OZEMPIC: GENERICS NOT AVAILABLE

OZEMPIC: GENERICS NOT AVAILABLE

If you’ve been relying on cheaper, off-brand versions of Ozempic, Mounjaro, or similar drugs to manage your weight or diabetes, the clock just ran out. As of this week, the FDA’s deadline has kicked in, making it illegal for compounding pharmacies to produce or sell unapproved versions of these popular GLP-1 medications.

The background here: The FDA says the shortage of these drugs—semaglutide (Ozempic, Wegovy) and tripeptide (Mounjaro, Zepbound)—is over. Since manufacturers like Novo Nordisk and Eli Lilly can now keep up with demand, the agency is closing the loophole that let smaller pharmacies whip up their own versions.

The grace period for compounded tirzepatide ended back in March. Thursday was the last day for compounded semaglutide.

This is more than an inconvenience for many patients—it’s a crisis. Olympia Pharmaceuticals, for example, was supplying over 70,000 people every week, according to its CFO Josh Fritzler. He told CNN, “We had to be transparent. ‘OK, we will prioritize the shortage need for the next three months to ensure we can meet as many patients as possible before this transition ends. Because many of them are scared that they will run out.”

Michelle Pierce, a 25-year-old from Texas, credits compounded semaglutide with lowering her blood sugar and keeping her out of surgery. Now that her supply is drying up, she says, “I don’t have any other options. I absolutely cannot afford to completely pay out of pocket.”

While patients and compounding pharmacies are frustrated, some doctors aren’t exactly mourning the off-brand meds. Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center in Boston, says the lack of FDA oversight worries her. “You just don’t have that security of [compounded versions] being FDA-regulated. I don’t know what’s in this compound. I don’t know about purity, I don’t know about safety. I don’t know about dosing. I don’t know about drug interactions. I really wouldn’t want to be responsible for that.”

Still, Dushay thinks the new restrictions might make it harder for patients to get the real thing, especially if there’s another rush for starter doses.

The FDA insists there’s no need to panic. According to them (and CNN), the drugmakers now have enough capacity to meet current and future needs. Novo Nordisk is “confident” in its supply, while Eli Lilly is warning patients to steer clear of “personalized” or “tailored” knockoff versions, which they say are illegal and dangerous.

Both companies are trying to widen access by rolling out online platforms and single-dose vials. However, the main hurdles for many are still price and lousy insurance coverage. “The shortage is much better; insurance coverage is much worse,” says Dr. Disha Narang, an endocrinologist at Northwestern Medicine Lake Forest Hospital.

On the compounding side, Lee Rosebush, chair of the Outsourcing Facilities Association, says his group tried to fight the FDA’s move in court and lost. He worries the new rules will hit patients hard: “What I’m afraid of happening at the end of this week when the deadline hits is that patients and providers won’t have access to the medications they need, and they will be financially impacted as they move forward because of this.”

As for Michelle Pierce, she’s managed to stash six months’ worth of her meds—but she’s worried about everyone else. “Some people are just now starting the compounded meds, unaware they could quickly lose access,” she says.