Semaglutide Goldrush

How many times have you walked by a luxury clothing boutique and wondered who would wear some of those outfits. And, of course, who could wear them in the first place. Over 40% of Americans are overweight or obese. For many of our citizens, “renting the runway” means having enough space just to comfortably move around much less slip into a Tory Burch print dress for a weekend.

But with the advent of appetite suppression drugs, more men and women can entertain thoughts of fashion rather than food, trading Chick-Fil-A for Chanel. People eat less because the drug targets GLP-1 receptors in the brain that regulate appetite. The active ingredient in drugs like Wegovy and Ozempic is semaglutide. It was launched as an effective diabetes treatment fifteen years ago. In larger doses, it puts the brakes on hunger and tells you’ve eaten enough. Long time food addicts on these medications suddenly aren’t thinking about chow all the time and strapping on the feed bag day and night. 

What makes these drugs so revolutionary is that they firmly repudiate obesity as a moral failing and address it as a lamentable metabolic condition. Simply put, these drugs allow people to create new lives for themselves built on blossoming self-confidence and the banishment of old hurts and shame. 

All over the internet, celebrities and influencers are flaunting their new slim and trim physiques, including Kim Kardashian who has made millions on bodacious exhibitionism. They have the engines of envy screaming in top gear. Both Wegovy and Ozempic have become scarce, however. So scarce that the FDA has issued an official notice of scarcity, allowing compounding pharmacies to mix their own “witch’s brew” of the medications. While the FDA warns they cannot vouch for the safety or efficacy of these potions, the agency is effectively “licensing” the fair use imitation of a patented medicine to these pharmacies. 

But the pharmacies can’t keep up with demand. Necessity may be the mother of invention but scarcity is the black sheep brother. A gray market gold rush is in full swing. People want these drugs badly, and many don’t care where their slimming fix comes from. As a recent story in the Washington Post detailed, craven opportunists are racing to set up off-brand stores on-line, patient safety be damned.  You can now go online and buy a Wegovy knock-off for a third of the list price of the real deal. 

QuickMD is one of these digital medicine shows “For $579 — and a potential wait of six weeks or more — QuickMD offered a month’s dose of brand-name Ozempic. Or patients could order a package of “semaglutide sodium,” presented as a comparable product for less than half that price that could ship in a week. One detail QuickMD left out: The FDA doesn’t consider semaglutide sodium to be the same ingredient in approved drugs like Ozempic and Wegovy. Instead, it has said the sodium version shouldn’t be used to make copies of the drugs in shortage and has not been shown to be safe and effective.”

The patent holder Novo Nordisk has admitted that it will be years before it can catch up to demand for both Ozempic and Wegovy. This admission along with FDA’s scarcity edict may well have emboldened competing pharmaceutical companies to challenge the drug patents in order to launch their own generic versions. So far the US Patent and Trademark Office has rebuffed them and upheld the validity of the Novo Nordisk patents. Yet, no doubt somewhere on this planet, one or more enterprising scoundrels are already producing illicit generic versions of the drug. Novo has also sued several clinics and pharmacies for trademark infringement and violation of other state laws. Caveat emptor.

Aspiring entrepreneurs seeking to seize the opportunity presented by the scarcity of Ozempic and Wegovy, take heed. The FDA's acknowledgment of the shortage undoubtedly unlocks potential avenues for alternative weight-loss medications. However, it is crucial to recognize that navigating the realm of patented drugs poses a complex web of regulatory challenges.