Few things eclipsed the national conversation about the coronavirus and the race to develop COVID-19 vaccines in 2021.
In this video clip from "The Pharma & Biotech Show," recorded on Feb. 9, Motley Fool contributor Taylor Carmichael asks Dr. Frank David, author of The Pharmagellan Guide to Analyzing Biotech Clinical Trials, whether he believes the accelerated vaccine approvals seen through the COVID-19 pandemic could become more commonplace.
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Taylor Carmichael: In COVID-19 in 2020, we got Emergency Use Authorization in under a year. Do you think it's possible that we are seeing a speeding up with the accelerated approval pathway for some drugs? Is it possible that we will see a shorter span or is that a one-off the COVID drugs, do you think?
Frank David: First of all, I'm not a regulatory expert, I'm not a policy expert. I dabble in those areas, but it's not my primary jam. Caveat emptor for everything that's about to come. My sense is that the agency is always interested in finding ways to help make the process more efficient within the constraints of demonstrating safety and appropriate risk-reward profile. I think we're going to see continued use of the pathways that are already in existence and a continued desire within the limits of the resources of the agency has available to move things along as quickly as possible. I don't think the agency is trying to hold things back.
The COVID situation raises the question of, do we think they are going to be additional use of these types of pathways or additional pathways like what we've seen with breakthrough therapy designation etc. I personally certainly in talking to clients and in just just observing the landscape, I don't think there's much of a drive to increase those types of pathways beyond where we already are. I think the general feeling is that COVID was a little bit as you said a one-off, where there was a huge public health need to move things even faster than they would ordinarily move. But for your average, let's say underserved rare disease, clearly, there are patients who want the drug, but there's a lot of pathways already that exist to help speed things up and companies are taking advantage of those pathways. If I were a bettor on this, I don't think I'd be betting that in the next, say, five years, we're going to see a dramatic expansion of rapid regulatory pathways. I think we're going to see continued use of the pathways that already exist.