FDA says weight-loss drug shortage is over, but patients worry about cost and availability

For many patients taking tirzepatide, a breakthrough drug used for weight loss and diabetes, the end of the shortage of the drug was anything but good news.

“I had an anxiety attack,” said Maria Galindo, who has lost 60 pounds since she started taking the drug. “I was actually sitting there, I was in the middle of a meeting, and then I read an email from our doctor and my face went completely numb.”

The 35-year-old mother is one of many patients taking a compound version of tirzepatide produced by a pharmacy while branded versions from Eli Lilly, Zepbound and Mounjaro, are rare.

She says she pays about $350 a month for the 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 although the FDA does not enforce patents, the agency regulates whether pharmacies make unauthorized copies of FDA-approved drugs—a limit the agency waives in the event of drug shortage.

The FDA officially deemed the nearly two-year tirzepatide shortage resolved earlier this month.

Days later, the Outsourcing Facilities Association, a trade group representing large-scale compounding pharmacies, sued the FDA over the decision, calling it “reckless and arbitrary.”

In response, the FDA voluntarily agreed to reconsider whether a shortage of tirzepatide still exists and will allow these large-scale compounding pharmacies to continue producing copies of the drug at this time, according to a court filing.

Neither the FDA nor Eli Lilly responded to a request for comment on the lawsuit.

“From pharmacists to therapists”

About 1 in 8 Americans have tried a GLP-1 drug to lose weight or fight diabetes, according to a Kaiser Family Foundation survey. THE trendy new class of drugs include semaglutide, sold by Novo Nordisk under the brand names Ozempic and Wegovy, and tirzepatide, sold under the names Lilly’s Mounjaro and Zepbound.

It is not known exactly how many people take a GLP-1 compound, but one estimate puts the number at 2 million patients in the United States, KFF Health News reported.

After the FDA’s decision, many patients on compounded tirzepatide took to online forums and social media to express their frustration and confusion over the loss of access to their medications.

Pharmacists across the country said at a recent industry roundtable that they had received a wave of calls from distraught patients and providers.

Scott Welch runs a hybrid pharmacy in Arlington, Virginia, that dispenses compounded and commercial prescription medications.

“I knew as soon as I heard that the FDA had removed the (tirzpepatide) injection from shortage, that there was going to be hysteria from patients and providers,” Welch said. “So the first thing I did was think about the patients and say, ‘Well, if I can’t make this any worse, I need to get into the commercial product.'”

Welch logged into his wholesaler portal and was surprised to see “zero allocation” for Mounjaro and Zepbound, meaning he was still unable to order any quantity of medication.

“I did not expect the FDA to face a shortage. I at least expect to be able to provide products and services to our patients,” Welch said.

An FDA advisory states that “prescribers may still experience localized and intermittent supply disruptions as products move through the supply chain.”

The FDA’s entry for tirzepatide on its online shortage list indicates that patients may not be able to immediately fill their prescription at a particular pharmacy. This is especially true for medications that must be refrigerated and have multiple dosages, such as most GLP-1 medications.

An Eli Lilly spokesperson said in a statement that “all doses of Mounjaro and Zepbound” are available and have been “since early August.”

Meanwhile, Welch said his “team has transitioned from pharmacists to therapists” as they counsel patients about the sudden loss of access to compounded medications.

When does the FDA resolve a shortage?

The FDA receives data from drug manufacturers on their ability to supply the market with commercial drugs. If the total supply of a drug cannot meet current demand, the FDA will consider it to be in shortage. During this time, compounding pharmacies are allowed to make copies of the medication to fill the gap.

Compounded drugs are not approved by the FDA, but the facilities in which 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 once again able to meet demand, the agency agreed to declare the shortage resolved, asking compounders to stop producing it. copies.

The FDA does not discuss its interactions with drugmakers as a matter of policy, a spokesperson said, so information exchanged between Eli Lilly and the agency before it determines that the shortage of tirzepatide was completed are unknown.

The spokesperson also said the agency “does not make drugs and cannot require a drug company to make a drug, make more drugs, or require a drug company to who she chooses to sell her product to.

Eli Lilly did not respond to a CBS News inquiry regarding reports of some pharmacists unable to order the drugs from their wholesalers.

Calls for change

Scott Brunner, CEO of the trade group Alliance for Pharmacy Compounding, says part of the problem is how the FDA determines when to resolve a shortage.

“The current status only allows them to take data from drug manufacturers, and we think they should be able to pull it from hospitals, health systems and pharmacies – those people are certainly on the front lines,” said Brunner.

The American Society of Health-System Pharmacists still includes tirzepatide on its own shortage list.

Unlike the FDA, “we often publish shortages earlier and we often leave these shortages a little longer, simply because we are following specific formulations or exact dosages,” said Dr. Erin Fox, deputy director of pharmacy. at the University. of Utah Health, whose team runs a drug information service that contributes to the company’s list.

Drugmakers “normally have extra capacity to prevent this” type of shortage, she said, and the quantity of tirzepatide is unusual.

Brunner is among drug industry leaders who want the FDA to create a new framework for drugs like tirzepatide, which have seen high compounding rates during shortages.

“Our primary concern is continuity of care,” the Alliance for Pharmacy Compounding wrote in an Oct. 7 letter to the FDA. “Patients who have received compounded tirzepatide cannot immediately switch to the FDA-approved product due to a variety of convenient ‘speed bumps.’

Patients face obstacles such as obtaining a new prescription and navigating insurance coverage when switching from a compounded medication to a commercial product.

“We’re talking about patients who are going without this medication for a considerable period of time even though they’ve had access to it,” Welch said.

Compounding pharmacists are preparing for the moment when semaglutide, sold by Novo Nordisk under the names Ozempic and Wegovy, will be removed from the shortage list.

“The FDA needs to take these concerns seriously and build this framework now for when the time comes. We don’t know when, but it’s coming,” Brunner said.

Another major concern is the increase in desperate patients trying to obtain tirzepatide online from unauthorized and potentially dangerous sources once compounders must stop producing the drug.

Compounding pharmacies, drugmakers and the FDA share concerns about fake or substandard weight loss drugs — even though regulated drugmakers are often lumped in with illicit sources.

Affordability issues

The ability of drugmakers to meet demand is only one part of access to tirzepatide and similar drugs. Patients must also be able to afford it.

In late August, Eli Lilly announced that it would sell single-use vials of Zepbound directly to patients at a significantly lower price than its injector pens.

Affordability is Galindo’s main concern. When she learned she would no longer have access to the compounded tirzepatide, she said she ordered a final three-month supply from her pharmacy with a credit card.

“I have an 8-year-old and I want to chase him and I want to play with him, and I couldn’t play with him because I was so heavy my body wasn’t pushing anymore,” Galindo said.

At her heaviest, she says she faced significant health issues, including insulin resistance related to polycystic ovary syndrome, joint pain and possible autoimmune issues. Now she is training for a half marathon without any pain.

“It’s a very dark place when you get to be depressed about how you look and how you feel, because I felt like my body was working against me instead of the other way around,” she said. Galindo said. “Honestly, I’m still very worried about being able to go back to that place.”