The Semaglutide Shortage Is Over. Will Compounding Vanish?
It’s official. FDA yesterday declared that the semaglutide shortage is over and now we wonder how quickly and completely the compounding of obesity medicines will vanish. From the very first days of launching semaglutide for obesity in 2021, demand has outstripped supply. The FDA officially declared the shortage in March 2022.
So it feels vaguely abnormal for the shortage to be over.
The Clock Is Ticking . . .
The official word is that the clock is ticking on massive dispensing of compounded semaglutide for relatively low prices. FDA says state-licensed compounding pharmacies (503A businesses) have until April 22 to stop selling semaglutide injection products “that are essentially a copy of an FDA-approved product.” These are pharmacies that make up doses for specific patients on a relatively small scale.
For 503B outsourcing facilities, the deadline is May 22. These facilities make semaglutide injection in large batches for healthcare providers to dispense.
Of course, Novo Nordisk is ecstatic to plug this hole in the patent protection for Ozempic and Wegovy. Dave Moore, the head of U.S. operations for Novo Nordisk, expressed the company’s pleasure:
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand.
“Patient safety remains our top priority and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them.”
The only thing missing from that heartful soundbite is mention that this takes a little pressure off the company’s pricing practices. So of course they are happy.
People who are getting good results from some of the better sources of compounded semaglutide at a lower price than Wegovy will not be quite so happy.
But Will Compounding Fade Away?
This is where the outlook is a little foggy. Former FDA Commissioner Robert Califf is not so optimistic that compounded semaglutide will disappear altogether. He told USA Today:
“There so much money to be made. There’s just an endless number of tricks that compounders could use. So I don’t think it’s the end of it, but it certainly will bring us into a new era after the time period has passed and all the lawsuits are finished.”
The CEO of Hims & Hers, a company that has been riding high on its sales of compounded semaglutide, signaled that they will adapt and persevere. He said in a post:
“We do compound semaglutide. Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs.”
After FDA announced the end of the semaglutide shortage and called for compounding of it to wind down, the stock price of Hims & Hers dropped by 26%. But it is still 421% ahead of its price a year ago.
Right now, Novo Nordisk could mostly squeeze compounding out of the market. But that would require bold action to genuinely open up access to their drug. It would leave them with a little less room to skim profits from this lucrative market.
We would love to see the company surprise us with such audacity. But we are not holding our breath. The money is so attractive. It’s easier to advocate for action by others while resisting price pressures.
The result will be that compounding will likely linger in the market to meet the needs of people left behind by high pricing and poor insurance coverage.
Click here and here for the announcements from FDA and Novo Nordisk, here for free access to reporting by the Washington Post.
The Sun at Foggy Morning, ink drawing by Alfred Freddy Krupa, licensed under CC BY-NC 4.0
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February 22, 2025
