It's great to see US innovation and our nation to kick the crap out of the Dutch* and allow people to eat anything they can catch...that's not made of metal or wood.
*Seriously? You don't know where they make Ozempic?
The FDA says the Zepbound shortage is over. That's rattling the weight loss industry
Compounding pharmacies now have 60 to 90 days to stop making off-brand versions of Zepbound
By Bruce Gil
PublishedYesterday
The U.S. Food and Drug Administration announced Thursday that the shortage of tirzepatide — the active ingredient in Eli Lilly’s popular diabetes and weight-loss drugs Mounjaro and Zepbound — is officially over.
The news could put pressure on companies that have been able to sell off-brand versions of GLP-1 weight-loss drugs because of widespread shortages.
Eli Lilly wants to replace Zepbound with an even stronger weight loss drug
The agency said, in a letter, that after a review it has determined that Eli Lilly has enough supply to meet and exceed current and future demand of the drugs. Compounding pharmacies now have 60 to 90 days, depending on the type of facility, to stop selling off-brand versions of tirzepatide.
Compounding refers to the customization of an approved drug by a pharmacy or physician to meet the specific needs of an individual patient. Current drug laws allow for compounded versions of patent-protected drugs when they are in short supply — and many weight-loss drugs, including Ozempic, have been in recent years.
“FDA’s decision today, reiterating that the tirzepatide shortage is resolved, reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them,” an Eli Lilly spokesperson told Quartz in a emailed statement. “FDA was also clear that compounders must immediately begin transitioning patients taking compounded tirzepatide knockoffs to FDA-approved tirzepatide medicines.”
The FDA originally declared the tirzepatide shortage over in October. However, an industry group, the Outsourcing Facilities Association (OFA), filed a lawsuit in Texas against the agency just days later, challenging its decision to remove the drug from its shortage list and demanding that the move be reversed.
In its lawsuit, the group called the FDA’s decision “reckless and arbitrary,” and argued that it would “deprive patients of a vital treatment for type 2 diabetes and obesity.” In a court filing, the FDA said pharmacists could resume making compounded tirzepatide as it reconsiders its decision to remove the drug from its shortage list.
Now that the FDA has reached a decision, telehealth companies, online pharmacies, and wellness spas that have been hawking compounded tirzepatide will need to stop selling them.
The OFA told Quartz it “fundamentally disagrees” with the FDA’s decision and that the agency should have sought out data regarding patients who rely on compounded tirzepatide.
”The fact of the matter is that patients across the nation continue to experience difficulty filling prescriptions for branded tirzepatide products and that pharmacy distributors continue to list branded tirzepatide products as out-of-stock or available in only limited quantities,” the group said in a statement emailed to Quartz. “That qualifies as a shortage by any definition.”
The ruling also previews what will happen when semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — comes off the administration’s drug shortage list. While both drugs remain on the list, the FDA said supplies of all doses of Ozempic and Wegovy are currently available.
Hims & Hers , the millennial-skewed digital healthcare company, has seen its stock grow nearly 200% this year off of sales of compounded semaglutide. Today, its stock fell over 9%.
Geoff Cook, CEO of the weight-loss app Noom, which recently began offering compounded semaglutide to its members, urged regulators in September to proceed cautiously when considering lifting the shortage declaration for the latest wave of brand-name weight-loss drugs. He warned that ending the declaration too soon could restrict consumers’ access to more affordable alternatives.
“We just continue to urge policy makers to take into account the fact that patients losing access to their medication is not a good thing and especially losing it over night would be not a good thing,” Cook told Quartz.
If and when the FDA declares an end to the semaglutide shortage, Cook said Noom would continue offering branded GLP-1 treatments and other weight-loss medications to its members. The company may also explore offering even more customized compounded versions of semaglutide that can be taken sublingually, instead of by injection.
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