Deep Dive Episode 313 - Medicare's New Drug Price Mandate: Healthcare & Innovation Implications

WEBVTT
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Regulation after regulation.
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There are all padated regulations that need to be.
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Changed one hundred and eighty five thousand pages.
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Now public accountability and transparency. There will be no public supports.
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It's really the best we can do.
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There's a regulation that doesn't make any sense.
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Why do you keep you.
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Know who wrote the regulatory laws you must comply with.
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Welcome to the Regulatory Transparency Project's fourth Branch podcast series.
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All expressions of opinion are those of the speaker.
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Good afternoon, and welcome to today's Regulatory Transparency Project. What
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are titled Medicare's new Drug Price Mandate, Healthcare and Innovation implications.
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You are so glad that you are able to join
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us today. My name is Sarah Clark. I am the
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assistant director of the Federalist Society's Regulatory Transparency Project. As
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a reminder, all opinions are expressed of those of the
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speakers the Federalist Society. We are honored to be joined
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by a fantastic panel of legal experts. In order to
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get right to discussion, I will leave individual introductions to
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our moderator. After the panel discussion, there will be a
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short period designated for audience questions. We ask you to
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submit them via Zoom's Q and a feature not the chat,
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and that the questions are pertinent to the topic at hand.
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Our moderator today is Adam Mossov, who is a professor
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of law at the Antonin Scalia Law School at George
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Mason University. He has published extensively on wy patents, copyrights,
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and other intellectual property rights have been and should be
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legally secure to innovators and creators as property rights. His
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scholarship has been relied on by the United States Supreme Court,
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by lower federal courts, and by US federal agencies. He
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has been invited to testify numerous times before the US
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Sunday and the House of Representatives on intellectual property legislation.
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You can find out more about today's moderator and panelists
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of fedsoft dot org. Full bio intros can also be
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found by clicking on the resources tab on the Zoom
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call screen. With that and we'll hand things off to
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Professor Massa to get us started. Professor Massa, thank you
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for joining us today.
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Right well, thank you, Sarah. It's a real pleasure to
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be here, and as Sarah indicated, we are just blessed
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to have a fantastic panel of a very thoughtful, scholarly
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and highly respected panelists to talk about this incredibly important
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issue at the intersection of kind of patent law, healthcare policy,
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and innovation policy. More broadly, so, the topic of our
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discussion today is, of course, the Medicare's new drug price mandate.
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This mandate was implemented in the Inflation Reduction Act, so
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a bill for which former Director Andre Youank who has
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said is one of the most significant pieces of patent
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legislation the Congress is probably enacted in the last several
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decades of which the word patent is never found once
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in the entire And why did he say that, Well,
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because the Inflation Reduction Act contains a provision that mandates
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that a quote maximum fair price end quote shall only
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be paid by the Center for Medicare and Medicaid Services.
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It goes by the acronym CMS in the Department of
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Health and Human Services, from a list of the top
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one hundred highest cost or highest priced drugs that Medicare
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pays for. So effectively, the CMS, the Center for Medicare
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and Medical Medicaid Services, will be composing effectively the price
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controls by dictating the price that drug UH companies can
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charge for their drugs as opposed to what was originally
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has and has been up until now negotiation between Medicare
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and Medicaid UH the inflation reduction refers to this as
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a negotiation, but it is. But you know, one could
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argue whether this is a negotiation of the sort of
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which one engages in in in the marketplace, or if
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this is a negotiation of the type of which one UH,
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of which was described in The Godfather, where an offer
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is made of which cannot be the which cannot be
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turned down and UH and to emphasize this point, you
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know that you know it is a that you know,
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it's not a traditional negotiation in that sense and which
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described in the in the in the in the legislation,
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even though they use that term. So when CMS offers
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this price to the drug companies, they have three options.
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They can't accept it whatever that price may be as
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determined by CMS. The law does not tell CMS how
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it's to determine this price, so it's left free to
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make the decision as to what it thinks is a
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fair price. As the law is the term that the
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law uses. The drug company can say no, we don't
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want to pay that price. Then the law imposes an
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excise tax on the on the drug company of on
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the total revenues received from that drug. The law states
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that it applies to sales, and so it's not limited
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just the excise tax to sales to Medicare. It's just
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all says sales, and that would be construed as all
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sales because there's no limitation on it in the statute,
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and that excise tax can can range up to as
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much as one thousand, nine hundred percent of the total
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revenues received from the drug. So that makes it very
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clear that this is an offer that the drug company
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can't refuse. When CMS makes their offer, the third option
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is is that they can say no and remove all
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their drugs from Medicare and Medicaid. Now that's a problematic
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for lots of reasons, and one of the in which
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we'll beginning into. But one of those reasons is that
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approximately forty percent of all drugs now purchased in the
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United States and healthcare are purchased through CMS, and so
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you would be effectively, you know, being removed from almost
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one half of the of the drug market as a
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drug company. Excuse me, so as you can see this
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is a very significant piece of legislation that imposes effectively
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great regulations as lawyers call them, or price controls as
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normally would be called, on the prices that can be
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charged by drug innovators for their new drugs. They're slowly
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adding more drugs. So the first there were first ten
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drugs were added in twenty twenty six, shortly before the
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Bide administration concluded its term in January. Per the statute,
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it added another fifteen drugs to the list. And they
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will and they will add successfully more and more drugs
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for the next two years up until by the point
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of twenty twenty nine there will be at least fifty
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five drugs that will fall within the scope of a
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maximum fair price mandate, and arguably more will be added
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in the ensuing years. There are significant there's significant amount
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of litigation over this law. Now there are probably about
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eleven pending cases and various courts around the country making
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a slew of statutory and constitutional arguments statutory under the
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Administrative Procedures Act and on constitutional claims from takings to
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excessive fines to do process and things of this sort.
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So I wanted to give the overview before so that
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our panelists didn't have to worry about kind of laying
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some groundwork so they can just jump in and provide
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their insights as the scholars and thought leaders that they are.
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And I want uh and so I want now to
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turn it over to them, and they're going to run
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it from here on. So you're gonna barely hear me
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as you as you shouldn't want to hear any more
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from me, And I am a firm believer, and you
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want to hear more from them and not from me.
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So I appreciated that Sarah gave all my accolades and everything,
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but I'm just going to give name, rank and serial number,
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and if you want to find out more about them,
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embrace this awesome online service we have Google them use
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chat GPT, although be careful they might it might be hallucinating,
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but but you know, you can finally find all of
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their many many accolades and professional achievements that they have
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that they rightly have earned in their in their in
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their excellent careers. So in order of just kind of
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kicking off our discussion, we won't, we have Lisa Willette
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from who is the Dean F. Johnson Professor of lot
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Stanford Law School. And then following her will be Brad Watts,
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who is Senior Vice President at the Global Innovation Policy
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Center at the US Chamber of Commerce. And the last,
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but certain not least, then we'll have Dan Troy, who's
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managing director at the Birth Birthday Research Group. So let's
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let's let's get in. So let's have some fun now
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for the next fifteen minutes. So so, Lisa, so, what
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are some of the legal and economic issues underlying the
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adoption of the most of the maximum fair price provision
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in the IRA for the drugs that are being purchased
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by CMS.
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Sure, so, thank thanks for inviting me to chat about this.
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I've spent more time thinking about the economic issues than
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the legal issues. So on. On the legal issues, I'll
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just say that to my knowledge, every district court and
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the want to tell at court that have reached the
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merits so far have rejected the challenges, and I'll tell
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the program. I'm sure we'll chat more about that later.
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But to me, the more interesting questions are the questions
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of innovation economics and the merits of this new program
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from a policy perspective. Uh, and my thoughts on it
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are more nuanced than just like pro or anti and
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I think if you little kind of step back to
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first principles from kind of innovation economics one oh one, Like,
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I think the goal of drug pricing policy from an
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innovation perspective shouldn't be low prices per se. I think
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the goal should be to design policies such that society,
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including public and private investments, invests in innovation up to
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the point where the marginal costs equals the expected marginal
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social benefit of those investments in terms of saving lives
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and improving health. And given the current innovation ecosystem like,
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one of the most important policies affecting this calculus is
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the expost reward that a firm gets for bringing a
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new drug to market. And these incentives matter. Even though
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the evidence based on patents generally is surprisingly weak, there
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is good evidence that increasing the returns to patented pharmaceutical
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products increases R and D effort on things that are
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more profitable. And the expost reward that firms expect that
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depends on factors, including the length of as exclusivity period
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and the price that can receive during that period. And
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so that's why the design of medicare price negotiation matters
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for innovation. So I think we have an innovation policy
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problem when the reward for producing a new drug is
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misaligned from the value that drug provides compared to existing
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products and the currently with errors in both directions, like
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there are sometimes when the reward is too high, causing
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firms to invest in things that extend exclusivity and profits
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with little demonstrated added value for patients. And there are
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also areas where the reward is too low compared to
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social value, meaning that we as a society are missing
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out on drugs and vaccines that would likely otherwise exist.
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And that latter problem they're like too low problem. I
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think that is harder to measure. It gets less attention.
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But there is some good ectorical evidence of that, including
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a study documenting under investment and treatments for the early
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stage cancer due to their long clinical trials and short
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exclusivity periods. And I think we should care about that
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if we want to be improving lives and improving access
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to medicines, that we want those medicines to exist in
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the first place, So medicare drug negotiation. This is one
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of many recent efforts to deal with the too high problem.
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Since before this, Medicare had very little ability to oppose
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any kind of market discipline on prices. I don't think
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with great evidence yet on how well it's doing that.
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I think it is good from my perspective that both
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the statute and cms's guidance require consideration of a drugs
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comparative effectiveness when setting these prices, which will hopefully limit
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the effect to which CMS error is too far toward
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reducing prices of drugs that do have evidence of added value.
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This program doesn't do much to deal with the too
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low problem, which has gotten less policy attention. I've argued
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in separate work that government payers like Medicare should in
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some cases be authorized to offer much higher reimbursements than
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they currently do for highly effective drugs and vaccines in
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areas where prices are currently too low to spur developments,
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and in wish that this problem, the potentially life stating
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medications that we're missing out on due to design of
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the current system, got as much attention as the issues
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related to the prices of medicines that already exist. I
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think I'll stop there for my initial thoughts and but
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happy to jump back in with more.
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Yeah, that was great. Thank you, Thank you for that.
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Overview was fantastic, fantastic and and and uh continuing kind
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of our overview opening comments, So, Brad, what are you
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know some of the kind of the can you give
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kind of the high level you know, legal and policy
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issues and concerns with the with the maximum fair price mandate?
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Yeah?
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Absolutely, I mean, first I want to start out by saying,
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you know, I I agree with you know, Lisa's the
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second half of what Lisa was saying about the two
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low problem, right.
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I think many of the innovated companies I.
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Get to work with would probably share that assessment that
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there are some fundamental dynamics at play that that do
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make it difficult to invest in some of these early
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stage treatments, some of these orphan diseases. And that is
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a real problem, right. And there are I think a
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ton of different people on the hill and then policy
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you know, positions thinking about that issue. But I do
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think it's a critical one, right because there are a
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lot of patient needs that are being at because fundamentally, right,
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the company can't recoup what they're spending on R and
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D for trying to treat.
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This disease state.
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And so I'm actually really glad you brought that up,
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because I do think it's an important consideration that often
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gets lost in this broader debate around innovation, price controls,
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patent terms, et cetera. You know, in terms of the
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policy issues at play, you know, as you noted Adam
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there at the start of the call, there's ten, I
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think lawsuits that are currently ongoing against the IRA at
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various stages. Some are still at the district court, some
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are on appeal, some are I think appealing questions fundamentalist standing.
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So there's all sorts of different stages of the litigation.
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You know, broadly, if I had to categorize where the
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lawsuits stand, and I think you noted this as well
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out and it's probably three buckets one or just kind
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of challenges around implementation, So I think administrative procedure issues.
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You know, is CMS going about this kind of in
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a black box? You know, the statute itself is pretty
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vague and ambiguous as to how CMS should go through
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this whole process. CMS and some of their guidance has
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been pretty vague and ambiguous and candidly less than transparent
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around how they're doing some of these things. So a
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number of challenges are focused on that piece. Some challenges
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are focused on the constitutionality of the issue, particularly when
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you start talking about price. I know one company that
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is challenging the IRA, you know, has made the point
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in their litigation that if you apply these penalties to
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the extreme, it would be our entire global revenue in
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a single year. You know, So you essentially have a
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really big issue with a takings problem, you know, when
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you're talking about confiscating a company's entire global revenue or
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not agreeing to a negotiated price.
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And then the third.
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Bucket I mean, and this is I think in conjunction
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with the other two argument. It's almost every single I
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think piece of litigation is making the innovation argument. Right,
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what are the long term impacts this policy is going
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to have on the proper system?
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You know?
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Again, these are all various stages of play. I can't
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imagine if these lawsuits are going away in time soon.
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But obviously policy making doesn't happen in a vacuum, right,
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There are plenty of efforts underway to look at this
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broader statutory scheme and what the right policies are is
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for innovation, separating from any ot on litigation. Hopefully that's
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a good high level summary.
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Yeah, it's excellent, thank you.
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And then and then Dan uh coming in to kind
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of complete our overall framing is kind of so what
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are the economics of drug R and D and what
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does this kind of tell us about the potential economic
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facts of the maximum fair price mandate in the i RA.
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Okay, so I should just give a couple of disclaimers.
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One is, I'm not an economist. I testify in pharmaceutical
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as an expert witness, and my views are my own,
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not just not the views of the Federal society. One
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legal point and then a few economic points. The legal
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point that I'm not sure we've hit home adequately, although
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I agree with everything that's been said so far, is
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that the statute itself does not provide a right of
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appeal for anything. There is no right of judicial review
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about the drugs that are selected, the process that is used,
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or of the prices themselves. Now that I think is
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pretty unusual in rate setting or price controls, because normally
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there's kind of some some do process taking fundament which
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enables you to say that these rates are just and reasonable.
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For example, in the Federal Energy regulatory commission context. Normally
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you have some right to go and have someone else
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determined whether or not CMS, which is in this case
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the judge, jury, and executioner, the beneficiary and the deciderer
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that there can be some independent check and there is
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no check here, and I think that that's what puts
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this in a very different constitutional box. But I'm not
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going to talk about the constitutional issues. You know, we
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throw around, and I totally agree with on both the
321
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too high and the too low, but it's just it's
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worth putting in perspective that when we talk about drug
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prices in America, nine percent of our total health care
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spend is on medicines, okay, and ninety percent of all
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prescriptions are generic drugs, and of course no generic drug
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willuld exist if not for brand name drugs. So if
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we want new drugs like the brand new Gilead two
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times a year shot which prevents people from getting HIV,
329
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and as someone who worked on Broadway in the late
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eighties and saw what a devastating disease that was, the
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fact that it is now preventable and treatable is a miracle,
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and we should you know, when we think about pharma company,
333
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we should think about, you know, the unbelievable good that
334
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has been done just in that arena, or a cure
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for HEPC ostensibly considered an expensive treatment when it was
336
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initially priced at eighty four thousand dollars, but it saves
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people from a liver transplant, which is more than ten
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times that, never mind the incredible misery associated with that.
339
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So if we want new drugs like those, we want
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cancer treatments, and yes there's certainly treatments that there aren't
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adequate incentives for, then we need to offer a competitive return.
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And I say this as having been the general counsel
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of glaxosmith Clein, having been in the room when the
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board and the senior executive team decided how much money
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we were going to spend on R and D. Okay,
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And the bottom line is, if there's not going to
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be an adequate return the investors, the people who own
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the company, the board, we'll say, either give us the
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money back in dividend or give it back to us
350
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to a share buyback. But don't spend the money on
351
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R and D unless you're going to get an adequate return. Now,
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the famous Tufts numbers that a new drug costs two
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point six billion dollars on average. In twenty seventeen, there
354
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was an article in Forbes that said that for entities
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that produce more than six drugs over ten years, which
356
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is to say, basically big pharma, the median cost of
357
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bringing a medicine to market is six billion dollars. Now,
358
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that does include normally the risks of failures, but more
359
00:20:32.799 --> 00:20:35.720
than nine and ton ten drug candidates fail, and if
360
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you're not going to you know, compensate people for the failures,
361
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then the entire business model doesn't work. So so now
362
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let's talk about what the returns are. Deloitte puts out
363
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a report every year on the internal rate of return,
364
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and you know, some people think that they're these super
365
00:20:54.039 --> 00:20:58.200
competitive returns and farmers making so much money. Well, in
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twenty twenty three, the internal rate of return earn was
367
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four point three percent, not exactly a windfall. In twenty
368
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twenty four went up a bit to five point nine percent,
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in twenty twenty two was one point two percent. These
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are not the kinds of returns that you know, enable
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governments to come along and say we're just gonna you know,
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dictate exactly what price we're going to pay for your
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drug and that it will have then no effect on innovation.
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We already know that the there's a what's called a
375
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pill penalty in the Medicare sham negotiation bill. I won't
376
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call it a negotiations. There's a gun to the head.
377
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The pill penalty is if you for a small molecule,
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you get nine years of exclusivity. For a biologic you
379
00:21:47.240 --> 00:21:51.079
get thirteen years. And biologics actually are you know, they're great, great, great,
380
00:21:51.119 --> 00:21:54.799
great innovations, but on balance, I'd rather take a pill
381
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than a shot, right or have an infusion. And yet
382
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many companies have talked about the fact that they are
383
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just stopping their programs for small molecule drugs because nine
384
00:22:04.839 --> 00:22:07.400
years is really not necessarily enough for them to make
385
00:22:07.480 --> 00:22:10.359
back their investment. And we already know that this is
386
00:22:10.559 --> 00:22:14.519
skewing in set investment. And there have been estimates by
387
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people like Thomas Phillipson and others that estimate that the
388
00:22:19.839 --> 00:22:22.759
number of drugs that will not be developed because of
389
00:22:22.880 --> 00:22:27.440
the dreat that this new Medicare program is well over
390
00:22:27.480 --> 00:22:30.880
one hundred. Now you know, it's the dog that didn't bark.
391
00:22:30.880 --> 00:22:32.799
We don't know what medicines we don't get well if
392
00:22:32.799 --> 00:22:35.319
you're a patient and you're waiting for a cure, then
393
00:22:35.440 --> 00:22:38.759
you are very well aware of the medicines that are
394
00:22:38.799 --> 00:22:43.119
not going to be developed. Last point, last point is
395
00:22:44.079 --> 00:22:46.960
there there was a study done that showed that in
396
00:22:47.000 --> 00:22:50.599
the it was in the the EU markets, and it's
397
00:22:50.720 --> 00:22:54.400
found the consequences of a ten percent drop in medicines
398
00:22:55.400 --> 00:22:59.480
in UH in price, a ten percent drop in medicine
399
00:22:59.480 --> 00:23:02.480
prices in ice controlled EU markets where of course they
400
00:23:02.519 --> 00:23:06.559
do price control, and yes, America subsidizes the rest of
401
00:23:06.599 --> 00:23:08.759
the world. We could talk about that, there's no doubt
402
00:23:08.799 --> 00:23:12.160
about it. But it led to a fourteen percent less
403
00:23:12.240 --> 00:23:16.079
venture capital funding, a nine percent decrease in biotech startup
404
00:23:16.119 --> 00:23:20.279
funding relative to the US, seven percent fewer biotech patents
405
00:23:20.279 --> 00:23:23.000
see at least getting the word patents in here, and
406
00:23:23.240 --> 00:23:27.359
an eight percent increase in the delay in access to medicines.
407
00:23:27.440 --> 00:23:30.759
And so you know, we are literally killing the goose
408
00:23:31.359 --> 00:23:33.599
that has you know, that is that is that is
409
00:23:34.279 --> 00:23:37.519
laying the golden eggs. That is not to say that
410
00:23:37.519 --> 00:23:40.480
the pharmaceutical industry is perfect. It's far from perfect. There
411
00:23:40.519 --> 00:23:44.119
are lots of you know, places where you know, we're
412
00:23:44.160 --> 00:23:48.839
probably overpaying for certain innovations and underpaying for other things.
413
00:23:49.359 --> 00:23:54.000
But it's a driver of our health and as a
414
00:23:54.079 --> 00:23:59.680
driver of our wealth as a society, the biopharmaceutical sector
415
00:23:59.680 --> 00:24:02.960
should be the most esteemed and not the least esteemed.
416
00:24:03.799 --> 00:24:06.759
And this policy is absolutely catastrophic.
417
00:24:08.279 --> 00:24:10.200
Can I just add two? I mean, if that's okay,
418
00:24:10.319 --> 00:24:13.039
then I mean, thank you. Those are all really helpful stats.
419
00:24:13.200 --> 00:24:15.920
I've seen a lot of them, some I have not heard,
420
00:24:15.920 --> 00:24:19.359
so that it's really justus educational for me too. But
421
00:24:19.599 --> 00:24:21.640
the only thing else flag is you know, this is
422
00:24:21.680 --> 00:24:25.000
not all anecdotal, right, Plenty of companies have said publicly
423
00:24:25.039 --> 00:24:27.960
that they were either reducing R and D spending into
424
00:24:28.000 --> 00:24:31.119
certain disease states or abandoning certain medicines that we're in
425
00:24:31.119 --> 00:24:36.000
development entirely somewhat of a document that tracks all of that.
426
00:24:36.039 --> 00:24:39.480
So I just point out that, you know, I think
427
00:24:39.720 --> 00:24:42.240
Lisa's point earlier is right. I mean, we're only three
428
00:24:42.319 --> 00:24:44.799
years into the program, so we probably don't have a
429
00:24:44.880 --> 00:24:48.440
ton of data yet, but we are seeing plenty of
430
00:24:48.440 --> 00:24:51.680
innovative companies already signaling to the market. This is where
431
00:24:51.680 --> 00:24:55.599
we no longer find a value based investment, you know,
432
00:24:55.640 --> 00:24:58.960
given our winded at R and D dollars and yeah,
433
00:24:59.039 --> 00:25:01.599
I think what may call t difficult rights again, and
434
00:25:01.680 --> 00:25:04.559
you brought it home to the patient perspective. If you're
435
00:25:04.559 --> 00:25:08.440
a patient hearing that, not only is that demoralizing, but
436
00:25:08.519 --> 00:25:10.920
you then ask yourself where is that potential.
437
00:25:10.519 --> 00:25:13.920
Fear coming from. I agree with with all. I mean,
438
00:25:13.960 --> 00:25:15.319
I think there's a lot we all agree on, and
439
00:25:15.319 --> 00:25:17.440
I think we agree that innovation matters and that the
440
00:25:17.480 --> 00:25:22.039
IRA will affect innovation. I think given the empirical uncertainties here,
441
00:25:22.079 --> 00:25:25.160
there are different estimates on just how much, and the
442
00:25:25.279 --> 00:25:27.599
estimates are usually in terms of just like trying to
443
00:25:27.720 --> 00:25:30.799
estimate the number of drugs, although ultimately it's not like
444
00:25:30.960 --> 00:25:33.680
counting the number of drugs isn't really the relevant metric,
445
00:25:33.839 --> 00:25:35.920
Like what it matters which drugs we're going to be
446
00:25:35.960 --> 00:25:37.880
losing out on and how much value they would have.
447
00:25:39.000 --> 00:25:41.119
And I think that we don't have the data like
448
00:25:41.839 --> 00:25:43.880
if this is implemented in a way that it's really
449
00:25:43.920 --> 00:25:46.160
the drugs that have the least added value for patients
450
00:25:46.160 --> 00:25:48.839
that are negotiated down like where there's the biggest wedge
451
00:25:48.839 --> 00:25:52.200
between private and social value, then that's less of a
452
00:25:52.400 --> 00:25:54.880
policy problem from a social wealth or respective. I mean,
453
00:25:54.880 --> 00:25:57.839
it can be devastating for the pharmaceuical companies they used
454
00:25:57.839 --> 00:26:02.240
to be getting those profits. But from a like social perspective,
455
00:26:02.240 --> 00:26:05.519
that's less of a problem than if this causes a
456
00:26:05.559 --> 00:26:08.000
loss of innovation the things that have the biggest out
457
00:26:08.039 --> 00:26:09.960
of value for patients. Right.
458
00:26:10.000 --> 00:26:14.799
But you're right, but we wouldn't as I mean, there's
459
00:26:14.799 --> 00:26:17.039
no reason to think that the only drugs that are
460
00:26:17.079 --> 00:26:19.240
being targeted are the ones that you described in that
461
00:26:19.279 --> 00:26:22.039
first category as the ones that are providing the least
462
00:26:22.079 --> 00:26:23.039
marginal benefit.
463
00:26:23.519 --> 00:26:23.720
Right.
464
00:26:24.200 --> 00:26:26.759
I mean that's because that's not the criteria that CMS
465
00:26:26.799 --> 00:26:30.160
is applying. They're just looking at, you know, how big
466
00:26:30.200 --> 00:26:33.119
is the medicare spend, which by the way, means it's
467
00:26:33.240 --> 00:26:36.839
an often prescribed drug, which probably means it's more valuable
468
00:26:36.880 --> 00:26:40.160
rather than less valuable. That's an oversliplification. You know, there
469
00:26:40.160 --> 00:26:43.160
may be other medicines in there that's that's not true
470
00:26:43.200 --> 00:26:45.839
of But you know, what we're doing is going after
471
00:26:46.160 --> 00:26:49.559
the most successful medicines, which yes, obviously make the most
472
00:26:49.559 --> 00:26:52.440
money in some senses, but also are presumably the ones
473
00:26:52.480 --> 00:26:55.680
that are having you know, the biggest impact at least
474
00:26:55.720 --> 00:26:56.680
in one way or another.
475
00:26:58.000 --> 00:27:03.559
I'll just but just to say, like we do at
476
00:27:03.640 --> 00:27:06.720
least in the statute of their guidance, they CMS is
477
00:27:06.759 --> 00:27:09.960
required to consider the drugs comparative effectiveness compared to other
478
00:27:10.240 --> 00:27:12.920
products when they're setting the price, and I don't think
479
00:27:12.920 --> 00:27:15.759
we have great evidence on how well they're doing that.
480
00:27:15.799 --> 00:27:17.599
I mean, I do agree with I think this was
481
00:27:17.640 --> 00:27:19.359
Brad's point that it would be useful there were more
482
00:27:19.359 --> 00:27:22.319
transparency and what CMS is doing and what factors they
483
00:27:22.359 --> 00:27:25.279
will consider to select drugs and set prices, which is
484
00:27:25.319 --> 00:27:27.839
important for influencing development. But like the more that they
485
00:27:27.839 --> 00:27:33.319
can do to being considered that added social like added
486
00:27:33.400 --> 00:27:37.799
value in terms of extending lives and improving health compared
487
00:27:37.799 --> 00:27:40.640
to the existing standard of care, then the better. From
488
00:27:40.680 --> 00:27:42.000
an innovation policy perspective.
489
00:27:42.079 --> 00:27:44.000
Is just kind of the other.
490
00:27:43.960 --> 00:27:47.119
Thing I think we can all agree on is that
491
00:27:47.680 --> 00:27:50.039
there's there's a provision which says if you go after
492
00:27:50.079 --> 00:27:54.039
the second indication, right then then then all of a sudden,
493
00:27:54.079 --> 00:27:56.160
the drug if it's an orphan drug and there's a
494
00:27:56.200 --> 00:27:59.680
second indication that it's into the program and other than
495
00:27:59.720 --> 00:28:01.799
that it's not in the program, and that is a
496
00:28:01.920 --> 00:28:04.920
clear disincentive for investment. Right, Why would I spend a
497
00:28:04.960 --> 00:28:08.559
penny on looking for a second indication and a second
498
00:28:08.640 --> 00:28:10.920
use of that medicine if A it can be used
499
00:28:10.960 --> 00:28:15.079
off label anyway, and B the minute I do that
500
00:28:15.160 --> 00:28:17.839
research and get a second indication, it gets swept up
501
00:28:17.880 --> 00:28:20.319
in the price controls, whereas before that it's exempt for
502
00:28:20.359 --> 00:28:21.480
the price controls.
503
00:28:22.160 --> 00:28:25.160
Kind of three points I'll make. And first, I mean,
504
00:28:25.200 --> 00:28:29.440
I think everyone I've seen, even groups that may aggressively
505
00:28:29.480 --> 00:28:31.839
push for price controls, seem to agree the lack of
506
00:28:31.839 --> 00:28:36.160
transparency and understanding of how this process works is an issue.
507
00:28:36.480 --> 00:28:39.319
Right to your point, at least some more broadway about
508
00:28:39.319 --> 00:28:42.160
innovation policy. It's hard to even sometimes have this debate
509
00:28:42.200 --> 00:28:44.480
because a lot of this is just in a black box.
510
00:28:44.559 --> 00:28:46.519
We really don't know how a lot of these decisions
511
00:28:46.519 --> 00:28:49.359
are being made to different metrics, And so I think
512
00:28:49.839 --> 00:28:52.720
all of us, no matter where we stand on these issues,
513
00:28:52.720 --> 00:28:55.680
could benefit right from just more transparency as to how
514
00:28:55.680 --> 00:29:00.759
the program actually operates. The second point in Fan correct
515
00:29:00.839 --> 00:29:02.960
me I'm wrong, but I believe at least for the
516
00:29:02.960 --> 00:29:07.119
first round of medicines that were selected for negotiation, it
517
00:29:07.160 --> 00:29:10.160
was price wasn't even a major factor in terms of
518
00:29:10.200 --> 00:29:12.559
what the price was when the medicine was selected. It
519
00:29:12.599 --> 00:29:14.480
seemed like they just went down the list and picked
520
00:29:14.480 --> 00:29:16.519
the ten most popular medicine.
521
00:29:16.200 --> 00:29:18.079
In medica the spend.
522
00:29:18.200 --> 00:29:20.960
It was the spend not correct, I mean, which to
523
00:29:21.039 --> 00:29:23.880
me also strikes me as just again whether you're agree
524
00:29:23.880 --> 00:29:26.000
with the policy or not fundamentally a odds with the
525
00:29:26.000 --> 00:29:29.079
purpose of the statute. But then, third, and finally, this
526
00:29:29.119 --> 00:29:31.559
is more of a bigger philosophical point of me as
527
00:29:31.599 --> 00:29:34.359
we talk about value based medicine. I mean, I guess
528
00:29:34.359 --> 00:29:36.480
the question I have is who determines the value right,
529
00:29:36.519 --> 00:29:38.839
Because if you're a patient waiting for a medicine, it
530
00:29:38.920 --> 00:29:41.400
may only be marginally effective for the vast majority of
531
00:29:41.440 --> 00:29:44.279
the population, But if it's affective for you, I think
532
00:29:44.279 --> 00:29:46.240
you would say that has a lot of value. And
533
00:29:46.279 --> 00:29:48.680
so to me, this comes back into is just a
534
00:29:48.680 --> 00:29:51.240
personal opinion philosophically to kind of a first principle, do
535
00:29:51.279 --> 00:29:53.759
we want the government deciding what is of value to
536
00:29:53.839 --> 00:29:57.160
society as a whole from a medical perspective? And that
537
00:29:57.279 --> 00:29:59.119
just gives me a bit of qualm. But you know,
538
00:29:59.119 --> 00:30:01.039
I just point all three of those out.
539
00:30:01.440 --> 00:30:04.200
Further, I think Leasa's article that addresses that a bit.
540
00:30:05.319 --> 00:30:08.119
Yeah, I mean, I think we do to the extent
541
00:30:08.200 --> 00:30:10.359
we as a society and decided we are like that
542
00:30:10.400 --> 00:30:13.000
people should have access to these, like if we are
543
00:30:13.000 --> 00:30:20.000
going to require coverage and and like it, with all
544
00:30:20.039 --> 00:30:22.680
the potential problems and conservas that have been raised about
545
00:30:22.920 --> 00:30:25.440
Medicare price negotiations, that we should recognize that it's not
546
00:30:25.480 --> 00:30:29.640
like the prior system was great there and nor is
547
00:30:29.680 --> 00:30:32.359
it I think fair to really describe the prior system
548
00:30:32.359 --> 00:30:35.559
as like a functioning market, because there was very little
549
00:30:35.559 --> 00:30:41.039
ability for Medicare payers to control prices in any way.
550
00:30:41.119 --> 00:30:45.000
I mean through Medicare Part D, which we've mostly been
551
00:30:45.200 --> 00:30:48.480
talking about, but also like Medicare Part B and Medicaid
552
00:30:48.519 --> 00:30:52.359
the way they link government prices to private sector prices,
553
00:30:52.400 --> 00:30:55.839
Like there's evidence about that distorting private markets in unhealthy ways,
554
00:30:55.880 --> 00:30:58.319
and so there's like a lot of ways that the
555
00:30:58.359 --> 00:31:01.720
government has already intervened in this market. It but like,
556
00:31:02.240 --> 00:31:07.720
since we're in a world where I think like widely
557
00:31:07.759 --> 00:31:13.319
held social value of providing medicines for Americans who need
558
00:31:13.359 --> 00:31:16.279
them through programs like Medicaid, Like if we're going to
559
00:31:16.400 --> 00:31:19.480
be right than I think you need the government also
560
00:31:20.720 --> 00:31:23.759
making some assessment of what is it that we're providing
561
00:31:23.759 --> 00:31:28.359
and is it like actually worthwhile and not just providing
562
00:31:28.359 --> 00:31:31.079
anything that anyone one wants, even if there's no evidence
563
00:31:31.119 --> 00:31:33.640
that it is actually useful. And there's like lots of
564
00:31:33.720 --> 00:31:37.240
organizations that I mean, like in my the article you're
565
00:31:37.240 --> 00:31:40.799
referring to, the Valuing Medical Innovation, I went through the
566
00:31:40.799 --> 00:31:46.319
process that iicer this nonprofit organization uses to assess medicines values,
567
00:31:46.359 --> 00:31:48.240
and I had some like critiques of some of the
568
00:31:48.279 --> 00:31:52.839
things they do, but I think it is a legitimate
569
00:31:53.759 --> 00:31:57.000
and thoughtful effort to try to figure out what the
570
00:31:57.240 --> 00:32:01.680
value is for for patients. That I mean, it requires
571
00:32:01.680 --> 00:32:08.079
some difficult ethical judgments about how to value different kinds
572
00:32:08.079 --> 00:32:11.000
of health gains and then also how to quantify, like
573
00:32:11.200 --> 00:32:15.759
how once you've converted a medicine to some metric like
574
00:32:16.079 --> 00:32:18.559
qualities or e B l igs or any of those
575
00:32:18.960 --> 00:32:21.400
metrics that are used for health technology assessment, you then
576
00:32:21.440 --> 00:32:22.960
have to put a dollar value on that, which is
577
00:32:23.000 --> 00:32:24.920
a different ethical judgment.
578
00:32:26.799 --> 00:32:28.759
But what's the title of your article again, I want
579
00:32:28.799 --> 00:32:29.799
to make sure people can.
580
00:32:30.400 --> 00:32:34.160
Sure it's Valuing Medical Innovation co offered with Daniel Hammel.
581
00:32:34.759 --> 00:32:38.799
If people google Lisa will let Valuing Medical Innovation and
582
00:32:39.400 --> 00:32:43.359
Type of Initials SSRN, you will find a downloadable pdf
583
00:32:43.400 --> 00:32:46.960
for it open access. This is, by the way, it's
584
00:32:46.960 --> 00:32:50.839
a fantastic discussion and I have to say it particularly
585
00:32:50.839 --> 00:32:53.000
warms I heart to hear the discussion about transparency and
586
00:32:53.000 --> 00:32:56.039
the need for transparency because this has been hosted for
587
00:32:56.160 --> 00:33:01.400
officially by the Regulatory Transparency Project at the Federalists. So, uh,
588
00:33:01.440 --> 00:33:04.519
it is a near and dear concern, uh that we
589
00:33:04.599 --> 00:33:07.160
think that both sides of the Aisle can agree on
590
00:33:07.240 --> 00:33:09.599
that there always should be transparency and how our government
591
00:33:09.599 --> 00:33:13.480
functions at all levels, and a lot of really great
592
00:33:13.759 --> 00:33:17.039
issues have been raised. I just want to remind the
593
00:33:17.039 --> 00:33:19.920
audience if you have any questions, we'll we'll be very
594
00:33:19.920 --> 00:33:22.680
happy to take them, so you feel free to post
595
00:33:22.680 --> 00:33:26.640
them into the into the into the question box and
596
00:33:26.640 --> 00:33:28.400
and then I'll read them to the audience. I'll read
597
00:33:28.400 --> 00:33:31.039
them to the panelists, So feel free to do that
598
00:33:31.079 --> 00:33:32.799
now if you wish. And then' and I'm just gonna
599
00:33:32.799 --> 00:33:34.400
turn it back to our panelist. I'm just gonna throw
600
00:33:34.400 --> 00:33:37.599
out another another question or two and then uh and
601
00:33:37.680 --> 00:33:39.519
leave it to them to continue their great discussion.
602
00:33:39.960 --> 00:33:40.240
Uh.
603
00:33:40.400 --> 00:33:45.240
Which so you know there you uh Dan talked about
604
00:33:45.279 --> 00:33:47.319
you know the fact that there's an international context to
605
00:33:47.359 --> 00:33:49.880
this that you know that other countries are imposing price
606
00:33:49.920 --> 00:33:53.160
controls and that and that, and in fact, President Trump
607
00:33:53.160 --> 00:33:55.720
has actually suppliciedly said other countries are free riding off
608
00:33:55.759 --> 00:33:59.920
of our off of our off of our system and
609
00:34:00.000 --> 00:34:04.599
and uh and but also you know, Lisa and and
610
00:34:04.599 --> 00:34:06.839
and Dan and Brad have also talked about how the
611
00:34:06.880 --> 00:34:08.519
you know, the systems complex, and there's a lot of
612
00:34:08.559 --> 00:34:11.599
other uh things that play in the system. It may
613
00:34:11.639 --> 00:34:14.519
not be working perfectly, but you know, if there's a
614
00:34:14.559 --> 00:34:16.639
lot of impact on it. I know that there's discussions
615
00:34:16.639 --> 00:34:20.079
about the role of program benefit managers, these kind of
616
00:34:20.440 --> 00:34:24.159
midstream people. There's some legislation has been prosed talking about them.
617
00:34:24.199 --> 00:34:28.280
So you know, to the extent that there are concerns
618
00:34:28.280 --> 00:34:31.239
about prices or in the desire within the context of
619
00:34:31.280 --> 00:34:34.079
having something like Medicare and medicaid to lower drug prices
620
00:34:34.079 --> 00:34:38.440
for particular communities within the United States. So what other
621
00:34:38.519 --> 00:34:41.480
policy tools do we have potentially or what are the
622
00:34:41.559 --> 00:34:45.880
things that we should our system account for in considering
623
00:34:45.880 --> 00:34:48.400
these types of issues or concerns for patients in our
624
00:34:48.440 --> 00:34:50.079
healthcare system. And I kind of just throw that out
625
00:34:50.119 --> 00:34:53.840
to the panel to suggest that maybe we uh, but
626
00:34:53.920 --> 00:34:55.719
you know, we started with Lisa, and maybe we should
627
00:34:55.760 --> 00:34:59.360
just continue with Lisa, uh, you know, kicking that off.
628
00:35:01.960 --> 00:35:05.239
Sure, I mean, there there's like lots of policy proposals
629
00:35:05.239 --> 00:35:07.440
out there. I mean, most of the polity discussion has been
630
00:35:07.480 --> 00:35:11.639
focused on the drug pricing issue and finding ways to
631
00:35:11.679 --> 00:35:14.480
reduce drug prices out of the concern that those are
632
00:35:15.000 --> 00:35:17.960
too high, and so in addition to Medicare drug price negotiation,
633
00:35:18.079 --> 00:35:24.920
there's been discussion about like using the government's marchin rights
634
00:35:24.960 --> 00:35:31.519
on patents that were developed with federal funding. As a
635
00:35:32.400 --> 00:35:36.039
the government has a right to effectively issue compulsory licenses
636
00:35:36.039 --> 00:35:40.639
on those in certain contexts, and so some people have
637
00:35:40.679 --> 00:35:44.239
suggested using that. I've done some metirical work saying that, like,
638
00:35:44.400 --> 00:35:46.079
I don't understand why this has got so much policy
639
00:35:46.079 --> 00:35:48.199
attention from either side, because it would affect so few
640
00:35:48.559 --> 00:35:51.119
actual drugs, because there's so few drugs that like only
641
00:35:51.159 --> 00:35:56.079
have patents with federal funding. There's been discussion about using
642
00:35:56.400 --> 00:36:00.599
a separate statute. It's twenty with the fourteen ide aids
643
00:36:00.599 --> 00:36:06.719
that under which the government, like patent infringement by or
644
00:36:06.760 --> 00:36:08.920
for the federal government can only be remedied by a
645
00:36:08.960 --> 00:36:11.599
suit in the court of Federal Claims for damages, and
646
00:36:11.679 --> 00:36:15.840
so some scholars and commentators have suggested the government use
647
00:36:15.920 --> 00:36:21.519
that basically issue compulsory licenses. I have generic production of
648
00:36:21.880 --> 00:36:26.440
high cost pharmaceuticals with remedy in the court of federal claims,
649
00:36:26.880 --> 00:36:29.760
and that doesn't depend on whether the patents are have
650
00:36:29.840 --> 00:36:33.360
federal funding or not. So like that approach could be used.
651
00:36:33.360 --> 00:36:35.760
I don't think it's actually gotten much policy traction, but
652
00:36:35.800 --> 00:36:41.400
there's a lot of scholarships on that. There's also scholarships
653
00:36:41.400 --> 00:36:46.360
about the government playing a larger role in drug production itself,
654
00:36:46.480 --> 00:36:52.480
like as a like directly procuring drugs, which the government
655
00:36:52.480 --> 00:36:54.480
doesn't in some context, and I mean we saw that
656
00:36:54.519 --> 00:36:58.559
in like in the COVID context, the government was kind
657
00:36:58.599 --> 00:37:03.320
of directly buying and the drugs, which but I think
658
00:37:03.400 --> 00:37:07.760
is also useful as an illustration of Sorry, this is
659
00:37:07.880 --> 00:37:09.320
a side here, but I think an important one. But
660
00:37:09.480 --> 00:37:13.480
like in these debates, when we talk about prices, people
661
00:37:13.559 --> 00:37:15.320
use the word price in two different ways that I
662
00:37:15.320 --> 00:37:17.239
think could use a lot of the debates, and there's
663
00:37:17.280 --> 00:37:20.280
really two prices that are relevant. There's the price that's
664
00:37:20.280 --> 00:37:23.760
received by the pharmaceutical manufacturer and there's the price that
665
00:37:23.840 --> 00:37:25.800
paid by the patient. And those don't have to be
666
00:37:25.840 --> 00:37:29.599
the same thing. So like COVID vaccines, the vaccine manufacturers
667
00:37:29.599 --> 00:37:32.599
got paid a lot of money for those vaccines, but
668
00:37:32.719 --> 00:37:35.400
the vaccines were free to all Americans who wanted them.
669
00:37:36.280 --> 00:37:38.360
And so I think it's important in these policy discussions
670
00:37:38.360 --> 00:37:40.679
that we recognize those can be delinked, and I think
671
00:37:40.719 --> 00:37:43.519
should be because I think there's a strong normative case
672
00:37:43.519 --> 00:37:47.440
for providing broad access to medicines and also providing a
673
00:37:47.440 --> 00:37:50.360
strong reward to incentivize the most valuable innovation.
674
00:37:51.239 --> 00:37:53.960
I would just jump down on that last point. I
675
00:37:54.000 --> 00:37:56.920
agree with you S one hundred percent, so awesome. The
676
00:37:56.920 --> 00:38:01.039
debate about like this price versus the patient pays is
677
00:38:01.280 --> 00:38:05.079
totally absent in some of these policy discussions and regards
678
00:38:05.079 --> 00:38:06.719
to where you land on the policy issue. I do
679
00:38:06.760 --> 00:38:10.960
think it distorts the debate around what the right policy
680
00:38:11.159 --> 00:38:14.840
is because the reality is very few patients right pay
681
00:38:15.039 --> 00:38:17.760
this price. That doesn't necessarily mean that they have their
682
00:38:17.800 --> 00:38:21.119
own struggles getting access because of insurance or whatever else,
683
00:38:21.199 --> 00:38:24.920
But the point being, I think when we lose sight
684
00:38:24.960 --> 00:38:27.800
of that distinction, it conflates a lot of issues and
685
00:38:27.840 --> 00:38:30.840
makes it much more difficult to point with precise policy
686
00:38:30.880 --> 00:38:32.079
and what the writing through is.
687
00:38:32.119 --> 00:38:34.800
So I just really glad you brought that up. Very
688
00:38:34.800 --> 00:38:35.239
good point.
689
00:38:35.800 --> 00:38:38.079
So I agree with that, but I think again, let's
690
00:38:38.119 --> 00:38:41.440
remember ninety percent of all prescriptions written in the United
691
00:38:41.440 --> 00:38:45.840
States are for generic drugs, and generic drugs are on
692
00:38:45.920 --> 00:38:49.760
average about eighty five percent less expensive than brand name drugs.
693
00:38:49.800 --> 00:38:52.320
Own by the way, generic drugs are less expensive in
694
00:38:52.360 --> 00:38:56.679
the United States than they are in the EU and
695
00:38:56.920 --> 00:39:00.960
in the UK. A couple of out the points. You know,
696
00:39:01.000 --> 00:39:04.239
I totally agree with you, Lisa, about the need to
697
00:39:04.280 --> 00:39:06.679
do cost benefit analyses if government is going to get
698
00:39:06.679 --> 00:39:09.159
involved in things. But we had when I was at FDA,
699
00:39:09.199 --> 00:39:13.079
there was a really interesting statistic that came up. We
700
00:39:13.159 --> 00:39:16.360
surveyed patients on their risk people well, we surveyed people
701
00:39:16.360 --> 00:39:19.079
on their risk tolerance who are not patients. The risk
702
00:39:19.079 --> 00:39:21.639
talents was like one in one hundred thousand. It was really,
703
00:39:21.760 --> 00:39:25.519
you know, very low risk tolerance. Then we surveyed patients
704
00:39:25.599 --> 00:39:31.159
people who are sick, and the risk tolerance went up radically.
705
00:39:31.400 --> 00:39:34.320
I mean it was like one in a hundred. Okay, fine,
706
00:39:34.360 --> 00:39:36.440
if it will help me, then I'm willing to take
707
00:39:36.480 --> 00:39:40.320
the risks. And so, you know, as we do cost
708
00:39:40.360 --> 00:39:44.280
benefit analyzes, we we should also take into account the
709
00:39:44.360 --> 00:39:50.039
way in which these medicines address the needs of people
710
00:39:50.320 --> 00:39:54.519
who really do need them. To other quick points. You know,
711
00:39:54.880 --> 00:39:57.519
I'm glad you raised the issue about. You know, there
712
00:39:57.559 --> 00:40:00.480
is this misconcer about the margin rights and how few
713
00:40:00.559 --> 00:40:04.719
drugs they apply to, because there's this misconception that NIH,
714
00:40:04.840 --> 00:40:09.960
which evolved veneration for NIH, but that NAH somehow contributes
715
00:40:10.000 --> 00:40:12.480
to all of the medicines that there are. That's just
716
00:40:12.559 --> 00:40:16.000
not the case. I mean, the leading twenty companies in
717
00:40:16.920 --> 00:40:19.039
spend on R and D in twenty twenty three, according
718
00:40:19.119 --> 00:40:21.800
to this Deloitte report, was one hundred and forty five
719
00:40:21.840 --> 00:40:26.199
billion dollars. That's three to five times the total NIH budget.
720
00:40:26.320 --> 00:40:30.880
And not everything that NIH spends is on is on
721
00:40:31.159 --> 00:40:33.960
is on medicines, very linimate is it on medicines. It's
722
00:40:34.000 --> 00:40:37.920
really on basic science. And even when the NIH, you
723
00:40:37.960 --> 00:40:41.000
know a few times that they've actually made, you know,
724
00:40:41.119 --> 00:40:43.400
discovered a medicine, they have to hand it off to
725
00:40:43.840 --> 00:40:46.400
a farmer company because it's the farmer companies that know
726
00:40:46.519 --> 00:40:52.440
how to get drugs through the FDA process. NIH has
727
00:40:52.440 --> 00:40:56.679
no idea how to do that. You know. We saw that,
728
00:40:56.800 --> 00:40:59.320
you know when when one of the big mistakes that
729
00:40:59.400 --> 00:41:00.840
was made in cod It was to try and have
730
00:41:00.880 --> 00:41:03.119
the CDC do the tests rather than have the private
731
00:41:03.159 --> 00:41:05.679
market do the tests that did not work out well
732
00:41:05.719 --> 00:41:11.159
and had frankly catastrophic circumstances or consequences. The last point
733
00:41:11.159 --> 00:41:14.039
I'll just make is, you know, I don't want to
734
00:41:14.039 --> 00:41:16.760
get into deep into the issue of PBMs, but BRG
735
00:41:16.920 --> 00:41:20.440
to study recently which showed that fifty percent of the
736
00:41:20.559 --> 00:41:24.719
drug spend goes to the pharmaceutical manufacturers and the other
737
00:41:24.800 --> 00:41:27.800
fifty percent goes to other players. So the people who
738
00:41:27.880 --> 00:41:32.800
are actually discovering new medicines, making those medicines, manufacturing them safely,
739
00:41:32.840 --> 00:41:36.239
and getting them to patients are only getting fifty cents
740
00:41:36.239 --> 00:41:39.159
on the dollar of what we spend on medicines in
741
00:41:39.199 --> 00:41:39.800
this country.
742
00:41:41.239 --> 00:41:44.360
I'll just jump in and say on the generic piece two,
743
00:41:44.480 --> 00:41:47.800
I mean, you know, welcome the other panelists and kind
744
00:41:47.800 --> 00:41:49.519
of what you've heard, but I mean, I do notice
745
00:41:49.519 --> 00:41:52.599
increasingly a lot of the generics are also concerned about
746
00:41:53.239 --> 00:41:55.679
various price controls and what that does in terms of
747
00:41:55.719 --> 00:41:59.159
market distortion for their products. You know, as we all know, right,
748
00:41:59.199 --> 00:42:05.000
generics opera vary in margin like restaurant level margins. You know,
749
00:42:05.159 --> 00:42:08.960
so anything further distorts the market away from generics is
750
00:42:08.960 --> 00:42:11.840
obviously very problematic for them. And so not only do
751
00:42:11.880 --> 00:42:14.000
we have the potential impact right on R and D
752
00:42:14.360 --> 00:42:17.079
for brandeds, but you know, the downstream.
753
00:42:16.519 --> 00:42:19.599
In fact you're kind of targeting that data.
754
00:42:19.119 --> 00:42:22.320
Is, you know, what happens if we had problems for
755
00:42:22.440 --> 00:42:25.920
generic marketplace? That also the extrap leads out to the
756
00:42:25.920 --> 00:42:28.559
broader innovation earth, broader medical ecosystem.
757
00:42:29.880 --> 00:42:33.119
Madam, you asked about the what what public policy tools,
758
00:42:33.159 --> 00:42:36.719
and a few were mentioned, But the most important public
759
00:42:36.760 --> 00:42:39.079
policy tool is one that we used to sort of
760
00:42:39.159 --> 00:42:41.360
use a little bit, but we've never really used and
761
00:42:41.400 --> 00:42:44.159
I don't think we're going to use in this is
762
00:42:44.280 --> 00:42:48.920
instead of actually forcing American companies to you know, pay
763
00:42:49.639 --> 00:42:52.960
the price controlled prices that are paid abroad, which will
764
00:42:53.000 --> 00:42:56.960
not allow for a reward to innovation, what we really
765
00:42:56.960 --> 00:43:00.360
should be doing in our trade talks is requiring other
766
00:43:00.480 --> 00:43:06.119
countries to pay a reasonable return instead of only a
767
00:43:06.159 --> 00:43:09.960
marginal cost return to you know, for medicines. Now that's
768
00:43:10.079 --> 00:43:12.320
kind of you know, I've recognized that's kind of you know,
769
00:43:13.599 --> 00:43:17.360
very chimerical and fantastical and you know, wishful thinking. But
770
00:43:17.960 --> 00:43:21.719
you know, you can try and drive you know, American
771
00:43:21.719 --> 00:43:23.480
prices down, but then there isn't going to be any
772
00:43:23.519 --> 00:43:26.599
reward for innovation, and won't we won't have new innovative medicines.
773
00:43:26.960 --> 00:43:29.480
Or you could say to the UK or I'm sitting
774
00:43:29.559 --> 00:43:32.840
right now where people don't have the same access to drugs,
775
00:43:32.880 --> 00:43:36.000
well maybe you should pay a little more now. Again,
776
00:43:36.079 --> 00:43:38.119
I don't think that's going to be the highest priority
777
00:43:38.159 --> 00:43:41.320
of any administration in their in their trade talks, but
778
00:43:41.400 --> 00:43:43.920
that's really what we need if we're going to try
779
00:43:43.960 --> 00:43:49.119
and address the problem of everybody free riding on American innovation.
780
00:43:49.519 --> 00:43:55.639
That said, just I'll use one drug. One example, cancer drugs. Cancer.
781
00:43:56.159 --> 00:43:59.000
The death rate from cancer fell in the United States
782
00:43:59.039 --> 00:44:01.840
thirty three percent for nineteen ninety one to twenty twenty three.
783
00:44:02.480 --> 00:44:06.639
In the UK it's fallen only nineteen percent. If God forbid,
784
00:44:06.639 --> 00:44:08.920
we should anybody should have cancer. But if you have cancer,
785
00:44:09.199 --> 00:44:10.880
you want to be in the United States because we
786
00:44:11.000 --> 00:44:14.760
have more medicines here available than anywhere else. Ninety four
787
00:44:14.800 --> 00:44:17.960
percent of one hundred and twenty four new medicines launched
788
00:44:18.000 --> 00:44:21.400
globally between twenty twelve and twenty twenty one are available
789
00:44:21.440 --> 00:44:25.880
in the United States versus forty nine percent in OECD countries.
790
00:44:26.280 --> 00:44:29.159
This is where you have access to many different therapies
791
00:44:29.159 --> 00:44:30.280
in many different choices.
792
00:44:31.679 --> 00:44:34.360
Yeah, that data is consistent with other data that I've
793
00:44:34.360 --> 00:44:38.840
seen too about how to this day, So and the
794
00:44:38.880 --> 00:44:41.159
others could correct me if I'm wrong, But well, more
795
00:44:41.199 --> 00:44:43.280
than half of all new drugs are still invented in
796
00:44:43.280 --> 00:44:44.400
the United States.
797
00:44:45.519 --> 00:44:48.440
Actually, eighty percent of the biopharmaceutical pipeline is here in
798
00:44:48.440 --> 00:44:52.239
the United States. That didn't used to be true until
799
00:44:52.639 --> 00:44:56.119
countries like Germany again killed their own golden goose by
800
00:44:56.159 --> 00:44:57.880
it imposing price controls.
801
00:44:58.440 --> 00:45:01.320
Now, I mean, Lisa raises are, it has raised a
802
00:45:01.320 --> 00:45:06.800
really interesting point about the lack of data on you know,
803
00:45:06.840 --> 00:45:09.239
on the impact of price controls. But this kind of
804
00:45:09.280 --> 00:45:13.039
creates kind of, you know, a catch twenty two in
805
00:45:13.079 --> 00:45:15.239
a certain sense, like if you and so like we
806
00:45:15.280 --> 00:45:17.079
can't make a decision about whether we, you know, we
807
00:45:17.119 --> 00:45:18.800
should have price controls or not unless we see the
808
00:45:18.840 --> 00:45:21.400
negative impact of price controls. So we we not the
809
00:45:21.400 --> 00:45:24.440
price controls. We get the negative impact, but then we've
810
00:45:24.480 --> 00:45:26.880
but then we've created, you know, we've undermined and killed
811
00:45:26.880 --> 00:45:29.440
the system through the price controls that are now showing
812
00:45:29.480 --> 00:45:31.639
us the negative impact, right, So we.
813
00:45:31.639 --> 00:45:33.679
Know what price controls do. I mean, again, I'm not
814
00:45:33.719 --> 00:45:35.920
the economist. I mean, look at the Soviet the old
815
00:45:35.920 --> 00:45:38.840
Soviet Union. We know what price controls do? They drive scarcity?
816
00:45:39.079 --> 00:45:43.559
I mean, but okay, I was gonna say, Adams, that
817
00:45:43.800 --> 00:45:45.760
point to me, we do have examples, right.
818
00:45:45.679 --> 00:45:48.960
Of what other countries have done. Pact talked about some
819
00:45:49.079 --> 00:45:49.719
of that data.
820
00:45:50.239 --> 00:45:53.760
But for me also the bigger concern, right is it's
821
00:45:53.960 --> 00:45:55.840
also you have to look out on a fifteen or
822
00:45:55.840 --> 00:45:58.320
twenty year time horizon. What does this do to the
823
00:45:58.480 --> 00:46:02.199
R and D infrastructure in this country? Right, Because as
824
00:46:02.239 --> 00:46:05.639
we all know, you can't build that back overnight. So
825
00:46:05.679 --> 00:46:09.440
if you enact policies right that undermine that it's not
826
00:46:09.599 --> 00:46:12.760
just the short term five, six, seven, ten year cycle
827
00:46:12.840 --> 00:46:16.239
of whatever medicine is in development, it's also twenty or
828
00:46:16.239 --> 00:46:18.920
twenty five years down the road. What does your innovation
829
00:46:19.039 --> 00:46:22.360
ecosystem look like? You know, are we still the place
830
00:46:22.400 --> 00:46:25.800
where eighty percent of medicines you know, are developed twenty
831
00:46:25.880 --> 00:46:28.599
five years from now? We keep imposing various forms of
832
00:46:28.920 --> 00:46:31.360
price controls, and so I think that's also in the
833
00:46:31.400 --> 00:46:35.960
policy discussion. Something that's also lost is we can't even
834
00:46:35.960 --> 00:46:40.079
if we let's say we impose further price controls fifteen
835
00:46:40.159 --> 00:46:42.079
years from now, we realize it's a policy to take
836
00:46:42.159 --> 00:46:46.159
and wipe them all away overnight. You can't rebuild that
837
00:46:46.239 --> 00:46:50.239
infrastructure overnight, right, There's longer term investments that have to
838
00:46:50.239 --> 00:46:52.480
be then made. So I just think as part of
839
00:46:52.519 --> 00:46:54.639
the policy discussion, we have to keep that in mind
840
00:46:54.679 --> 00:46:57.719
as well. It's not a dichotomist you know, black or white,
841
00:46:57.920 --> 00:47:00.960
do X do? Why you can reverse works the time?
842
00:47:02.599 --> 00:47:04.800
At least I've invoked you, so I don't need, I
843
00:47:04.800 --> 00:47:06.800
don't need, sorry to put you on the spot. But
844
00:47:06.880 --> 00:47:10.360
maybe uh yeah, you know, since this framing which is
845
00:47:10.440 --> 00:47:13.880
which is the I think the kind of dominant you know,
846
00:47:14.159 --> 00:47:17.280
classic framing for how we kind of assess patent policy,
847
00:47:17.280 --> 00:47:19.280
innovation policy. Right as we need the data, we need
848
00:47:19.320 --> 00:47:22.079
to see what will happen, but then it kind of
849
00:47:22.079 --> 00:47:24.159
puts us in this chicken and egg problem of well,
850
00:47:24.199 --> 00:47:26.920
then when we adopt systems that might weaken or eliminate,
851
00:47:27.400 --> 00:47:29.639
then we get the data, but the then then it
852
00:47:29.719 --> 00:47:33.840
might be too late. So so is I maybe you
853
00:47:33.840 --> 00:47:36.280
can just it's the classic metaphor question, I guess by
854
00:47:36.280 --> 00:47:38.119
the professor. So of course the professor is asking the
855
00:47:38.119 --> 00:47:42.920
other professor the foundational you know, first principles type question.
856
00:47:45.079 --> 00:47:48.880
Yeah, I mean I don't think it's as bad as bad.
857
00:47:48.960 --> 00:47:51.679
I mean, we we don't have all the data, we
858
00:47:51.679 --> 00:47:55.360
don't know everything. We we do know that incentives matter,
859
00:47:55.719 --> 00:48:00.800
and so like to the extent we can, like CMS
860
00:48:00.880 --> 00:48:04.480
can issue guidance on exactly how it's going to be
861
00:48:04.519 --> 00:48:08.400
implementing this program and make clear clearer what the role
862
00:48:08.440 --> 00:48:15.519
of comparative effectiveness is. Like, I think that is useful.
863
00:48:15.559 --> 00:48:21.360
And it's not like they're suddenly saying every drug like
864
00:48:21.400 --> 00:48:24.599
on the day of launch is subject to like generic pricing.
865
00:48:24.639 --> 00:48:29.360
I mean that so yes, it does have a large
866
00:48:29.400 --> 00:48:37.559
impact on certain high spend drugs, but it is a
867
00:48:37.599 --> 00:48:40.079
small number of drugs that get at it every year.
868
00:48:40.199 --> 00:48:43.920
And I don't think that this is such a radical
869
00:48:44.039 --> 00:48:49.800
change that is going to completely destroy the US pharmaceutical sector.
870
00:48:52.039 --> 00:48:54.639
So you make, you know, and there is an interesting
871
00:48:54.679 --> 00:48:57.480
point that people forget, you know, people you wusk people
872
00:48:57.480 --> 00:48:59.079
in the street, how many drugs do we have a year?
873
00:48:59.280 --> 00:49:01.599
Be very few people will know the real numbers, which
874
00:49:01.639 --> 00:49:04.960
is the high I think maybe once we touched fifty,
875
00:49:05.000 --> 00:49:07.000
but it's these days sort of in the forties, but
876
00:49:07.039 --> 00:49:08.760
a lot of them are kind of forrare disease or
877
00:49:08.800 --> 00:49:13.159
orphan drugs. Even as recently as bios I was, you know,
878
00:49:13.400 --> 00:49:15.960
I left the year after biox when FDA had kind
879
00:49:15.960 --> 00:49:18.599
of lost its scientific self confidence and was getting battered.
880
00:49:19.320 --> 00:49:21.480
The approvals were in the twenties. So it's not like
881
00:49:21.519 --> 00:49:23.800
we're getting a lot of new drugs per year, right
882
00:49:24.079 --> 00:49:27.199
And so you know, even a few medicines who we
883
00:49:27.239 --> 00:49:30.119
don't that we don't have do I think do make
884
00:49:30.159 --> 00:49:33.840
a big impact. And you know, the less study al
885
00:49:33.920 --> 00:49:39.840
site adam is Ran did something comparing new prescription drug
886
00:49:39.880 --> 00:49:43.800
availability and launched timing in the United States versus other countries. Okay,
887
00:49:43.840 --> 00:49:46.599
so we do we actually have we not a it's
888
00:49:46.639 --> 00:49:49.599
not a randomized clinical trial, but we have systems where
889
00:49:49.639 --> 00:49:52.400
they have price controls and systems where they don't. Okay.
890
00:49:52.639 --> 00:49:54.960
So if two hundred and eighty seven drugs launched between
891
00:49:54.960 --> 00:49:59.000
two thousand and eight, eighteen and twenty twenty two, seventy
892
00:49:59.039 --> 00:50:01.880
four percent of them are available in the United States,
893
00:50:02.000 --> 00:50:04.360
and they are generally available at least a year faster
894
00:50:04.519 --> 00:50:07.599
than everyone else. Forty eight percent of those drugs are
895
00:50:07.639 --> 00:50:10.920
available only the United States. Fifty two percent of those
896
00:50:11.000 --> 00:50:13.880
drugs are in Germany, forty three percent here in the UK,
897
00:50:14.079 --> 00:50:17.920
and twenty eight percent in Canada. Now in many systems,
898
00:50:17.960 --> 00:50:19.800
I mean, I've had many conversations with people in the UK.
899
00:50:19.840 --> 00:50:21.280
Here in the UK was like, yeah, okay, I guess
900
00:50:21.280 --> 00:50:23.239
I'm getting you know, I'm not going to get new drugs.
901
00:50:23.400 --> 00:50:24.920
I'm seventy years old. I'm not going to get a
902
00:50:25.519 --> 00:50:27.800
new replacement. I accept that as part of my belief
903
00:50:27.840 --> 00:50:32.440
in the NHS. I don't normally find that attitude among
904
00:50:32.480 --> 00:50:34.079
American patients.
905
00:50:35.559 --> 00:50:38.519
But this also is up moving US toward UK style
906
00:50:38.840 --> 00:50:42.760
drug pricing. And I mean, like, I think that the
907
00:50:42.880 --> 00:50:47.159
US should be more like other countries in having the government.
908
00:50:47.280 --> 00:50:50.320
Given that we have public provision and coverage of drugs,
909
00:50:50.360 --> 00:50:53.119
I think there should be like more public paying attention
910
00:50:53.159 --> 00:50:55.559
to whether we're getting value for those drugs. But I
911
00:50:55.599 --> 00:50:59.199
also think that the value that many other countries place
912
00:50:59.280 --> 00:51:03.280
on health gains is vastly too low, and that even
913
00:51:03.320 --> 00:51:05.599
in the US, the value that I sert placed on
914
00:51:06.119 --> 00:51:08.960
health places on health gains is vastly too low compared
915
00:51:08.960 --> 00:51:11.920
to how we generally think about the value of health
916
00:51:12.159 --> 00:51:16.159
gains and life extensions in other cost benefit analysis context
917
00:51:16.199 --> 00:51:19.800
with other federal agencies, and the effect of this. I mean,
918
00:51:19.800 --> 00:51:21.599
like interestingly, when I talk about this with kind of
919
00:51:21.599 --> 00:51:23.719
people on each side of this debate, I think there's
920
00:51:23.760 --> 00:51:27.400
an ambiguous effect which potentially has some potential for political compromise,
921
00:51:27.440 --> 00:51:29.119
and that like some farm of people I talk to
922
00:51:29.480 --> 00:51:31.239
like the idea that they could get much more than
923
00:51:31.280 --> 00:51:33.360
they're currently getting for some drugs, and that I think
924
00:51:33.400 --> 00:51:36.719
that like Medicare should be authorized to reimburse based on
925
00:51:36.760 --> 00:51:40.480
demonstrated evidence of value and like truly valuing health gains
926
00:51:40.480 --> 00:51:45.159
the way we do in other regulatory contexts. Some patient
927
00:51:45.199 --> 00:51:47.920
advocates I've talked to think that like this would obviously
928
00:51:47.960 --> 00:51:50.880
lower overall costs because basically all the new drugs have
929
00:51:51.039 --> 00:51:54.840
very little evidence of value, and so like if you're
930
00:51:55.039 --> 00:52:00.440
truly having value based pricing, then like any of the
931
00:52:00.519 --> 00:52:03.440
drugs that we're currently getting don't have that evidence, And
932
00:52:03.480 --> 00:52:06.159
so I think there's like empirical uncertainty on that I
933
00:52:06.199 --> 00:52:08.119
have not spent a lot of time like trying to
934
00:52:08.199 --> 00:52:12.920
understand the empirics of the assessments of what that value is.
935
00:52:12.920 --> 00:52:16.280
But I think there are questions about whether how many
936
00:52:16.320 --> 00:52:20.119
of those new drugs we're getting are actually causing significant
937
00:52:20.159 --> 00:52:22.920
health then that's compared to the existing standard of care,
938
00:52:23.000 --> 00:52:25.159
which again is the point that we don't just need
939
00:52:25.159 --> 00:52:27.000
to be counting drugs. We need to be thinking about
940
00:52:27.559 --> 00:52:30.599
how good those drugs are and making it more profitable
941
00:52:30.599 --> 00:52:32.519
and I think vastly more profitable to do things that
942
00:52:33.320 --> 00:52:36.000
really are the most beneficial for patients.
943
00:52:36.400 --> 00:52:36.559
Right.
944
00:52:36.639 --> 00:52:41.039
So, I mean I can speak from very practical experience,
945
00:52:41.039 --> 00:52:42.639
having been in the industry, been in the room when
946
00:52:42.639 --> 00:52:46.320
people make these decisions. If we knew in advance, Okay,
947
00:52:46.480 --> 00:52:49.079
here's the system by which you know, if I make
948
00:52:49.159 --> 00:52:54.199
investments and I show that there's value in this medicine,
949
00:52:54.519 --> 00:52:57.920
and then I will get rewarded for it, then you know,
950
00:52:58.800 --> 00:53:01.559
each medicine is at tend to fifteen year investment, as
951
00:53:01.559 --> 00:53:05.159
Brad said. But then I can make decisions and say, okay,
952
00:53:05.199 --> 00:53:07.960
I'm gonna I want to maximize my profits. That's why
953
00:53:07.960 --> 00:53:11.199
I'm in business, That's why investors give me money. I
954
00:53:11.239 --> 00:53:12.880
also want to help patients, which is why I'm in
955
00:53:12.920 --> 00:53:15.320
the industry. But you know, if I can make more
956
00:53:15.360 --> 00:53:18.800
money by making a drug that has more comparative effectiveness
957
00:53:18.840 --> 00:53:25.360
than fine, but ironically, you know the icers of the
958
00:53:25.360 --> 00:53:28.239
world than nice and whatever. They make judgments based on
959
00:53:28.280 --> 00:53:33.599
comparative effectiveness data that if you actually did that study
960
00:53:33.760 --> 00:53:37.360
and tried to communicate about that to your patients, FDA
961
00:53:37.400 --> 00:53:41.039
would almost certainly say you cannot communicate that because the
962
00:53:41.079 --> 00:53:45.599
study isn't adequate. The standards that FDA imposes for making
963
00:53:45.679 --> 00:53:49.760
any kind of comparative efficacy statement, they're basically impossible to meet.
964
00:53:51.159 --> 00:53:53.079
I think this is a fantastic discussion. I mean, we
965
00:53:53.119 --> 00:53:56.880
probably could have a three hour weather on these issues.
966
00:53:57.199 --> 00:54:02.280
Unfortunately we only have an hour, and so some of
967
00:54:02.320 --> 00:54:05.880
the we did get two questions primarily related to the
968
00:54:05.880 --> 00:54:09.039
international arbitrage issue and the kind of the classic international
969
00:54:09.039 --> 00:54:11.280
public choice problem that we talked about of other countries
970
00:54:11.559 --> 00:54:13.880
free loading off of the United States and and how
971
00:54:13.920 --> 00:54:16.920
this is happening. I think the these this was addressed
972
00:54:17.199 --> 00:54:21.119
in both directly and indirectly by comments by Barrad and
973
00:54:21.199 --> 00:54:24.519
Dan and Lisa throughout our discussion, and so I just
974
00:54:24.599 --> 00:54:26.840
want to kind of bring us to a conclusion and
975
00:54:27.039 --> 00:54:29.039
kind of give our each of our panelists kind of
976
00:54:29.039 --> 00:54:31.079
an opportunity to kind of give a few kind of
977
00:54:31.079 --> 00:54:35.800
closing remarks. Again, thank you for the fantastic exchange, and
978
00:54:35.840 --> 00:54:39.400
we'll go in reverse order. Uh So, so we'll kick
979
00:54:39.440 --> 00:54:41.920
We'll start off with you, Brad, So just a couple
980
00:54:42.119 --> 00:54:44.400
like one, one or two minute remarks and then and
981
00:54:44.440 --> 00:54:46.400
then we'll uh, we'll bring we'll bring it home for
982
00:54:46.440 --> 00:54:46.920
the audience.
983
00:54:47.440 --> 00:54:49.840
I'll try to keep it for forty five seconds. Ours.
984
00:54:49.840 --> 00:54:53.159
Thanks to the ped for hosting this, Thanks to Lisa
985
00:54:53.159 --> 00:54:55.400
and Dan for being on the panel with me. Look,
986
00:54:55.440 --> 00:54:57.440
I think you said it best, Adam, right, these issues
987
00:54:57.440 --> 00:55:02.000
are really complex, and they're really big real world implications
988
00:55:02.480 --> 00:55:07.679
about getting policies around pharmaceutical innovation right or home. I
989
00:55:07.679 --> 00:55:10.239
think what you saw here right is just how complex
990
00:55:10.320 --> 00:55:13.480
those issues can be in a microcosm.
991
00:55:14.079 --> 00:55:14.280
You know.
992
00:55:14.320 --> 00:55:19.239
I think as we think ahead two not only future policies,
993
00:55:19.280 --> 00:55:20.679
but where we want to be as a country in
994
00:55:20.719 --> 00:55:23.119
twenty to twenty five years, it's important to get it
995
00:55:23.199 --> 00:55:25.440
right because we don't want to be an innovation desert,
996
00:55:25.840 --> 00:55:27.519
but we do want to be a place right where
997
00:55:27.519 --> 00:55:30.760
people get the types of cures and treatments to that
998
00:55:31.159 --> 00:55:34.000
a quality of life. And so, you know, I welcome
999
00:55:34.079 --> 00:55:36.920
the chance to have this discussion today, and I hope
1000
00:55:36.920 --> 00:55:38.400
we do more of it in the future. Because I
1001
00:55:38.400 --> 00:55:41.679
think informed policy making is the best in this area
1002
00:55:41.719 --> 00:55:46.480
and not kind of cliches that differently in the political.
1003
00:55:46.039 --> 00:55:54.159
Slogans thank you, yeah, and.
1004
00:55:51.400 --> 00:55:55.079
So thank you to everybody for participating. And at least
1005
00:55:55.079 --> 00:55:58.440
I'm scanned your article, but I look forward to learning
1006
00:55:58.480 --> 00:56:03.599
from you and reading it even more deeply. I think
1007
00:56:03.679 --> 00:56:06.199
we we know what doesn't work. We can look at
1008
00:56:06.239 --> 00:56:09.320
other countries where it's a monopsony where the government is
1009
00:56:09.360 --> 00:56:12.800
the only buyer, and where patients are not actually literally
1010
00:56:12.840 --> 00:56:16.280
allowed to learn about medicines because there's no direct to
1011
00:56:16.280 --> 00:56:21.360
consumer advertising and there's no communication to patients. And we
1012
00:56:21.480 --> 00:56:26.239
know that those systems have problems, you know, are far
1013
00:56:26.320 --> 00:56:28.480
less than ideal. Now our system is not far from
1014
00:56:28.519 --> 00:56:31.679
ideal as well, but we are, you know, the ones
1015
00:56:31.719 --> 00:56:35.400
who are driving innovation and making modern miracles, like I
1016
00:56:35.440 --> 00:56:38.280
said with respect to this new Gilead drug or curing hepsi.
1017
00:56:38.800 --> 00:56:42.400
And I'm just very afraid that, you know, people are
1018
00:56:42.440 --> 00:56:45.039
not taking into account what you be a very important
1019
00:56:45.039 --> 00:56:48.280
thing you said at the beginning, Lisa, which is incentives matter.
1020
00:56:48.760 --> 00:56:51.360
People seem to believe that you know, that they can
1021
00:56:51.480 --> 00:56:54.599
just force drug companies to, you know, make medicines and
1022
00:56:54.599 --> 00:56:56.639
they'll keep doing it no matter what you know the
1023
00:56:56.719 --> 00:56:59.039
incentives are, and that's just not going to work.
1024
00:57:00.320 --> 00:57:04.320
And then Lisa, Yeah, I generally agree with all of that.
1025
00:57:04.360 --> 00:57:06.519
It's been a great discussion. I'll just add on the
1026
00:57:06.559 --> 00:57:09.599
international point that I agree we pay more than other countries,
1027
00:57:09.599 --> 00:57:12.079
and in that sense, other countries are free riding us,
1028
00:57:12.079 --> 00:57:14.800
although I don't think that's a good reason to cause
1029
00:57:14.880 --> 00:57:18.679
us to stop investing. And like the the amount that
1030
00:57:18.719 --> 00:57:22.360
we are paying should be based on considering what makes
1031
00:57:22.360 --> 00:57:25.119
sense for American patients, and we shouldn't pay more just
1032
00:57:25.719 --> 00:57:28.280
or or pay less just the sense of, like, we
1033
00:57:28.400 --> 00:57:31.599
don't want to pay more than our economic peers. And
1034
00:57:32.440 --> 00:57:34.960
I think generally, like whatever the next steps of pharma
1035
00:57:35.000 --> 00:57:37.440
policy or form are, I hope that policymakers remember that
1036
00:57:37.519 --> 00:57:40.800
things like encouraging generic entry aren't important goals in and
1037
00:57:40.840 --> 00:57:43.920
of themselves, like means the end of saving lives and
1038
00:57:43.920 --> 00:57:47.079
improving health through having the right structure of incentives and access,
1039
00:57:47.079 --> 00:57:49.360
and that this overall goal should be kept front and center.
1040
00:57:50.280 --> 00:57:54.000
Excellent, Well, I mean we often talk about the aspirational
1041
00:57:54.199 --> 00:57:59.039
ideal of having evidence based conversations and to promote evidence
1042
00:57:59.079 --> 00:58:02.000
based policy making by our officials, and I really want
1043
00:58:02.039 --> 00:58:05.119
to thank all three of our panelists for exemplifying this
1044
00:58:05.199 --> 00:58:07.719
ideal in fact and this what I think was a
1045
00:58:07.800 --> 00:58:12.360
really robust and uh and and very substantive discussion. So
1046
00:58:12.440 --> 00:58:15.960
thank you to all of you, and uh, thank you,
1047
00:58:16.000 --> 00:58:18.800
and I'll turn it back to the Federal Society at
1048
00:58:18.800 --> 00:58:21.800
sarah to uh to uh to close it out.
1049
00:58:23.280 --> 00:58:26.880
Thank you so much Professor Masso for moderating, and thank
1050
00:58:26.920 --> 00:58:29.840
you for everyone on our panel for joining us and
1051
00:58:29.920 --> 00:58:33.000
for sharing your insights today. Thank you also to our
1052
00:58:33.039 --> 00:58:36.440
audience for tuning in and for your questions. For more
1053
00:58:36.480 --> 00:58:40.039
content like this from the Recuatory Transparency Project here at
1054
00:58:40.039 --> 00:58:43.599
the farder List Society, please visit us at right project
1055
00:58:43.639 --> 00:58:44.159
dot org.
1056
00:58:44.519 --> 00:58:46.679
Thank you on behalf of.
1057
00:58:46.599 --> 00:58:49.960
The Federal Society's Regulatory Transparency Project. Thanks for tuning in
1058
00:58:50.000 --> 00:58:53.119
to the Fourth Branch podcast to catch every new episode
1059
00:58:53.159 --> 00:58:56.840
when it's released. You can subscribe on Apple Podcasts, Google Play,
1060
00:58:57.320 --> 00:59:00.840
and speaker lates from our TP. Please visit our website
1061
00:59:00.880 --> 00:59:04.280
at reg Project dot org. That's r e G Project
1062
00:59:04.320 --> 00:59:04.960
dot org.
1063
00:59:13.800 --> 00:59:15.719
This has been a FEDSOC audio production