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Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

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The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21.

Drugmakers respond

The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.

“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off of the list at a time when the agency has acknowledged ‘supply disruptions,’ which immediately created a major access issue for patients everywhere,” OFA Chairperson Lee Rosebush said in a statement. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”

The move is also likely to please patients who have come to rely on cheaper, more readily available compounded versions of the drugs. For some, compounded products may have been their only access to tirzepatide.  Still, those drugs are not without risk. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not go through the same safety, efficacy, and quality reviews. And the agency has warned of dosing errors and other safety concerns with compounded versions.

The one party that is certainly unhappy with the FDA’s move is Eli Lilly, which had reportedly sent cease-and-desist letters to compounders. In an emailed statement to Ars, a spokesperson for Lilly said that there was sufficient supply of the company’s drug and continued use of compounded versions is unwarranted. “Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.

Lilly also noted the FDA’s safety concerns about the compounded versions, adding that its own examination of some compounded products found impurities, bacteria, strange coloring, incorrect potency, puzzling chemical structures, and, in one case, a product that was just sugar alcohol.

“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.

In terms of the supply “disruptions” the FDA mentioned and that some patients and pharmacies have reportedly experienced, Lilly said that the supply chain was complex and there are many reasons why a given pharmacy may not have a specific dose at hand, such as limited refrigerated storage space.

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Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

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Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

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Eli Lilly raises price of Zepbound while trumpeting discount on starter vials

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Pharma misdirection —

Cost for insured patients without coverage for the drug rises from $550 to $650 a month.

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An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company’s press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month’s supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month’s supply of vials with the 2.5 mg doses will cost $399, while a month’s supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

“This new option helps millions of adults with obesity access the medicine they need,” Lilly said in its announcement of the vials and their prices.

The company also included a quote from James Zervos, chief operating officer of the nonprofit Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity,” Zervos said. “We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality.” Even President Biden chimed in on social media, saying he was “pleased” by the discount, though he urged drug companies to cut prices “across the board.”

“No rational reason, other than greed”

But, that wasn’t the end of the news. When Lilly released its press release, people noticed that the company had also increased the price of Zepbound pens for those who have insurance plans that don’t cover the drug. In the past, Lilly offered a “savings card” that allowed these patients to buy a month’s supply of any dosage of Zepbound pens for $550. Now the price is $650, a nearly 20 percent increase.

Lilly did not respond to Ars’ request for comment or questions about why the company increased the price for some patients.

Sen. Bernie Sanders (I-Vt.), a longtime critic of the pharmaceutical industry and their drug pricing, was quick to weigh in. He called the vial prices a “modest step forward” but noted that, even with the price reduction, millions of Americans still won’t be able to pay for the drug. At $549 a month, the price of the drug is a little over the average monthly payment for a used car, which was $523 in the first quarter of this year, according to Experian. As for the increase in pen pricing, Sanders called it “bad news.”

“In addition, Eli Lilly has still refused to lower the outrageous price of Mounjaro that Americans struggling with diabetes desperately need,” Sanders went on. “There is no rational reason, other than greed, why Mounjaro should cost $1,069 a month in the United States but just $485 in the United Kingdom and $94 in Japan.”

In May, a Senate committee report concluded that uptake of such weight-loss and diabetes drugs stands to “bankrupt our entire health care system,” given the high prices and large demand in the US. The report was produced by the Senate’s Health, Education, Labor, and Pensions (HELP) committee, which is chaired by Sanders.

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