Hello, and welcome to the Boats and Verdicts podcast, hosted by the policy and Litigation team at Bloomberg Intelligence, investment research platform at Bloomberg LP. This podcast series examines the intersection of business policy and law. I'm Doing Right, an analyst with Bloomberg Intelligence covering government healthcare policy.
And I'm Tish Walker, an analyst with Bloomberg Intelligence covering pharma patent litigation.
So our topic for today is the Biden Administration's proposal to update marching rights under the Buy Dole Act to include a specification that price can be a factor in determining that a drug is not accessible to the public. While BIDOLE applies to any taxpayer funded invention, our focus will be on drugs and drug prices. This action is in stark contrast with the Trump administration's efforts to frankly do the opposite, which is to prohibit the exercise of
marching rights on the basis of price alone. Stepping back. This is part of a broader effort by the Buying administration to keep the focus on its policies to lower healthcare costs, specifically drug prices, after passage of the Inflation Reduction Act. So, what is the Bidual Act. What are
marching rights? How have marching rights been used in the past, How could expansion as proposed under the framework impact manufacturers and research institutes, institutions that accept federal funding, and if applied, will it ly to lower prices? Today we have doctor Aaron Kesselheim, a professor of medicine at the Harvard Medical School and faculty member in the Department of Medicine at
Brigham and Williams and Women's Hospital. He's also the director of Portal the Program on Regulation Therapeutics and Law, based out of the Brigham and Women's Hospital. Doctor Kesselheim, Welcome to the Boats and Verdicts podcast.
Thank you very much. It's a pleasure to be here.
Now, just to kick things off, can you tell us a bit about your work at Harvard Medical School.
Sure. I'm a primary care doctor and a professor of medicine at Harvard Medical School, and I run a research center called the Program on Regulation Therapeutics in Law, which is an interdisciplinary research center that accepts no funding from the pharmaceutical industry and studies issues related to prescription drug development and regulation and use and pricing.
Now, setting the stage a bit, what is the Bidole Act.
Sure The by Dole Act was a piece of legislation passed in nineteen eighty that allowed it basically set a ground rule that institutions that received government funding and created patentable inventions from that government funding would retain title to that invention and be able to exclusively license it to organizations or companies that could then commercialize the innovation.
Now, it seems like there's four key pillars that open the door for the government to exercise marchin rights. Can you go over those briefly?
Right? So, in setting up this default that would allow the institutions to exclusively license inventions or discoveries made with government funding, the Congress also created what's called marching rights to allow the government, in extreme cases where those exclusive rights were not being used in the way that the government might want them to be used to then be able to step back in and say, you know, no way.
You know, we're going to try to find other folks to be able to license those rights to as well, because ultimately the goal here is to turn government in funded inventions into commercialized items that could benefit the public. And so there was this this part of the statute called marching rights that said that, you know, if the if there if one of four different circumstances were met, the government could relicense that exclusively licensed product to another
another entity. And those four circumstances were if the licensee hadn't taken effective steps to achieve practical application of the invention, if health or safety needs exist that are not reasonably satisfied by the licensee, If the government funded invention was is required for public use and that use is not satisfied by the licensee, Or if the licensee violated its agreement to manufacture the product the United States. Those are the four circumstances that you're talking about now.
Tish and I have a number of podcasts focus on drug pricing, specifically around the Equation Reduction Act, but we're now seeing this conversation about trick prices applied to marching. So how does marching fit in with the current effort on reducing drug prices and increasing access.
Well, there's been apart from the Inflation Reduction Act, which is you know, relatively novel, there's been a forty year debate over whether or not the phrase practical application in the first of those four categories, practical application is defined in the Statute as making the product available such that its benefits are available to the public on reasonable terms. That's the phrase used in the statute, and there's been a discussion over whether reasonable terms includes the price that
the drug is made available at. And so if there's some you know, piece of a discovery, you know, either a drug or a you know, a medical device or something like that, that is discovered with government funding and then licensed to a commercial entity, and that commercial entity makes the product available at such a high price that people can't access it, that, you know, is that grounds for the government to exercise marching rights under the under the bi Dole Act. That's been the sort of ongoing
discussion over the last over the last forty years. Now, you know, obviously the link with the Inflation Reduction Act is that the Inflation Reduction Act also is intended to try to ensure that the government, in this case Medicare, pays a fair price for certain very expensive drugs. But
there's sort of you know, they're different. They're intended to you know, focus on different as different products and address different address different problems, but they're you know, they're both kind of under this sort of broader umbrella of issues that may or may not affect high drug prices.
And so has this administration or even prior administrations been asked to apply march in with certain drugs based on price. What's the history here?
So the history is that there have been about a half a dozen times over the last forty years, in the case of the of the healthcare, prescription drug and device market, where marching rights have been invoked as a potential solution to try to address high prices. There was a or or lack of availability of a product. There was a case of an HIV medication, and a there was another case of an eye drop medication, you know, in in the early two thousands, where marching rights was invoked.
And as they said, there have been about half a dozen times where marching rights have been invoked. And of those half a dozen times, really two of them or three of them were related to the drug being priced at a very high level and whether that was enough to sustain marching rights. And in none of those cases, including cases where the drug was priced at a really high level, did did the ni H ever even begin to take up marching rights as a as a potential consideration.
So no times has it ever been invoked. And it in particular, you know, of those six or so times, the three of them that in that's that explicitly involved high prices, where whereas not it was not, you know, the the ni H declined to invoke marching rights and and and imply that that pricing alone is not enough of a consideration too to make a claim for marching rights.
Now, this seems to be their reading of the statute. Uh. What's your take on what the legislative intent was of the by Dole Acts, specifically the marching requirements, because we are seeing some pushback by former staff who worked on this law that price was never meant to be a factor when applying or exercising march in what's your take on the intent going into developing this law.
Well, I mean, I think it's pretty clear if you look back in the late nineteen seventies, because the Bidole Act wasn't just introduced and passed in a single legislative session.
It evolved over the course of the you know, the end of the nineteen seventies, and I think it's I think it's very clear that if you look at the legislative history of the Act that that that price was considered as part of this reasonable terms catch all phrase, and that what the people in Congress were very concerned about was this idea that there would be this public investment in developing a product and then a company would make it available at a you know, at an unreasonably
high price and uh and people wouldn't be able to access it. And so I think it is I think it is clear that if you look at the detailed legislative history of the bill, that that most of the people when they were talking about this this safety net in the bill, that they were thinking about price as part of it. And indeed, when Congress around that same time and in the later years, uses the phrase reasonable terms in other statutes, they very explicitly mean price as well.
So it's a phrase that oftentimes that Congress intends to encompass price. Now, part of the controversy that you point out and comes from the fact that many years later, Buy and Dole wrote a an op ed in The Washington Post in which they explicitly said that, oh, we never meant for marchin rights to encompass price. But you know, by that time both Buy and Dole were working for consulting firms that had a financial vested interest in in
them making that claim. And and you know, legislative history isn't is really should be based on a read of the of the record leading up to a bill rather than you know, these sort of post hawk statements made decades later.
And you know, just you know, bringing it back to you know, we're talking about, you know, the focus on drugs here and one of the sort of the threshold issues being you know, it needs to be a subject invention. So we're looking at something that's going to have some level right of federal funding for us to even be here, you know, seeing if marchin rights, you know, would even be a possibility related to a certain drug. So, so what percent of FDA approvals include some level of federal funding?
And are there certain therapeutic areas that maybe are more likely to have government investment or government funding as compared to other therapeutic areas well.
I think it's important to recognize that every single drug approved by the FDA has is based on federal funding. One hundred percent. There are all drugs are based on federal funding. To NIH that leads to incredibly important discoveries in basic and translational science. And in some cases sometimes that federal funding even occurs later in later stages, you know, leading to you know, proof of proof of design and
stuff like that. But the Bidole Act and Marchin Rights only applies when there is a patent that has government rights as part of the patent. And there is a very small number of FDA approved drugs that have patents that can be explicitly linked to government sponsored funding. To government funding, We're talking on the order of, you know, a few dozen drugs over the last forty years, whereas you know, the FDA approves forty or fifty new drugs every year, you know, so we're talking that, you know,
of all the drugs that have federal funding. The Bidole Act and Marching Rights only applies when there's a patent, and you know, the number of drugs that have that is actually very, you know, really quite small.
Okay. So with that background, we have a sense of what the administration wants to do and expanding the ability to exercise march In with the focus on direct prices and whether that invention is available on reasonable terms. I think I look at the document that's for comment, I see words like reasonable, extreme, and unjustified which is a caveat to actually exercising marchin rights. What's your sense of where that bar should be set in terms of what
is reasonable? But then also when you think about some of the other language, as I mentioned earlier, extreme and unjustified, is that kind of a way for the administration to back out of exercising marchin rights. Help me kind of wrap my head around how these terms can be defined so that this would be something that is a bit more predictable.
Yeah, I think that's a really important issue because you know predictability and you know ex anti understanding what the response onsibilities are for you know, government uh inventions that have government sponsored patents associated with them is a really important issue. And so you know, I think that it would be more useful to have a clear definition of
what reasonable terms are. So, for example, one definition could be that you know a product is made available on reasonable terms when that product's price is you know, on par with the price that the product is made available to other industrialized countries in Europe or Canada or Australia or Japan. And so you know, if other countries are getting a drug at a certain price, you know there's no reason that the that the US should be spending two to four times higher than you know, for its
for the product in the in for American patients. But in fact, that is what often happens for brand name drugs, is that in the US we spend two to four times more than is spent in other countries. So that might be a uh, you know, a clear ex anti rule for how to define what reasonable terms are in terms of price. And the Biden administration proposed guidance. As you said, you know, you see phrases like extreme and unjustified, you know, at which you know, are a lot more
vague in terms of how they would be applied. And so you know, ultimately the application of marching rights is going to be up to you know, the the executive agencies n I H and the other agencies that are tasked with implementing this, and so you know, it's gonna it's gonna be you know it. You know, those kinds of of phrases that that aren't clearly defined, you know, may may be subject to some you know, variable interpretations
over the years depending on who's in charge. So and I think it's also important to recognize that that it is very challenging administratively, you know, and judicially to implement
marchin rights in the first place. So you know, it's a it's really a safety net for circumstances where you know, products are really you know, manufacturers or or entities that are commercializing a government funded project product, you know, really are taking advantage in ways that that are unfair to US patients, you know.
So you know, I think we just talked about how the terms you know, reasonable and extreme and unjustified, they can be a little bit subjective and maybe you know, subject to variation depending on different administrations. But you did give at least, you know, one example of maybe of a potential way to you know, consistently apply you know, marchin rights, which is perhaps looking at pricing in other
jurisdictions compared to the US. So if you were at NIS, or if you were advising the White House here, what are some factors you think that could be applied in this sort of in a consistent manner that could trigger marchin rights to maybe get away from some of that you know, subjective language.
So I agree, I think that I think that that would be one way of trying to implement you know that in a in a more predictable fashion. And in fact, you saw recently that there there was some news about a government license for a COVID nineteen monoclonal antibody development with a private company, where you know that that kind of language of you know, the US price should be on par with other industrialized countries prices was part of that was part of that U the license for that
particular product. So that's one example. I mean, you could
imagine other formulations as well. You can imagine that you know, maybe maybe it's defined as a value based price according to some you know, independent valuation organization, or you could imagine that a reasonable price is defined as the cost of production plus a certain percentage that would allow for a reasonable royalty to the manufacturer, you know, cost of production plus one hundred percent or two hundred percent or whatever people decide is a fair royalty for for the
entity that's taking on the the responsibility of commercializing the product.
Yeah, and you know, it'll be interesting to see if we see more of that in some of these you know contracts that are are being you know developed between the government and you know third parties. But you know, going back to when we were setting the considerations and sort of setting the stage for a vidol. You know, you mentioned that a subject invention and a patent that is a subject invention is a threshold right for exercising Marchin rights. And you know, there's multiple patents that can
cover let's say a drug product. You can have patents that cover the compound itself, could cover salt forms, formulations, method of using, and usually you see some sort of combination of all of these different types of patents that might be protecting a certain product. So, in your view, is it going to be a rare case where all the patents that cover a drug would be subject to Marchin rights? And you know, how would compulsory licensing of
some but not all of those patents affect access. So for example, maybe one of those six patents or three of those six patents might be subject inventions, but there could be other patents that protect the drug that aren't necessarily subject inventions.
I do think it is going to be the rare case that all of the patents on a drug are connected to government funding. And one of those rare cases actually exists. There's a drug called ensoludamide or extandy where all the FDA listed patents are. It's a cancer drug used in prostate cancer, very effective drug developed entirely at UCLA before being licensed out for manufacturing and commercialization, and
all of the patents are linked to government funding. And so that's a pretty clear case where marching rights could be available. In other cases, as you point out, it might only be one out of you know, six or twelve or you know, even more patents that relate to marchin rights. What we've found actually in our research is that of the drugs that are linked to government funded patents, a lot of those government funded patents are the are on the active ingredient and are like the central most
important patents. And so I think that you know, the process of exercising marching rights on some of these very important patents, even if there are other patents available, you know, that might lead a company that's commercializing the product to consider what whether or not its price is fair and consider adjusting it if it seems like there's a possibility that another company could get access to its you know,
sort of most important intellectual property. It's also the case, by the way, that the government has the authority under a different section of the of the Federal Statute of the Federal Code called section fourteen ninety eight, in which the government is allowed to use patented innss for its
own use. So you could imagine marching rights applying to the one patent that is the central, you know, active ingredient patent, and then the government relying on section fourteen ninety eight to allow the use of the other five or nine or fifteen patents on the drug, you know, to allow the other manufacturer to supply the product to
Medicare and Medicaid or other other government payers. So there are there are ways around this, this pro this issue that you're talking about, where marching rights might only apply to one out of the huge thicket of patents that a manufacturer builds around its brand name drug.
Yeah.
No, it's interesting that you mentioned section fourteen ninety eight, and maybe this could be a whole other podcast, but I know certainly that that's something that I don't know if you followed the COVID vaccine litigation, but I've done and some research on these, and that's certainly a defense that Maderna has put forth in terms of some of the patent infringement actions that have been filed against them for their COVID vaccine, basically saying that the government authorized
via Section fourteen ninety eight for them to you know, basically use a third party's IP. So I think it'll be interesting to see how that. I think the case where you're seeing it right now is the arbutus being Madernist. So it'll be interesting to see how that sort of
plays out. But I think what's also interesting there is while it might alleviate that third party from infringement, I do think it also provides the patent owner could always go after the government I think through the Court of Claims for patent infringement, but then could be limited potentially
on damages that they could get back there. But you know, it's interesting, you know, we're talking about needing the patent and maybe not having all the patents, but you know, can you discuss a little as well about how compulsory licensing isn't necessarily the same as tech transfer. So you know, for example, it would be one thing to potentially license a patent to a third party for them to develop it, but you're not necessarily transferring the know how, right, Like,
how do you make that drug? How do you manufacture that drug. So you know, with that in mind, what do you think the process would look like for the government to use the license and to contract with a generic manufacturer to make you know, a particular drug at a lower price, you know, And do you think, you know, would that impact how long it would take for the drugs to be produced.
I think it's a very important point, and I absolutely agree that it is not as simple as just transferring a patent to another manufacturer and then you know you're going to be able to have a product. You know, not only do you have to, you know, deal with the issue is that you're talking about about know how and manufacturing capacity, you know, you also have to deal with FDA approval of the manufacture of the product from
that manufacturer. So you know, this is again all of this points to the fact that marching rights is not a large scale solution to issues related to prescription drug prices.
Marching rights is a very very focused, very very small scale solution for a very small number of products, you know, But it's important that it exists, and it's important that it applied to cases where the drug prices are too high, because when public funding develops, an essential medication like the cancer drug or the HIV medication, or the or the eye drop that I was talking about earlier. It is really important that that patients have fair access to those products.
And but but I agree with you that all of those are important issues. Now, you know, in the case of ns alutamide, there actually is another manufacturer that you know, that a generic manufacturer that that could make the product available and has received tentative approval from the FDA to do so. But for the existing intellectual property rights that exist,
you know, that protect the brand name product. So there are some drugs that are going where the where the you know, transfer of know how isn't very challenging, as in the case of a drug like ends alutamide. And then there are other products like another one of the petitions for marching rights over the years related to a drug called a galasidase for Fabria's disease, which is a biologic product that really wasn't a pricing issue, is more
of a supply issue, you know. But that's a much more complicated biologic drug, and having finding other manufacturers to make that is is a is a bit of a of a of a bigger task. So but I agree with you that that's an important issue.
Yeah, and I think that's a good note that you make on the ends alutamide, right, is that, well, if there's somebody that's waiting in the wings that has the approval, they just need the license to the patents, right, that's
sort of a different scenario. And certainly, you know, I think one thing that maybe could be thought about is like, at what point would a generic manufacturer potentially go to the government and request a license through march in whether it would be you know, when they file their new drug application or they're abbreviated new drug application, or at
some point during the litigation. I think it probably would need them to do an assessment, right on what are the patents that cover the drugs, what are the key ones that are you know, the barrier to access for them, and are any of those you know, subject to government funding.
Yeah, and I guess as I'm thinking about this, you know, I we just passed or Congress just passed the President signed the law, the Inflation Action Act, And you mentioned this earlier, and we've had some questions today about providing a bit more predictability based on the way some of these words are used in the draft framework. Now, is it reasonable for somebody to say, and I know you've said that the way we're looking at Marching now, it would only apply to a very small number of drugs.
Is it reasonable or unreasonable? I need to use those words since we talked about it earlier. But is it reasonable to assume that because we have the IRA, we don't necessarily need these to expand the Marching authority because at least with IRA, you know, we'll know what the prices are coming up this year potentially. Is it reasonable to assume that there's a more predictable process and maybe a more efficient tool more lewing prices than this, uh,
expanding this story through Marching? What do you what's your response to that?
Well, I think that the Inflation Reduction Act and Marching Rights are separate, complementary tools. And and again, as I said, you know, the Inflation Reduction Act is you know, applies to a small number of drugs that meet certain minimum criteria for for medicare spending in terms of you know, minimum of two hundred million dollars a year in medicare spending and have to be on the market for nine to eleven nine to thirteen years after after approval and
have to you know, subject to other exemptions. So you know, the Inflation Reduction Act has is you know, an an incredibly important and transformational piece of legislation, but it also is limited in certain ways. And that you know, it applies to a certain small number of drugs at at the very end of their exclusivity and only in the and only applies to to medicare, uh to the prices
paid in medicare. Whereas you know, marching rights applies to cases where a drug is developed with substantial public funding that will that that that leads to the development of one of the key patents for the drug, or sometimes all of the key patents for the drug. As I said, you know that those those two don't necessarily overlap. In the case of Extandy, ex standy didn't qualify for the first round of Medicare negotiation because it, you know, it was it was not one of the top ten top
selling drugs in medicare this year. Whether it qualifies in future years, you know, we'll we'll see.
But probably will yeah, I mean, we'll see.
You know, who knows. But there, you know, there, I think they are complementary and I think they both feel different policy needs. And again I don't I don't. I don't feel like either the IRA makes the makes the need for marching rights to be you know, a real uh a real uh you know, important safety net uh unnecessary, or that marching rights in any way makes the Inflation Reduction ACTU necessary. I think they just apply in different circumstances, you know.
And anytime we see some sort of new policy, and not that bi dole is new, right, but the thought of using price right as a as a consideration, you know, is there's always a discussion about the implications and the
consequences or maybe unintended consequences. So it's probably important if we maybe talk through some of those, so, you know, if this framework is implemented, you know, we you talked a little bit about how often you know, agency inventions or even university inventions, right are often very very early
on and can be very foundational and drug development. How do you think this framework could impact licensing and collaboration agreements that we see between for example, academic medical research
centers and biotech companies. You know, oftentimes universities have a tech transfer office where they're generating a lot of revenue for their university by out licensing some of these key, you know, fundamental inventions that help support you know, further development or even you know, maybe in the case of
extandy right that are actually to a drug itself. Do you think manufacturers are going to start pricing in this new what they might consider a new march and risk and could that lead to lower prices for government funded research or create maybe a direct hit to tech transfer offices such that they're not getting as much revenue as maybe they could beforehand.
Well, you know, I do think that, uh, I do think that that the ability for academic centers to uh coordinate with commercial entities that ultimately manufacture and bring a
drug through the regulatory approval process. I mean, I think that that process is a very important one, and it's it's very important to make sure that it remains vital and and and that you know, it remains a conduit because you know, that really is the process through which, uh most of the transformational drugs and and and most important new uh new ways of treating medical conditions end
up getting to patients. So it's important that we have this conversation and make sure that that any changes that make that are made in policy, you know, don't don't affect that that vital pathway. And I personally don't think that, you know, the the extension of marchin rights to include
prices would affect that for a number of reasons. I mean, I think, first of all, as I said, it really only affects an extremely small number of drugs overall, like we're talking as you know, we're talking you know, six cases of proposed marching rights over the last you know, forty years. And in addition, you know, a lot of large drug companies have don't invest in basic science and don't invest in the in the kind of work and when they count on on on new and important ideas
emerging from government funded research at academic centers. And so the idea that as a result of this change in policy, that that large manu that manufacturers would turn away from the ideas coming out of academic centers is you know, is completely absurd to me. That you know, they they don't have any other place to find that information because a lot of the large companies have divested out of there, out of their own research centers, uh in in into
to a large extent. So you know, would it be the case that that that manufacturers would price this in to the royalties that that academic centers would receive. I mean, maybe, you know, I think that if you look at it, there are a couple very successful academic in terms of financially successful, a couple very financially successful academic transfer offices, but a lot of take transfer offices aren't, you know,
sort of major financial successes. And so you know, I don't know that that's going to be that disruptive to the to the process. And you know, ultimately, and as I said, the equity here is is important to keep in mind that these are these are inventions and discoveries that that really have a substantial amount of public contribution
to them. And the fact that a company can then charge high prices that make them inaccessible to some members of the public or to make them make them be a drain on the on the the healthcare system, you know that that really doesn't seem very fair.
You know, And I think maybe you sort of answered my next question as well. As you know, often when we see changes like this, some of the criticism we see sometimes from you know, uh, the pharmaceutical industry itself, is like, oh, this is gonna you know, you're confiscating our property. This is going to stifle innovation, This is going to reduce R and D investment. This ultimately is going to be harmful to to people and not beneficial. What's your response to you know that sort of criticism.
Well, you know, any time you change pharmaceutical policy, the pharmaceutical industry will say that you will no longer see any more new drugs. Like that's their constant refrain. Ever since the you know, the you know in time for Time Immemorium Tracksman Act meant would mean that there is no more innovation that you know, the the the Inflation Reduction Act means that there's not gonna be any more innovation.
In fact, since the Inflation Reduction Act has passed, I saw one statistic out of the Congressional Budget off is that venture capital funding in the in the pharmaceutical industry has only increased. So, you know, I think that you hear this when you hear that refrain so many times in every circumstance, at some point, you know, you tend to you tend to like tune out the crying wolf aspect of this, and you know you really need to just assess the the policy on its own legs and say,
you know, what are we really talking about here. We're talking about, you know, how how how fair it is for for the for the government and for public the public funding to pay through taxpayer dollars an invention and then to have to pay exorbitant fees for that product on the back end as well. Doesn't seem very fair.
And at the same time, we're talking about such a small number of products and and such an essential source of innovation that this government funding through through research at academic centers as a as a source for new innovation, that like, you know, I just think that with all of those things together, I don't think that I think that this is yet another circumstance where we have to not take the the pharmaceutical industry you know, crying wolf, uh, you know, seriously.
And and to that point, we've seen this administration move forward on some of these policies where there has been significant industry opposition, and as we know, there's significant opposition industry opposition to what the administration has proposed. And time will tell if this actually does happen, if there's a final framework, what it might mean in terms of how
these companies think about their investment strategies. Just just like as you said on the IRA, you know, innovation might not be stifled, It just might change and require a bit more thinking and thought in terms of kind of the what's next for each individual company based on their pipeline. So time will tell there. But to your last question and answer, like for you to bring out your crystal ball for this final question, which is now that it's twenty twenty four and it's an election year, how do
you see this getting resolved? My sense is that, you know, this is part of a broader effort by the administration to keep the emphasis or the focus on their efforts to address high healthcare costs, whether it's insurance costs or in this instance, drug pricing. So I tend to think that we'll see something this year in terms of a final framework. Do you agree with that or can you give us a sense of what might be in store
for the next several months. And do you think it's going to change any kind of behavior by pharma in terms of how they look at their pipelines.
Well, I do think that there will be a final framework this year. I also think that the Biden administration will use this step if it does, in fact, you know, survive into the final framework. I think it will use this step as evidence that it is taking steps to
address high drug prices. And I think, you know, I think it is really important to recognize that, you know, despite the as we've talked about before, the relatively small number of products that this will apply to, and the challenges of applying it, it really is a transformational step after forty years of Republican and Democratic administrations alike denying that reasonable terms includes prices, for the Biden administration to step forward and include price in the discussion of what
reasonable terms is. So even though it will only apply to a small number of products, and it you know, is incredibly administratively and judicially challenging to use. And you know, I do think that it is valid for the Biden administration to use this as a in its in its you know, uh political campaign, as an example of how it has really taken, you know, new steps in this area that have never taken have never been taken before.
But I do not think that in the looking into my crystal ball for twenty twenty four, I don't think that even if this guidance gets finalized, I don't think that we'll see it be applied to any drugs. And even if we do see it, you know, the initial steps be taken around one drug. You know, the lengthy process it will take to actually make that happen will stretch well into twenty twenty five or even you know,
twenty twenty six. So we may see a final product, we may see it be used in political campaigns, but I do not think we will see it actually be implemented around a particular product.
Well, let's definitely revisit this a year from now and see what's happened in what the reaction has been. And I'm sure we'll see this potentially play out in another venue, i e. The courtroom potentially at some point, but time will tell. And with that we'll wrap up this episode of Boats and Verdicts. We're grateful to doctor kessel him for joining us today, and we thank you the listener
for joining us as well. As a reminder, you can read all of our bi research on the Bloomberg terminal at Big Thanks for listening, and have a great day.