During the task force briefing President Trump announced authorizing to the FDA to relax regulationsto speed up clinical trials for several anti-viral remedies to treat coronavirus. Specifically citing a therapudic drug known as chloroquine President Trump noted trials are underway and could be made available for treatment “almost immediately.”
FDA commissioner Stephen Hahn told reporters scientists still have to conduct clinical trials to see if chloroquine, hydroxychloroquine, and several other anti-viral medications are effective against coronavirus. However, since chloroquine and hydroxychloroquine are already FDA approved to treat malaria & arthritis, they could be used to treat other conditions, including coronavirus, in an “off label” basis.
DR. HAHN: So, before the President nominated me and I was confirmed as Commissioner for Food and Drugs, I was a cancer doctor. And I’ve sat across from countless number of patients and had to talk to them about their diagnosis and their treatment. And one thing that was really important is to provide hope. I have great hope for how we’re going to come out of this situation.
What’s also important is not to provide false hope, but to provide hope. And, as a doctor, that’s the way I come to this. I’m speaking now to the American people as Commissioner of Food and Drugs, but that part of me has not left. Just look at the way the American people have responded to our calls for mitigation, for social distancing. The American people have great resiliency, and I’m so incredibly proud of how the American people have responded.
As the President mentioned, he asked us to be aggressive, to break down barriers to innovation, and to accelerate the development of lifesaving treatments. And we’re doing that at the FDA.
The FDA is committed to continuing to provide regulatory flexibility and guidance, but let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective and that we are continuing to do that.
Our folks — and they’re tremendous professionals — are working day and night to do this. You just can’t even imagine how much they’re working to provide this support for the American people and I thank them.
Since early January, long before the first domestic case, FDA began working in collaboration with CDC. I also want to note that we stood up an incident command group and had been focused on the coronavirus since the very beginning of this public health emergency. This is, in addition, an all-of-government and all-of-America approach and I’ll describe what I mean by that, in terms of the development of therapeutics.
An important part of that work is expanding the potential therapeutic options associated with coronavirus, and we’ve learned from our colleagues across the globe about this. But I want to focus on one thing: I was a cancer researcher before all this, and one thing I know about this great country of ours is that we have unbelievable innovators. We have people who, every day, it’s their job to develop treatments for all sorts of diseases. We are incredibly blessed, as a country, to have this.
And as is true in any illness, these great American innovators — academia, private sector — they have engaged us about the best possible treatment options. We are looking at everything that’s coming across our desks as possible treatment options for coronavirus, and we’re extremely encouraged by the interest and the promise that we’ve seen from these great American innovators.
Now, again, we need to look at it. We need the data, we need the information to make the absolute best decisions for the American people. But I want to assure you, we have over 17,000 people at FDA who are doing this every day.
We need — we need to make sure that these — this sea of new treatments will get the right drug to the right patient at the right dosage at the right time. As an example, we may have the right drug, but it may not be in the appropriate dosage form right now, and that may do more harm than good. Those are the things that that’s our job to look at. And that’s why it’s really important we have these dedicated professionals looking at these aspects of therapeutic development.
At the same time, we’re also working through different mechanisms to actually get drugs into the hands of providers and patients.
The President mentioned this, but one of the mechanisms is called compassionate use. Let me just tell you about this. If there’s an experimental drug that’s potentially available, a doctor could ask for that drug to be used in a patient. We have criteria for that and very speedy approval for that.
The important thing about compassionate use — and that’s what the President meant, “This is even beyond Right to Try” — is that we get to collect the information about that. Because one of the things that I’ll promise the American people is we will collect the data and then make the absolute right decisions based upon those data about the safety and efficacy of the treatments.
We are working expeditiously, and we are working to make sure that these products are as safe and effective as they possibly can be. Let me tell you about a few things that we’re currently working on. And this is a plan that was developed with many of the people at this table, our infectious disease experts on the task force.
In the short term, we’re looking at drugs that are already approved for other indications. So they’re already approved, as the President said, for other diseases.
As an example, many Americans have read studies and heard media reports about this drug, chloroquine, which is an anti-malarial drug. It’s already approved, as the President said, for the treatment of malaria, as well as an arthritis condition.
That’s a drug that the President has directed us to take a closer look at, as to whether an expanded-use approach to that could be done to actually see if that benefits patients. And again, we want to do that in the setting of a clinical trial — a large, pragmatic clinical trial — to actually gather that information and answer the question that needs to be answered and — asked and answered.
Let me give you another example: There’s a cross-agency effort about something called convalescent plasma. This is a pretty exciting area. And again, this is something that we have given assistance to other countries with as this crisis has developed. So FDA has been working for some time on this.
If you’ve been exposed to coronavirus and you’re better and you don’t have the virus in your blood, we could collect the blood. Now, this is a possible treatment; this is not a proven treatment — just want to emphasize that. Collect the blood, concentrate that, and have the ability, once it’s pathogen-free — that is, virus-free — to be able to give that to other patients. And the immunoglobulins — the immune response — could potentially provide a benefit to patients. It’s another thing that we’re looking at.
Over the next couple weeks, we’ll have more information on that. We’re really pushing hard to try to accelerate that. That’s in the sort of more medium- and short-term. And that’ll be a bridge to other therapies that will take us three to six months to develop.
And this is a continuous process. There is no beginning and end to each of this. This is — you know, we’re pushing this through.
The other great thing about the great innovators of America is some of them tell us it’s taken us years — years — to develop therapies. They’re looking at pushing that to the months period of time. And we’re trying to provide them the reg- — the regulatory flexibility, but, at same time, the scientific oversight to make sure that gets done in the best way possible for the American people.
The President mentioned that there is a vaccine trial currently being performed. It’s a phase-one trial, so it’s the earliest study that gets done. We expect that to take 12 months to get to completion — to actually a time where we could approve a vaccine. But that’s — these are all things to bridge to the prevention part of this with a vaccine. It’s exciting work. And the President is right: This is record time for the development of a vaccine and impressive public-private partnership.
The FDA’s efforts to facilitate the development of these products are focused on ensuring timely access, while also meeting the agency’s world-respected gold standard, relying on strong data from clinical trials to determine if an experimental or an off-the-shelf drug that’s used for something else can safely and effectively treat patients.
We want to assure the American people that FDA is all hands on deck, as the President mentioned — these efforts — and continue to work with interested sponsors to help expedite the work. We remain steadfast in helping to foster the development of safe and effective therapies for COVID-19. Thank you. (transcript)