Starting today, pharmacies can no longer make cheaper alternatives to popular weight loss drugs, driving up costs for millions. Dr. Celine Gounder joins to explain what this means for patients.

Washington

Pharmacies are now prohibited from making compounded or generic versions of popular weight loss drugs such as Ozempic and Wegovy. This rule change is expected to increase costs for millions who previously relied on cheaper alternatives produced by compounding pharmacies. Compounding pharmacies had been operating under a legal loophole during a shortage of these medications, but that loophole has now been closed.

According to CBS News medical contributor Dr. Celine Gounder, some of these compounded drugs were made with research-grade semaglutide, which is not always sterile or guaranteed to be the correct ingredient. In certain cases, other substances, including insulin, have been found in these compounded drugs, posing significant health risks to patients.

Patients who previously accessed these medications through compounding pharmacies now have several options. They can discontinue use, switch to an older and less effective drug called liraglutide, pay out-of-pocket for branded versions from manufacturers' direct programs, or seek assistance through patient assistance programs or clinical trials. The closure of the loophole is intended to address concerns about the safety and legality of compounded versions, which were never intended to be a long-term substitute during shortages.



New rule blocks generic versions of Ozempic and Wegovy

In this morning's Health Watch, millions of Americans use GLP-1 weight-loss drugs, but starting today, pharmacies are no longer allowed to make cheaper, generic versions of drugs like ozempic and wagovi. Joining us now to explain what's going on and what you need to know is CBS News medical contributor, Dr. Celine Gounder, who is also editor-at-large for public health at KFF. Dr. Gounder, tell us a bit about these generic versions and what should people who depend on them do? What are their options? So now that we're seeing the closing of this loophole for compounding pharmacies, so these are these knockoff, counterfeit versions. There are a few different options. But they aren't legal, right? They have been. Well, they've been operating in a gray area, and that's why that loophole is closing because they're counterfeit drugs. They're not actually legal, and we'll get into the details of why that's a problem. But what can you do if you're somebody who's been accessing them that way? Well, you can stop taking them, number one. Number two, you can switch to an older version of the GLP-1 drugs called Lyra Glutide. It's cheaper, but it's also less effective. You can pay out-of-pocket. So you have LilyDirect and Novacare that are doing direct-to-consumer for $500 or less a month. For the Ozempic and Wegovy? Right, for Ozempic, Wegovy, and then you also have Menjaro and ZepBound from LilyDirect. And then your other option is to see if your doctor can access some kind of patient assistance program or clinical trial to get you the drug that way. But so these so-called knock-off or off-label or off-brand, they are the same active ingredient? Well, not exactly. So they are using research-grade semaglutide in this case, and the problem with that is it's not sterile. And so you're injecting yourself with something that is not sterile, and in some cases, it's not even semaglutide. It's something else altogether. And so that's why there's some very real health dangers here. There have been cases where they have found insulin. If you give yourself a shot of insulin, that can put you in a coma. That can kill you if you take a really high dose of it. But the government was allowing people to access these compounded drugs because there was a shortage of these weight-loss medications, and that's ended? So there was this loophole that allows compounding pharmacies, as long as there is a shortage, to help provide these medications to patients. But that loophole has never been tested and used in this way. So it was really stressing the system in a way that created a lot of new concerns about safety for patients. All right, Dr. Gounder, thank you so much.

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