Hundreds of thousands of Americans stand to soon lose their access to cheaper weight-loss drugs, with a federal crackdown on copycat versions threatening to disrupt treatment and raise costs.
The Food and Drug Administration has ordered producers and sellers of the less expensive products to wind down operations in the coming weeks now that it has declared there are no longer shortages of the blockbuster drugs Wegovy and Zepbound.
Produced through a process of mixing drug ingredients known as compounding, the copycat medications had spawned a booming multi-billion-dollar industry. Patients turned to compounding because their health insurance would not pay for the brand-name drugs and they could buy the compounded versions for less than $200 a month in some cases.
Eli Lilly and Novo Nordisk now offer the brand-name drugs for $500 a month in most cases to patients who pay with their own money instead of going through insurance. Until recently, patients sometimes had to pay over $1,300 a month.
The F.D.A. ordered compounding for versions of Eli Lilly’s Zepbound to end last month. Small compounders have until April 22 to stop making and selling versions of Novo Nordisk’s Wegovy; large compounders have until May 22.
It is not clear how the F.D.A. will enforce these deadlines. The Health and Human Services Department, which oversees the F.D.A., declined to answer questions for this article.
Robert F. Kennedy Jr., the health secretary, has criticized the weight-loss medications, saying that people would be better off eating healthy food, though he said last week that they were “extraordinary drugs.” He has not weighed in on the cheaper copycats.
The compounding industry has been waging a public-relations campaign and fighting in court to reverse the orders, but has been unsuccessful so far. Although the market for compounded weight-loss drugs is expected to shrink under federal scrutiny, it’s unlikely to dry up altogether. Some providers plan to keep offering the drugs at dosages that aren’t standard or by mixing in vitamins, moves they hope will allow them to skirt the crackdown.
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