Telemedicine has transformed weight loss treatments, but recent FDA changes threaten to upend the industry. Dr. Leo Damasco and Phoebe Gutierrez explore the impact of removing GLP-1 medications like tirzepatide and semaglutide from the shortage list, what it means for telehealth companies, and how providers can pivot to stay ahead.
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Recent FDA changes have rocked the telemedicine industry, specifically affecting providers and patients who rely on GLP-1 medications for weight loss. As tirzepatide and semaglutide are removed from the shortage list, compounding pharmacies will soon lose the ability to produce affordable alternatives. This shift has major implications for physicians, telehealth companies, and millions of patients.
Dr. Leo Damasco and Phoebe Gutierrez break down the regulatory landscape, explain why Big Pharma plays a key role in these changes, and discuss what providers should do next. They discuss the financial impact on telemedicine startups, the likelihood of legal challenges, and strategies for doctors to pivot before revenue streams dry up.
If you're a physician in telemedicine, a healthcare entrepreneur, or a patient relying on compounded GLP-1 medications, this episode is a must-listen.
Telemedicine Talks explores the evolving world of digital health, helping physicians navigate new opportunities, regulatory challenges, and career transitions in telemedicine.
🔹 Dr. Leo Damasco – A pediatrician and emergency medicine doctor who transitioned into telemedicine, finding flexibility and new opportunities along the way.
🔹 Phoebe Gutierrez – Former state regulator turned startup executive, now helping companies and physicians build smarter, compliant, and sustainable telemedicine businesses.
Connect with Phoebe Gutierrez:
Telemedicine, Digital Health, Physician Careers, Medical Regulations, Virtual Care, Weight Loss, GLP-1 Medications, FDA Regulations, Telehealth Startups
TELE TALKS EP 5===
[00:00:00] So today on telemedicine talks, we're going to talk a little bit about some new key changes that have been made in the prescribing world that are really going to probably rock a lot of companies, patients, providers, and physicians. We're going to be jumping into Weight loss today mainly focused on, the FDA changes related to trizepatide and semiglutide and how, removing those from the short list ultimately is going to have some implications for patients.
Yeah, this is huge. This is a bomb really in terms of the telemedicine world. Over the past two years, the weight loss just exploded, doubled in market share, what, eight, ~seven, ~8 billion in market share over the past two years. And ~the market share, ~the market really relied on the availability of these compounding GLP 1s, right?
And it relied on [00:01:00] the GLP medication to be on the shortage list. And that's why the compounders did what they did, or could do what they did. And now that these medications, semiglucides, terzapatides, are no longer on the shortage list, the compounders are no longer able To, compound medication, make it available for the patients.
Yeah, this is if it goes through it's going to send reverberations through the entire community because well, the telemedicine community really leans on weight loss as one of the big moneymakers and one of the big market shares. So let's rewind. So what does it mean to be on the shortage list, baby?
What, why is that important? And yeah take us back a little on how we got here. Ultimately it's a big supply and demand issue, right? So the way that compounding pharmacies are, somewhat regulated in the United States today are that when drugs are added to that short list.
That means compounded [00:02:00] pharmacies can do what they necessarily need to do to distribute drugs to reduce any barriers. And really the idea is that compounding pharmacies are a safety net that are helping in these kinds of instances, right? Yeah. So ~once a company, on an FDA approved drug list, let's say, such as, Tirzepatide and all of those things.~
Once a drug is no longer considered on a short list, it then gets removed and companies and patients are no longer able to access those compounding drugs because they have to now use a drug that has been approved by the FDA now. And how do you get on the short list? you talked about supply and demand, who defines supply and demand and, how do we get there?
Cause you know they the GLP ones are off the short list, but honestly, just looking at the market being in the market and, having the opportunity to prescribe these drugs. I still think, there's way more people that need these drugs, use these drugs than, the pharmacies are.
Able to able to supply them. And then this is just me, [00:03:00] I, obviously I'm not in the nitty gritty of it, but yeah, the demand's out there, right? Like how are they going to keep up with it? So what defines that rules? It's not the patient's wanting it, right?
It's not necessarily the patient's wanting it. I think there's a couple different things ~that, ~that factor in, right? At the end of the day, ~like you, ~you gotta follow the money trail, right? ~So it is, there is a huge implication in terms of ~Patients can still access the drugs, and if you have enough money to purchase the drugs, from ~again, through ~the companies that have the FDA approved drugs, it's okay, and you'll be able to continue getting the treatment that you need.
If you meet medical necessity for a very specific criteria, you can also continue to have that covered by your health insurance. But there's a huge group, especially in the GLP 1 community currently, that ~is, ~has been able to access those drugs at a fraction of the cost because compounded pharmacies, again, just like when you and I go to the doctor and we get a prescription, they always ask, do you want the generic or do you want the name brand?
[00:04:00] 99 percent of the time we're like, give us the generic cause it's five bucks right? ~I'm not, ~I'm paying one fifth of the cost of the same medication, the same effectiveness. And, you hit upon a good point, right? So these brand names ~are what the cost, the ~market cost off the shelf is ~what, ~like a grand a month ~to get a dose of these drugs, ~to get month's worth of these drugs versus the compounded pharmacies.
We're selling these drugs at 200 to $400 a month, that's what 60, 70% of the cost. And that made this medication very available to a huge subset of people. And a lot of times too, the people that actually need these medications belong in that subset of people that maybe can't pay a thousand dollars a month.
~So this this is a big thing yeah. ~No, and that's exactly it, right? So again, ~it's the, ~it's not so much that the drugs aren't going to be accessible, it's can a person who is used to paying 250 cash ~pay ~with a telemedicine company now be able to ~You know, still, ~still afford the same treatment, the same [00:05:00] drug with the same outcomes, but at, five times the cost that they're used to paying.
So you're going to see a lot of, ~in, ~in my opinion, you're going to see a lot of pissed off patients. You're going to see a lot of patients that are upset with doctors and telemedicine companies where they don't understand that this isn't a company thing. This isn't. Something that they are controlling, but it's really the FDA that ~has, again, ~has to go back to the way that the law is written, which is, compounding pharmacies can distribute these types of drugs, but only when there's real shortages.
~Yeah. Yeah. ~And what do you think the chances are? It's on the chopping block. It's already there. The FDA said no longer shortage. Now, they're allowing the compounding pharmacies ~to, quote, wind down ~to wind down their supply. Terzapatide was taken off the shortage list, what, a month or two ago, and Semiglutase just now and the FDA was giving these compounding companies a few months.
In two, three months, these compounds are not going to [00:06:00] be available. Right now, what do you think the possibility is of somebody stepping in and being like no this is a horrible move. are there possible ways around this? The short answer is no. I know that a lot of the companies that I consult for that I have, again, in health tech up until this point, doing weight loss treatment has been guaranteed revenue. It's been hot. It's been something that again, like everybody wants and they know that if they offer it, that they could sell it. And I. As much as people are being really optimistic and hoping that, there's going to be some sort of reversal I don't see that happening.
I see, again, that the FDA is just doing the normal process. I think, with some of these GLP 1 drugs, this was the first time in a long time where a drug was able, on the shortage list and was able to really be sold to the masses. And as much as like people are going to say Oh, there's going to be a lawsuit and [00:07:00] they're going to pause it.
That's just not necessarily how the law or the regulations work in this industry. There have been multiple already lawsuits against the FDA, mainly coming from the compounding pharmacy side, where they're saying like you are You know, screwing with our money here. And even if you decide to reverse it a month after this, you've still screwed up our money.
And the FDA is too bad, so sad. You knew what you were getting yourselves into. And if you thought this was going to be a perpetual thing, you have been misinformed. And that's what I've also told a lot of the companies that I'm working with that are doing, weight loss. If they don't have a contingency plan, if they don't have another like revenue stream or another service that they are exploring.
I'm starting to give them tips on like other markets that they might want to pivot into and try to, go into, you have to really think about these companies and these organizations are going to lose a significant amount [00:08:00] of their current user base for the simple fact of affordability.
And again, I go back to, yes, there are going to be instances where insurance can continue to cover this. But again, you're going through the insurance hurdle of the medical necessity and let's fight with getting denied and let's fight with the reimbursement. And a lot of companies, nowadays.
Can't take on that financial risk of sure. Let's give you the drug and let's hope insurance pays us back in a month You know, my take is just you know, I think that Everybody is hoping there's going to be some reversal. I know i've talked to lots of doctors who are like, oh, no, there's a lawsuit and i'm ~like and ~like the federal government gets sued all the time ~like ~That doesn't change what they're doing.
It just says like and I promise I'll stop talking after this. But I think the other thing that you have to think about is who are they going up against? Big Pharma. Do you think Eli Lilly wants this to continue? Absolutely not! You want to talk about The money piece, like they are really, like up [00:09:00] in arms about how much of their market share that they're giving away to these compounded pharmacies.
So you got to think about who, who actually has the money to win the battle here. Oh ~yeah. ~Yeah. And it's not the little guys, right? It's not going to be the small moms and pops compounding pharmacies that are out there, trying to hustle and work the bigger companies, right? ~It's going to be, ~it's going to be the big pharma folks with, their deep pockets and they can go on and on.
One comment about the insurance pay, right? lot of people got access, cash pay because insurance wouldn't cover it, right? ~Insurance, the ~insurance has strict criteria on who gets these medications. And the criteria is clinically based somewhat, but it's not necessarily encompassing of.
Who could benefit or of everybody that could benefit from the medication. So it's going to be ~these, ~this patient population that's going to miss out, that they're not going to be, they're not going to fall under the insurance umbrella, ~that that, yeah. ~When we were dealing with cash pay, was definitely more available to those [00:10:00] not necessarily fitting the tight criteria ~that ~insurance.
And as we know, especially on the doctor's side, the criteria set by the insurance may not be the most clinically, optimal criteria out there, right? So that's my worry, right? ~I honestly this medication, ~the use of this medication and weight loss, but not just in weight loss in~ in just ~the wider medicine realm in general.
It's huge, we found that it was beneficial with cardiac disease, with renal disease, with neurologic disease, so forth and so on. It ~got people, ~got people more active, got people, just out there. And it changed a lot of people's lives. And ~on, ~on the doctor side I'm sad and worried that this is what we're going to lose on.
So this is huge. So what do you think the next steps are? A lot of doctors, and then the telemedicine side rely on this, right? They've gone all in and practicing weight loss medication. And, one thing I do recommend, just like you're recommending to your companies is, on the doctor's side, maybe start looking for an alternate [00:11:00] revenue stream.
Great. The weight loss market was out there. It was easy to get into. Everybody was doing it right. Even those that didn't start out in the weight loss market, jumped on the weight loss market. Those that started out in erectile dysfunctions, men's health, women's health, any kind of health, jumped on the GLP market. And those that started out as other markets, I think they're going to be safer, but you're right. These companies that. Jumped on the weight loss bandwagon and only relied on the weight loss bandwagon and the doctors that support them You know that ~they're gonna ~they're gonna find themselves in a little trouble and yeah it's it may be time to start looking at a backup plan, especially if this thing doesn't go through right? exactly and I think like one thing to just consider and to factor in is like most of the telehealth companies that have again are primarily doing weight loss, maybe is their only revenue stream, most of those telehealth companies probably won't survive this.
And again, like you have to go back to if they [00:12:00] primarily are cash pay. They don't necessarily have all their processes in place to start the insurance process. They might not have the funding. Again a lot of people that I try to explain is insurance is not like a real time payment. You have to have a good six months worth of money in your back pocket to pay your providers and take that risk on.
So really just thinking about like the companies that you're working with are they going to survive this? Do they have contingency plans? ~And do they really, again, like some of them are a little, out there. But ~do they really think that they're going to need the same workforce that they have today?
If, they have an 80 percent reduction in memberships ~or, ~and again we could take ~like ~the big name, which is, hims and hers. that lost, after both drugs came off the short list they dropped 35 percent in, ~like ~their stock.
If HIMSS is impacted at that level. You have to think these little mom and pop places or some of these other not as well [00:13:00] established companies are also going to be, in the same boat, if not even worse, because they don't have the market share that HIMSS does. Yeah, no, that's a great example, because, HIMSS and HERS, for those that don't know or don't necessarily practice too much, telemedicine market, ~Hims and Hers ~started as a men's health and a women's health company erectile dysfunction, so forth and so on, and they have ~various ~various income streams, various ~kind of ~lines of medicine they practice, and they did jump on the GLPs, and it's been very successful for them, ~and ~ they will be okay, I think because they will be able to fall back on their other revenue generating streams.
The smaller companies that jumped on that don't have these alternate streams. Yeah, they don't have the comfort of doing that. And the doctors that are supporting them, heads up yeah. You may need to start looking and start looking at different avenues.
So my biggest thing is and again this is what I'm telling companies that I'm working with is, you can't like a pivot [00:14:00] is okay. And you could actually pivot in a really interesting and smart way. Think about instead of, focusing solely on the drugs and the prescribing aspect, maybe go into health coaching, maybe go, physicians don't want to hear this, but yeah, maybe get some dietitians, maybe try some non medication options.
And again, like maybe it could be like a kind of organic pivot into integrative medicine or functional medicine. I think there are options they have, but it really is to your point, HIMSS has gosh, 12, 15 services that they offer. Most companies that I know usually pick one until they're ready to expand.
And if you are a company or working for a company that solely does weight loss, I think there are some questions that you're going to need to ask yourself around the viability of that company long term. And again it's, this happens all the time. Companies, get funded, they have all this money, and then they run out [00:15:00] of runway.
They run out of, the funds that they need to keep the operations moving day to day. And so it, I think it's going to be really interesting to see what happens in about 60 days when, these drugs are not able to be produced by these pharmacies any longer. Yeah, I know.
True. True. And let's also talk about the patient backlash, right? You're a doctor on the front lines. Are you ready to talk to your patients about this? Hey the cost of your medication, the cost of your treatment may go up a hundred to a hundred percent. You're gonna have some very unhappy patients, why?
Why are you doing this to me? So another thing to prepare for, ~prepare to be, to ~prepare to lose some patients, prepare to have some angry patients and yeah. Be prepared. Yeah. I'm guessing that again, like if you think about a normal consumer, they are not going to understand what these rules mean.
They're not going to understand why they're going to take it out on the doctor. They're going to, you told [00:16:00] me that like I should start this and now like I've been taking it for two years and what the hell am I supposed to do? And so I think, yeah, your point is completely I think physicians should prepare for some of that backlash, maybe, start thinking about some talking points that they can, explain to their, patients so they You know, soften the blow, but no, absolutely you're going to have some very disgruntled folks on your hands.
Yeah. No these patients depended on this, right? ~They, ~their whole lives changed because of it. And about these medications, right? Once you stop it, ~right? ~Unless you've changed your lifestyle, unless you change your diet, your weight's coming right on back. So yeah ~that's going to happen.~
That's going to happen. Because a lot of these people have been on the maintenance doses of these medications, keeping their weight low because of the medications. So yeah, hopefully there was, a good diet plan, a good exercise plan enacted. Cause yeah going to be some changes happening.
So ~yeah. So bottom line. ~Yeah. If you're a provider, you're a company start preparing now, right? Figure out your next move. The [00:17:00] industry we think is going to change a lot. The chances of this shortage, we think is not going to get reversed and, this may be the new reality. So yeah if you're a doc out there, pharmacist, whatever, and you're already seeing backlash or the effects, the ripple effects of this, we'd love to know about it.
We'd like to hear from you. Drop us a line, drop us a line in the comments, email us. At info at telemedicine docs. com and yeah, let's talk about it. Let's talk more and let's dig deeper.