The Battle Over Weight Loss and Compounded Drugs

In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight loss drug industry. Following the February 2026 announcement that the GLP-1 shortage is officially resolved, the "Golden Age" for compounders has vanished overnight, leaving companies like Hims & Hers in the crosshairs of both the FDA and Novo Nordisk.

Darshan takes us from the tragic "ghost" of the 2012 NECC fungal meningitis outbreak to the modern-day "Compounding Wild West." We explore the crucial differences between Section 503A and 503B pharmacies and why adding Vitamin B12 to a patented molecule isn't the "customization" compounders claim it is.
Key topics include:

• The NECC Legacy: How a 2012 tragedy created the Drug Quality and Security Act (DQSA) and why the FDA is using it to end the mass-marketing of copycat drugs.
• The Science of the "Bluff": Why "not adulterated" does not mean "safe and effective" under the FD&C Act.
• Novo Nordisk vs. Hims & Hers: The billion-dollar patent battle and why the DOJ is now getting involved.
• The Shortage Shield: What happens to telehealth platforms the moment the FDA "Shortage" flag disappears.

Don't let your healthcare be decided by an Instagram ad. Understand the intersection of biochemistry and federal law to protect your health and your practice.

Transcript

Darshan 0:00

Welcome to Darshan Talks. To learn about healthcare, you're actually allowed to understand. I'm your host, Darshan Kulcarney. Today we're tackling the biggest legal and medical collision of the decade. The war over weight loss medications. We're going to talk about why the FDA, the very agency meant to protect you, sometimes causes the shortages that put you at risk. We're going to talk about the compounding wild, wild west. And most importantly, we're going to talk about the tragedy from before 2012 that changed the law forever. And why that coast is the reason companies like him and hers are suddenly running for cover while Nova Nordisk is going onto the offensive and launching a scorched earth offensive, if you will. The fact is that healthcare sits at the intersection of two of the most complex languages on earth: biochemistry, federal law. My life has been spent living at that intersection. I started as a doctor pharmacy, I stood at the counter, I talked to patients, I wondered how the molecular structure of drugs would uniquely interact with a patient's personal biology. And I quickly learned that chemistry is only half the answer. It's the law. So I went back and amongst a few other degrees, I also became an attorney. I've spent 20 years navigating the FDA, the Department of Health and Human Services, and the halls of Congress. When you subscribe to this podcast, and I hope you do, you aren't just getting an influencer's opinion on the latest health trend. You're getting the dual lens view from someone who knows the signs and the court transcripts. So if you want to understand why a local compounding pharmacist is currently in legal panic, we have to go back to about 2009. And let's talk about a dirty little secret from the industry. The FDA often causes the very shortages it's trying to fix. Now we all want the FDA to be strict. We want them to walk into a factory and say, this floor isn't clean enough. Shut it down. But here's the paradox. When you do this to a major plant for compliance issue, maybe it's just a paperwork error, maybe it's a cooling fan that isn't up the spec, maybe it's multiple companies. Either way, you're raising expectations, and the shortage of that drug stops instantly and possibly forever. So in 2009, when the FDA unilaterally declared that they're going to start regulating and insisting that there's a higher quality than drug manufacturers of meat, several drug manufacturers said that it was simply not worth it for them to keep making the drug. They had incredibly thin margins, and these new requirements would push them into unprofitability. So suddenly you had massive drug shortages. I remember I was working as a pharmacist, and we had 200, 300 of them at a time. Patients who had cancer couldn't get their medications. Pharmacies were the saving grace. Compounding pharmacies came in and tried to fix that problem. Before 2012, compounding pharmacies were largely just the neighborhood apothecary. It mixed a little bit of cream for a rash, liquid version for a child who couldn't swallow, something for your vets, so that you can give it to horses or to your pet. They were all regulated by the state boards of pharmacy, but not the FDA. With these shortages, the neighborhood apothecaries suddenly became high-volume drug manufacturers with none of the oversight that the FDA provided. So inevitably, we became due for a tragedy. That tragedy was the New England Compounding Center with the NECC. The NECC wasn't acting like a neighborhood pharmacy. They were acting like a massive drug manufacturer, but without any of the FDA's good manufacturing practices oversight. They were mass-producing vials of a drug called metalprenicillin acetate. It's used for back pain, but it's also just a simple steroid. There's nothing exotic about it. But they wanted to move fast. Since they had high volumes, they were making loads of money, they had orders to fill. And hopefully because they also wanted to just help patients. But they skipped things that were essential, like sterility testing. Let me be clear, sterility testing possibly wasn't even required at this point. We just didn't have the rules at that point. But it should have been expected. And if you're a pharmacist making that high volume of drugs, we should have known. And the result was horrific. The vials were contaminated with black mold. Doctors across the country injected that mold directly into the spines of the patients, and it caused a fungal meningitis outbreak that killed 64 people and sickened nearly 800 more. I remember where I was when the news broke. Every pharmacist in the country felt a pit in their stomach. We knew that the world was about to change, and we knew that certain pharmacists, the ones from NECC, they were looking at jail time and they did go to jail. In response, Congress passed the Drug Quality and Safety Act, the DQSA of 2013. This law created a great wall. It created two new classes of pharmacies, the 503A and the 503B. 503A are your traditional pharmacies. You can only make a drug if they have a specific prescription for a specific patient. There has to be customization. And we're going to talk about this because that's where we are right now. Then there are 503Bs. These are the outsourcing facilities. They can mass produce. You have to follow much stricter FDA rules like a mini Pfizer, and you can only compound what's on the FDA shortage list. But when the drug hits the FDA shortage list, it triggers a legal loophole of the Food, Drugs, and Cosmetics Act. The law says if the big guys can't make it, we will let the compounders step in so that patients don't die or suffer. This was the golden age for compounders, and went on until possibly right about now. This is when compounders were legally allowed to copy the most profitable drugs in the world because the FDA's own oversight had contributed to the shortage. What if that golden age has just ended and why does it matter today? Well, it matters because for the last two years, these compounders have been trying to blur the lines between the two sections that sell you these weight loss drugs. And the FDA is finally saying, remember the NECC, we aren't letting that happen again. This is the part of the podcast where I tell you to put on your science hats. When you see a telehealth ad for compounded semaglutide, you always use words like safe and FDA approved. As a pharmacist and a lawyer, I need you to know that these words are being used as a legal shield. Quite bluntly, in many cases, they're a lie. And they have been called out. The FDA has cited them because they do not represent a scientific reality. In the world of the FDA, there are three distinct pillars of a drug. There's efficacy, there's safety, and there's adulteration. There's also misbranding. We aren't going to talk about it right now. Let's talk about efficacy. Speaking of a drug like Regovia Proof, Novanordis has to spend billions of dollars on efficacy studies. They had to prove to the FDA that this specific molecule in this specific concentration, manufactured in a specific way, delivered in this specific way, actually makes people lose weight or addresses diabetes over five years. But safety is a little bit more complicated. Lawyers for compounders and the compounders themselves are saying, we've done the testing, we can show that our product is made in a clean environment, therefore it's safe. That's a fundamental misunderstanding of how the word safety is used under the Federal Food, Drugs, and Cosmetics Act. Specifically, safety is defined for the product. You need to show that a product made in a specific concentration in a specific way delivers the specific format. That if there's harm, that level of harm is acceptable. In this specific scenario for a specific disease state, we don't actually know the answer. We might know that the facility in which it comes from is clean and makes the product in an acceptable way, but we don't know enough about the product itself. That product has not been evaluated. And that's the difference between, say, RC colo and coke. They may both have similar ingredients, but they're not the same. And when there's a drug shortage, that may be good enough, but when there isn't, there's a vast difference between the two. Compounders have zero safety and efficacy studies. They're just assuming that because the product is similar enough to Novo's product, it will work the same way. In the eyes of the law, that product is an unapproved drug. So what about adulteration? This is what compounders focus on. They'll show you a piece of paper, this fancy piece of paper with a big title on it called certificate of analysis. It shows that the raw ingredients are not adulterated. It means that there's no lead, there's no mold, there's no poison, it's not a safety issue. That's the assertion that they're gonna make. They're going to say it's the exact same ingredient as the original approved drug. They might say it's FDA approved, but that's not true. It's not going to be the original approved drug because that would be a patent violation. And there's no evidence that this similar product is good enough or that the differences are meaningless. And without that evidence, the compounded drug is effectively snake oil being made in a clean environment. Essentially, compounders are mixing two concepts. They want you to believe that because the product is not adulterated, it is therefore safe and effective. And those two things are completely different. It's a massive leap that the law simply does not support. So, how did we get to a point where everyone is buying these copycat drugs? For that, we have to blame or thank COVID. Before 2020, telemedicine was a niche service. But during the pandemic, with no way to access medications of physicians, the government loosened the rules. Doctors could prescribe almost anything over video call. When the weight loss craze hit, companies like Him's and Hers, Roe, and Noom realized that they had a built-in delivery system. They paired a five-minute online consultation with a compounding partner. Let's be honest, it was a brilliant business move. They didn't have to buy the expensive brand name drug. They could mark up the cheap compounded version by 500% if they wanted to. And they could hide behind the FDA shortage list as their legal justification. And for a while they were the darlings of Wall Street. They were disrupting healthcare. But disruption in tech is fine. Disruption in the Food, Drugs and Cosmetics Act may be a felony. Nova Nordis sued multiple times, but they lost. They were told by the judge or by the court that the Food Drugs and Cosmetics Act allows compounding pharmacies to make these drugs, and to the extent they don't, only the FDA can enforce the FDNC Act. And since Novo Nordis is not the FDA, they don't have the right to enforce. There was no patenting issue because they were making copies that were similar but not the same. And then the marketing issues. And we'll talk about it a little bit further, but as long as they were not showing specific harm to Novo Nordis, those claims were allowed. The compounders are smart enough to avoid or at least cloud the issue. So let's get to today. Why did Hymns and Hers, a company worth billions, suddenly pull that compounded Wigovi pill after only four days in the market? Hymns and Hers and Roe, in February 2026, it was announced that they're going to start making a compounded pill. There was no shortage. They tried to assert that it was the personalization for patients, but there's no patient care whose pill needs to be personalized. Furthermore, is it really personalization if you've got a literal ton of them sitting in your pharmacy waiting for the next patient to come in? In the past, the DEA has said that, you know what, unique decisions that need to be made for the patient to decide whether a medication is appropriate. If you give the prescriber pre-printed forms, that's not unique anymore. In the same way, if you have a literal pile of medications and you're just saying use one of these, is that really personalization? How is this any different? So what we have now is where the FDA has stopped being polite. In 2026, the FDA and the Department of Health and Human Services issued a joint statement. They said that the compounders were no longer just filling a gap. They were trying to replace the regulated pharmaceutical industry entirely, and that's not okay. The FDA began bringing lawsuits under the Food, Drugs and Cosmetics Act. They began essentially targeting the quote unquote essentially a copy rule. That rule says that even during a shortage, a pharmacy cannot make a drug that is essentially a copy of a commercially available product unless there's a change that produces a clinical difference for an individual patient. Now, compounders start to get cute. They start adding vitamin and they said, look, it's not a copy, it's a customized wellness blend. And the FDA's response, nice try. Adding a vitamin to a patented drug does not make it a new drug. It makes it an unapproved, misbranded, and adulterated version of a patented drug. We're already seeing versions of this with some of the rectile dysfunction drugs as well, where they're combining products that no one has really asked for and saying, come buy these. So the FDA commissioner is referring these cases to the Department of Justice for criminal investigation. These disruptors are going to realize that the game is over. This is why Hims and Hers took the backseat. The legal team seems to have realized that the shortage shield is gone. Now, personally, I don't think it's over. I do think there will be other claims made, and quite bluntly, the market is simply too big and too profitable to ignore. Now, while the FD is attacking from the regulatory side, Novo Nordisk, the maker of Ozempik and Wigovi, is attacking on the civil side. Since last year, Novo has been a scorched earth campaign. They aren't just suing for money, they're suing for trademark infringement and false advertising. And they've won some and they've lost some, but in this specific case, it's very clear that Novo owns the molecule. Novo's also going after the telehealth platforms themselves. They're arguing that by marketing compound or semaglutide, these companies are confusing the public into thinking that they're getting the FDA approved one. In fact, if you look at the warning letters, you're going to see that they claim that the product is FDA approved when it's not. Here's the kicker. Novo has finally fixed the supply chain. They've notified the FDA that the shortage is officially over. The moment that shortage flag disappeared from the FDA website, every compounder still making the drug became a lawbreaker overnight. And let me be clear, compounders sued. They said the shortage was not over, and yet the FDA said, no, no, it's done. We've covered a lot today. We went from the tragic mold-filled vials of the NECC to the boardroom battles of hims and hers and Nova Nordis. And you may be asking, Darshan, why do I need to know this? I just want to lose 20 pounds. You need to know this because your health has been used as a pawn in a multi-billion dollar legal chess match. If you're taking a compounded drug, you need to know if that pharmacy is a 503 or a 503B. You need to know if they've done stability testings, or if they're just hoping that the drug doesn't spoil in your mailbox. When you subscribe to Darshan Talks, you get the truth behind the marketing. You get healthcare you can understand, backed by the expertise of a pharmacist who knows the signs and an attorney who knows the rules. Don't let your healthcare be decided by an Instagram ad. Let's look at the law, the science, and the reality together. So thank you for joining me on this on this deep dive. The story is moving fast and literally by the hour, so by the time this comes out, it's maybe already out of date. Hit subscribe, leave a review, and remember in the world of healthcare, the most powerful medicine is knowledge, and you're allowed to understand it. I'm Darshan Kulkarney, and this is Darshan Talks.