How Does FDA's Decision Represent a Broader Regulatory Recalibration?

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.

Bregman 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 FDA’s decision representing a broader regulatory recalibration around rapidly growing therapeutic categories?
Jay Bregman: I think that it's long overdue that intellectual property rights were respected in America for these very difficult to produce, difficult to develop, difficult to be regulatory approved type drugs.

I mean, I just can't imagine if my company developed something at a cost of several billion dollars, and then saw some guy down the street that was able to copy it and sell it for a third of the price because they didn't have to pay for any of the development costs. I mean, I would be outrageously upset.

So, I think what the what the FDA is really doing is cleaning up an issue that never really became a big issue in the past. Compounding has always happened, but it's really been so niche for generic drugs.

Mostly it's really only been exploited by people that were trying to get around the rules with regard to brand medication in the case of these mass market GLP-1 drugs.

I think the FDA should review all of those regulations in a way that respects the rights of intellectual property holders and gives pharma companies and biotechs the incentive to produce more breakthrough therapies

Pharmaceutical Executive: What second-order effects might this action have on innovation in the GLP-1 space?

Jay Bregman: I think what you're going to see right now is millions, literally millions of customers who are not obviously getting these drugs from their employers, but they're buying it direct with the compounders onto the market, right?

So, the question will be, how quickly can the pharmaceutical manufacturers and their partners react to something like that so that they can produce a better mouse trap to be able to provide branded drugs at the acceptable price, but also with an acceptable experience.

Because one of the things that people forget about the many companies that were compounding. It wasn't just lower cost. It did invest in the user experience, and it probably was a lot better than, frankly, most of the direct to consumer and direct to employer platforms that are out there today.

Everybody's got to up their game to be able to get those millions of customers that are coming onto the market. They clearly want to stay on the drugs, its just a question of whether the market will be able to provide them an opportunity to do so.