Podcast

Matt Stoll (00:01.541)
Welcome to On Background, our podcast where we talk with health policy experts in and out of government service and talk to them about their career after they’ve left the federal government. Today, we have a repeat guest. We’re joined by Marta Wyszynska, who was formerly the Chief Healthcare Economist for the HHS Officer of the Inspector General and is now a Senior Fellow at the Brookings Institution. Marta, welcome back.

Marta Wosinska (00:28.492)
It’s great to be back. Thank you for having me here.

Matt Stoll (00:31.223)
Excellent. And today we’re going to be talking about manufacturing quality in drug, Jesus. We’re going to be talking about manufacturing quality for pharmaceuticals. Steve, why don’t you kick us off?

Steve (00:46.781)
I just hope you don’t edit out that… that… that…

Matt Stoll (00:48.707)
I will.

Steve (00:49.941)
I don’t know. mean, that’s the authenticity of the whole moment. Marta, it’s great to have you here. We’re joined also with Tom Gunderson, formerly Piper Sandler, and Brianna Mayer, an expert in pharmaceutical markets, formerly from industry and also an instructor faculty at the Carlson School. So Marta, you have been, it’s great to have you back, especially after giving a command performance at the Senate Aging Committee,

about drug supply chain issues and many things that are going on. I do think it’s important to level set a little bit, because if you can explain a little bit about just a little bit about how this aspect of these things work. know, we know that the FDA is involved to make sure that people don’t, you know, ingest bad chemicals into their body, but talk a little bit more about the differences between the different drugs and the supply chain aspects that really led into why you were testifying for this.

of the Using Committee.

Marta Wosinska (01:52.61)
Thanks, Steve. you know, a big reason why FDA exists is because the drugs that we take, and a lot of the other products, but prescription drugs in particular, are not really fully what an economist would call experience goods. You can’t really necessarily observe whether they’re going to be working for you. And that’s particularly true when it comes to

things like impurities. if you think about, know, typically a doctor who prescribes a drug to a patient, you know, when a patient is not responding to a drug, they normally will think, you know, maybe there’s something about the patient’s condition might have changed. You know, we should consider another drug. They don’t really think about manufacturing quality and the fact that the product might not have been made to specifications. So,

FDA has sort of a dual role. the one hand, when they do drug approval, the drug has to establish that they are safe and effective.

clearly effectiveness and safety will vary from drug to drug and there’s going to be a trade off, right? You might be willing to accept more risks if the drug is particularly effective and if there aren’t sort of other alternatives. So the approval process is really important. It differs for branded versus generic drugs. The branded drugs are the very first time we’re seeing a new drug molecule on the market. They have to actually prove through clinical studies that they are both safe and

effective. A generic drug is a copy after patents expire or are settled. A generic drug is a copy that comes on the market and they just have to establish that they’re just like the branded drug.

Marta Wosinska (03:50.766)
what is not different across branded and generic drugs. So while the approval process differs, what happens after the drug is approved on the market doesn’t actually differ when it comes to FDA requirements. Once the drug is approved, the manufacturer has a bunch of specifications. So this is what the drug is gonna have. This is the process that we’re going to use to make the drug. And then they have to replicate, be able to replicate that process.

they go through approval, they have to prove to FDA that they can actually replicate it. And then after they come on the market, they have to continue proving to FDA that they can actually make it to specification. And again, it’s super important to do that because we as consumers are not necessarily going to be able to see whether or not the drug is actually performing as it should.

Marta Wosinska (04:50.073)
with Steve, you are mute.

Steve (04:53.566)
That’s super helpful. I want to do one very important thing before we go much further because we have a limited time with this podcast and it’s really important. I want everyone to get their best singing voice on and to wish Marta a happy birthday. So we will just do the first refrain of just happy birthday to you. Happy birthday to you. Happy birthday dear Marta. Happy birthday to you.

Matt Stoll (05:04.389)
no.

Matt Stoll (05:11.972)
birthday to you birthday to you happy birthday dear marta happy birthday day to you completely un

Thomas Gunderson (05:14.467)
Happy.

Bryana Mayer (05:18.332)
Dear Marta.

Thomas Gunderson (05:20.184)
Happy to-

Marta Wosinska (05:23.661)
Wow, well thank you so much. Are you really going to put this in?

Matt Stoll (05:28.302)
Well yeah. I mean, edit…

Steve (05:30.598)
It shows we’re human. I mean, there’s some things AI just can’t do. So…

Thomas Gunderson (05:30.734)
I did not sign up for that.

Marta Wosinska (05:30.979)
This is great.

Steve (05:42.26)
Tom, question over to you.

Thomas Gunderson (05:46.264)
So you gave us a sense of, I just want to dig in a little bit before I ask the next question, but do they, do the generics have to show an exact same process to get the exact same molecule? Or can they say, look, we put it in our black box and we got exactly the same molecule coming out at the end. Or do they have to show that the process is the same as the original drug?

Marta Wosinska (06:14.457)
If they can do it in the same way, then that’s quite possible. But sometimes they can get around a patent, a process patent by showing that the process that they use actually ends up with basically a bioequivalent drug.

So they can use a somewhat different process, but they have to establish with FDA that the process that they use to make the drug is going to produce something that is bioequivalent, that behaves the same way as the branded version.

And when they do this, will get, with the approval, there will come a therapeutic equivalence code, which basically means that when a pharmacy dispenses it, it really doesn’t matter which generic they use because ultimately it doesn’t matter what process they ended up using, that process generates a drug that behaves at the body in the same way.

So, you know, clearly the process is really, really critical. And when, and this is where good manufacturing practices step in, because what you want is it’s one thing to get the drug approved, but you want to make sure that they follow that process that gives us the drug that we need over and over and over again. Right. And so there’s a

Thomas Gunderson (07:16.558)
Got it.

Marta Wosinska (07:39.89)
there’s a whole set of principles around good manufacturing practices that basically establish of that basically assure it’s about quality assurance. How do you assure that the drug that you’re making is going to be what you basically promised you’re going to be making?

Thomas Gunderson (08:01.718)
I said I was going to make a chocolate cake and it sure as heck better be a chocolate cake when I take it out of the oven kind of thing.

Steve (08:05.863)
you

Marta Wosinska (08:07.449)
Exactly. And well, so not just the chocolate cake, right? Because there’s a lot of variation in chocolate cakes. You said you’re going to make this very specific chocolate cake using this set of methods. It better be that it comes out the same way, right? So you will have to specify not only which ingredients you’re using, but maybe from where because it might make a difference if you use an ingredient from here or there. So you might actually have it from this flour and not some other flour if it makes a difference. You might need to have the oven at this temperature preheated for

this much for this amount, because you really want to have very little variation. There are some some bands that are allowed for the differences in the final product, but it has to be pretty tight and it definitely cannot make enough of a difference in how it behaves in the body.

Thomas Gunderson (08:58.264)
Got it. Thanks. How is this process different in Europe?

Marta Wosinska (09:08.161)
So both FDA and EMA and the national authorities in Europe have the same set of principles, which is that the manufacturer has to follow good manufacturing practices. But how the oversight is done is different. both Europe and the FDA very much rely on

inspections. So during an inspection, FDA will go into a facility and they will basically look at whether the manufacturer is following good manufacturing practices. They will and it’s about, they might look at how things are laid out. Are they following a set of procedures? Do they have a clear set of procedures? Do they do proper level of quality control and quality assurance?

Do they keep track of problems? And what is their resolution of problems if they run into a problem? just a very sort of long list of things that they should be doing. But as you can imagine, frequently, FDA goes into a facility at one point in time, right? And the question is to what extent will one visit end

You know, an FDA can only spend so much time in there and they might not be able to see everything, right? So the question is, how, to what extent can FDA’s inspection really give us the kind of assurance that the system is really replicating this? This becomes particularly important for generic drugs because for generic drugs, you remember I said that these drugs are therapeutically equivalent.

But what therapeutic equivalence means that it doesn’t matter which one you buy. So what this means is that buyers, be it wholesalers, pharmacies, male pharmacies, hospitals, they will want to buy the cheapest, right? Because it’s FDA approved, it’s therapeutically equivalent, it really should not matter which one you get. And when the manufacturer is faced with, need to make it the cheapest, you might start thinking about not having…

Marta Wosinska (11:35.502)
you know, really fast turnovers, maybe not, you know, maybe where you source your products. Maybe you don’t, you know, you have a problem with your line, but maybe you’ll just push it a little harder. You’ll put band-aids on problems when it really requires you shutting down and really investing some money in it. So there’s this constant pressure on manufacturers because it is a race to the bottom.

And I frequently said, you know, the race is, there’s a race to the bottom and the bottom is falling out. Prices have really been sort of diving in. puts pressure and quality assurance is overhead, right? And you really will want to cut costs. So, you know, I frequently compare FDA to a traffic cop trying to enforce speed limits. So just think about how you drive, right? You know, when there’s a red light, I mean, speed camera, right? What do we do?

We slow down. Once we pass the speed camera, what do we do? We generally speed up, right? No, it’s not just enforcement that matters, right? If the weather is bad or there’s a lot of traffic, you’re not gonna speed. But if it’s a clear day, you’ve got places to go, there’s no camera, you’ll probably speed, unless the ticket was $5,000, right? Then you’ll be like, oh, there’s no cop, know, maybe I will speed.

If you think about sort of FDA and inspecting facilities and this constant pressure to cut costs, It’s sort of like FDA is that traffic cop. You know, you don’t have speed cameras. And especially when you go to countries like India and China, it’s really very difficult to do unannounced inspection.

So what you end up doing is you have to set them up in advance, six weeks in advance. This is like basically you’re driving down the highway and from like a mile away, you can see that there is a traffic off just basically doing a speed check, right? I mean, of course you’re gonna slow down. So, you know, the FDA goes into these facilities and they see like everything is perfect or goodness, if they show up a day early, they’re burning documents. So lots of things like that. And so it’s…

Marta Wosinska (13:52.718)
The probability of getting caught is far from one and the consequences of getting caught are if I catch you, you need to fix it.

So this is a very long answer. I’ll sort of, you asked me how does this look like in Europe? Europe also inspects, but Europe has a different system in that they have another element, which is an element, they have a person that works for the company if it’s within the EU, for the manufacturer or the importer if the product is imported from India.

who has legal liability and they need to sign off that the drug was manufactured under good manufacturing practices. The way I sort of think of it is that, so they do audits, they look at all sorts of documents and they have to sign off on every batch and a batch could be several million pills.

but it’s whatever was produced, you know, with the same system before they changed to a different product and needed to introduce, you know, other, other products. So what it does is it increases the probability of catching a problem because this person is sort of like the second set of eyes on what the manufacturer released, but the consequences really go up, right? Because that person actually has both civil and criminal liability for signing up.

If there is a problem with the product and the product creates harm, that person can get into a lot of trouble. And there are definitely cases where that has happened. But I think generally what has happened is that before it gets there, they basically say, I am not willing to sign off on this. And that sort of raises the equilibrium, right? People slow down, the company slows down. So it’s really interesting because they have this additional layer that

Marta Wosinska (15:53.006)
puts a lot more responsibility, honestly, where it should be. It’s a legal requirement on the manufacturer to uphold the good manufacturing practices. And in a sense, it sort of shifts the weight towards that.

Bryana Mayer (16:07.606)
So you mentioned in your previous podcast with on background that there’s a really a fairly narrow profit for generic drugs and that could perhaps incentivize some manufacturers to make some changes like you alluded to in terms of some of the ingredients and kind of moving fast through the light, through the traffic light. What is that threshold for when a company, a manufacturing company would have to notify the FDA in the United States?

Marta Wosinska (16:08.429)
Thank

Bryana Mayer (16:37.638)
of an ingredient change? it only if it’s, you know, active ingredients? Do they have to be notified of inactive ingredient changes? What does that look like?

Marta Wosinska (16:50.467)
So for, so I guess I will answer it in two ways. One is that they have to, if they change the active ingredient manufacturer, they will have to get approval from the FDA. If it’s for inactive ingredients or some of the chemicals, if they’re an API manufacturer, they don’t have to be notifying the FDA. But I would say when it comes to manufacturing quality,

what really matters is the process of how you combine the products. As part of good manufacturing practices, you’re supposed to test the quality of the ingredients that you get. But the bigger thing around manufacturing quality is really how you put the things together. So it really matters, particularly at the finished step. Did you put the right amounts in there?

Did you have fully clean equipment or do you end up with bacteria in it or shavings of metal or maybe through the process, you you end up with some other impurities. So a lot of it is, can you take the inputs, you’re supposed to test the inputs, but it’s not just the quality of inputs, but how you put them together and to what extent you might end up with contaminants.

Bryana Mayer (18:07.184)
Okay. And in your paper with the Brookings Institute on Rethinking Manufacturing Quality Oversight for Prescription Drugs, this was published on October 8th, you mentioned that the US and EU oversight systems could potentially be backwards. Can you explain a little bit more what you mean by that?

Marta Wosinska (18:27.447)
Yeah, it’s interesting. know, if you were to ask me which country or which region would have more of a here’s sort of a general set of principles, here’s a set of incentives, let the market figure it out, right? Versus here’s a very detailed list of what you need to do.

I would have said US has the kind of more market driven approach where the responsibility, especially with our legal system, would be on the firm, right? Let the market figure it out and sort of discipline itself. And Europe would be the one with a very detailed list. So one thing to point out, Europe uses good manufacturing practices, which is a set of principles. United States actually has a very prescriptive list of

current good manufacturing practices. And so I would have expected it to be the other way around, right? And what we have is actually a very prescriptive process in the United States and a much more kind of let the market, a set of incentives that let the market figure it out in Europe.

Matt Stoll (19:40.686)
And so that leads into my next question. kind of to flip those expectations again. So there’s been a lot of talk about how little product testing is done outside of the manufacturer and there’s been a greater call for testing of products. That’s part of the EU’s regime. Can you describe the role that product testing plays there?

Marta Wosinska (20:04.173)
So it’s interesting. it is really, it is indeed the case that if the product is imported from countries that don’t have mutual recognition agreements with EU, then the product has to be tested. The countries that don’t have mutual recognition agreements are countries like, so the United States does have one, Australia does have one, Japan has one, South Korea.

the countries that don’t, the big ones are China and India. So when a manufacturer from India wants to sell a product in Europe, not only do they have to use a qualified person, a QP, but the QP, the product gets parked in Europe and it gets tested, sampled, in addition to what was done by the manufacturer.

And the QP is supposed to use that as part of the information. What’s interesting is when I issued the report and I sent it to a few people in Europe that have been in this sort of manufacturing quality space for a long time, their reaction was, are over emphasizing the role of testing. actually one person said, know, actually testing, and the reason why they’ve said that

is that

You know, there’s a difference between quality control and quality assurance. When you test a batch, you’re going to take a small sample of potentially several million units. And it depends what you test for, right? There are certain things where the distribution, if there’s a problem, the distribution is going to be pretty uniform. And for those things, you probably will have a relatively small false negative rate, right?

Marta Wosinska (22:00.43)
But if you’re testing for things that are potentially much more sporadic and much more random, then you will have a very high false negative rate. So it doesn’t necessarily give you all that much information. The perfect example, so impurities, very hard to detect, right? Because it’s not going to be systematic. It just somehow showed up in the product. Sterility, goodness, you know, that’s really hard.

So there are certain things you could test for in certain nuts. And so you have a very high false negative rate. And because of this, it can be helpful, but the question is what is the marginal value of it? You know, the emphasis really should be on quality assurance. And the QP is more about quality assurance than quality control because they are supposed to audit the manufacturer, understand the processes.

that is more predictive of what the product is going to come out. So in a sense, sort of what FDA would be doing in one inspection, but they do it for every batch with every batch. I mean, they don’t inspect the facility, but they can see and they’re highly trained. can spot various things. So definitely it adds some information, but it absolutely adds to cost. And frankly, I’ve been told that to a large extent, it’s sort of a protectionist.

you know, industrial policy type of a tool more than actually a quality assurance tool. So it’s there. And the question is sort of what’s the marginal value of that relative to the QP. And I think, you know, what I was sort of hearing from people who work in that space is that the QP really trumps the sort of the testing part of that system in terms of quality, kind of quality oversight.

Matt Stoll (23:48.668)
So if I’m repeating back what you said, placing more emphasis on making sure the processes are consistent and accurately performed versus testing the product because of the false negative rate in product testing. Got it. Yeah.

Marta Wosinska (23:55.747)
That’s right.

Marta Wosinska (24:02.381)
That’s right. So I’ll give you an example. So in New York City, when you walk into a restaurant, you see a grade, right? So I thought, well, I’ll actually look up how they do this. And what is the process for this? They don’t test it for bacteria. It’s all about process. How are you storing your food? How are you dealing when you have meat? How are you sort of dealing with, you know, it’s all about process.

There’s no quality control. It’s all about quality assurance. And it’s the same concept, basically. You should really be thinking about quality assurance and not quality control just because you get the return on the amount, the time spent, the return on investment in a sense, on quality assurance is much greater than on quality control.

Matt Stoll (24:52.023)
And a very similar approach applies to device as well. Tom, you can weigh in on that as well. But we worry about making sure the manufacturing processes are consistent and audit those heavily. Products are still tested, but there’s a heavy reliance on making sure that the lines are being run consistently from step to step.

Marta Wosinska (25:14.253)
Yeah, no, that’s right. and, you know, and what worries me about a little, you know, somewhat about the policy conversation that we’re having is that there’s so much emphasis. The product testing sounds like such a good idea. But I don’t think there’s enough appreciation for the fact that there’s just such a large false negative rate. And ultimately, the way to go about it is to do it through quality assurance and not as much quality control again.

It does add new information, but the question is where do you get the biggest bang for the buck? And it really is more on the quality assurance side.

Thomas Gunderson (25:45.006)
Okay.

Thomas Gunderson (25:55.097)
So is this sustainable in Europe from the standpoint of, you know, why would anybody want to be a qualified person, a QP? What I was reading was that the net number is going down because more are retiring early and fewer are being brought in. What can can the system still work or how can the system still work if there’s those kinds of pressures?

Steve (25:55.316)
you

Marta Wosinska (26:24.909)
So there’s two questions here, or I will break it up into sort of two answers, two parts. One is, to what extent one would need to evolve the EU system and to what extent they face challenges. And as I talked to QPs there, they definitely have ideas about how to do this and how it’s set up.

and what requirements there are for QPs. So there’s a lot of room for improvement in how they do that. And there’s a question about how they could be using technology to sort of inform how they do this. It shouldn’t be all paper-based, right? You should be doing a lot more data analytics. You know, how do we incorporate AI into the job of what a QP does, right?

And to what extent can you then, you know, given that somebody is signing off on this and the AI is sort of informing this, you know, how does one deal with this? So it’s a valid set of questions. But there’s another piece to what you said, which is why would anybody want this job? And I think this particularly, it’s particularly relevant for the US, given how

you know, how much we like to litigate, right? Who would want that kind of an exposure? What I would say to that is that there are two pieces to this. There is sort of a self correcting mechanism in here because even manufacturer cannot release a batch into the market without a QP sign off. Two things will start happening. Number one is clearly a QP is going to

pay get paid a lot more than the head of quality for a company, right? Because they carry so much more responsibility. But importantly, what’s also going to happen, so you know, there’s a benefit there for the QP. But also what’s really important is because they have so much power, it gives them it gives them a lot more leverage with the company itself, right?

Marta Wosinska (28:35.961)
If the company is not giving them access to documents, they will not want to this responsibility. They might reject one or two batches and at some point they will quit. The company then cannot release the product. And not only that, if they go through QPs quickly, FDA would be on it and say something is going on fishy here. Let’s really, really investigate them. So there is this sort of a market feedback in this, both through how much they make, but also through the, you know, can

Can the company sort of maintain them and the signals that it sends to the market? It varies by country, but they have code of conduct. They have sort of visibility. You know, if you’re a QP that gets caught of wrongdoing, you’re like, you better change jobs and profession entirely. So again, a lot of pressure on them, but because of this, they’re really well respected. can really, they can get jobs in a lot of companies. They are in demand.

Steve (29:31.284)
you

Marta Wosinska (29:34.297)
So there’s sort of this balancing that the market allows it to do.

Thomas Gunderson (29:42.723)
Thanks.

Bryana Mayer (29:45.97)
So you’ve proposed a deed for increased regulation. Is there an appetite with the current administration to increase regulation around drug manufacturing?

Marta Wosinska (29:58.778)
So that’s a great question. I mean, I would characterize sort of the current stance and not just the current stance, but just generally when Republicans are in power, it’s always to deregulate. What is really interesting here, however, is that there’s also great interest in leveling the playing field for domestic manufacturers. my sense is that the administration also is willing to embrace

you know, European manufacturers and some of the allies, they’re really concerned about products coming especially from China, but also somewhat uneasy about Indian manufacturing. And I think when you sort of take this into account, there are two ways to level the playing field, right? One is by lowering standards, but there’s not much less, I would not want us to deregulate less on manufacturing quality, they really want us to be going lower on that.

We’ve had problems with domestic manufacturing plants, creating drug shortages and having manufacturing quality problems. It has definitely happened. But what you can do is increase the costs on the ones where the playing field isn’t there. So if you think about it, FDA does not have the ability to inspect and properly oversee manufacturers in India and China. Well, how about we level the playing field by raising the requirements on them?

This does help domestic manufacturers, right? So it’s regulation but used in a way that helps the administration accomplish its goals. So I very much do think that there is sort of an opportunity there despite sort of the general let’s deregulate across the board.

Steve (31:47.988)
you

That’s actually a really good take on these writing that needle. mean, having been involved in the Trump one and the whole D reg process, but at the same time, you the supply chain issues, particularly with this administration, really, it’s coming back after all the supply and chain things that went through with COVID and other components that are out there. All the issues you’re raising, it’s definitely a trade off. There’s a D reg aspect of it, but there’s also the question of what the quality of supply chain is, what can be relied upon. You know, don’t even put it the

other tariff question into play. But actually, I want to throw one question out that I think is relatively objective and won’t get into trouble as we’re writing down. One thing, as you probably know, is I teach actually students in China, actually Brianna has done this as well, and they have lowered their drug prices dramatically in China. I think President Xi has commanded a 75 % cut last year and an additional 10 % cut or 15 % cut this year on top of that.

I guess I’m just curious, is that something to watch just because that level of capital being squeezed out of essentially a very, shall we say, economical supply chain market probably would cause concern in terms of those products moving overseas to us? Or am I just worried for no good reason?

Marta Wosinska (33:18.265)
So, you when I talk to policymakers, I frequently ask them, what problem are you trying to solve? Because depending on what problem you’re trying to solve, you should be thinking about a different solution. The qualified person proposal is a way to address the uneven playing field and FDA’s inability to oversee manufacturers in certain countries.

It is not about geopolitical risk with China, although it might help if we’re worried about geopolitical risk and this would shift demand because, right, this will impose costs on manufacturers that are in those countries, right? And to the extent that their products become more expensive, demand might shift towards domestic or European manufacturers. So it could have an effect on sort of the geopolitics, but it’s really sort of a secondary effect.

If we’re worried about sort of our reliance on China, we need to be thinking about it in a, you know, there are other tools that we should be using. And this is one of the things that that that would help. I’m not sure, Steve, if that actually addresses your question, but

Steve (34:31.924)
you

No, I I’m not sure there’s a perfect answer for it, but I really appreciate your taking one from the fences, as it were, because it’s one that’s of concern and not one that’s easily addressed. But I just want to, as we’re winding up our half hour conversation, just want to, especially on your birthday, Marta, thank you so much for sharing this time with us. mean, I think this is a very complicated

complex area that I think you’ve helped to, if nothing else, demystify a little bit and also highlight just how, on the one hand, how impressive the FDA can be to sort of make sure we get a safe drug supply, but also just all the intricacies that are involved for that level of oversight is non-trivial and very different than a lot of the world that, say, Tom or Matt normally deal with, which is medical devices, which is, as we know, a whole.

other world of constituencies.

Marta Wosinska (35:37.516)
Yeah. Well, so, you know, again, thank you for inviting me and the opportunity to speak to to to this proposal. You know, as you know, very well, Steve, nothing happens quickly, especially if it involves Congress. So it’s it’s really important at this point to to a lot of people that all a lot of manufacturers in Europe that I’ve talked to, it’s like,

Why don’t you guys have that system? It’s so obvious. But for us to actually start sort of thinking about this and seriously taking this into account and thinking about how it fits with policy goals and so on, it will be a long process. So I expect to be kind of talking about this issue and doing some follow-up work on it over the next few years.

Steve (36:35.44)
and and and

Marta Wosinska (36:35.513)
Unless I come up with a way to do it administratively, which could be. And so there’s a good question whether it could actually be done without a need for Congress to step in because that would change the dynamics quite a bit.

Steve (36:38.942)
Yes.

Matt Stoll (36:51.855)
I would say a few.

Steve (36:52.092)
And when that happens, come back to On Pike Ground and tell us how it would actually work. I’ll turn to Matt to bring us into a landing position here.

Matt Stoll (37:01.169)
I was going to say a few years is probably optimistic. It’d probably be more than a few. No, I think that’s a really good last word.

Marta Wosinska (37:04.537)
Hahaha

Marta Wosinska (37:09.625)
User fees, it’s always with FDA, any changes to FDA laws. It’s every five years there’s a big bill that comes up and a lot of things get attached. So I am sort of eyeing 2027. So a couple of years, 2027 is when the next big FDA bill is going to be passed. And so that’s sort of my target.

Matt Stoll (37:20.133)
Good point.

Matt Stoll (37:32.228)
Excellent.

Steve (37:32.468)
And although I’m not from originally Minnesota, I will say that those bills which have a very odd name really should have a Minnesota origin. They are the UFTA bills because, know, Padoofa and everything else like that. UFTA, yes.

Marta Wosinska (37:44.409)
They’re the oofas. Yeah, gadufa, padufa, bazufa. Yes, there’s lot of oofas there.

Matt Stoll (37:45.679)
doofa.

Matt Stoll (37:51.398)
Some great acronyms have come out of those. No, I think that’s a great place to wrap it up. Thank you, Marta, again for coming back on. Really appreciate it. Always happy to talk to you. Have a good night.

Marta Wosinska (38:01.53)
Thank you so much. Good night.