Eli Lilly’s weight loss drug Zepbound is no longer in short supply, the FDA said, worrying patients who use cheaper, off-brand versions of the drug.
On Thursday, Dec. 19, the U.S. Food and Drug Administration announced in a statement that after two years of being in shortage, tirzepatide — the active ingredient in Zepbound and its counterpart Mounjaro for diabetes — is fully available again.
"FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved," the agency said, per CNBC. "FDA continues to monitor supply and demand for these products."
Since the shortage began, specialty and compounding pharmacies have been allowed to sell off-brand versions of the weight loss drug. People were able to get prescriptions easily through telehealth, and the cost was much lower than traditional prescriptions not covered by insurance.
Weight loss drugs that use tirzepatide as the active ingredient cost around $1,000 per month without insurance, and the off-brand alternatives are often more affordable, according to Business Insider. Alternatives for tirzepatide can cost around $250 to $350.
Now that the shortage is over, specialty and compounding pharmacies — such as Henry Meds and Him — must stop selling their off-brand versions of the weight-loss drugs.
"People are concerned. They're saying, 'This has been life changing but I don't have $1000 to pay out of pocket and my insurance isn't going to cover it," Ted Kyle, an obesity care and health professional, told Business Insider.
The outlet notes that telehealth companyRohas a new partnership with Eli Lilly to offer ahalf-price version of Zepbound that will be sold in vials. The move will sidestep supply-chain issues with the prefilled pens as well as compete with compounded drugs, according to Business Insider.
The FDA has also cited overdoses as a concern, as it has received reports of patients giving themselves the incorrect dose of off-brand drugs.
"These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug," the FDA said in a statement, noting that some of these overdoses may be related to the off-brand drugs having different formulas than name brands.
This isn't the only recent weight loss drug shortage to impact the U.S. in recent years — the FDA has previously stated that semaglutide, the active ingredient in Wegovy and Ozempic (made by competitor Novo Nordisk) is in shortage.
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Eli Lilly and other drug companies have also been attempting to crack down on off-brand versions of its weight loss drugs, suing medical spas, compounding pharmacies and weight loss clinics, according to CNBC.
In turn, an organization representing compounding pharmacies, called the Outsourcing Facilities Association, sued the FDA in October, CNBC reported, over the its decision to remove tirzepatide from the drug shortages list several days prior. The pharmacies alleged that the FDA ignored evidence that showed there is still a tirzepatide shortage. The FDA quickly responded, saying it would leave tirzepatide on the list for a period of time as they reevaluated, allowing the compounding pharmacies to keep making the drugs.
The demand for GLP-1 drugs has grown in recent years, thanks in part to marketing from telehealth companies, the AP reports, which are not held to the same standards as drug companies.
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