FDA Flips the Switch Again on Tirzepatide Compounding
On again, off again. With impressive nimbleness, the U.S. Food and Drug Administration reversed course on tirzepatide compounding in large-scale pharmacy facilities. On October 2, they told those facilities to knock it off. Late last week, the agency told them to carry on – for now.
FDA was responding to a lawsuit filed by compounding pharmacies to challenge the FDA declaration that the tirzepatide shortage was over. The agency said in its response that it would “reevaluate the decision at issue” and promised it “will not take action” against compounding pharmacies that want to keep selling compounded tirzepatide.
So the door is open again for compounded tirzepatide.
But When Is the Shortage Really Over?
It is hard to tell just how lasting this reprieve for compounding pharmacies will be. The American Society of Health-System Pharmacists tracks drug shortages separately from FDA and still lists tirzepatide among current drug shortages. A senior director at ASHP, Michael Ganio, explained why the drug is still in short supply even though Lilly says they are filling all the orders they receive:
“This can be the kind of thing that just takes a couple of weeks for supply to even out. Distribution centers get replenished and then they send it out to pharmacies. The pharmacies probably all have back orders and they have customers that maybe have been getting it from the compounding pharmacy and are now trying to get it from a retail pharmacy and community pharmacy.”
A Short Supply and a High Price
In truth, supply, demand, and price work together to determine whether everyone who needs a drug can get it. If the price of a drug is so high that it is out of reach for most of the people who need it, does the small available supply represent a shortage? To the drug company that wants to maintain its exclusive rights to supply, the answer is clearly and emphatically NO!
But the presence of compounding pharmacies offering a large supply of the drug at a much lower price creates a challenge to that claim. We suspect that this will be a fraught subject until the price and the supply put advanced obesity medicines within reach for all of the people who need them.
Click here, here, and here for more on this situation.
Rotary Light Switch in Baden-Württemberg, photograph by 4028mdk09, licensed under CC BY-SA 3.0
Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.
October 17, 2024
