When Chris Spears' pharmacy didn't have the obesity drug his doctor prescribed in 2023, he found another option while scrolling on Facebook. His feed was full of advertisements for alternatives to the brand-name medicine sold through online telehealth companies. So he tried one.
"The medication worked brilliantly, absolutely phenomenal. But what I didn't enjoy was ... the experience was clunky," Spears says.
So Spears, a former tech consultant who lives in Decatur, Ga., saw a business opportunity. He started his own weight loss telehealth company, OrderlyMeds, which signed up its first patient on January 1, 2024.
The company now serves 40,000 patients a month, he says. After customers complete health screenings, it connects them with health care providers who can write prescriptions, which are then filled by pharmacy partners.
These off-brand obesity drug alternatives aren't generics but have been available for several years. That's because the Food and Drug Administration allows specialized pharmacies to make what are essentially copies of brand-name drugs when the agency determines those medicines are in short supply. These are called compounding pharmacies. They're the kinds of partners OrderlyMeds has been working with. Soon, though, the company will also do its own compounding, Spears says.
High demand for obesity drugs and manufacturing constraints at the brand-name drugmakers created a boom in these dupes, called compounded drugs, and consumer websites to obtain them. Compounders that make the drugs and telehealth companies that sell them have offered cheaper, more readily available alternatives for patients.
Now the shortages of Novo Nordisk's Wegovy and Eli Lilly & Co.'s Zepbound are over. The FDA determined in December and February, respectively, that the companies could meet demand. Grace periods for the compounding pharmacies expired this spring. Some have already stopped compounding obesity drugs.
A new chapter for compounded obesity medicines
That change would mean the end of the large-scale compounding era for obesity drugs.
Some telehealth companies have transitioned to agreements with Novo Nordisk and Lilly to sell their medicines to patients without insurance. But others are producing their own medicines with a twist.
At OrderlyMeds, Spears recently said he is leasing a new facility in Tampa and hiring 100 people to make compounded tirzepatide and semaglutide – the active ingredients in Eli Lilly's Zepbound and Novo Nordisk's Wegovy, respectively.
He says OrderlyMeds will personalize the medicines by adding one of nine supplements, like vitamin B-12, based on patients' unique needs. That way, the drugs won't be copies, but individualized obesity drugs. Spears says OrderlyMeds will still be following "the letter of the law," referring to the rules against making essentially copies of available medications.
Traditional compounding involves making drugs according to doctors' orders to meet patients' personal requirements.
It's not clear whether OrderlyMeds' approach will work, but the telehealth platform is one of several companies testing the FDA's rules by continuing to make and sell the compounded drugs.
But where's the line between making "essentially a copy" of a commercially available drug and the personalized medicines compounding pharmacies have provided for decades?
"The line is not very well defined," says Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who focuses on pharmaceutical policy. "I think that's why we're seeing certain companies who are willing to stay and test the waters."
According to FDA's guidance documents for industry, Congress didn't bar just compounding of exact copies, but included the word "essentially" in the law "to ensure that compounders do not evade the limits in this section by making relatively small changes to a compounded drug product and then offering the drug to the general public without regard to whether a prescribing practitioner has determined that the change produces for the patient a significant difference." Minor changes in strength aren't enough, the document says.
Asked about some specific examples, like adding a B vitamin, a spokesperson for the Department of Health and Human Services, which includes the FDA, referred NPR back to the guidance document but didn't answer the question directly.
Click here to lose weight
Marketing of the compounded obesity drugs on social media has increased in recent months.
Last October, 40 ads for compounded obesity drugs started running on Facebook, Instagram and other Meta platforms, according to an NPR analysis of data from the company's ad library on April 30.
But in April of this year, after the brand-name shortages were over, nearly 2,000 ads started running.
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The ads are for telehealth heavyweights such as Hims, as well as some smaller companies, including one called Mochi Health that has been sued by Eli Lilly. But the ads also include even lesser known companies selling alternatives to obesity drug injections, such as patches, drops and oral pills.
"When we got started, there was some crowding, but not nearly what it is today," says Spears, who is continuing to offer compounded tirzepatide despite getting a cease and desist letter from Eli Lilly in April.
Mochi CEO Myra Ahmad says the surge in ads reflect "a significant mindset shift" around personalized obesity treatment, and that its ad strategy is focused on "comprehensive and customized care solutions."
A trickle, then a flood
Compounding pharmacies have been around long before weight loss drugs. Their typical role is creating custom versions of medicines for patients who are, for example, allergic to an ingredient in the original version. They're usually prohibited from making "essentially" copies of available approved drugs, according to federal law, but they can do it if the original drug is in short supply.
That's what happened with obesity drugs. Demand was so high that Novo Nordisk and Eli Lilly couldn't keep up. Semaglutide, the active ingredient in Wegovy and Ozempic, went into short supply in March 2022, and tirzepatide's shortage began that December.
"It's an unfortunate situation that there was a shortage for the medicines," David Moore, executive vice president of Novo Nordisk's U.S. operations, tells NPR. "It was unprecedented demand … really no one could have anticipated."
At first, just a few compounders were stepping in to make it, but that changed. And the compounders put a dent in brand-name sales.
In a May 7 call with Novo Nordisk investors, Moore said that compounded versions of its drug were so common that fewer people were taking the brand name Wegovy.
Scale of compounding is difficult to measure
Because most compounding pharmacies are regulated on the state level and are not required to report which drugs they're making, the total number of compounders making semaglutide and tirzepatide is a mystery. But the largest compounding pharmacies, called outsourcing facilities, report what they're making to the FDA.
In the first half of 2023, only one outsourcing facility told the FDA that it was making semaglutide. By the second half of 2024, the most recent data available, 10 said they were making it.
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According to a report by the Brookings Institution, the importation of ingredients used by compounders making obesity medicines grew, too. What are known as active pharmaceutical ingredients are largely imported from China, says report author Marta Wosinska, a health care economist who has held leadership roles at the FDA and the Federal Trade Commission.
When she first looked at the import data, she thought it was a mistake. "One kilogram is 4 million doses," she says. "And you have shipments of 50 kilograms going through."
The imported active ingredients aren't illegal, but they're not scrutinized by regulators to make sure they're safe either, she says. While the ingredient manufacturers are required to register with the FDA, that doesn't mean their factories have been inspected or that they're making the active ingredients used in compounded obesity drugs in line with a set standard. Until the drug goes generic, such a standard doesn't exist.
Welcome to the internet
Access to affordable compounded obesity medicines has been life-changing for some patients whose insurance doesn't cover them. It's helped many lose weight for the first time in their lives. But other patients have found themselves stuck with thousands of dollars worth of compounded medication they are afraid to use after learning about potential quality problems.
Without much federal oversight, it's hard for patients to know if a deal is too good to be true.
Sabina Hemmi was taking a compounded obesity medicine, when the price jumped from $550 a month to $875 a month. "I was like, 'What the hell?' "
She started shopping around, but found it confusing. Most telehealth sites offering compounded obesity drugs didn't list prices and wouldn't reveal them to would-be customers until after they'd filled out online forms with personal and medical information.
So Hemmi, who founded a data company to help video gamers play better, started a website to help people sort through the mess. At first, it was just a listing of a few dozen companies and their prices. The website has since grown to include reviews and warnings about telehealth providers with ties to pharmacies cited for regulatory violations, for example.
Hemmi says new companies and websites ask every day to be added. Often, she says, the sites didn't exist two weeks earlier. She only adds new companies after vetting them.
As she's doing her due diligence, companies sometimes go from enthusiastically answering questions to being ghostly silent – especially when it comes to answering specifics about the identities of their health care providers. "That's when they drop off."
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, says compounding pharmacies' products were never meant to compete with name brand drugs, but the confluence of drug shortages, high prices and limited insurance coverage created an unprecedented situation.
Many compounders are following state and federal regulations, filling only obesity drug prescriptions that doctors deem necessary for individual patients, he says.
"It's really easy to look at what's happening right now … as a bunch of greedy compounders trying to circumvent the FDA drug-approval system – and no doubt there's some opportunism at play here, particularly in the telehealth space – but that's not the full story," he says. "And indeed, much of what we're seeing at present is not from compounding pharmacies at all, but from telehealth platforms, third-party marketers and illicit actors."
If you can't beat 'em …
For their part, Eli Lilly and Novo Nordisk are now adjusting to the marketplace the shortage created -- by offering some of their products at lower prices, on websites that continue to offer compounded versions of the drugs they invented. Both companies launched direct-to-consumer initiatives within the last year, offering the brand-name drugs at lower prices for patients not using their insurance.
On Monday, Eli Lilly said that in July it will add the highest doses of Zepbound — 12.5 milligrams and 15 milligrams — to its website for patients paying cash. That would make all FDA-approved doses available this way. The drugmaker also dropped the price for all self-pay doses of Zepbound to no more than $499 a month for people who renew within 45 days. Although Zepbound usually comes in an autoinjector pen, the discounted offer is for vials of medicine patients inject with an old-fashioned syringe.
"They're basically trying to get in this game," says Leigh O'Donnell, head of shopper insights at Kantar Media, a market research and consulting firm.
Novo Nordisk also recently partnered with several telehealth companies, including Hims and Hers, whose controversial Super Bowl Ad, "Sick of the System," took a swipe at the company by including an injector pen in the same light blue as Novo Nordisk's Ozempic.
Now, brand name Wegovy is for sale on Hims' website through a direct-to-consumer offering right next to a compounded version. Hims told investors it plans to largely end compounded semaglutide, but that it would continue compounding personalized doses for some patients. According to a quarterly financial filing for investors, the company believes there are legal paths to continuing to offer certain compounded obesity medicines following the shortages.
As for Spears at OrderlyMeds, he says companies like his eventually won't be needed for people to access affordable obesity drugs, and he's OK with that.
"I think the longer that the compounded option exists, the further the price gets driven down of the branded [drugs], which is overall just a good thing."
You can contact NPR pharmaceuticals correspondent Sydney Lupkin at slupkin@npr.org.
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