What’s the Real Reason for a Stalemate Over Compounding?
FDA told a Federal judge yesterday that the agency isn’t yet sure whether there’s still a shortage of tirzepatide in the U.S. The agency needs more time to think about this. So for now, we have a stalemate on compounding of both semaglutide and tirzepatide. They are still on the FDA shortage list and compounders are free to churn out low cost alternatives to the mostly unaffordable branded and high-quality products that Novo Nordisk and Eli Lilly make under the brand names of Ozempic, Wegovy, Mounjaro, and Zepbound.
If you wonder why this contentious issue is so hard to resolve, this is one puzzle that’s easy to solve.
It’s all about the money.
Pharma IP Protection Has Sprung a Leak
The pharmaceutical companies that created this multi-billion-dollar bonanza very definitely don’t like the leak in their IP protection that compounding has created. Patents and proprietary technology are the foundation of the pharmaceutical business model. For as long as their patents endure, they feel entitled to a monopoly. Patent law says so. The reason is to encourage innovation. And there can be no doubt that these remarkable new medicines represent a bonanza of medical innovation.
Novo and Lilly do some fine posturing about their concerns for patient safety. These products are too hard for compounders to make safely, they insist. But law professor Robin Feldman offers a strong dose of reality about the core of this dispute:
“It’s the inordinate amount of money that is changing hands for the new weight-loss drugs, their incredible efficacy, the runaway demand. It’s all about the dollars.
“When someone tells you, ‘it’s not the money, it’s the principles’ . . . it’s the money.”
Can We Call It Greed?
In a word, yes. Greed is an insatiable desire for material gain (food, money, land, or possessions) or social value (such as status), or power. So indeed, everyone in this mix is motivated by greed. Pharma is greedy for all the profits it has earned by investing in medical innovation. Compounders are greedy for a piece of the action and respect for the role they play in plugging the hole in the supply chain. Finally, patients are greedy for better health and a better life.
Everyone wants to be better off because of the advance in medical care that new obesity medicines represent. And the stalemate over compounding is all about who gets what share of the benefits. The large sums of money in play are mere markers for the benefits people are chasing.
Click here, here, and here for more perspective.
Adoration of the Golden Calf, painting by Alexander Ivanov / WikiArt
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November 22, 2024
