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

For many patients on tirzepatide, a transformative medication used for weight loss and diabetes, the end of the drug's shortage was anything but welcome news.

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

The 35-year-old mom is one of many patients taking a compounded version of tirzepatide produced by a pharmacy while Eli Lilly's brand-name versions, Zepbound and Mounjaro, have been in short supply.

She says she's been paying about $350 per month for compounded tirzepatide. Her insurance doesn't cover Zepbound, and she can't afford the list price of around $1,000 per month.

Eli Lilly holds the patent for tirzepatide, and while the FDA doesn't enforce patents, the agency does regulate whether pharmacies are making unauthorized copies of FDA-approved drugs — a limit the agency waives if there is a shortage of the medication.

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 tirzepatide shortage and will allow those large-scale compounding pharmacies to continue producing copies of the drug for now, according to a court filing.

The FDA did not respond to a request for comment on the lawsuit.

A spokesperson for Eli Lilly told CBS News that "all doses of Mounjaro and Zepbound" are available and have been "since early August," and that the "FDA continues to note the shortage as 'resolved.'" 

The company also raised concerns about unauthorized versions being sold. "No patient should be exposed to unapproved knockoff drugs with heightened risks, particularly when safe and effective FDA-approved medicines are available," the company said in a statement. "Yet many entities continue to mass produce unapproved tirzepatide knockoffs that may expose patients to potentially life-threatening risks, including versions that are manipulated as to dose and form solely to try to evade legal restrictions.  To advance patient safety, they should stop marketing their unapproved tirzepatide knockoffs to new patients and instead assist current patients' transition to FDA-approved medicines."

"We will continue to pursue appropriate legal avenues against entities that put patients at risk," the statement said.

"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 poll. The buzzworthy new class of drugs include semaglutide, sold by Novo Nordisk under brand names Ozempic and Wegovy, and tirzepatide, sold as Lilly's Mounjaro and Zepbound.

It's unknown exactly how many people are taking a compounded GLP-1, but one estimate puts the number at up to 2 million patients in the U.S., KFF Health News reported.

After the FDA's decision, scores of patients on compounded tirzepatide took to online forums and social media to voice frustration and confusion over losing access to their medications.

Pharmacists from around the country said at a recent industry roundtable they have received an onslaught of calls from distraught patients and providers.

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

"I knew as soon as I heard that the FDA had taken the [tirzpepatide] injection off the 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 said, 'Well, if I can't compound this anymore, I need to get in 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 amount of the medications.

"I didn't expect that when something comes off a shortage coming from the FDA. I at least expect to be able to get product and service our patients," Welch said.

An FDA notice states that "prescribers may still see intermittent localized supply disruptions as the products move through the supply chain."

The FDA's entry for tirzepatide on its online shortage list says patients might not be able to fill their prescription at a particular pharmacy right away. That's especially true for medicines that need to be refrigerated and have multiple dose strengths — like most GLP-1 medications.

Meanwhile, Welch said his "team has gone from pharmacists to therapists" as they counsel patients over the sudden loss of access to the compounded medications.

When does the FDA resolve a shortage?

The FDA receives data from drugmakers about their ability to supply the market with commercial medications. If a drug's total supply can't meet current demand, the FDA will list it as in shortage. During this time, compounding pharmacies are permitted to make copies of the drug to help fill the gap.

Compounded medications aren't FDA-approved, but the facilities in which they are made 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 agreed to declare the shortage resolved, telling compounders to stop producing copies of it.

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

The spokesperson also said the agency "does not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug or mandate who a pharmaceutical company chooses to sell its product to."

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 statute only allows them to consider data from drugmakers, and we believe they ought to be able to pull from hospitals, from health systems, from pharmacies — certainly these folks are on the front lines," Brunner said.

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

In contrast to the FDA, "We will often post shortages earlier and we often leave those shortages on a little bit longer, just because we're tracking specific formulations or exact strengths," said Dr. Erin Fox, associate chief pharmacy officer at University of Utah Health, whose team runs a drug information service that contributes to the society's list.

Drugmakers normally "have extra capacity to prevent this" kind of shortage, she said, and the sheer amount of tirzepatide compounding is unusual.

Brunner is among compounding industry leaders who want the FDA to create a new framework for drugs like tirzepatide that have seen high rates of compounding while under shortage.

"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 'speedbumps.'"

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

"We're talking about patients going without this medication for a substantial amount of time when they've had access to this," Welch said.

Compounding pharmacists are bracing 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 that framework right now for that moment that is coming. We don't know when, but it is coming," Brunner said.

Another major concern is an uptick in desperate patients attempting to get tirzepatide from unauthorized, potentially dangerous sources online once compounders have to stop producing the drug.

Compounding pharmacies, drugmakers and the FDA share concerns about fake or subpar weight loss drugs — even though regulated compounders often get lumped together with illicit sources by the manufacturers.

Affordability concerns

Drugmakers' ability to meet demand is just one part of access to tirzepatide and similar medications. Patients also need to be able to afford them.

At the end of August, Eli Lilly announced it would sell single-use vials of Zepbound directly to patients at a significantly lower price than its injection pens.

Affordability is Galindo's top concern. When she got word she'd be losing access to compounded tirzepatide, she says she ordered a final, three-month supply from her pharmacy on 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 that my body wasn't pushing anymore," Galindo said.

At her heaviest, she says she faced significant health challenges, including insulin resistance linked to polycystic ovarian syndrome, joint pain and potential autoimmune issues. Now, she's training for a half marathon without any pain.

"It's a very dark place when you get to being that depressed over how you look and how you feel, because I felt like my body was working against me instead of the other way," said Galindo. "I am honestly, still to this day, very worried that I could get back to that place."