For many patients taking tirzepatide, an innovative treatment used for weight loss and diabetes, the end of the drug shortage was hardly welcome news.
“I had anxiety attacks,” said Maria Galindo, who has lost 60 pounds since starting the drug. “I was actually sitting there, in the middle of a meeting, reading an email that my doctor had sent me, and my face went completely numb.”
My 35-year-old mother is one of them. Patients taking combined forms of tirzepatide While manufactured by pharmacies, Eli Lilly’s brand name versions Zepbound and Mounjaro are in short supply.
She says she pays about $350 a month for compounded tirzepatide. Her insurance doesn’t cover Zepbound, and she can’t afford the list price of about $1,000 a month.
Eli Lilly holds the patent for tirzepatide, and the FDA does not enforce the patent, but it does regulate whether pharmacies are making unauthorized copies of FDA-approved drugs. Authorities have waived this restriction in cases of drug shortages.
The FDA officially Tirzepatide appears to be in short supply for nearly two years. It was resolved earlier this month.
Days later, the Outsourcing Facilities Association, a trade group representing large pharmacies, sued the FDA, calling the decision “reckless and arbitrary.”
In response, the FDA voluntarily agreed to reconsider whether there is still a shortage of tirzepatide, and for the time being, these large pharmacies will not be able to manufacture copies of the drug, according to court filings. It is said that it will be allowed to continue.
The FDA did not respond to requests for comment on the lawsuit.
An Eli Lilly spokesperson told CBS News that “all doses of Munjaro and Zepbound” are available and have been available “since early August,” and that “FDA continues to note the shortage is ‘resolved.’ I’m doing it,” he said.
The company also expressed concerns about: invalid version It’s on sale. “No patient should be exposed to unapproved counterfeit drugs that pose an increased risk, especially when safe and effective FDA-approved drugs are available,” the company said in a statement. “However, many companies are producing large quantities of unapproved tirzepatide knockoffs that can put patients at potentially life-threatening risks, including versions with manipulated doses and shapes just to circumvent legal regulations.” To increase patient safety, the company should stop marketing the product by administering an unapproved tirzepatide imitation to new patients and replacing it with the FDA-approved drug in current patients. support the transition to ”
“We will continue to pursue appropriate legal action against organizations that endanger our patients,” the statement said.
“From pharmacist to therapist”
About 1 in 8 Americans has tried a GLP-1 drug to lose weight or treat diabetes. According to a Kaiser Family Foundation poll. of A new kind of drug that is popular These include semaglutide, sold by Novo Nordisk under the brand names Ozempic and Wegovy, and tirzepatide, sold as Lilly’s Mounjaro and Zepbound.
It is unclear exactly how many people are taking combination GLP-1, but some estimates put the number at up to 2 million patients in the United States. KFF Health News reported.
After the FDA’s decision, many patients prescribed tirzepatide took to online forums and social media to express their frustration and confusion over the drug’s lack of availability.
Pharmacists across the country said at a recent industry roundtable that they are under fire from distraught patients and health care providers.
Scott Welch runs a hybrid pharmacy in Arlington, Virginia, dispensing both compound and over-the-counter prescription drugs.
“As soon as I heard that the FDA had acquired this drug, I knew it. [tirzpepatide] “They said that if we injected the missing amount, patients and health care providers would go into hysteria. So the first thing I did was think about the patient and say, ‘We can’t make this any better. If you can’t, you need me,’” Welch said. It’s for commercialization. ”
Welch was surprised to log into the wholesaler’s portal and see “zero allocations” to Mounjaro and Zepbound. This means that you cannot order any quantity of the drug yet.
“We didn’t expect to see a shortage from the FDA when something happened. We’re hopeful that at least we’ll be able to get the product and serve our patients,” Welch said.
Ann FDA notification “Formulators may still experience intermittent localized supply disruptions as products move through the supply chain,” it said.
F.D.A. Tirzepatide entry The online shortage list states that patients may not be able to have their prescriptions filled immediately at certain pharmacies. This is especially true for drugs that must be refrigerated and have multiple dose strengths, like most GLP-1 drugs.
Meanwhile, Welch said, “the team has gone from pharmacists to therapists” as they counsel patients about the sudden unavailability of their compounded medications.
When will FDA resolve the shortage?
The FDA receives data from pharmaceutical companies regarding their ability to supply over-the-counter drugs to the market. When the total supply of a drug does not meet current demand, FDA lists the drug as: shortage. During this period, compounding pharmacies are allowed to make copies of medications to fill any gaps.
Although combination drugs are not FDA-approved, the facilities where they are manufactured must comply with certain federal or state regulations, depending on their classification.
More than a month after Eli Lilly told the FDA it was able to meet demand again, the agency declared the shortage resolved and agreed to tell formulators to stop making copies.
A spokesperson said the FDA does not discuss its interactions with drug companies as a matter of general policy, so it is unclear what information was exchanged between Eli Lilly and the FDA before determining that the tirzepatide shortage was resolved.
The spokesperson added that the agency “does not manufacture medicines and cannot require pharmaceutical companies to make or increase the dosage of medicines, nor can it mandate that pharmaceutical companies choose where to sell their products.” He also said.
seek change
Scott Brunner, CEO of the industry group Alliance for Pharmacy Compounding, said part of the problem lies in how the FDA decides when to resolve shortages.
“Current law only allows data to be considered from pharmaceutical companies, and we believe that pharmaceutical companies should be able to obtain data from hospitals, health systems, and pharmacies. ,” Brunner said.
American Association of Health-System Pharmacists still included Tirzepatide is on its own shortage list.
In contrast to the FDA, “we often report shortages sooner and leave shortages a little longer just because we’re tracking specific formulations and exact strengths,” says the university’s deputy chief pharmacy officer. said Dr. Erin Fox. A team at the Utah Department of Health operates a drug information service that contributes to the society’s list.
She said drug companies typically “have the capacity to prevent” this kind of shortage, and called the high dosage of tirzepatide unusual.
Brunner is among compounding industry leaders who want the FDA to create a new framework for drugs like tirzepatide, which are in short supply but have high compounding rates.
“Our primary concern is continuity of care,” the Compounding Pharmacy Alliance wrote in an Oct. 7 paper. letter To the FDA. “Patients receiving combination tirzepatide cannot immediately transition to FDA-approved products due to a variety of practical ‘speed bumps.’
Patients face hurdles when switching from compounded medications to over-the-counter products, including obtaining new prescriptions and navigating insurance coverage.
“We’re talking about patients going without this drug for a significant period of time after it becomes available,” Welch said.
Compounding pharmacists are preparing when semaglutide, sold by Novo Nordisk as Ozempic and Wigovy, comes off the shortage list.
“FDA needs to take these concerns seriously and build a framework now for that moment to come. We don’t know when, but it’s coming,” Bruner said.
Another major concern is the increase in desperate patients attempting to obtain tirzepatide online from unauthorized and potentially dangerous sources after compounders were forced to stop manufacturing the drug. .
Compounding pharmacies, drug companies, and the FDA share concerns about counterfeit or substandard weight loss drugs, even though regulated compounders are often lumped in with illegal sources by manufacturers .
affordability concerns
Access to tirzepatide and similar medicines is only partially dependent on the ability of pharmaceutical companies to meet demand. Patients must also be able to afford them.
In late August, Eli Lilly announced that it would sell single-use vials of Zepbound directly to patients at a price significantly lower than the company’s injection pens.
Affordability is Galindo’s biggest concern. When she received word that the compounded tirzepatide would no longer be available, she says she ordered the last three months’ supply from the pharmacy with her credit card.
“I have an 8-year-old child and I want to chase him and play with him, but I couldn’t play with him because he was too heavy and I couldn’t put any strength into his body,” Galindo said. Ta.
At her heaviest, she says she faced serious health problems, including insulin resistance, joint pain and potential autoimmune issues related to polycystic ovary syndrome. Now she is training for a half marathon without feeling any pain.
“When I feel depressed about how I look or feel, I feel very dark because I feel like my body is working against me instead of against me,” says Galindo. said. “To be honest, I’m still not sure if I’ll be able to go back there.”
