FDA looks to put the brakes on compounded GLP-1s

As GLP-1s remain popular across the U.S., the Food and Drug Administration says it’s now prepared to rein in a fast-growing corner of the market: compounding pharmacies and telehealth companies that sell lower-cost, compounded versions of weight-loss medicines. These products have increasingly cut into the market share of brand-name manufacturers Novo Nordisk and Eli Lilly.

But after years of allowing compounders to flood the market with bespoke weight-loss drugs, how will the FDA put the genie back in the bottle — especially without risking another shortage?

“Marketplace Morning Report” host David Brancaccio spoke with Marta Wosińska, a senior fellow in economic studies at the Brookings Institution’s Center on Health Policy, to discuss where the industry is headed next. The following is an edited transcript of their conversation.

David Brancaccio: I want to start with compounders. They were allowed to assemble these weight loss medicines because initially there was a shortage, but — we covered this — regulators, some time ago, declared the shortage over. How have these compounders kept at it?

Marta Wosińska: Compounding laws have a lot of loopholes. So, if pharmacies were to customize the product — which is really how compounding is supposed to be done — they can continue compounding, even though the drug is not in shortage. The issue is, is that the law doesn't sort of draw a line between the scale for compounding versus when it becomes commercial manufacturing.

Brancaccio: Now, the reason we're talking is the FDA is saying it's going to try to curb some of this further. It will use, “all available compliance and enforcement tools.” What kind of tools do drug regulators have in the U.S.?

Wosińska: They have incredible power of what products they allow through the border. They don't have to see that there is an actual problem with the product, they just need to suspect that there is a problem with the product. My take on this is that the landscape dramatically changed. You now have Novo and Eli Lilly participating with the Trump administration in these most favored nation agreements, they are on Trump Rx, they have now really leaned in, dropped their prices quite a bit. Now [the] FDA has a lot more of an ability to now use those tools and protect those deals that they have basically made with these two manufacturers.

Brancaccio: Can Lily or Novo, the big pharmas, can they meet demand?

Wosińska: The fact that they're now shifting towards selling pills really makes a difference in terms of the ability to produce a lot of product quickly. Injectable products really have major bottlenecks in production.

Brancaccio: You've worried about standards, or lack thereof, in this whole area. What are some of your concerns?

Wosińska: My concern was that the compounding pharmacies have been importing product — that's basically where the company sets their own standards. They can decide what kinds of impurities they're going to test. They decide what is an appropriate level of impurities. They decide what is considered a pure product. That makes me very nervous that we don't have a set standard for these products, and it's being used by millions of patients.