  Speaker 2: Power called the ruling a win for patient access, while
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  Speaker 2: Lily said it will keep pursuing. It will keep pursuing
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  Speaker 2: cases against compounders selling unapproved GLP one versions. You know,
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  Speaker 2: if a compound pharmacy, if a compounder of pharmacy and
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  Speaker 2: independent compounder of pharmacy is out there and you want
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  Speaker 2: to jump on this Week in Pharmacy and talk about
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  Speaker 2: some of the things that you experience from some of
• 10:34
  Speaker 2: the wholesalers or I'm sorry, the pharmer manufacturers, please reach
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  Speaker 2: out to me. I do want to give a shout
• 10:42
  Speaker 2: out to the CEO, Sean Norian. Sean is a champion
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  Speaker 2: of patient care. I've talked to many times, Proud of
• 10:52
  Speaker 2: what he's built through. In Power, just keep a heads
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  Speaker 2: up on compounding and flag us. If you get contacted
• 11:02
  Speaker 2: by a pharma manufacturer and it's unfair, Oh and flag us.
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  Speaker 2: We'd love to tell the story. We'd love to tell
• 11:11
  Speaker 2: your story. We'd love to get you involved on the
• 11:16
  Speaker 2: Pharmacy Podcast Network through This Week in Pharmacy, we have
• 11:20
  Speaker 2: a really interesting interview about the future of generics. I
• 11:26
  Speaker 2: don't want you to miss this. This is from a
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  Speaker 2: guy who's been in the industry for twenty plus years.
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  Speaker 2: He knows the intricacy, he knows the details, he knows
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  Speaker 2: the market around generic medications and how a Supreme Court
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  Speaker 2: case could change the game. You do not want to
• 11:46
  Speaker 2: miss this. We'll be right back with more tworks.
• 11:56
  Speaker 3: This episode of This Week in Pharmacy is sponsored by
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• 13:18
  Speaker 4: Hey, Returning to twerks today, Andy Crawford, Vice president of
• 13:23
  Speaker 4: pharmaceutical Sales and Marketing with a key source. Andy, it's
• 13:28
  Speaker 4: so good to see you, Nay.
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  Speaker 1: Likewise, my friend, thanks for having me again. Appreciate you.
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  Speaker 4: Hey, you posted something that we didn't get a chance
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  Speaker 4: to talk about the week that it came out. It
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  Speaker 4: was published through Drugstore News. One of my favorite authors,
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  Speaker 4: Sandra Levy wrote us Supreme Court, here's generic drug patent
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  Speaker 4: case that could impact generic drug industry, and you had
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  Speaker 4: some comments on that. I was really interested in bringing
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  Speaker 4: a LinkedIn post that you put out to kind of
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  Speaker 4: dig into this concept because it's the It's exactly what
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  Speaker 4: she wrote, it's it's gonna it's gonna change some things.
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  Speaker 4: So talk to our listeners about this.
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  Speaker 5: Yeah, sure, I think I don't think this innovation is
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  Speaker 5: anything new, right, Skinny skinny labeling, which is really what
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  Speaker 5: the article and the post revolves around is, was really
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  Speaker 5: designed to balance innovation and affordability. But I think some
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  Speaker 5: think it's becoming somewhat of like a strategic weapon speak,
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  Speaker 5: you know, as a generic manufacturer labeling and using their
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  Speaker 5: generic alternatives for indications other than maybe what they were
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  Speaker 5: intended for. And I think the other side of the
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  Speaker 5: coin and me being pro generic, right, that's my uh,
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  Speaker 5: that's those my people, that's my wheelhouse is you know, well,
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  Speaker 5: is this just you know, patent extension tactics for for
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  Speaker 5: some of the brand companies, right? And then and ultimately
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  Speaker 5: how we all, even the government, you know, we all
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  Speaker 5: want to say, well, how does this really impact assisting
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  Speaker 5: and benefiting the consumer ultimately? As generics and the attention
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  Speaker 5: of generics are obviously the lower prices of pharmaceuticals for
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  Speaker 5: patients across the country and ultimately one of the biggest
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  Speaker 5: levers that can be pulled and learn healthcare costs. So
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  Speaker 5: it's really an interesting kind of case in I think
• 15:34
  Speaker 5: something that I think your listeners and why I kind
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  Speaker 5: of feel strongly about is that the issue impacts more
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  Speaker 5: than just manufacturers, right, depending on I think the outcome
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  Speaker 5: of this, and many think that the outcome will probably
• 15:45
  Speaker 5: be a little bit more mute than some of the
• 15:47
  Speaker 5: articles you allude to. But it really affects the whole
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  Speaker 5: pharmaceutical supply.
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  Speaker 1: Chain, you know, me and distribution, you know.
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  Speaker 5: Pharmacies servicing patients, maybe we're a doesn't available anymore, PBMs,
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  Speaker 5: sourcing provider, prescribing behavior. I mean, the list goes on
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  Speaker 5: and on and on, right, So it was a really
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  Speaker 5: interesting thing and I think more to come and more
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  Speaker 5: to watch.
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  Speaker 4: So how do you how do you see or a
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  Speaker 4: what do you speculate the Supreme Court's decision? If it
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  Speaker 4: affects the speed and confidence for which generic drugs enter
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  Speaker 4: the market, how do what's your opinion?
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  Speaker 2: How does that play out?
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  Speaker 4: And depending on how they decide what they decide to
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  Speaker 4: do with with HIKMA.
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  Speaker 5: You know, I'm not an expert on you know, why
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  Speaker 5: and how NDAs are filed and what gets pushed through
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  Speaker 5: the FDA proof and what doesn't I think, you know,
• 16:43
  Speaker 5: a pharmacist, and many of your listeners, being pharmacists, are
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  Speaker 5: probably more apt to answer that question than me in
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  Speaker 5: those in development with manufacturers. But I think it goes
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  Speaker 5: back to my original comment, which is what is the
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  Speaker 5: the patent and the indication of use for? And what
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  Speaker 5: is maybe the generics labeling? Skinny labeling alluding to an
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  Speaker 5: indicated use that maybe is not.
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  Speaker 1: What the original patent was intended for.
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  Speaker 5: So I think I don't think the government in the
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  Speaker 5: Supreme Court wants to restrict or funnel generic market entrants.
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  Speaker 5: If anything. You know, the FDA and have been very
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  Speaker 5: supportive of faster.
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  Speaker 1: Entrance to market for generics.
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  Speaker 5: And that's why we've seen so many a DA A
• 17:30
  Speaker 5: and DA which is the abbreviated new drug application that
• 17:34
  Speaker 5: a generic manufacturer files for when they want to bring
• 17:38
  Speaker 5: a product to market. Why those have come through so
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  Speaker 5: much quicker that the FDA has really been supportive of
• 17:45
  Speaker 5: bringing more of those products to market, and ultimately that
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  Speaker 5: benefits the consumer and benefits healthcare in America.
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  Speaker 4: Andy, what what should pharmacists pharmacy owners understand about You
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  Speaker 4: mentioned skinny labels, patent in indications and generic substitutions When
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  Speaker 4: counseling patients or working with working with or even communicating
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  Speaker 4: with prescribers.
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  Speaker 5: I just think that, you know, if if there was
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  Speaker 5: an intended consequence from this court case, maybe does that
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  Speaker 5: I guess the downstream effect to patients and prescribers is,
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  Speaker 5: does that give them less options in the future?
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  Speaker 1: Right?
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  Speaker 5: I think that's one of the biggest outcomes that could
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  Speaker 5: happen from this. Fewer fewer launches, more litigation risk, delayed competition,
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  Speaker 5: and ultimately what does that all mean for the consumer?
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  Speaker 5: Possibly higher cost of drugs. You know, I think that
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  Speaker 5: what the manufacturer, what the manufacturer probably will see from
• 18:50
  Speaker 5: this is maybe what's likely to happen is skinning levels
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  Speaker 5: will most likely continue to survive, but I think manufacturers
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  Speaker 5: will likely have to kind of tighten up their guardrails
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  Speaker 5: around marketing language, right, promotional claims, and public communications about products.
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  Speaker 5: So compliance, probably that burden of compliance from coming to
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  Speaker 5: market in an entry on a new generic, probably increase
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  Speaker 5: would be.
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  Speaker 1: That would be what my intuition would be from a
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  Speaker 1: result of this.
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  Speaker 4: All right, So I guess my last question, and this
• 19:28
  Speaker 4: is more about the ruling, is marketing. So we always
• 19:33
  Speaker 4: talk about different facets of marketing and compounding, for example,
• 19:38
  Speaker 4: gets themselves sometimes in trouble if they're not seeing the
• 19:41
  Speaker 4: right ways of marketing a compound.
• 19:44
  Speaker 2: So what about marketing?
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  Speaker 4: Could the ruling against Tikma make generic manufacturers more cautious
• 19:50
  Speaker 4: in marketing, education, communication with providers. I don't like that.
• 19:54
  Speaker 4: I'm a communicator, I'm a marketer. I'm a communications person.
• 19:57
  Speaker 4: I want more of it.
• 19:58
  Speaker 2: I don't want less of it. So what's your thoughts
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  Speaker 2: around that?
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  Speaker 1: Yeah?
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  Speaker 5: Quite possibly, Yeah, I think so. I think you know
• 20:06
  Speaker 5: that could be a result of this. But back to
• 20:09
  Speaker 5: the original I think you know idea behind this whole
• 20:13
  Speaker 5: court cases. Is there off patent use or pushbraw patent use,
• 20:18
  Speaker 5: an indication of the product being manipulated in any.
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  Speaker 1: Way from a generic manufacturer.
• 20:26
  Speaker 5: The uncertainty really comes down to for a lot of
• 20:29
  Speaker 5: us in the distribution space. You know, when we talk
• 20:31
  Speaker 5: about marketing, I would call it less marketing, more transparent communication.
• 20:37
  Speaker 1: Hey, there's a new market entrant on this product.
• 20:41
  Speaker 5: If it's a first to market, there's a significant advantage
• 20:44
  Speaker 5: and a significant financial advantage on a product coming first
• 20:47
  Speaker 5: to market because usually there's a pretty high delta between
• 20:50
  Speaker 5: acquisition costs of a single source even a single source
• 20:54
  Speaker 5: generic or a brand to a.
• 20:56
  Speaker 1: Multi source generic.
• 20:58
  Speaker 5: Right, So if that generic maybe has lost its exclusivity
• 21:03
  Speaker 5: and day one any one hits, you've got five or
• 21:06
  Speaker 5: ten more entrants coming to market, which would significantly erode
• 21:10
  Speaker 5: acquisition costs. And I think you know, timing, sourcing, strategy,
• 21:15
  Speaker 5: reimbursement dynamics, price, competition, They're all things I think that
• 21:20
  Speaker 5: would be influenced depending on the outcome of this case.
• 21:25
  Speaker 4: So well for the listeners, Andy has been honored as
• 21:29
  Speaker 4: one of our Pharmacy fifty Most Influential People for twenty
• 21:32
  Speaker 4: twenty five and your insights are prevalent on LinkedIn. So
• 21:37
  Speaker 4: if you're listening and you have not connected with Andy Crawford,
• 21:41
  Speaker 4: easy name and to remember Andy Crawford with key source,
• 21:45
  Speaker 4: reach out to Andy, follow his posts, ask questions. Andy,
• 21:49
  Speaker 4: thank you so much for being a guest on twerks
• 21:53
  Speaker 4: and we hope to have you back.
• 21:54
  Speaker 1: Thanks again, appreciate you