Latest / Making Medicine / The FDA Decoded: Roles, Responsibilities & What They Mean for Drug Development

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The FDA Decoded: Roles, Responsibilities & What They Mean for Drug Development · Making Medicine

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  Speaker 1: At Making Medicine. We're reporting on the headlines, not making
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  Speaker 1: medical recommendations. For personal health questions, always ask your doctor.
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  Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice.
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  Speaker 1: Consult your own advisors before making decisions.
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  Speaker 2: So across the spectrum from just submitting your application will
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  Speaker 2: the FDA even accept it for review, to actually giving
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  Speaker 2: you the red light or green light to market your drug,
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  Speaker 2: there's been inconsistency and not clear communication and that's really
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  Speaker 2: the challenge of this instability for the biotech industry.
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  Speaker 1: Welcome back to the Making Medicine podcast, where science, policy
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  Speaker 1: and innovation meet. I'm your host, John Stanford. A lot
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  Speaker 1: happened this week, from a Senate Louisiana primary race to
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  Speaker 1: ACA rules coming out of CMS. We've also got a
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  Speaker 1: press pass this episode where we'll meet with Biospace's Jeff
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  Speaker 1: Axed to talk about the ongoing swirl at the FA.
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  Speaker 1: We've got a lot to cover, so let's get into
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  Speaker 1: the show. We are back with another press pass segment
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  Speaker 1: and thrilled to have Jeff Axed, managing editor over at Biospace,
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  Speaker 1: who's joined us. We asked Jeff to come back because
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  Speaker 1: we've been talking about the FDA writ Large on almost
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  Speaker 1: every episode the last several weeks, and one of the
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  Speaker 1: consistent questions we've been getting back from listeners is what
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  Speaker 1: are the different offices do and what are the consequences
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  Speaker 1: of this position being open or this turnover? And Jeff,
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  Speaker 1: who is fresh off of several award winning pieces coming
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  Speaker 1: out of biospace covering industry over the last couple months,
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  Speaker 1: has put out an incredible chart tracking these people, So
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  Speaker 1: it only made sense to take her and her viral
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  Speaker 1: chart and bring her on the show. So, Jeff, welcome back.
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  Speaker 1: We're thrilled to have you for a press pass segment.
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  Speaker 2: Hi, John, thank you so much for having me back.
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  Speaker 2: It's good to be here.
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  Speaker 1: Let's start at the very top and work our way down. FDA,
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  Speaker 1: of course, sits inside the Department of Health and Human Services.
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  Speaker 1: Can you frame that relationship? And we talk a lot
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  Speaker 1: about RFK Junior, how does FDA sitting inside HHS play out?
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  Speaker 1: Writ Large?
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  Speaker 2: I think that's different under this administration. I think RFK
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  Speaker 2: has been very involved in the agencies and certainly in
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  Speaker 2: creating their leadership and creating the goals or agenda for
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  Speaker 2: the different agencies. So while the FDA may have operated
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  Speaker 2: more independently in the past. I think there is more
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  Speaker 2: interplay between the agencies all within HHS at this point.
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  Speaker 2: But of course FDA is the Food and Drug Administration,
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  Speaker 2: so they regulate the food and drugs that are coming
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  Speaker 2: into our markets.
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  Speaker 1: And you would say, historically maybe FDA has been a
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  Speaker 1: little arms length from the Secretary's office, and in this
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  Speaker 1: case they seem to be much more swimming trying to
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  Speaker 1: at least all swim in the MAHA direction.
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  Speaker 2: Together, I would agree, And certainly I think that's even
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  Speaker 2: more apparent if you look at the CDC and so yes,
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  Speaker 2: there's definitely a lot more MAHA agendas trickling now, which
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  Speaker 2: makes sense, right, you know, the administration comes in with
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  Speaker 2: its goals. I'm not totally clear on how much direct
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  Speaker 2: interaction there is on a daily basis, but you know,
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  Speaker 2: another great example of this is you're seeing, you know,
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  Speaker 2: in the past, Marty McCarey as FDA Commissioner, along with
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  Speaker 2: Jay Badacharia from NIH and whoever was running the CDC
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  Speaker 2: at the time, have shown up at you know, alongside
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  Speaker 2: RK and making announcements on social media for policy changes,
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  Speaker 2: or showing up at the White House. For most favored nations.
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  Speaker 2: So I think that there's much more of a public
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  Speaker 2: facing element to this administration alongside the secretary.
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  Speaker 1: It's an interesting call out about some of those faces
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  Speaker 1: might not be seen at a drug pricing event in
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  Speaker 1: the past, but it seems they're putting, hey, if health's
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  Speaker 1: in your job description, you're showing up at this, at
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  Speaker 1: this event at the White House. That's already helpful. Let's
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  Speaker 1: dig a little deeper into the FDA, obviously still in
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  Speaker 1: the news and the shoes or the dominoes still falling
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  Speaker 1: to get my analogy right of Marty's departure. But let's start,
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  Speaker 1: maybe first with CEDAR Center for Drug Evaluation and Research.
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  Speaker 1: What does it do and why does it matter to
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  Speaker 1: the biotech community.
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  Speaker 2: So this is the standard drug review unit, So outside
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  Speaker 2: of biologics and kind of novel therapies, our standard old
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  Speaker 2: small molecule and other simple drugs are reviewed by CEDAR.
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  Speaker 2: This is one agency that has had zero stability since
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  Speaker 2: the start of the administration. It has turned over multiple times.
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  Speaker 2: We've had five different directions. Maybe we're up to six
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  Speaker 2: now I should count on my own chart, you know,
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  Speaker 2: it's it's been quite a few and so yes, this
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  Speaker 2: is This is the agency where anybody, any biotech or
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  Speaker 2: a pharma with a small molecule or drug or other
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  Speaker 2: simple drug will submit you know, their application and get
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  Speaker 2: a review time. This is one area where we have
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  Speaker 2: seen the Commissioner's National Priority vouchers come into play. There
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  Speaker 2: have been some of those given out for these types
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  Speaker 2: of drugs to accelerate the review time from ten to
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  Speaker 2: twelve months to one to two. But yeah, it's the older,
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  Speaker 2: more basic review unit because Sieber, which we'll get to,
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  Speaker 2: is the biological unit that's newer because we haven't had
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  Speaker 2: biologic for nearly as long. So Cedar is kind of
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  Speaker 2: the old original FDA review unit.
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  Speaker 1: So if there was a place for stability, it would
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  Speaker 1: be Sedater. You go the NDA process. We're going through
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  Speaker 1: this and as you said, five six directors over the
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  Speaker 1: last I guess we're at sixteen months now, and we
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  Speaker 1: will link to for everybody listening. We have a link
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  Speaker 1: to Jeff's great chart that I really can't say enough
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  Speaker 1: about because you can visually see the instability you get
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  Speaker 1: at some point. Turnover for better or for worse does
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  Speaker 1: lead to instability. What are the consequences? As you said,
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  Speaker 1: zero stability out of theater, so much turnover in the role.
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  Speaker 1: What are some of the consequences you've observed from that.
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  Speaker 2: Well, I think there have been delays, certainly drug delays.
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  Speaker 2: I think another concern that everybody has across the industry
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  Speaker 2: and across divisions is the reversals. Of course, a little
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  Speaker 2: bit of you know, not clear communication on expectations for
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  Speaker 2: the companies. Companies think they're aligned and then they're not.
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  Speaker 2: Disc Medicine is a good example of this. That's another
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  Speaker 2: one of those voucher recipients, and that was under seed
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  Speaker 2: Although as we'll get to I know, we're trying to
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  Speaker 2: stay focused on Seedar yet, but it's hard to talk
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  Speaker 2: about SEDAR separately from SEVERER because there's been so much
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  Speaker 2: interplay between the two. So DISC is a great example
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  Speaker 2: of that. Then I prosad former SEVERER director had to
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  Speaker 2: roll in the DISC decision, and then conversely, we've seen
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  Speaker 2: you know, past or former CEDAR director stepping in on
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  Speaker 2: SEBER decisions. So it's been a lot of back and
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  Speaker 2: forth between the two. I don't feel like there's a strong,
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  Speaker 2: you know, wall between them. I don't know if there
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  Speaker 2: should be, but we're definitely seeing I think inconsistency across
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  Speaker 2: the FDA in those drug decisions, and we talked about
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  Speaker 2: this last time I was on the show. I feel
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  Speaker 2: like biotechs feel like they're getting blindsided. They're not expecting.
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  Speaker 2: They're expecting one decision and they get the other. And
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  Speaker 2: this goes for actual drug decisions. And then I think
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  Speaker 2: the the focus of our topic last time was the
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  Speaker 2: Maderna's They were just putting in the application to be
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  Speaker 2: reviewed and they got to refuse to file letters. So
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  Speaker 2: across the spectrum from you know, just submitting your application,
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  Speaker 2: will the FDA even accept it for review, to actually
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  Speaker 2: giving you the red light or green light to market
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  Speaker 2: your drug, there's been inconsistency and not clear communication and
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  Speaker 2: that's really the challenge of this instability for the biotech industry.
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  Speaker 1: Well, let's go from C Dur with a D to C.
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  Speaker 1: Burr Center for Biologics and Evaluation and Research. Talk to
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  Speaker 1: us about what SEBER does and why it is different
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  Speaker 1: historically from CEDAR.
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  Speaker 2: Sure so SIBER like I said, it's a newer, newer
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  Speaker 2: division within the agency. This is for biologics so and
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  Speaker 2: any sort of novel modality. So as we're talking gene therapy,
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  Speaker 2: sell therapies. I mean, there's much more than that. But
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  Speaker 2: all the new stuff, all the exciting stuff that we're
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  Speaker 2: always talking about in biotech these days, that's going to
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  Speaker 2: be under review at SIEBER. The challenge there is that
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  Speaker 2: they're new and novel drugs and so or therapies. I
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  Speaker 2: should say, we don't call them drugs, although that'll slip
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  Speaker 2: out every now and then. But these therapies there aren't
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  Speaker 2: solid regulatory pathways, and so a lot of what Seeber
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  Speaker 2: does is innovate new regulatory pathways to support these unusual
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  Speaker 2: or new modalities. And so I think CEDAR again it's
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  Speaker 2: the older, more you know, historic division, and it's you know,
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  Speaker 2: there's always evolution to the policies and there's you know,
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  Speaker 2: different incentives that the FDA can do to accelerate review.
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  Speaker 2: But generally the review for drugs is much more well trodden. Mean,
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  Speaker 2: we know how that works versus the review for biologics,
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  Speaker 2: especially as we talk more and more about rare diseases
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  Speaker 2: where you have small patient populations, You're not just going
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  Speaker 2: to have that massive phase three randomized double blind control trial.
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  Speaker 2: So you have to have these innovative pathways, and you know,
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  Speaker 2: we'll get into it a little more, I'm sure. But
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  Speaker 2: Marty McCarey was a big proponent of accelerating approvals for
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  Speaker 2: rare diseases and these innovative pathways, and a lot of
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  Speaker 2: those are now in question with his departure.
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  Speaker 1: Yeah, and it sounds like, well, let's see what you
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  Speaker 1: think about this could consider because it is so grounded
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  Speaker 1: and not too adventurous in the clinical trial approval pathway,
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  Speaker 1: Concedeer tolerate more instability because of that history, whereas Sieber
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  Speaker 1: really needs the stability because you're you are inventing so
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  Speaker 1: much is new and tailor made to whatever specific therapeutic
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  Speaker 1: area we're going after, or is it damaging across the board?
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  Speaker 1: Neither of them can tolerate stability or instability.
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  Speaker 2: I would say it's damaging across the board. But it's
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  Speaker 2: interesting that you have that instinct because I would almost
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  Speaker 2: said the reverse. I feel like introducing instability to the
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  Speaker 2: more historic more well I want to say, well rutten,
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  Speaker 2: but you know, consistent and well known agency of ceter
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  Speaker 2: It almost feels like the throwing instability there could be
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  Speaker 2: more disruptive than in Sieber, where a lot of these
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  Speaker 2: drug developers they don't know exactly what the regulatory path
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  Speaker 2: is going to look like going into it. What's a
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  Speaker 2: little bit of change like they're prepared for, you know,
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  Speaker 2: back and forth with the FDA and a little bit
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  Speaker 2: of accommodations and you know, tailoring a regulatory path for
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  Speaker 2: their product.
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  Speaker 1: You know, you're wandering into the wild West with SEBER.
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  Speaker 1: You don't think you're wandering into the wild Okay, I
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  Speaker 1: like that. I know. We won't go to sub sub
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  Speaker 1: agency office here, but one within SEBER the Office of
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  Speaker 1: Therapeutic Products. Now Nicole Verdoon and her deputy both recently
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  Speaker 1: placed on leave. Just that office, in particular, Office of
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  Speaker 1: Therapeutic Products. How do you see a gap in leadership
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  Speaker 1: having an impact there?
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  Speaker 2: It's unclear to me at these subagencies because there has
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  Speaker 2: been so much leadership involvement in the decisions across the
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  Speaker 2: board and even leadership interference with decisions. So I'm actually
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  Speaker 2: not clear that that makes any difference. You could have
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  Speaker 2: stable leadership there and they could be overridden by the
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  Speaker 2: SEBER director or even the commissioner. So, because there's been
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  Speaker 2: so much turnover across the board and so much direct
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  Speaker 2: involvement of the leadership that we've had. I'm not clear
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  Speaker 2: that really makes any difference, to be honest.
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  Speaker 1: Interesting and would you say that's another new trend with
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  Speaker 1: this administration is how far down leadership is reaching into
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  Speaker 1: sub agency. That's not something we've seen before.
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  Speaker 2: Right, correct, And that's absolutely been a big part of
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  Speaker 2: the drama over the past year and a half. And
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  Speaker 2: that's I think a big part of why Prosod's out.
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  Speaker 2: And you know, they claimed it was a one year
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  Speaker 2: leave of absence when they told us about this a
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  Speaker 2: ten eleven months into his tenure, but it came right
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  Speaker 2: off of modernegy and some other instances of his intervention.
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  Speaker 2: And you know, McKay got called up to Trump to
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  Speaker 2: hear his frustrations, and then not long after that we
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  Speaker 2: heard that Prisad was leading. So I do think that
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  Speaker 2: the leadership has been more involved, and I think that
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  Speaker 2: that's getting pushed back from the industry. And I think now,
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  Speaker 2: like you said, we're seeing the dominoes fall from that
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  Speaker 2: because Trump doesn't like things coming back to him complaints, right,
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  Speaker 2: They want things to be well run and no complaints
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  Speaker 2: going up the ladder. And so I think the leadership
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  Speaker 2: intervention is a big part of those complaints.
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  Speaker 1: We don't typically on this show wander too much into
• 12:07
  Speaker 1: the device space. We stay in our lane. But I
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  Speaker 1: don't want to ignore another major center, the Center for
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  Speaker 1: Devices and Radiological Health. Any thoughts on how its structure
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  Speaker 1: differs relative to CEDAR and SEBER or anything you'd call
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  Speaker 1: out about that particular office, you know it's.
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  Speaker 2: You say that you don't wander it too much. We
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  Speaker 2: don't wander into it a lot.
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  Speaker 1: Either.
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  Speaker 2: We don't cover medtech at Biospace, So I'm actually not
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  Speaker 2: very expert on that is I have not I will
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  Speaker 2: say this that I have not heard in our circles
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  Speaker 2: where we're focused purely on drug development, a lot of
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  Speaker 2: complaints filtering in. So either it's going okay or it's
• 12:44
  Speaker 2: staying within the medtech world. But I'll be perfectly honest,
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  Speaker 2: I don't have a ton of expertise in that department.
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  Speaker 1: Well, well will agree that it's not our space. For
• 12:53
  Speaker 1: those of you who wanted to know it's out there,
• 12:55
  Speaker 1: it's out there, but it's not making medicine. It's not biospace.
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  Speaker 1: But either they are keeping the complaints. It does seem
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  Speaker 1: like we're not hearing about disruption in the device space
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  Speaker 1: quite as much, but I won't read too much into that.
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  Speaker 1: I want to you know, within the FDA is also
• 13:13
  Speaker 1: the office of the Commissioner, And you know, in some
• 13:17
  Speaker 1: of our coverage of the FDA and some of the
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  Speaker 1: great reading we've been doing by you and your colleagues
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  Speaker 1: is you know, the FDA is huge. It's one fifth
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  Speaker 1: of the economy, and we obsess over getting new drugs
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  Speaker 1: approved and clinical trials. They do cover a lot of
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  Speaker 1: the other stuff this office of the Commissioner and the
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  Speaker 1: commissioner themselves historically, how much were they reaching into the
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  Speaker 1: day to day operations of CEDAR and Seber or were
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  Speaker 1: they busy with other things tobacco, food, cosmetics, agriculture to
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  Speaker 1: some extent, How much did we typically see the Commissioner's
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  Speaker 1: office focusing just so much on drug This.
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  Speaker 2: Feels new to me. I mean, there's certainly one off
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  Speaker 2: examples in the past with other commissioners how they've played
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  Speaker 2: a role, or directors stepping in on individual decisions is
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  Speaker 2: probably even more common than the commissioner. But I do
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  Speaker 2: feel like we're at a different level here. I don't
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  Speaker 2: think that we've had this level of commissioner involvement and
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  Speaker 2: part of it I'm speculating here, but I feel like
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  Speaker 2: mcarey's involvement specifically could have been driven by the controversy
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  Speaker 2: that Prisad was generating, because McCarry recruited Prosad and then
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  Speaker 2: he even recruited him again and convinced him come back.
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  Speaker 2: After that, you know, he left three months on the job,
• 14:34
  Speaker 2: went back to California, came back ten days later. So
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  Speaker 2: that was at McCarey's behest, and so I there might
• 14:39
  Speaker 2: be some level of ownership that McCay felt over the
• 14:42
  Speaker 2: controversy that Prosad was generating. And again he got called
• 14:44
  Speaker 2: all the way up to Trump's office because of things
• 14:46
  Speaker 2: that Prisad was doing. So I wonder if just the
• 14:49
  Speaker 2: personal relationships here might be driving the involvement of the commissioner.
• 14:53
  Speaker 2: But in generally, I would say the commissioner's more involve
• 14:55
  Speaker 2: and to your point, not necessarily busy with agriculture or
• 14:59
  Speaker 2: food or any these other but just high level policy making.
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  Speaker 2: And that is something that mccarrey did do a lot of,
• 15:04
  Speaker 2: is just new regulatory pathways, new programs, changes from the
• 15:09
  Speaker 2: two trials to the one trial, all these different initiatives
• 15:11
  Speaker 2: that McCay was initiating. That's where the commissioner is more
• 15:13
  Speaker 2: focused on how is the agency run and how has
• 15:15
  Speaker 2: drug view run, not the individual decisions.
• 15:18
  Speaker 1: You've been super generous with your time. I am going
• 15:20
  Speaker 1: to steal a bonus question, but I know we've got
• 15:23
  Speaker 1: to get you out of here. Advisory committees for our
• 15:28
  Speaker 1: listeners as a closer, can you talk about their historic
• 15:31
  Speaker 1: role of ad coms and maybe what some of the
• 15:35
  Speaker 1: swirl about their use or lack thereof is in the
• 15:38
  Speaker 1: current environment.
• 15:39
  Speaker 2: Yeah, ad comes. I mean, I think they're great. I
• 15:42
  Speaker 2: think most of the industry would agree with that. It's
• 15:44
  Speaker 2: outside experts, scientists, other folks with expertise in an area
• 15:49
  Speaker 2: of a particular review come and sit together review the
• 15:51
  Speaker 2: application and give their feedback to the FDA and their recommendation.
• 15:56
  Speaker 2: And I think we saw an evolution away from this
• 15:59
  Speaker 2: right off the bat. I can't remember what month it was,
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  Speaker 2: but sometime in earlier twenty twenty five McCary the first
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  Speaker 2: change was that they didn't want anybody with any industry
• 16:08
  Speaker 2: experience city on ad comms. You know they're concerned about
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  Speaker 2: I think it was FDAs in the pocket of industry
• 16:14
  Speaker 2: or some of these accusations, and so they were trying
• 16:16
  Speaker 2: to distance industry and FDA. That's a challenge because a
• 16:20
  Speaker 2: lot of this very specific expertise, for example in vaccines,
• 16:23
  Speaker 2: does have industry experienced, so that became a problem. And
• 16:27
  Speaker 2: then the FDA also instituted these expert panels, which was
• 16:31
  Speaker 2: never quite clear how they were recruiting the people on
• 16:34
  Speaker 2: how it differed from an ad com. But the feedback
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  Speaker 2: we got from the few that happened before they stopped
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  Speaker 2: happening was that they were there to support an agenda.
• 16:41
  Speaker 2: So there was a lot of pushback to these so
• 16:43
  Speaker 2: called expert panels, and then we just had this drought
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  Speaker 2: of nothing, no expert panels, no ad coms for nine months.
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  Speaker 2: That drought was recently broken by Astrogenica. They did have
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  Speaker 2: a double adcom recently. So I think there's a little
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  Speaker 2: bit of chatter like are these coming back? I think
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  Speaker 2: industry wants them back, and certainly, with all this leadhip turnover,
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  Speaker 2: if we're not going to have stable leadership, we can
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  Speaker 2: at least have some advice coming into the agency to
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  Speaker 2: help the reviewers. And you know, honestly, I might even
• 17:09
  Speaker 2: take that back into the reverse. I did read something
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  Speaker 2: recently about the absence of Marty McCarey, and so Kyle Diamantes,
• 17:15
  Speaker 2: the head of Food at FDA, is currently acting Commissioner,
• 17:19
  Speaker 2: and the speculation that I heard is we actually might
• 17:22
  Speaker 2: see less leadership intervention at this point because Diamonts is
• 17:26
  Speaker 2: the first acting FDA commissioner in over fifty years to
• 17:29
  Speaker 2: not have the scientific and medical credentials, and so maybe
• 17:31
  Speaker 2: he won't feel confident and intervening, and maybe the drug
• 17:34
  Speaker 2: review teams will be able to operate more independently. Either way, though,
• 17:38
  Speaker 2: I think adcoms would be valuable to those review teams.
• 17:40
  Speaker 1: We will have to have you back on in a
• 17:41
  Speaker 1: couple months to see how Kyle is doing, to see
• 17:44
  Speaker 1: what the impact of the acting title in the role does.
• 17:47
  Speaker 1: Do we see more ad comms, Do we see stability
• 17:50
  Speaker 1: at Cedar Sieber? We don't know, But if there's one
• 17:52
  Speaker 1: person to ask, it'll be you, Jeff. So we will
• 17:54
  Speaker 1: have you back on and so grateful that you took
• 17:57
  Speaker 1: time to be with us for this press pass.
• 18:00
  Speaker 2: Absolutely thanks for having me.
• 18:01
  Speaker 1: Our first headline from the week takes us from the
• 18:04
  Speaker 1: great conversation with Jeff at the FDA to the other
• 18:07
  Speaker 1: end of the healthcare spectrum and the centers for Medicare
• 18:09
  Speaker 1: and Medicaid service and a recent rule. This rule covers
• 18:14
  Speaker 1: everything about the Affordable Care Act plans it comes out
• 18:17
  Speaker 1: each year, and this will be the rule for twenty
• 18:19
  Speaker 1: twenty seven. There are a number of things to talk
• 18:23
  Speaker 1: about for healthcare wants, but what caught our eye was
• 18:26
  Speaker 1: an expansion of catastrophic plans. These are plans that have
• 18:31
  Speaker 1: very high deductibles and offer a skinnier set of benefits
• 18:34
  Speaker 1: in exchange for lower premiums. Why does this matter to us?
• 18:38
  Speaker 1: There are pros and cons of offering these plans to individuals.
• 18:41
  Speaker 1: They typically tend to be more healthy, and they want
• 18:44
  Speaker 1: to keep more dollars in their pocket instead of spending
• 18:46
  Speaker 1: them on premiums. But one of the drivers of the
• 18:50
  Speaker 1: continued pressure to do something in healthcare policy is exposures
• 18:55
  Speaker 1: of individuals to costs that are meant to be societal,
• 18:58
  Speaker 1: for example, a high cost drug, and so it's something
• 19:03
  Speaker 1: that we're watching. If we're opening the door to more
• 19:07
  Speaker 1: plans that really expose individuals to very high costs in
• 19:11
  Speaker 1: the tens of thousands of dollars if they get sick,
• 19:14
  Speaker 1: it is a bit of a gamble, and we know
• 19:17
  Speaker 1: that we've seen individuals be very upset in recent years
• 19:21
  Speaker 1: with their insurance coverage and why it's not operating as insurance,
• 19:25
  Speaker 1: and so we do see in this rule a move
• 19:28
  Speaker 1: towards allowing more plans that could lead to deep out
• 19:32
  Speaker 1: of pocket costs, whether on medicines, hospitals, or doctors, and
• 19:36
  Speaker 1: that's something that we need to be talking about. Our
• 19:39
  Speaker 1: next story comes out of the Department of Commerce, who
• 19:42
  Speaker 1: released formal procedures for pharma companies seeking terra relief under
• 19:46
  Speaker 1: the April Section two thirty two proclamation. Applications for this
• 19:51
  Speaker 1: relief are due June twelfth. The framework, companies with approved
• 19:56
  Speaker 1: on shoring plans qualify for a reduced twenty per per
• 20:00
  Speaker 1: tariff rate instead of the default one hundred percent tariff
• 20:04
  Speaker 1: rate that was announced back in April. Companies that also
• 20:07
  Speaker 1: enter into an HHS MFN Most Favored Nation Pricing agreement
• 20:12
  Speaker 1: qualify for zero percent tariffs through January twenty twenty nine.
• 20:16
  Speaker 1: There are detailed manufacturing investment and reporting requirements, plus enforcement
• 20:21
  Speaker 1: mechanisms included in the retroactive tariff increases. If companies miss
• 20:25
  Speaker 1: their commitments June twelfth, just around the corner is the
• 20:29
  Speaker 1: application deadline. So assessing whether or not you want to
• 20:33
  Speaker 1: pursue the onshoring plan or possibly a most Favored Nation
• 20:37
  Speaker 1: plan is something companies need to be talking about now.
• 20:40
  Speaker 1: As we said on previous episodes, these tariffs aren't just
• 20:45
  Speaker 1: about trade policy. They're a cudgel to change some behavior
• 20:49
  Speaker 1: in this case, whether through onshoring or signing a most
• 20:52
  Speaker 1: Favored Nation agreement. Those are the off ramps to these
• 20:56
  Speaker 1: pretty draconian tariffs. We'll see what companies explore these off
• 21:00
  Speaker 1: ramps coming up with the June twelfth deadline. More to
• 21:03
  Speaker 1: come on tariffs and pharma on future episodes. The other
• 21:07
  Speaker 1: headline comes from the world of politics. On Saturday night,
• 21:11
  Speaker 1: Senator Bill Cassidy lost his Republican primary in Louisiana. He
• 21:15
  Speaker 1: finished third with about twenty five percent of the vote,
• 21:18
  Speaker 1: while Julia Letlow, who had President Trump's endorsement, and State
• 21:22
  Speaker 1: Treasurer John Fleming will go to a runoff on June
• 21:25
  Speaker 1: twenty seventh. Senator Cassidy is the chairman of the Senate
• 21:29
  Speaker 1: Help Committee, the Health, Education, Labor, and Pensions Committee. He's
• 21:34
  Speaker 1: a physician and the first to chair that committee since
• 21:37
  Speaker 1: nineteen thirty three. That committee has the primary oversight and
• 21:41
  Speaker 1: confirmation body for the FDA and IH and CDC. In
• 21:46
  Speaker 1: other words, Senator Cassidy and his experience in the healthcare system,
• 21:50
  Speaker 1: has been a major voice on every story we've talked
• 21:54
  Speaker 1: about in healthcare over the last decade. But here's why
• 21:57
  Speaker 1: timing right now could be particularly incorporate important. We just
• 22:01
  Speaker 1: covered the FDA's leadership transition, no permanent commissioner, no permanent
• 22:06
  Speaker 1: directors its cedar or receiver, no permanent CDC director, and
• 22:10
  Speaker 1: no confirmed surge. In general, every one of those positions
• 22:14
  Speaker 1: will require Senate confirmation and the help Committee that is
• 22:18
  Speaker 1: Senator Cassidy's committee is the gatekeeper. And so we'll have
• 22:22
  Speaker 1: to see after a very contentious and politically divisive within
• 22:27
  Speaker 1: the Republican Party election has played out, and Senator Cassidy
• 22:31
  Speaker 1: knows he won't be in the next Congress, he'll be
• 22:33
  Speaker 1: someone to watch both for these confirmations broader laws that'll
• 22:37
  Speaker 1: come before the Committee. Before we close out, a quick
• 22:40
  Speaker 1: look at our own Life Science Investment Trackers data that
• 22:45
  Speaker 1: are updated now through the first quarter of twenty twenty six.
• 22:48
  Speaker 1: As a reminder, incubate the makers of making medicine keep
• 22:52
  Speaker 1: track of SEC filings and other regulatory filings to try
• 22:56
  Speaker 1: to get the pulse of how policy might be shaping
• 22:59
  Speaker 1: different choices by biotech companies and their investors. We have
• 23:02
  Speaker 1: three trackers. One that tracks the impacts of the Inflation
• 23:05
  Speaker 1: Reduction Act, in particular the pill penalty. We have a
• 23:09
  Speaker 1: Rare Disease tracker that looks at the impact of orphan
• 23:13
  Speaker 1: drug designation changes under the Inflation Reduction Act and the
• 23:16
  Speaker 1: fix under orphan cures. And we of course track most
• 23:20
  Speaker 1: favored nations. So here are the numbers. In the first
• 23:24
  Speaker 1: quarter of twenty twenty six, our IRA tracker found three
• 23:28
  Speaker 1: hundred and thirty four SEC filings from companies that flag
• 23:32
  Speaker 1: the IRA as a material business risk to their companies.
• 23:36
  Speaker 1: Three hundred and thirty four filings in a single quarter.
• 23:39
  Speaker 1: That number tells you the laws effect on the investment
• 23:42
  Speaker 1: in R and D decision making isn't fading. There's still
• 23:46
  Speaker 1: very much reverberating and syncing in more deeply across the industry.
• 23:51
  Speaker 1: The wait and see how this impacts me moment of
• 23:54
  Speaker 1: twenty twenty four and twenty twenty five is certainly behind
• 23:57
  Speaker 1: us on the Most Favored Nation tracker. Q one was
• 24:00
  Speaker 1: also significant. One hundred and eighty five new companies flagged
• 24:04
  Speaker 1: Most favor Nation pricing policy as also a material business risk.
• 24:09
  Speaker 1: That brings our cumulative count to three hundred and eighty
• 24:13
  Speaker 1: six unique companies since we started tracking back in twenty
• 24:16
  Speaker 1: twenty five. From our view, this is companies telling their
• 24:20
  Speaker 1: investors in writing with the weight of law behind it,
• 24:24
  Speaker 1: that most Favored Nation is reshaping how they think about
• 24:27
  Speaker 1: the business. That's why getting these policies are so critically important.
• 24:31
  Speaker 1: And finally on rare disease, which gave some genuinely encouraging
• 24:36
  Speaker 1: numbers about how policy doesn't just have to have a
• 24:39
  Speaker 1: negative impact can have a positive impact. The first quarter
• 24:43
  Speaker 1: of twenty twenty six added one hundred and nineteen new
• 24:46
  Speaker 1: orphan drug designations and nearly one billion dollars in new
• 24:50
  Speaker 1: investments in rare disease. That brings our trackers total to
• 24:53
  Speaker 1: nearly two and a half billion invested in rare disease
• 24:56
  Speaker 1: since the passage over the Orphan Cures Act. Links to
• 24:59
  Speaker 1: the tra will be in the episode notes. We update
• 25:02
  Speaker 1: these quarterly, so if you're not already checking them out,
• 25:04
  Speaker 1: they're worth taking a look at, particularly as we look
• 25:07
  Speaker 1: to measure what good policy like Orphan Cures Act or
• 25:10
  Speaker 1: some concerning proposals like the Inflation Reductions Pill Penalty, as
• 25:15
  Speaker 1: well as the broader expansion of most Favored Nation are
• 25:18
  Speaker 1: meaning in real time to America's biotech community. That wraps
• 25:22
  Speaker 1: up this episode of the Making Medicine Podcast. A huge
• 25:25
  Speaker 1: thank you to jeff As from Biospace for joining us
• 25:28
  Speaker 1: for a press pass. You can find the Biospace HHS
• 25:32
  Speaker 1: Leadership visualization and all of the sources we reference today
• 25:36
  Speaker 1: at the link in the description. Be sure to subscribe
• 25:38
  Speaker 1: on YouTube and follow us on our other channels so
• 25:41
  Speaker 1: you don't miss upcoming conversations. Do you have thoughts on
• 25:44
  Speaker 1: anything we discussed today, how FDA instability might be affecting
• 25:48
  Speaker 1: your portfolio or your company. Let us know we might
• 25:51
  Speaker 1: feature your comment in next week's episode. Thanks for listening,
• 25:54
  Speaker 1: and as always, keep innovating.
• 26:00
  Speaker 2: Two