Some Bark, Little Bite

Where else is USP asserting its influence?

USP had its origins in compounding. And I've even heard people say that manufacturing may change so it becomes more like compounding, so that people can get the right dose at the right dose frequency. Or complex new biologics are going to be assembled at the bedside before delivery.

FDA is obviously going through some problems. What is USP's role in resolving some of the issues that have been raised about drug safety and oversight.

I go back to that point of independent testing. Let's say Company X has a problem with their potency or their strength. Well, you don't want FDA to have to knock on their door and say, "May we use your reference standards to test the quality of your products?" I'm a strong advocate for FDA to be able to test independently.

Where do you get your reference standards?

We get what we call candidate bulk materials from all over the world—pioneers, generics, chemical supply houses. At the end of the day, however, we think of them as unknown things that we then move through a very careful process to establish a public reference standard.

That process involves us checking chemically to make sure we know exactly what we've got, sending it out for collaborative testing so that everybody can do an additional check against us, and then packaging and making it available for sale one lot at a time so that all the manufacturers throughout the world can test to a single standard.

That's the value of the "one-lot" concept. When that one lot goes down, we replace it with another lot. If you think about it, it's not the way pharmaceutical manufacturing works. There can be a multiple of lots, even from one manufacturer. And when you get to generic substitution, there could be scores of lots in the marketplace at any one time. But they all should be testing to this single standard.

It's a very nifty system if you think about it. And as much as I like PAT [process analytical technology]—I'm very supportive of the science in back of PAT—it makes me nervous when they don't talk about end-product testing. Because if you don't do end-product testing to a single reference point, pretty soon you start losing that link between all lots and all manufacturers.

But who would argue with better quality by design? In my mind, those are things people should be doing anyway without the sort of cheerleading aspect of it.

Some people would say FDA doesn't need to cheerlead, it needs to get out of the way.