What Happens When Pharma Can’t Supply? Chaos
FDA tells us we have a problem – actually two of them, and they’re connected to a third. First, counterfeit versions of the Ozempic brand of semaglutide injections are finding their way into pharmacies. These fakes present an inherent risk of problems with safety and effectiveness. Second, compounded versions of semaglutide are selling in some dubious settings – including Groupon. These two problems are large because of the third problem. Semaglutide, especially in the form of Wegovy for obesity, is in short supply. When pharma can’t supply an important new medicine, chaos descends.
The Counterfeits
NBC news reports that counterfeit versions of Ozempic have become a global problem. Last week, FDA seized thousands of these fakes, warning wholesalers, pharmacies, and consumers to be on the lookout for more. Recently in Austria, patients landed in the hospital after they received Ozempic fakes. Regulators suspected these fakes may have contained insulin instead of semaglutide. This substitution could have caused the symptoms that required hospitalization.
Timothy Mackey is a professor of global health at the University of California, San Diego, where he studies counterfeit drugs. He told NBC:
“The thing about this product is that it’s very popular; people are going to use it. Global regulators are trying to shut down the counterfeit drugs wherever they may go. Americans or anyone around the world are susceptible to counterfeits.”
Sketchy Offers of Compounded Semaglutide
Compounded semaglutide offers a slightly different problem. While compounding pharmacies have a role to play when drug shortages are a problem, FDA has warned that the safety and efficacy of some of these offerings is problematic.
And then there are the high-trending offers for semaglutide on Groupon. Obesity medicine expert Caroline Apovian told Medscape that the news of this is cause for concern:
“What I’m hearing is extremely unfortunate. It’s very disturbing to me. I can’t believe it actually. Even when monitored by the best doctors in the country for obesity medicine, you can get serious side effects.”
Shortages at the Root of the Problem
At the root of the problem is the shortage of semaglutide. Counterfeiters are exploiting the poor supply of semaglutide.
The only reason that compounding pharmacies have an opening to supply their own versions of this product is because both Ozempic and Wegovy are on the FDA drug shortages list. FDA regulations allow this. But FDA says:
“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
Right now, all forms of Ozempic are listed as “currently available” on the FDA drug shortages website. For Wegovy, only the highest dose, 2.4 mg, has this status. All other doses have “limited availability.” This is in sharp contrast to the brands of tirzepatide that Lilly sells. All strengths of Mounjaro are listed as “available.” Zepbound is not currently in shortage.
This situation bears watching. When pharma cannot supply an important new drug, the result is chaos. For want of semaglutide, we’re suffering with a lot of that.
Click here and here for more on the problems with counterfeit semaglutide. For more on the sketch offers of compounded semaglutide, click here. For more on the continuing shortage, click here and here.
Nature Looks Back at Us (peach with mold), photograph by Luigi Chiesa, licensed under CC BY-SA 3.0
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December 30, 2023
