Whose job is it to make sure off-brand weight loss compounds are up to snuff?

I'm David Brancaccio in Los Angeles. The Food and Drug Administration says it's preparing to

rain in a key corner of the prescription weight loss drug market, compounding pharmacies,

and telehealth companies that mix together components and dispense lower-cost

versions of these medicines. These represent competition to the rights holders of GLP1 drugs,

Novo Nordisk of Denmark and Eli Lilly of Indiana. Originally, the government allowed the off-brand

system to deal with a shortage. Marta Voschinska is a senior fellow in economic studies at the Brookings Institution Center on Health Policy. She joins us now. Welcome.

Good morning. Thank you so much for having me. 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? 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 that the law doesn't sort of

draw a line between the scale for compounding versus when it becomes commercial manufacturing.

Now, I mean, the reason we're talking right is the FDA is saying it's going to try to curb some of this further. It will use, quote, all available compliance and enforcement tools. What kind of tools do drug regulators have in the U.S.? 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 favorite nation agreements. They are on Trump RX. They have now really leaned in, dropped their prices quite a bit. Now FGA 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. Can Lily or Novo, the big pharma, can they meet

demand? 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. But you've worried about standards or lack thereof in this

whole area. What are some of your concerns? My concern was that the compounding pharmacies

have been importing a product that's basically where the company sets their own standards.

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