What Risks and Opportunities Does FDA's Single-Trial Approval Pathway Create?

In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses the FDA's recent policy shift removing the requirement for two clinical trials for drug approvals, moving towards a single trial default to expedite drug approval. This change aims to cut red tape and enhance patient access, but it also raises concerns about increased litigation risks and potential higher drug costs.

A transcript of his conversation with Pharmaceutical Executive can be found below.

Pharmaceutical Executive: What risks and opportunities does FDA’s single-trial approval pathway create?

Ron Lanton: Well, if I'm a manufacturer and I have less trials, there's always that risk management of, is it going to be okay? Is everything going to work, and if it doesn't, are we going to be sued? That is very real.

So I do think that, you know, there'll probably be some risk management protocols internally that a lot of manufacturers will start to do just as a standard operating procedure. Like I said, I do think that there'll be hesitation about decreasing the price because you're into some unnavigated waters.

This is something that's brand new for everybody. But I think just that whole thought of whether there's going to be litigation because of an adverse effect is going to be everybody's question. But you know, if you are the manufacturer, and you believe in what you put out, you're probably going to do some more internal trials before you get to that point. I just don't think they'll be as robust as we've normally seen.

PE: How will manufacturers respond to FDA’s new approval process?

Lanton: The other thing that I think will be a little bit more utilized by the manufacturers is the new program that the FDA announced last year in regards to the section 232 tariffs that was in the news when they talked about the Commissioner's National Priority Voucher. I think with that, the manufacturers will probably take more of an active role in that.

I think to get a normal priority review is usually six months, but if you're undergoing this voucher program, it's more like one to two months, but you still have to do certain things that align with the administration's goals in order to make it so that it is one to two months.

Something like you got to make sure that you're increasing affordability and you're meeting an unmet need, and one of the main things about it was that you had to not only address a public health crisis, but you also had to make sure that you onshore and that was something that was very, very important to the administration.

They wanted to make sure that if you were operating overseas, that you bring all that manufacturing back to the US.