428: FDA Meets on Drug Shortages

ROBERT JOHNSON: 

This is Public Health Review Morning Edition for Thursday, May 25, 2023. I'm Robert Johnson for the Association of State and Territorial Health Officials.

We're in Chicago this week where ASTHO is holding its annual TechXpo conference. It's also where public health leaders met with the FDA to talk about drug shortages that could make it tougher to respond to some health concerns. ASTHO's chief medical officer Dr. Marcus Plescia tells us about the FDA meeting here in Chicago.

A lot in the news lately about drug shortages, and some of them have caught the attention of public health. What is going on?

MARCUS PLESCIA: 

We've seen two really significant drug shortages for public health recently—we've been hearing from our membership about them.

The first thing that popped up was a shortage of medication called INH, or isoniazid, and that's a very important drug that's used together with other drugs to treat tuberculosis; and tuberculosis treatment and care of patients who have tuberculosis in the community is a big activity of public health, both at the state and local level, so that's caused quite a bit of problems. It seems like that may be a little bit more of a regional shortage. And there's been some ability to work that out through sort of shunting health departments to other health departments or finding other manufacturers.

But even more concerning is a shortage now that's come to our attention of bicillin. Bicillin is a form of penicillin, a drug that most people have heard of. It's a very important drug for many infectious diseases that we treat in public health at the community level, and particularly for the treatment of syphilis. There are other treatments for syphilis; but for pregnant women, bicillin is the route we've got to go in. For pregnant women, having syphilis is really, really important because it can end up being passed on in-utero to the infant; and then you get cases of congenital syphilis, which is just a horrible, horrible situation. So we've been very, very concerned about this shortage of bicillin and trying to work out, you know, what's being done and are there some steps that we can take to help with that.

JOHNSON: 

We're talking here in Chicago, and there was a meeting as part of the gathering this week with the FDA to talk about this. What did you learn?

PLESCIA: 

So we learned that FDA actually has a very sophisticated team that monitors and tries to intervene with shortages; and I think that it's just useful to understand how the system works. And you know, the system certainly has some shortcomings, but FDA monitors drug shortages, and oftentimes manufacturers will communicate with FDA ahead of time. So, sometimes FDA can get sort of the early notification that there's a problem potential problem, and that gives more opportunity to intervene.

FDA does have quite a bit of power to do some things that can be helpful in these situations. Oftentimes, the main cause of drug shortages is manufacturing quality issues, and sometimes those are quality issues that FDA can work with the manufacturer to circumvent so that they don't have to stop producing, they can continue to produce. It's ultimately up to FDA—they're the regulators who decide about that. And so sometimes they can do some things to allow manufacturing to continue as long as it's considered to be safe. FDA can also work with other manufacturers to scale up manufacturing.

So, you know, there are a number of places that FDA can step in and try to avert and sometimes even prevent these shortages in the first place. So that's been very helpful for us to learn about and understand better and make some of the context at FDA so, in the future, I think we can be a little bit more versatile in helping our members when we start to run into these problems.

JOHNSON: 

ASTHO members are thinking about these concerns right now. Is there anything they can do?

PLESCIA: 

Well, the biggest thing that they can do is when they're starting to see these issues crop up in their communities, is notify us and notify FDA. I mean, that was the first thing we heard from FDA is sometimes they don't know that something's popping up. And the sooner they know, the sooner they can potentially use whatever mechanisms they have to try to avert it. Sometimes in a situation where there are more regional problems, stocks of various medications can be shared from one health department to another. That's a little more complicated to make work, but that's something that ASTHO was also willing to help be an arbitrator of.

JOHNSON: 

Today is the last day of the TechXpo, but you still have time to sign up for an online ticket. You'll be able to watch on-demand all of the meetings that happened during the first two days of the Xpo. Get more information using the link in the show notes.

That'll do it for today's newscast. We're back tomorrow morning with more ASTHO news and information.

I'm Robert Johnson. You're listening to Public Health Review Morning Edition. Have a great day.