Ozempic and similar drugs for type 2 diabetes and weight loss are in such high demand that drug manufacturers are having a hard time keeping up. So pharmacies stepped in to fill the void, producing their own versions of the drugs for more than two years.

Compound versions especially popular as cheaper alternatives for people with insurance does not include them.

But now brand manufacturers are trying to stop compounding pharmacies.

Novo Nordisk and Eli Lilly are moving to end compounding of their drugs altogether. They say that they are no longer in scarcity (a necessary condition for legal consolidation in this case) and that it is already very difficult to consolidate. The compounding industry disagrees.

As the battle continues over who gets what share of the multibillion-dollar obesity drug market, some patients are wondering how and from whom they will get their next injection.

He says what lies beneath the fight? Robin Feldman“The enormous amount of money changing hands for new weight-loss drugs, their incredible effectiveness, runaway demand. It’s all about the dollar,” said , a law professor at the University of California.

“When someone tells you, ‘It’s not about the money, it’s about the principles,’ it’s about the money,” he says.

scarcity rule

Understanding why pharmacists can make compound copies semaglutide (main ingredient in Ozempic and Wegovy) and tirzepatide (main ingredient in Moonjaro and Zepbound), you should understand scarcity rule.

Compounding pharmacists are licensed to prepare specialty medications for people who need them. For example, they will make a liquid version of a branded pill for a patient who cannot swallow pills.

The drugs they produce are not generic; Rather, they purchase ingredients from Food and Drug Administration-registered suppliers and prepare finished versions for prescription patients, especially for compounded drugs.

According to the law, compounders are not allowed to prepare.actually a copyThere is an exception where an existing FDA-approved drug is available, but the supply of that drug is in short supply.

This changes when the famine ends. That’s starting to happen with these drugs.

/Jennifer Burch

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Jennifer Burch

Currently, two of the drugs — Zepbound for obesity and Mounjaro for Type 2 diabetes — cannot be legally combined, but the FDA has said it will turn a blind eye to the practice for now while it evaluates whether ending the shortage sooner is right. this autumn. Therefore, patients and drug manufacturers are stuck in confusing legal limbo.

“Everyone knows … injections will eventually come off the shortage list, and patients need to be prepared for that.” says Scott Brunner, CEO of the Pharmaceutical Compounding Association.industry trade group. “Compounded copies of these FDA-approved drugs are not a long-term treatment for these patients.”

End famines, end compounding

The fight over compounding has intensified in recent months and has taken twists and turns.

During the summer Eli Lilly Declares Zepbound and Mounjaro “available”,” implying that there was no longer a supply shortage. On October 2, the FDA officially removed them from the board. official drug shortage list.

This meant that compounders would be acting illegally if they compounded tirzepatide, the main ingredient in Zepbound and Mounjaro.

By the way FDA guidelinesSmall pharmacies cannot make copies of existing brand-name drugs more than four times per month. And bulk compounders, called outsourcing facilities, can’t fill orders 60 days after the shortage ends.

Owner Jennifer Burch small compounding pharmacy and a regular retail pharmacy about 25 miles away in Durham, N.C., tried to order more Zepbound and Mounjaro the week the Tirzepatide shortage ended, assuming their patients would switch from compounded versions of the drugs to branded versions.

But he couldn’t. At the time, he could only order one box a day. This meant he could only see 30 patients a month, and the number of his patients receiving compounded tirzepatide was much higher than that.

He told NPR in November that he could only order two boxes a day, but that wasn’t enough yet.

Scott Welch, compounding pharmacist A person living in Arlington, Virginia, says he cannot order as many Eli Lilly medications as he needs. He said he had “thousands” of patients who used compounded products before the shortage ended.

“There’s limited allocation for everything,” he said, checking in real time on a Zoom call with NPR. “But they’re completely out of Zepbound, 15 milligrams and 10 milligrams, Mounjaro 10 milligrams… There’s no allocation, zero availability to order any of them.”

Compounders respond

On October 7, Outsourcing Facilities Associationa trade group of large-scale compound manufacturers, sued the FDAHe questioned whether it was appropriate to remove tirzepatide from the shortage list.

The FDA looks at a number of factors, including the drug manufacturer’s ability to fulfill pre-orders, before deciding whether to remove something from the list. Lee Rosebush, who chairs the trade groupHe says the agency isn’t doing enough. No one from the institution asked their group or its members how many patients they had prepared medication for.

“You might think this would be a basic question because how do you know what the real market is if you haven’t even asked how big it is?” Rosebush says. As a result, he argues, it’s difficult to know whether Eli Lilly will be able to provide medication to all patients using brand-name drugs. And Those using composite versions and need to switch.

Currently, reliable estimates of the compounding market for these drugs are not available.

A few days after the lawsuit was filed, the agency said it would reconsider its decision and grant permission. compound manufacturers will continue to prepare tirzepatide Meanwhile.

Eli Lilly reiterated to NPR that the drugs “have been available since August.”

“Our current manufacturing investment, exceeding $20 billion over the past four years, is the most significant in our history and will enable us to continue to expand our capacity to safely deliver these medicines to the people who need them,” Eli Lilly spokeswoman Courtney Kasinger said. he wrote. email.

The company has also filed three lawsuits against compounding manufacturers for improper marketing practices and use of an unsafe version of tirzepatide, he said, noting the FDA’s warning letter against a compounding pharmacy in California that was recently shut down after a poor inspection.

And now Novo Nordisk has taken a step that could indicate that semaglutide, the main ingredient in Ozempic and Wegovy, may also soon be off the FDA’s shortage list. It is stated that all doses of Ozempic and Wegovy are “available” as of October 30.

Is it too difficult to put together?

And drugmakers are trying other ways to stop compounding blockbuster drugs.

Novo Nordisk last month filed a petition Adding semaglutide, the main ingredient of Ozempic and Wegovy, to the FDA’s list of drugs deemed too difficult to compound safely. Eli Lilly bought it similar action in August.

“Our candidate presents numerous examples of these risks, including unknown impurities, peptide-related impurities, faulty strengths, and even cases where no semaglutide is present in the product,” Novo Nordisk spokesperson Jamie Bennet wrote in an email to NPR. “The urgency of the situation requires urgent action.”

But there is a problem. The FDA drug list they reference? Not available yet. A. proposed federal rule The outlines of how such a list would work have not yet been finalized.

“Comment period proposed rule It closes on June 18, 2024, an FDA spokesperson wrote in an email to NPR. “The agency is in the process of reviewing the comments to issue a final rule.”

Brunner, who chairs the compounding pharmacy trade group, finds Novo Nordisk’s timing puzzling.

“What’s most interesting is that it took over two years to gather enough concern about patient safety that they thought this molecule should be pushed out of bounds,” says Brunner, who chairs the compounding pharmacist trade group. “Compounders have been preparing the drug under FDA guidance for the last two, two and a half years.”

The FDA says it will respond directly to Novo Nordisk.

Caught in the middle

While the fight over diabetes and weight-loss drugs is unprecedented, drug companies aren’t exactly using a new tactic, says Feldman, a law professor at the University of California, San Francisco.

“It’s just part of the game,” he says.

Feldman says government agencies don’t want to become bogged down by lawsuits and other processes that prevent them from doing their normal work. First of all, lawsuits are expensive and institutions cannot afford them.

“So when companies file these types of lawsuits, it will cause the agency to be hesitant in future cases,” he says. “So this creates a dynamic where companies on both sides, whether compounders or pharmaceutical companies, can threaten to tie them up for a period of time.

“If they both do this, God help the people.”

Burch and Welch, pharmacists interviewed by NPR in North Carolina and Virginia, both say they received cease and desist letters from Eli Lilly before the tirzepatide shortage officially ended.

Since they are small businesses, none of them have lawyers on their staff. One chose to continue compounding in light of the FDA pausing the application while it re-evaluated the deficiency. The other chose to purchase the compound tirzepatide from an outsourcing facility, a manufacturer of another type of compound, rather than continuing to produce the compound on its own.

Some compounding pharmacies no longer fill these prescriptions at all.

Welch says he fears that when his customers can’t get branded or blended products from him, they will turn to what he calls black market websites that may have counterfeit products that could be harmful. “This is my biggest fear.”

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