After trying to lose weight her whole life, Lisa Hallock finally started to see lasting results from a compounded semaglutide, the active ingredient used in Ozempic. As a busy mom of three who had tried other weight loss drugs, strict calorie restriction and diet programs like WeightWatchers, Hallock was intrigued by GLP-1s when they began gaining buzz but found them inaccessible.
“It was really too expensive. Of course, my insurance didn’t cover it, and so the only thing that would have been affordable to me is compounded,” she said, which she ultimately did when Hims & Hers began offering it.
Compounded drugs are allowed when there is a significant shortage, which has been the case for many GLP-1s, or when a consumer needs a specialized formula that’s not available. By using Hims & Hers’ compounded version, Hallock pays $165 a month for the drug, not including the cost of the regular doctor’s visits required, compared to $1,000-plus a month for the brand name. According to Hallock, being able to lose weight and cut down the food noise without a strict diet has allowed her “a new level of freedom.”
However, with impending FDA changes around compounded drugs, it could all be taken away.
According to the FDA, semaglutide, the class of drugs like Ozempic, and tirzepatide, the class of drugs like Mounjaro, are no longer in short supply, therefore prohibiting compounding. According to the firms’ statements, companies supplying compounded versions of these drugs have just a few months before it will be considered a violation.
“This is just a slap in the face,” Hallock said, noting she’s concerned about what she’ll do if she can’t stay on semaglutide.
She’s not the only one. Sources say this could be a regulation that impacts hundreds of thousands of people, if not more.
“We have such a mass of so many millions of people using these meds, and now you’re potentially going to take them away, but we don’t have a solution, and people have become dependent on them,” said Dr. Alexandra Sowa, obesity medicine doctor and author of “The Ozempic Revolution.”
It also poses a significant risk for the many companies, like Hims & Hers, FuturHealth, Wisp, Ro and more, that have built their businesses on compounding. However, many companies are tight-lipped in sharing what their strategy will be aside from noting that they do offer brand-name versions.
“We’re closely monitoring evolving regulations around compounded weight loss medications and will continue to adapt our strategy as needed,” said John Levan, cofounder of FuturHealth, a telehealth company that provides compounded medication and nutrition coaching. He said the company hasn’t changed its model yet.
A WeightWatchers representative said: “Recent news does not mean any near-term changes to existing treatment plans or medication availability. As availability evolves, we are prepared to support members with alternative options, including FDA-approved, branded GLP-1s and other compounded medications like liraglutide (a GLP-1 injection that is administered daily].”
Meanwhile, Wisp chief executive officer Monica Cepak said the company has doubled down on alternatives, including brand name drugs and GLP-1 boosting supplements to ensure customers have options.
“We will be working with our patients to introduce them to offerings that are still available, and we’ll be working with our pharmacy partners to come up with new solutions,” she said.
With the increasing concern, Hims & Hers also has a petition going on its site “[urging] Congress and the FDA to preserve access to compounded GLP-1 treatments.” To ensure users have options, Hims & Hers, along with many other providers, do offer weight loss drugs that are unaffected by these announcements though not as buzzy, such as Metformin, a tablet-based diabetes medication.
Some sources suggest there could be loopholes in the compounding world, but it’s very murky.
“You’re hearing some telehealth guys talk about [continuing] to compound it, but it’s going to be custom,” a source said.
This could look like new ingredients being added to mitigate extreme side effects or if there’s a case where a very small dose is needed that isn’t available from a brand. However, some experts say this may not be possible as they predict the FDA will be cracking down harder than ever before.
Aside from the companies, consumers also face significant risk. With only brand names available, GLP-1 users are faced with extremely high costs. For those who can no longer afford the medications, sources say they could gain most, all or even more weight back. There’s also concern that people may resort to unregulated black market drugs.
Given these challenges, drug manufacturers are trying to respond. For example, Novo Nordisk recently announced it would reduce the price of its drug Wegovy to $499 a month for those paying out of pocket. Meanwhile, Eli Lilly has also dropped the price on some of the lower doses of Zepbound.
“It’s a step in the right direction,” said Sowa. “We really need to push the drug makers to bring it down to European prices for cash pay, but also to have expanded insurance.”
For many, these price drops aren’t enough though.
“That’s [still] too expensive,” Hallock said. “I will have to go off the medication or find a way to start saving my pennies.”
In the wake of this news, there have been several lawsuits filed by The Outsourcing Facilities Association, which represents compounding pharmacies, to reverse the FDA’s ruling. The case regarding tirzepatide was denied, while the one on semaglutide remains open. Sources say these types of lawsuits will likely continue, as companies, compounding pharmacies, drug manufacturers and GLP-1 users all seek a solution.
