The FDASIA Mandate and Interdisciplinary Communication

Panelists analyze the FDASIA act and consider whether it is an effective measure for the FDA to prevent drug shortages.

Troy Trygstad, PharmD, MBA, PhD: So, Erin, FDASIA of 2012.

Erin Fox, PharmD, BCPS, FASHP: Yes, it was very exciting. So, this really helped us formalize and legally require manufacturers.

Troy Trygstad, PharmD, MBA, PhD: And this was?

Erin Fox, PharmD, BCPS, FASHP: The FDASIA. So the Food and Drug Administration Safety and Innovation Act.

Troy Trygstad, PharmD, MBA, PhD: An act, OK. So this is legislation.

Erin Fox, PharmD, BCPS, FASHP: This is the law. President Obama signed it.

Troy Trygstad, PharmD, MBA, PhD: And the motivation behind the legislation was what?

Erin Fox, PharmD, BCPS, FASHP: The FDA needs as much advance information as possible if they’re going to work to prevent a shortage. Prior to this law, FDA didn’t get that. Manufacturers were not required to tell the FDA if they were going to stop production or quit making something. In fact, we had that really severe shortage of chemotherapy drugs because a plant in Irvine closed overnight without telling the FDA, and a third of the products that were made in that facility were chemotherapy drugs. And that happened at a time when other companies were having shortages, as well. And so FDA needs that notification. FDASIA legalizes that.

Troy Trygstad, PharmD, MBA, PhD: So it’s sort of a disclosure act.

Erin Fox, PharmD, BCPS, FASHP: Yeah. Just tell us. And you know what, that information is not public, so the companies are not at risk.

Troy Trygstad, PharmD, MBA, PhD: OK.

Erin Fox, PharmD, BCPS, FASHP: Where it needs to change is that the FDASIA doesn’t actually require the companies to tell the FDA why they’re having a shortage. And without that why, it really does hamper FDA’s ability to prevent drug shortages.

Troy Trygstad, PharmD, MBA, PhD: So it sounds to me like they’re saying this was a step in the right direction, but you’re a planner by nature, and planning is easier the more information that you have.

Erin Fox, PharmD, BCPS, FASHP: Absolutely. And FDA needs that information to really help do a difficult job. They shouldn’t have to prevent shortages. In an alternate reality, we would have all the basic products that we need, and manufacturers would have very high quality product and make all of the medications that we need. But that’s not where we are right now.

Troy Trygstad, PharmD, MBA, PhD: Rich, do you have stress balls in your desk? I need to know this information.

Richard Montgomery, RPh, MBA: I actually have this thinking putty stuff. It’s actually kind of cool. And you pull it out and you’re sitting there thinking, 'Oh, now what’s going to happen.'

Troy Trygstad, PharmD, MBA, PhD: Because you’re planning it in a space where you need more information but you’re not getting that information, right?

Richard Montgomery, RPh, MBA: You’re not getting it, and sometimes you just have to pick up the phone and work your way up the chain.

Troy Trygstad, PharmD, MBA, PhD: I mean, this sounds like a social network.

Richard Montgomery, RPh, MBA: Well, it is.

Troy Trygstad, PharmD, MBA, PhD: It sounds like you all are part of a social network.

Richard Montgomery, RPh, MBA: We talk to each other, and I’m sure product managers see Erin’s phone number come up. They probably cringe a little bit.

Troy Trygstad, PharmD, MBA, PhD: They answer her phone before your phone?

Erin Fox, PharmD, BCPS, FASHP: Probably not.

Richard Montgomery, RPh, MBA: Maybe not, I don’t know. You’ve just got to get to the right person, and sometimes you’ve just got to be persistent and just say, 'OK, why?' You’ve got to figure out what’s going on and where are we going with this and then what are we going to do. Then it’s a scramble to see how much we have on hand, where’s it at, how much is still at the wholesalers, what are the next steps.

Erin Fox, PharmD, BCPS, FASHP: Can you make the EHR [electronic health record] changes?

Richard Montgomery, RPh, MBA: Yeah, can we make the ER [electronic record] changes?

Troy Trygstad, PharmD, MBA, PhD: So there’s more to this as far as relationships it sounds like, as well. Information will help.

Erin Fox, PharmD, BCPS, FASHP: Yes.

Troy Trygstad, PharmD, MBA, PhD: Is bureaucracy a problem? Can somebody quickly go in and inspect when they say, 'Hey, we’re ready,' or are there time lags that can be compressed? If you had a magic alder wand, what would you change in the system that you think would help create a better plan for these shortages?

Erin Fox, PharmD, BCPS, FASHP: You know I think if there was a way to magically get more capacity and very high quality factories into the mix, that would be great. But FDA can do a lot of things. They have things in their toolbox, things like expediting an inspection. So, if they know a company is having a shortage, they will work quickly to expedite any inspections. Or even if they know companies want to get a product approved and that approval is in line, they’ll jump it to the head of the line to try to make sure that they’re doing everything they can to prevent shortages.

Troy Trygstad, PharmD, MBA, PhD: Is there a formal process for that, like a decibel meter?

Erin Fox, PharmD, BCPS, FASHP: FDA has that leeway.

Troy Trygstad, PharmD, MBA, PhD: Or is it totally informal?

Richard Montgomery, RPh, MBA: I think it’s criticality.

Troy Trygstad, PharmD, MBA, PhD: So the nature of the products.

Richard Montgomery, RPh, MBA: They hear the noise. I mean, just in the DC area alone, there are several major hospital systems right there, and I’m sure they reach out to them when they hear the noise.

Troy Trygstad, PharmD, MBA, PhD: Your neighbor is a physician.

Richard Montgomery, RPh, MBA: Yeah. They have their finger on it, and they have people that monitor some of this stuff. So I think they know what’s going on. It’s just a matter of how soon do we jump in.

Erin Fox, PharmD, BCPS, FASHP: Yeah, and that manufacturer has to be ready for that inspection. That’s the other part.

Richard Montgomery, RPh, MBA: Right. That’s the other thing. We don’t want to jump in and then the corrective action plan didn’t meet the need, so then you’re already back to square one again. And then you have X amount of time for your action plan and the whole process to revalidate your system. Yeah, it’s a tricky game. It’s a balancing act.