Signs That Compounded GLP-1 Medicines Are Not Fading
Why can’t they just go away? When compounded GLP-1 medicines started showing up two years ago, they seemed like a temporary distraction. In The New Yorker, Jia Tolentino described a dubious concoction of semaglutide she obtained from a compounding pharmacy for herself to mix and inject. “No thanks,” we wrote, hoping this sketchy business would fade quickly.
Now, we see no signs of this happening.
News on several fronts suggests this business is becoming entrenched.
Legislation
Bipartisan legislation has cropped up in both the Senate and the House to strengthen the definition of drug shortages that open the door to compounding pharmacies. The main thing we see in this legislation is that it requires FDA to assess information from healthcare providers, pharmacies, and patients in decisions about drug shortages. In short, it says that a pharmaceutical manufacturer telling FDA there’s no shortage is not good enough. If patients can’t get a drug they need, then there’s a problem.
Senator Tim Kaine, a co-sponsor of this legislation, said this about it:
“Drug shortages can have tragic consequences for patients and force providers to ration life-saving medications. We must do more to ensure that Americans have access to the treatment they need. That’s why I’m introducing this bipartisan legislation to help prevent and limit the impacts of these dangerous shortages.”
This legislation is a signal that the compounding loophole will not get any smaller.
Legal and Regulatory Skirmishes
Another signal can be found in the response of compounding pharmacies to a Novo Nordisk request that FDA declare there are “demonstrable difficulties” for compounding semaglutide. The claims Novo is making about the complexity of compounding semaglutide are “simply false,” they say. With facts and data, they make their case well.
Beyond refuting the factual claims Novo Nordisk is making, the compounding pharmacies question the company’s claim to be putting the interests of patients first. They say it plainly. Novo’s request is self-serving.
Why?
This brings us to a fundamental question. Why do we have this problem of limited access to GLP-1 medicines? It is hard to credibly deny that money is getting in the way. Lilly and Novo are making plenty of money with their high-price, low-volume strategy. They would like to plug this leak in their IP fortress, but not by lowering their prices.
PBMs add to the problem, because they retain a portion of the discounts taken off from high list prices. Lowering the list price would hurt their business model.
So we have a two-tier system. People who have less money and constrained health insurance wind up with a choice between potentially risky compounded products or nothing at all. With sufficient wealth or generous health insurance, other people get a highly regulated pharmaceutical product.
This is pay as you go healthcare and it is a tragedy for many people.
Click here and here for more on the drug shortage legislation. For the response from compounding pharmacies to the “demonstrable difficulties” petition, click here. More about the role of greed in this mess can be found here. For a new position statement from the American Diabetes Association, click here.
Portorož Tunnel Valetta, photograph by Isiwal, licensed under CC BY-SA 4.0
Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.
December 4, 2024
