• Tirzepatide, the active ingredient in Zepbound and Mounjaro, is no longer in short supply, the FDA says.
• Cheaper versions of the drug, known as compounded tirzepatide, might be restricted in 2025.
• Patients could face higher costs and tougher access, and telehealth is racing to adapt.

The FDA has announced that popular weight loss medication tirzepatide is no longer in shortage, potentially removing cheaper versions of the drug from the market by early 2025.

Tirzepatide is the active ingredient in Eli Lilly's drugs Mounjaro and Zepbound, branded to treat diabetes and obesity, respectively.

They're part of a class of medications called GLP-1 agonists, including semaglutide (sold as Ozempic and Wegovy), which have transformed obesity treatment in recent years. These injections work by mimicking hormones in the body that regulate appetite and blood sugar, helping patients lose as much as 25% of their body weight.

Manufacturers have struggled to meet the intense demand for these drugs. This opened the door for pharmacies to offer custom-made versions with the same active ingredient, known as compounded GLP-1 medication, at a significantly lower cost — around $250 to $350 per month for tirzepatide, compared to Zepbound's list price of $1,059.

With the official shortage over, the FDA has signaled it will crack down on compounded tirzepatide, affecting patients who've relied on the lower-priced medication.

"People are concerned. They're saying, 'This has been life changing but I don't have $1000 to pay out of pocket and my insurance isn't going to cover it," Ted Kyle, a health professional with decades of experience in policy, marketing, and obesity care, told Business Insider.

Eli Lilly did not immediately respond to Business Insider's request for comment.

Most compounded versions of tirzepatide won't be allowed without an official shortage

The FDA's annoucement on December 19 to officially remove tirzepatide from the shortage list means compounding pharmacies will be restricted from making what are essentially copies of the brand-name version. These copies use the same active ingredient — in this case tirzepatide — but are not FDA-approved, although the manufacturers are held to other regulatory standards.

Compounding pharmacies have staunchly disagreed with the decision.

"The drugs they are advertising are not yet available in quantities to meet demand. Until they are, state-licensed pharmacies will continue to prepare compounded copies, operating within FDA guidance to provide patients access to life-changing medications during this period when the drugmakers cannot," Scott Brunner, CEO of the industry trade group Alliance for Pharmacy Compounding, wrote in a statement on LinkedIn.

The FDA had previously moved to end the shortage in October, but delayed the decision after a compounding industry organization filed a lawsuit alleged it hadn't given proper notice. An update on that case is expected in early January 2025.

As it stands now, the FDA's decision will give makers of compounded tirzepatide up to 90 days before enforcement to "avoid unnecessary disruption to patient treatment," per the announcement.

Companies are racing to adapt

The FDA decision also raises questions for the booming telehealth industry that connects patients with weight loss drugs, as companies like Henry Meds and Hims offer compounded GLP-1s — some have removed compounded tirzepatide from their websites.

For now, businesses will still be able to offer some lower-cost medications for weight loss since semaglutide, better known as Wegovy and Ozempic, is still considered to be in shortage.

In some cases, telehealth execs are pivoting to strike a deal with pharmaceutical companies.

Earlier in December, telehealth company Ro announced a partnership with Eli Lilly to offer a half-price version of Zepbound, Lilly's brand-name tirzepatide product. The cheaper option is sold in vials in an effort to sidestep supply-chain issues with the prefilled pens and compete with compounded drugs.

More brand-name GLP-1 drugs are on the horizon

More FDA news could continue to change the trajectory of GLP-1 drugs in the coming months.

The FDA also announced the approval of the first generic version of a once-daily GLP-1 injection for Type 2 diabetes on December 24. It could pave the way for similar generic medications, including those for weight loss.

And more brand name GLP-1s are in the works as biotech startups and pharmaceutical companies race to find the next blockbuster medication.

For now, access to weight loss drugs is out of reach for many people who could benefit from them.

"This is going to be a continuing tension for years to come," Kyle said. "Maybe compounding will go away but the issue won't go away because the pricing does not match the scale of need."

• The Food and Drug Administration released new guidelines on what foods can be labeled "healthy."
• The new guidance now allows foods like salmon, avocados, and olive oil to be labeled "healthy."
• "Highly sweetened" yogurts and cereals however can no longer be qualified as healthy, the FDA says.

Your "healthy" yogurt may be getting a rebrand soon.

On Thursday, the US Food and Drug Administration published its new and improved definition of what constitutes a "healthy" food, tightening up the limits on added sugars, salt, and saturated fat in foods that carry the label.

In a meticulous 318-page document, the federal agency details strict parameters for companies that wish to call their foods "healthy."

For example, a fruit-based food can't be "healthy" anymore if one serving has more than 2% of a person's recommended daily value of sugar. The same goes for veggies, meat, and eggs, while grains can have up to 10% DV of added sugars.

This could change how some brands currently market their food products as a healthy snack alternative.

The last time the FDA issued an update on the "healthy" label was three decades ago, according to the agency.

Under the new standards, the agency said foods such as "water, avocados, nuts and seeds, higher fat fish, such as salmon and olive oil will now qualify to use the 'healthy' claim."

The new guidance comes as competition in the heath food aisle intensifies — the global health and wellness food market was valued at roughly $878 billion last year, according to a 2024 market data study from Data Bridge.

The FDA's report estimates that the changes could make a dent in chronic diseases nationally, saving about $686 million over 20 years.

The cost to manufacturers, meanwhile, comes in at $403 million over 20 years for "reformulating, labeling, and recordkeeping," per the report.

The rule won't change food labeling overnight: it's not slated to take effect until 2028, and it's an optional one — food labels don't have to mention they're "healthy."

But it comes just as President-elect Trump prepares to take office. Robert F. Kennedy Jr., who Trump has tapped to lead the US Departmet of Health and Human Services, the umbrella federal health agency that oversees FDA, has recently proclaimed he's waging war against big food companies, vowing to "Make America Healthy Again" and take chemical dyes out of our Fruit Loops. (In case you were wondering: Fruit Loops, with 24% of a person's recommended daily dose of added sugars per serving, do not make the new "healthy" claim cut.)

"If the incoming administration is truly serious about making Americans eat healthier, then they should embrace the power of food labeling," former FDA official Peter Lurie, executive director of the Center for Science in the Public Interest, told The New York Times.

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On May 7, 2011, Georgia resident Tonya Brand noticed a pain on the inside of her right thigh. As the pain grew worse in the 4- to 5-inch area of her leg, she headed to a hospital. There, doctors suspected she had a blood clot. But an ultrasound the next day failed to find one. Instead, it revealed a mysterious toothpick-sized object lodged in Brand's leg.

Over the next few weeks, the painful area became a bulge, and on June 17, Brand put pressure on it. Unexpectedly, the protrusion popped, and a 1.5-inch metal wire came poking out of her leg, piercing her skin.

The piece of metal was later determined to be part of a metal filter she had implanted in a vein in her abdomen more than two years earlier, in March 2009, according to a lawsuit Brand filed. The filter was initially placed in her inferior vena cava (IVC), the body's largest vein tasked with bringing deoxygenated blood from the lower body back up to the heart. The filter is intended to catch blood clots, preventing them from getting into the lungs, where they could cause a life-threatening pulmonary embolism. Brand got the IVC filter ahead of a spinal surgery she had in 2009, which could boost her risk of clots.

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