It seems that both Novo Nordisk and Eli Lilly are dreaming of a bigger ban on competition for their wildly successful obesity drugs. With semaglutide and tirzepatide, they have valuable assets that meet a tremendous medical need. And they really do not like the compounding pharmacies taking big bites from their apples.
So this week, the news surfaced that both Novo and Lilly have asked the U.S. Food and Drug Administration to put semaglutide and tirzepatide on a list of drugs that are too hard for compounding pharmacies to make. The magic phrase here is demonstrable difficulties. FDA keeps a list of drugs that present demonstrable difficulties for compounding pharmacies.
The bottom line, according to both companies, is a danger to consumers. Novo Nordisk cites 542 adverse event reports and ten deaths between October 2018 and June 2024. With the demonstrable difficulties designation, compounding pharmacies could no longer make these drugs legally.
Danger to Profits
Scott Brunner is CEO of the Alliance for Pharmacy Compounding. Naturally, he expresses a dim view of this move:
“To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument.
“I get that Novo doesn’t like it, but the answer is not to restrict patient access, as Novo’s October 21 letter attempts, it’s for it to fix its supply chain.”
In other words, it is not clear that the priority is to protect patients. It seems more like profits are the first priority.
Profits and People
Both Lilly and Novo have invested billions of dollars in these drugs. They are reaping big rewards with billions of dollars in sales and profits. They continue to invest in innovative research that will benefit many millions of people – if and when those people can gain access to these drugs.
But right now, those drugs remain out of reach for the vast majority of people who need them. They are out of reach because the supply is woefully inadequate and thus the price is astonishingly high. This is especially true in the U.S. where prices are higher than most everywhere else in the world.
We understand why these companies might dream of a ban on competition for their obesity drugs. But the answer is not to ban competition, keep supplies low, and prices high. The real answer is to compete effectively by meeting the tremendous need in the marketplace.
This will be no small task. But the company that does it best will prosper.
Click here, here, here, here, and here for more on this evolving situation.
The Dream, painting by Henri Rousseau / WikiArt
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