FDA says knockoff versions of Lilly obesity drug must come off the market
Source: AP
Updated 6:26 PM EST, December 19, 2024
WASHINGTON (AP) — Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday.
The Food and Drug Administration said that a nationwide shortage of Eli Lilly’s Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.
The decision is a win for Lilly — which had been pressing the FDA to take the step for months — and is expected to impact how patients access the drugs, including how much they pay. Zepbound is FDA-approved to treat obesity and Mounjaro is approved for diabetes. They use the same active ingredient, tirzepatide.
The FDA said Thursday that “Lilly’s supply is currently meeting or exceeding demand,” after two years of shortages. Both drugs are part of the GLP-1 class that has shown unprecedented results for helping people shed weight by decreasing appetite and boosting feelings of fullness. Wegovy and Ozempic — competing drugs from Novo Nordisk — remain on the FDA’s shortage list.
Read more: https://apnews.com/article/obesity-drugs-zepbound-shortage-fda-13d18b0e3e74a7f7355521bf8e38cb5b
Link to FDA STATEMENT - FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
Link to FDA DECLARATORY ORDER (PDF) - https://www.fda.gov/media/184606/download?attachment
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I know someone who takes Mounjaro. It is $1200 a dose. Each dose is 2ml. $1200 for 2 ml. Each package has four doses in it. $1200 X 4 = $4800 per sale. The number of sales for this miracle drug that lets one live a lifetime of stubborn refusal to take care of oneself and then just toss the consequences out of the window. For a price that assures the makers that only those who will keep coming back would want to afford it, of course. After all, we can't help the peons. They are the ones paying all that money for weight loss and gym memberships and training videos. Weight loss is a multi-billion dollar a year industry. You think they are going to allow unrestricted access to something that will remove that income? So, do you think they are going to allow 'knock-offs' when they make that kind of money with each sale?
No wonder it is so popular. It has both the promise of effort-free weight loss and the idea that you must be a special rich person since you can afford it. Now, the idea that it will help people? Probably number eleven or so on the list of why they made it.
So freaking sick of the financial bias when it comes to healthcare. 