Copycat Ozempic, Mounjaro proliferate even in postshortage era

The Hill

5 hours ago

Copycat versions of popular drugs like Ozempic and Mounjaro have continued to proliferate in a postshortage era, with some experts saying 'regulatory neglect' is allowing for potentially dangerous, unapproved drugs to reach consumers.
When the Food and Drug Administration (FDA) adds a drug to its official shortage list, compounding pharmacies can sell their own versions of that drug so patients can continue to access medications.
This was the case when weight loss drugs like tirzepatide and semaglutide went into shortage due to high demand. Online companies like Hims & Hers and Ro entered the GLP-1 market with compounded versions of Wegovy and Zepbound.
These medications contain the same active pharmaceutical ingredient as the branded version but are formulated slightly differently, such as altering a medication for a patient who can't swallow pills. Due to the often highly individualized nature of compounded drugs, they are not FDA-approved.
But although the FDA has since removed these drugs from its shortage list, stakeholders say compounded drugs continue to be sold, and lawmakers in Congress have begun raising concerns with federal regulators.
There are two types of compounding pharmacies, 503A and 503B. 503A compounding pharmacies fulfill personalized, patient-specific prescriptions. 503B compounding pharmacies can do the same while also fulfilling bulk orders for clients like hospitals.
Prior to the end of the shortage, telehealth companies primarily relied on 503B compounders, but according to those in the drug space, online sellers are turning to 503A compounders to keep the lucrative business going.
Novo Nordisk, the manufacturer of semaglutide, partnered with Hims & Hers to sell a low-cost version of its branded product Wegovy after the shortage officially ended. But that partnership was dissolved after Novo Nordisk accused Hims & Hers of illegally continuing to sell compounded versions of its drug 'under the false guise of personalization.'
Experts in the field say the maneuver falls into a regulatory 'gray area.'
'I hesitate to even call these people compounders. Because what they really are are illegal pharmaceutical companies,' said Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest.
'You don't compound for tens of millions of people, and you don't personalize for tens of millions of people. That's just kind of a fake brand extension.'
In July, a bipartisan coalition of House lawmakers sent a letter to FDA Commissioner Marty Makary asking that he direct his agency to address the flow of illicit anti-obesity medications (AOM) into the country.
While not specifically focused on compounded drugs, the letter did note the possibility for ambiguity between these medications and illicitly sourced drugs.
'We understand the distinction between legitimate compounded drugs prepared in state-licensed pharmacies and counterfeit or compounded drugs made from illicit ingredients obtained from illegitimate sources,' wrote the lawmakers. 'However, unapproved AOMs continue to be widely marketed online, in print, and on television.'
Sen. Marsha Blackburn (R-Tenn.) sent a letter to the Federal Trade Commission in July, calling for the agency's action on online advertising of compounded GLP-1s. She was reiterating warnings that a bipartisan group of state attorneys general had made.
'Amid the unprecedented demand for these miracle medicines, foreign criminals and con artists are defrauding and endangering Americans by selling and shipping counterfeit or deceptively-marketed GLP-1 drugs and active ingredients,' she wrote.
A spokesperson for Ro said the company 'does not market or advertise compounded GLP-1s.'
The Hill was able to find a half-dozen lower-profile companies still marketing compounded GLP-1s online.
Hims & Hers, perhaps the most well-known of these online companies, disputed Pitt's characterization.
'Anyone claiming that we compound personalized medications for tens of millions of people is simply wrong and is mischaracterizing our business. We follow the carefully written compounding regulations and only offer access to compounded treatments when a licensed provider determines it is clinically necessary, in their independent judgment, for their individual patient,' the company said in a statement to The Hill.
'That's the future of healthcare: a system centered on the individual where providers have a way to treat the individual in front of them.'
The Federal Trade Commission declined to comment as its investigations are nonpublic. The FDA did not respond to a request for comment.
Pitts expressed incredulity that federal regulators hadn't stepped in already, saying, 'How long can the FDA permit kind of regulatory neglect, to allow this problem just to snowball until they get engaged?'
Although the continued sale of compounded GLP-1s falls into a regulatory gray area, Pitts believes it goes against the 'spirit' of the regulations.
He further cited the '5 percent rule' for compounding pharmacies, which dictates that the percentage of compounded drugs that a pharmacy distributes out of state not exceed 5 percent, saying online sellers have exceeded this rule by '10,000-fold.'
According to recent polling, consumers are concerned about where compounded drugs originate from.
A poll conducted by the firm Fabrizio Ward, run by President Trump's 2024 campaign pollster Tony Fabrizio, found that 64 percent of surveyed voters don't believe compounders should be able to continue to make drugs outside of the current legally permitted circumstances.
Voters in the survey were split when asked how confident they were that online pharmacies sold safe, FDA-approved drugs, with 46 percent saying they were confident and 41 percent saying they were not. A majority of voters — 78 percent — said they had concerns about bulk, compounded versions of drugs like Wegovy and Zepbound coming into the U.S. from overseas sources.
During the active shortage of GLP-1 products, questions were raised over where compounding pharmacies were sourcing the active pharmaceutical ingredients for their products. Telehealth companies have said their products come from FDA-regulated facilities.
'There's a difference between a product being made in an FDA-approved facility and a product being manufactured on an FDA-approved line for that product,' said Pitts. 'The FDA does not inspect production lines for illegal manufacturing, that just does not happen. So, it's an entirely fake proposition.'