What's an example of that? I mean, you say it's an all-of-government approach, but if you can't say like we're gonna get this process that could get this drug out there much faster going - like why not - why not today? Well, I guess I just wonder, I mean, President Trump said yesterday he's clearing red tape like no one before has ever done. But there is an all-of-government approach on this. So we're working on that now where obviously supply and availability of a drug is an issue. And one of the ways we're going to try to make this available on a more widespread basis is through this expanded access approach. What I'm saying is an individual doctor has to incorporate the data to make the decision for their individual patients. Soshould they? I mean, are you telling them that they should if they have a patient who is really suffering? And this is a drug that's available to physicians to prescribe now. We'll be providing - not we FDA - but the CDC will be providing some guidance about that with respect to potential therapeutic options. And this is an individual doctor decision. I mean, if we're going to get to a point really soon where there are that many sick people, doesn't the risk assessment change? I mean, can't you speed up the kind of things you're talking about to get these kind of drugs to people right now? But when it comes - we're in a health crisis where people are describing having a shortage of hospital beds. But you don't want to promote false hope.īut that kind of that kind of process you're talking about, I mean, I know obviously safety is so important. And I do very much believe there's hope here from a therapeutic point of view. But I mentioned yesterday, and David I think this is so important - I'm a cancer doctor and you always want to provide hope. We're going to have the ability to do what's called a pragmatic trial. And what we'd like to do is to make this particular drug available to what's called expanded access. Some of the reports are encouraging and we're gathering all those data. We don't have all of the data per say now. And the problem with the current situation is that we don't have all the facts. You know, what I want to know is what are the data behind this? And I mentioned this yesterday because it's such an important thing for a doctor - right drug, right patient, right dose, right time. So I'm a doctor and I'm seeing a patient and I'm thinking about this. You know, I'm going to put my doctor hat on, not my FDA hat, David, if that's OK. FDA does not regulate the practice of medicine, the doctor's got to make that decision based upon individual patient situation. I'm a doctor.Īnd you could write a prescription for a drug that's an off label. So multiple steps that have to take place, they have to be done under controlled conditions, so that we can make sure that we have the right answer.īut so - could doctors prescribe chloroquine soon? I mean, are we talking about days? If if this is something that that has already been approved to treat malaria, it's presumably safe. After the safety phase of this, then it gets moved to can the vaccine elicit an immune response? Which of course, we would consider to be protective against the virus. So the safety consideration is very significant. But remember, the vaccines are given to people who don't have the disease, who are otherwise healthy. So you may ask why is safety so important? It's always important, of course, with any therapy or prevention, such as a vaccine. But very quick development, as I mentioned yesterday, realistically, we're looking at a year to get a vaccine up and running and available. So really record speed there, David, in terms of getting a vaccine to a virus and as you know, it's - the safety is really critical here, which is why we have to be careful about the development. What is your agency doing to speed up the process of getting a vaccine tested and deployed?įDA Commissioner Stephen Hahn: So as you probably know, David, a vaccine candidate vaccine was put into a Phase One trial, and that's the earliest of phases of trials to safety trial on Monday. Morning Edition host David Greene: So obviously a vaccine against this virus offers the best public health defense. Here, a transcript of their full interview. Food and Drug Administration Commissioner Stephen Hahn speaks during a House Appropriations Subcommittee hearing in Washington, D.C., on March 11.įood and Drug Administration Commissioner Stephen Hahn speaks with NPR's David Greene about the development of a vaccine and the use of existing drugs to treat COVID-19.
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