As long as the drugs are in shortage, the US Food and Drug Administration allows compounders to step in to make copycat versions. Lilly’s chief executive officer said at the beginning of the month that the Zepbound shortage should be over “very soon,” but it was still ongoing as of Wednesday morning, according to the FDA’s website.
Lilly now considers the brand-name drugs to be available and thinks compounded drugs made at state-licensed facilities shouldn’t be sold anymore, a spokesperson said.
“The FDA is currently working to determine if the available supply of tirzepatide would meet our definition of a resolved shortage,” said Amanda Hils, a spokesperson for the agency.
At least one telehealth company, Zappy Health, has stopped offering prescriptions for the medicines to new patients. “While we believe these letters are unfounded, a company like ours may not be able to withstand legal battles against well-funded corporations,” founder Michel Choueiri wrote in a message to patients seen by Bloomberg.
“Eli Lilly is trying to shift the blame for their own failures and making a whole lot of new enemies in the process,” Choueiri said in an email to Bloomberg. “We are doctors, not lawyers. We save lives, we do not destroy them.”
New drugs used for weight-loss, made by Lilly and Novo Nordisk A/S, have been in shortage since as early as March 2022, according to the FDA. That’s allowed compounding pharmacies to produce their own version of the medicines, which are often cheaper for patients. Compounded weight-loss drugs are bringing in as much as $1 billion a year for their makers.
According to federal law, state-regulated compounders can only regularly make copycat drugs if they brand-name versions aren’t “commercially available.” FDA guidance says that drugs on the shortage list are not considered to be commercially available.
The cease-and-desist letter came as a surprise to Paul Rivas, owner and CEO of Rivas Medical Weight Loss. His network of 11 clinics in Maryland gets its compounded drugs from a federally regulated facility, he said. Federal law allows those types of facilities to make the drugs as long as they’re on the FDA shortage list. He said that he would happily prescribe Lilly’s brand name drugs if they were available. But when he calls around to pharmacies, the drugs are often out of stock.
“Usually pharmaceutical companies and doctors work together,” Rivas said. “Why send a law firm after us? It doesn’t make any sense.”
Strive Pharmacy, a state-regulated compounder, didn’t received a cease and desist letter, but ten clinicians who prescribe the pharmacy’s drugs did, said Chief Clinical Officer Matt Montes de Oca. His legal advisers told him the letters were “a scare tactic,” and he said that it was still allowed to compound the medicine because it’s on the FDA shortage list.
The FDA determines what’s in shortage based on information provided by the drugmakers. Drugs can remain on the shortage list until the agency can verify that manufacturers have enough to meet the demand, and that the company has built up sufficient safety stock, an FDA spokesperson said. That’s why a shortage might persist even if individual doses are listed as available.
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