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

For many patients on tirzepatide, a breakthrough drug used for weight loss and diabetes, the end of the drug shortage was not welcome news.

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

The 35-year-old mother is one of many patients taking a compounded version of tirzepatide produced by a drugstore, while Eli Lilly’s branded versions, Zepbound and Mounjaro, have been scarce.

She says she’s been paying about $350 a month for compounded thirzepatide. 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 while the FDA does not enforce patents, the agency regulates whether pharmacies make unauthorized copies of FDA-approved drugs, a limit the agency waives if there is a shortage of medicines

The FDA officially deemed the nearly two-year shortage of tirzepatide 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 there is still a shortage of tirzepatide and will allow large-scale compounding pharmacies to continue producing copies of the drug for now, 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 for weight loss or diabetes, according to a Kaiser Family Foundation survey. The a new class of trendy drugs they include semaglutide, sold by Novo Nordisk under the brand names Ozempic and Wegovy, and tirzepatide, sold as Lilly’s Mounjaro and Zepbound.

It is not known exactly how many people take a GLP-1 compound, but one estimate puts the number as high as 2 million patients in the US. KFF Health News reports.

After the FDA’s decision, dozens of compounded tirzepatide patients took to online forums and social media to express frustration and confusion at losing access to their medications.

Pharmacists across the country said at a recent industry roundtable that they have received a flood of calls from distressed patients and providers.

Scott Welch runs a hybrid pharmacy in Arlington, Virginia that dispenses compounded and over-the-counter prescription drugs.

“I knew as soon as I heard that the FDA had pulled the (tirzpepatide) injection from the shortage, that there would 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 add this anymore, I have to go into the commercial product.’

Welch logged into his wholesaler portal and was surprised to see a “zero allocation” for Mounjaro and Zepbound, meaning he still couldn’t order any quantities of the drugs.

“I didn’t expect when something came out that there would be a shortage coming from the FDA. At least I hope we can get products and services to our patients,” Welch said.

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

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

An Eli Lilly spokesman 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 gone 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 about their ability to supply commercial drugs to the market. If the total supply of a drug cannot meet current demand, the FDA will list it as a shortage. During this time, compounding pharmacies can make copies of the drug to help fill the gap.

Compounded drugs are not FDA-approved, but facilities where they are manufactured must meet certain federal or state regulations, depending on their classification.

More than a month after Eli Lilly told the FDA it could meet demand again, the agency agreed to declare the shortage resolved and told the components to stop making copies.

The FDA does not discuss its interactions with drugmakers as a matter of general policy, a spokesman said, so it is unknown what information was exchanged between Eli Lilly and the agency before it determined that the tirzepatide shortage had ended .

The spokesman also said the agency “does not make drugs and cannot require a drug company to make a drug, make more of a drug, or commission whomever a drug company decides to sell its product to.”

Eli Lilly did not respond to an inquiry from CBS News about reports from some pharmacists that they were unable to order the drugs from their wholesalers.

Ask 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 address a deficiency.

“The current statute only allows them to look at 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,” he said. Brunner.

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

In contrast to the FDA, “We’ll often issue shortages earlier and often leave those shortages a little bit longer, just because we’re tracking specific formulations or exact strengths,” said Dr. Erin Fox, associate director of pharmacy at the University . of Utah Health, whose team runs a drug information service that contributes to the society’s list.

Drugmakers typically “have extra capacity to prevent this” kind of shortage, he said, and the large compounding amount of tirzepatide is unusual.

Brunner is among compounding industry leaders who want the FDA to create a new framework for drugs like tirzepatide that have experienced high rates of compounding while in short supply.

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

Patients face hurdles like getting a new prescription and navigating insurance coverage when switching from a compounded drug to a commercial product.

“We’re talking about patients going without this medication for a considerable amount of time when they’ve had access to it,” Welch said.

Compounding pharmacists are preparing for when semaglutide, sold by Novo Nordisk as Ozempic and Wegovy, comes off the shortage list.

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

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

Compounding pharmacies, drug manufacturers, and the FDA share concerns about fake or substandard weight loss drugs, although manufacturers often side with illicit sources.

Accessibility concerns

The ability of drug manufacturers to meet demand is only one part of access to tirzepatide and similar drugs. Patients must also be able to pay for them.

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 injection pens.

Affordability is Galindo’s main concern. When she learned she would lose access to the compounded tirezapatide, she says she ordered a final three-month supply from her pharmacy with a credit card.

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

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

“It’s a very dark place when you get to be so 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,” Galindo said. “Honestly, to this day I’m still very worried about going back to that place.”