How FDA's Action Against Non-FDA-Approved GLP-1 Products Affects the Competitive Landscape

In a conversation with Pharmaceutical Executive, Jay Bregman, CEO and co-founder of Andel, discusses the potential impact of the FDA's increased scrutiny on non-FDA approved GLP-1 products, particularly on the competitive landscape for obesity and diabetes therapies.

Bregamn believes the FDA's action is overdue, as it will likely lead to a crackdown on compounders and affect 1.5 million users of compounded drugs. The discussion also touches on the need for new distribution strategies for pharmaceutical companies and digital health platforms, emphasizing the importance of compliance and legitimate branded drugs.

A transcript of Bregman’s conversation with Pharmaceutical Executive can be found below.

Pharmaceutical Executive: How do you see the FDA’s intent to take action against non-FDA-approved GLP-1 products affecting the competitive landscape for obesity and diabetes therapies in the near term?
Jay Bregman: I think this move is, frankly, long overdue. I think these companies that have been producing competitive drugs have really been skirting, threading the needle on laws with things like micro dosing, etc. And you know, my personal opinion is that these, these actions of these companies are reducing the incentives of pharma to produce legitimate new breakthrough drugs that pass through the FDA approval process and without that, what will there be to compound?

I think the big effect of this is likely to be a massive crackdown on compounders in the near future. The estimates that Novo’s CEO put out is that there are approximately 1.5 million people using compounded drugs, primarily semaglutide. I actually think that that's a very low number. Nobody really knows what the big number is.

So I think the bigger question for the ecosystem and society and for these companies is when those 1.5 million get the notice that they're not going to be able to be accessing their compounded drugs anymore, where are they going to go?

They're obviously not going to the DTC platforms, because I think anybody that could afford to go to the DTC platforms for branded drugs would have gone there before taking the compounded alternative. So, what's going to happen then? Are they going to go to make an attempt to go get the employer to fund it? We think at Andel that they're going to be going to a greater market for our employer supported systems, direct to employer systems that allow the employer to pitch in a little bit to a direct consumer priced item. But you know, that's the big question.