1/2 This is from Dr. Yo’s second interview with Dr. Javitt (RLFTF).
It gives a little more clarity on Expanded Access Programs and EUA. Also it’s interesting from the point of view of how RLFTF is handling things. I think this will take two posts.
Y
Could you talk a little bit about the EUA and the submission to the FDA.
J
Sure, and I can’t tell you that I know what the FDA is going to do, but we told the FDA what our problem is, which is that they very generously gave us the right to treat people all across the country with this drug under an Expanded Access Protocol. That means that people who are too sick to be enrolled in our clinical trial, people with cancer, people with comorbidities that make them the wrong candidate for a clinical trial, are able to be treated under our Expanded Access Program.
The problem is the Expanded Access Program requires that hospitals set up an IRB, that they basically go through a research pathway in order to be able to give this drug to patients. And over and over we’ve had heartbreaking incidents where families have called us, we’ve done our best to supply drug, but hospital administrators who are just up to their eyeballs in this pandemic, can’t really mobilize fast enough to call an IRB meeting for one patient to get an investigational drug.
So over and over again despite everything we’ve tried to do to support families, patients have died before we were even able to get the drug to their hospital. So what we’ve asked the FDA to do is not expand the indication because we’re going to wait for additional trial data to come in before we ask the FDA to expand the indication. But we’ve asked the FDA to let us use the law Congress passed under Emergency Use, which is much simpler administratively for hospitals than the law Congress passed under Expanded Access. Basically, a mid-sized hospital wouldn’t have to have a meeting of it’s Institutional Review Board for one patient to get our drug. So that was the reason we asked for the Emergency Use Authorization.
Y
Can you talk a little bit about -- because there’s a big confusion. We’re not prepared for pandemic medicine. And exactly what you said, Dr. Javitt, I personally went through this with patients, friends of mine that -- doctor friends of mine who had patients, trying to get some of these emergency medications, or these new therapeutics. It’s a logistical nightmare: IRB, the infectious disease doctors, pharmacies, CMO, everyone’s involved and it’s a logistical nightmare.
I want to point out something that over the past couple of weeks looking at your website after our initial discussion, I just want to just say how much I was impressed on your website, how you streamlined all that information. I think people should go and look at the NeuroRX website, because there are so many doctors, there are so many ICU doctors that have no idea about these medications, and even if they were interested, the first question all of them ask me is, “How do I get it?” So it seems like you, in trying to get the EUA, you’re trying to circumvent some of those issues we’re facing in clinical medicine.
J
Yes, the Expanded Access Program that congress and the FDA set up works really well for an experimental cancer medicine, where you have days to weeks to decide that you want to use this investigational drug in a patient and to go through the procedures that are required. But unfortunately, people with critical COVID-19 who are on ventilators, they have hours to days. And there’s just not enough time to go through all of those procedures if you really want to do the best thing for the patient.
Y
So if, let’s say the FDA does grant an EUA or they accept the request, how does that change in terms of the clinicians on the ground getting the access to the medication?
J
It would mean that a clinician could call the hospital pharmacy, order the medicine, the pharmacy will call our national supply chain, and the medicine will be there the next morning.
Y
That’s pretty incredible. Now, in terms of like what are -- not to get into specifics because you may not be able to talk about it but in terms of over-all -- just talking in generalized terms -- what are some of the things the FDA is looking for when you’re submitting -- what is some of the information that they’re looking at?