How FDA's Removal of the Two-Trial Requirement Affects Development Programs

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: How do you see FDA’s decision to remove the two-trial requirement affecting development programs?

Ron Lanton: Well, I think it's significant. What the FDA did, it was a really major policy shift.

The one interesting thing that's a little bit different than in previous FDA policies is that they want to do a more robust post market surveillance to make sure that if they do approve something, that they are watching this, to make sure that there are no adverse effects.

As far as manufacturers go, what are their kind of next steps? Obviously they don't have to worry about two trials, but I think that every effort that they had before is just going to be shrunk into the one super trial. So they're going to want to make sure that they combine enough resources in here to make it so that, yes, you know this is going to be producing the same result and so forth.

I do think, though, that there is the risk that drugs will not be priced any lower, simply because it's kind of like a savings bank or something like that, where, what if this doesn't work? Or what if post market surveillance notices something else and the drug has to be pulled. So you still have R&D cost that went into all of that.

So do we recoup our R&D cost faster? Or how can we do that? Maybe one way is just to keep the drug cost elevated, just until we make sure the coast is clear, sort of say.