How the COVID-19 Pandemic Has Impacted the FDA’s Approval Process

Pharmacy Times® interviewed Chad Landmon, JD, chair of intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider, on the FDA’s emergency use authorization (EUA) process for COVID-19 vaccines, such as the expedited process for the recently authorized Johnson & Johnson COVID-19 vaccine.

Alana Hippensteele: Has the COVID-19 pandemic impacted the FDA approval process in any way?

Chad Landmon: So, I think it has in a couple respects. Generally, FDA had to dedicate so many resources to COVID-19 that resources were taken away from looking at other things. I mean not intentionally, obviously FDA's got its full job to do, but just by the very nature of taking up people's time focusing on COVID-19, as they as they should have been, other things have slowed down.

I mean certainly we've seen FDA inspections, which are kind of necessary for the approval process, have been at times non-existent given to just COVID-19 and travel restrictions. So, the flip side of moving quickly to review all the COVID-19 therapies and vaccines is that FDA has slowed down a little bit on reviewing everything else on the core of its job. So, I think it'll be interesting as we get past the pandemic to see how FDA can refocus its efforts.

The other thing I think is the FDA has learned a lot about looking at real-world evidence. So, generally the FDA, when it's reviewing and approving products, it's looking at clinical data of controlled clinical studies. So, we know where the patients or the subjects are, we control as much as we can about them, and we do direct comparisons, usually between either placebos in a treatment or maybe between different treatments.

There's been a lot of discussion over the last 10 or 20 years that once you start dosing patients in the real world, there's also a lot of data that gets collected, and it's not perfect because you don't know what patients and people are doing in their lives and what else they may be exposed to, but there's a lot of information that comes from that.

There's been a big push by the industry to get FDA to start thinking more about using real-world evidence, potentially expediting approvals based on more limited clinical studies, and then relying on the real-world evidence that comes in later. I think with COVID-19, it has kind of proven that model can work in the right circumstances.

I mean certainly with all the EUAs, I mean not only with the vaccines, there were EUAs on treatment, there were EUAs on tests that have been used, and FDA has been able to look back and look at the real world evidence, digest it, and see should they make changes with the approval status or does it more fully support the approval of the test or the therapy.

So, I think that's been a very positive development. I know FDA is still kind of digesting what they're learning through the real-world evidence, and so is the industry, but it’ll be interesting to see how that plays out going forward.

Alana Hippensteele: Yeah. What are some of the issues the pharmaceutical industry may be facing as drug companies seek regulatory approval for other drugs and vaccines tied to the COVID-19 pandemic?

Chad Landmon: Yeah, so it'll be interesting kind of going forward. One of the things FDA looks at in granting all of these EUAs is whether there are alternative treatments, alternative vaccines out there. So, there are companies still working on vaccines, and there are obviously a lot of companies continuing to work on therapies. It will be interesting to see as they go to FDA with their data, whether that slows down obtaining an authorization.

It'll also be interesting as companies approach it: Do they need to seek full safety and efficacy approvals instead of the abbreviated EUA pathway? I think we will start to see therapies—maybe vaccines, but certainly therapies—who do end up going through the full kind of review at FDA. So, it'll be interesting to see how they deal with FDA on those.

Then going back to my example on the real-world evidence, I think how companies will point to that for the products that are already on the market, and how FDA has used that. So, encouraging FDA to kind of continue to go down that path as they look at new therapies and new vaccines.

Alana Hippensteele:Right. Is there anything you plan to keep your eye on this year in terms of important potentially upcoming EUAs or approvals by the FDA?

Chad Landmon: Yeah, so on EUAs, it'll be interesting to see, as I said as companies continue to file them, how FDA treats them, how quickly they move on them. So, I'm certainly interested to see how FDA goes about that.

I am very interested to see how FDA gets back to the normal or the new normal. There's been a lot of discussion particularly on the inspection front of how FDA gets back in to do the inspections both domestically and internationally, and how we can kind of get over the somewhat slow down that has happened because of COVID-19.

So, I think how FDA can kind of get things back together and move on from COVID-19, get back to its core mission—I mean, unfortunately, I think COVID-19 is going to be with us for a while, and FDA certainly still needs to dedicate a lot of resources to that—but it will be interesting to see how FDA both takes what it has learned with COVID-19 and applies it to new therapies and new areas, and also how FDA kind of gets itself back to normal and focusing on its core mission.

Alana Hippensteele: Yeah. Thank you so much for taking the time to speak with me today, Chad.

Chad Landmon: Thanks for having me.