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A Q&A with the FDA’s Bill Doub

Q. What is your biggest priority in terms of inhaled drugs?
A. Well I think we all need to be looking more at DPIs. I have this fear that we’ve already had to switch from the CFCs to the HFAs, but we know that the HFAs are really bad greenhouse gases, a thousand times worse or more than CO2 , and I’m just afraid that eventually there’s going to be another equivalent of the Montreal conference that says you’ve got to get rid of these.

We haven’t done a lot of work with DPIs but I think we’re going to do much more. DPIs seem to be pretty effective from what I see, though one of the problems with DPIs is that they all look different, and if I’m a generic manufacturer, what do I have to do to make sure I meet criteria that require the patient is not going to be confused if he’s given a generic for the inhaler he’s been using. That’s a big concern, and OGD has spent some money to have some people look at that.

Another one of the complications for the DPI devices is they all have different resistances, and we’ve published a couple of papers with Cirrus from North Carolina and to see what you could do to modify something for a drug that had a lot different resistance.

I also think we’re going to be seeing more systemics. Up until a few years ago, there were no systemic inhalables or very few. Insulin sort of came and went in a flash, so . . . it’s coming back, yeah. Pfizer lost a lot of money on that project, and so I think it’s given some people pause to think about delivering protein drugs by inhalation; but you know, there are so many advantages to delivering drugs by that route I think we’re going to see more systemic inhaled drugs. And I think that probably it’s easier to deliver those drugs as dry powders than it is to try to get them to dissolve in HFA.

I think we will also see protein drugs delivered nasally. There’s a lot of development, a lot more nasal products I think in Europe than there are in this country. Whenever I go to meetings like RDD, I see nasal inhalers that I’ve never seen before.

Q. What other changes do you see coming up?
A. Well, the industry is changing, all of us old guys are going away. I really like what I’m doing; I like being involved; so I’m thinking it might be another year or two or so before I retire. My wife retired some time ago, and she’d like to go someplace really nice and have me available to go with her.

Q. Do you have somebody at the lab who you see as a successor?
A. Well, I’ve been told to make sure that I do if I’m going to retire!

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published on February 3, 2014

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