The Ozempic Boom Is So Big That Pharmacies Are Taking an Unusual Step: They’ll Going to Start Making It Themselves

The surge in new weight-loss drugs is unprecedented and remarkable, to say the least, and I may still be understating the situation. Ozempic and other GLP-1 agonists have broken new ground with no real precedents.

One striking example is what’s been happening in the U.S. since last year. Hundreds of pharmacies are manufacturing and selling these drugs without paying the patent owners, taking advantage of a legal loophole to do so.

The “Ozempic year.” 2023 saw these drugs become a mass phenomenon. Although pharmaceutical companies had been manufacturing them for years, the overwhelming demand exceeded the supply.

What’s more, the supply shortage created a significant bottleneck and business opportunity.

What is a pharmacy, really? Traditionally, all pharmacies manufactured the drugs they dispensed themselves. However, this changed radically with the growth of the pharmaceutical industry during the 20th century and the increased complexity of drug production. In many cases, pharmacies have become retail outlets with no capacity to manufacture anything.

This doesn’t mean that they can’t do so. In many countries around the world, including the U.S., under the Food and Drug Administration policy, the law allows pharmacies to manufacture versions of patented drugs under certain circumstances, such as shortages and customization.

A “huge scientific experiment.” The introduction of standard “magistral formulas” in healthcare has sparked a significant shift in the industry. Laboratories and large chains have seized the opportunity to capitalize on this new approach, despite the fact that the law wasn’t originally intended for this purpose.

In essence, they’re now using a regulatory mechanism that was meant to address the standardization of pharmaceutical presentations to facilitate the mass production and marketing of patented drugs.

Angela Fitch, former president of the Obesity Medicine Association, highlighted this unprecedented development in healthcare, stating, “We’ve never done this before in healthcare, right? To me, this is like a gigantic, huge science experiment.”

Magistral formulas in the era of precision medicine. This isn’t just the case of Novo Nordisk, the Danish pharmaceutical company behind Ozempic. Other pharmaceutical companies are also heavily involved in this area, and it seems likely that there will be a legal battle that could potentially change the pharmaceutical industry.

At the end of the day, major corporations are pushing to change the law around magistral formulas. These are important for certain patients, but they’ve created a flexible loophole allowing an industry to operate outside normal regulations.

It would be paradoxical to lose the most customizable mechanism of traditional pharmacy just as medicine is moving towards greater personalization.

A broken balance. The issue is that imposing restrictions would have serious implications for the health of many people who rely on magistral formulas and could even affect society’s ability to respond to shortages of important drugs. This delicate balance has been in place for years. If it’s disrupted, who knows what the consequences will be.

Image | Tbel Abuseridze (via Unsplash)

Related | The Race for the ‘New Ozempic’ Has Another Competitor: Pfizer and Pill to Lose Weight Fast