Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, remarked on the stress on generic companies ("a silent crisis that's very bad"), drug shortages (the "root cause is the marketplace and economics") and even marijuana ("we are totally agnostic about cannabis") at a Sept. 21 discussion with members of the Alliance for a Stronger FDA.
One topic not broached in Woodcock's hour on stage was continuous manufacturing, a long-time interest of hers. BioPharma Dive caught up with her after the event for her view on how adoption of the production technique is advancing in the pharmaceutical industry.
The long-time FDA drugs chief previewed what she'll say at a headline speech at a London conference set for Oct. 3 and reaffirmed her belief in continuous manufacturing. She said the agency won't force companies that want to stay "in the 1940s" with traditional practices — as long as they meet FDA standards.
This interview has been condensed and edited for clarity.
BIOPHARMA DIVE: Has continuous manufacturing progressed over these past few years the way you thought it would?
JANET WOODCOCK:I thought it would progress very slowly, and it's progressed very slowly. I take the long view on things, and it is the future of manufacturing.
In two weeks I'm going to London [for the International Symposium on Continuous Manufacturing of Pharmaceuticals]. They are going to have a combined symposium on small molecule and bio-continuous manufacturing. All the big companies are there presenting. They have skin in the game now.
I think these things take a lot of time. We have like 50, 60 years worth of tradition. This is a risk.
With generics, we just talked about their capital problems. They are worried that this would be another anti-competitive thing. It's made continuous, [generics companies fear brands will argue], higher quality because you can monitor the quality much better. Then they'll say, 'Oh well the FDA will force us to make it to that quality.'
Would you appease that concern from generics? That that is not happening?
WOODCOCK:I'm going to do that at the meeting in London and say, "Look, just because you can make it to this level of content uniformity, that doesn't mean it has to be made to that level of content."
We have ICH [International Conference on Harmonization] guidelines on content uniformity, and it's nowhere near what you can achieve with continuous. The nice thing for those who adopt continuous is they can effortlessly achieve that quality. It doesn't require a tremendous amount of effort.
But it'll take years. I knew that from the get go. This is no overnight thing. I think there are other threads now that will contribute to this. There's more interest because of the need for surge capacity, natural disasters, bio-terrorism attacks, drug shortages and so forth. I think there's much more understanding of [how] we need a more flexible system and what we have is relatively inflexible.
So you see mindset and upfront costs as the two big barriers?
WOODCOCK:Definitely. And partly, for the innovator, their goal is to get that asset out the door and recapture their investment and make money before the patents expire.
But if you look at the agenda [for the London conference], you can see all the big companies are there talking about their continuous efforts. It'll take time, but I think you'll see in the finished dosage form there's the most solid business case because the way they do it now is just such a mess.
Would high volume or small personalized medicine get that benefit?
WOODCOCK:Any of it. The problem is, if you're doing a solid oral dosage form, if you try to mix solids in mass quantities, you're just doomed. It's like scaling up a cake recipe, like giant proportions.
They have these giant mixers and they are supposed to see if they are homogenous, so they have to wet it to mix it. Then they have to dry it and granulate it.
With continuous, they have a falling stream and they just blow some air in it and they have the correct proportions introduced into the stream. Then they capture the stream in a tablet. It's like, duh [laughs]. What could go wrong, almost? They have sensors to make sure the active [ingredient] is still falling.
A couple people attempting this have blown out their computer systems the first time they did it because it captured data on every tablet. The USP [United States Pharmacopeia] guidelines for market products say take 30 tablets on a run and you combine those [to] get content uniformity. There's no comparison here, right? Yet it's so much simpler. It's literally the size of this podium here [and] you can produce tablets.
Do you anticipate the agency putting out more incentives in the future, say the next five years?
WOODCOCK:Probably not, we're just going to help people. We think there's enough incentives business case-wise and we have to be fair to everybody.
If you still want your manufacturing to be like the 1940s, OK. If you can meet the standards, OK with us because there's a lot of sunk costs there.