Latest / Making Medicine / Unpacking Uncertainty: Trump’s Health Policies & Future of FDA | Press Pass with Nyah Phengsitthy

Transcript

Unpacking Uncertainty: Trump’s Health Policies & Future of FDA | Press Pass with Nyah Phengsitthy · Making Medicine

• 0:00
  Speaker 1: There's a lot going on.
• 0:01
  Speaker 2: We're seeing the Trump administration move very quickly. The frustration
• 0:05
  Speaker 2: is definitely there.
• 0:06
  Speaker 1: How do you sift the news from the noise?
• 0:09
  Speaker 2: The main friend and theme that I've been seeing. There's
• 0:12
  Speaker 2: a lot of uncertainty. There's always a certainty in the industry,
• 0:15
  Speaker 2: but I think right now is very present. It's very heightened.
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  Speaker 1: This is a new FDA, no doubt about it.
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  Speaker 2: We've been writing a lot about the vaccine industry, which
• 0:24
  Speaker 2: I wasn't really writing about before. There's so many knowns
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  Speaker 2: and unknowns.
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  Speaker 1: There's so much to unpack and yet also so little.
• 0:36
  Speaker 1: Hello everyone, and welcome back to the Making Medicine Podcast,
• 0:40
  Speaker 1: where science, policy and innovation meet. As always, I'm your host,
• 0:44
  Speaker 1: John Stanford. As we continue the rollout of the new
• 0:48
  Speaker 1: and improved Making Medicine Podcast, we'll be introducing our listeners
• 0:52
  Speaker 1: to new segments of the show. Today, we have Naya
• 0:55
  Speaker 1: Pang City from Bloomberg Law with us for a new
• 0:58
  Speaker 1: segment called press Pass, where we will feature different voices
• 1:02
  Speaker 1: in the media space who cover the issues affecting those
• 1:05
  Speaker 1: of us in the Incubate network. And now onto the show. Well,
• 1:10
  Speaker 1: thanks Nia for joining the Press Pass, where it's critically important.
• 1:14
  Speaker 1: You're central to so much of this conversation in the media.
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  Speaker 1: You've done such a wonderful job covering where policy and
• 1:22
  Speaker 1: the drug industry and making medicine all meet. So it's
• 1:25
  Speaker 1: natural that we would want to pick your brain a
• 1:26
  Speaker 1: little bit because there's a lot going on, and maybe
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  Speaker 1: that's the best place to jump off. What do you
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  Speaker 1: think are the biggest couple of headlines or trends that
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  Speaker 1: you're watching in the Trump administration?
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  Speaker 2: Great, well, thank you John for having me. It's great
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  Speaker 2: to always talk about everything that's happening in the pharmaceutical industry,
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  Speaker 2: especially as we're seeing the Trump administration move very quickly
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  Speaker 2: with some drug pricing policies, and there's a lot of
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  Speaker 2: action going on in congrege, especially with the One Big
• 2:01
  Speaker 2: Beautiful Bill recently passing. And then we're also seeing some
• 2:04
  Speaker 2: of the programs like the meta character of Priss Negotiation
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  Speaker 2: Program unravel under the Trump administration. I would say some
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  Speaker 2: of the biggest headlines that I have been writing about
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  Speaker 2: or have been digging deep into, really all I have
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  Speaker 2: to do with how the industry has been reacting to
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  Speaker 2: some of the Trumpetminstration's policies. Or introduction of policies. Let's say,
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  Speaker 2: so that is every time he makes news on tariffs
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  Speaker 2: that are coming or most wayfor nation, and his move
• 2:35
  Speaker 2: to revive that policy. We've been writing a lot about
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  Speaker 2: the vaccine industry, which I wasn't really writing about before,
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  Speaker 2: and it's been interesting to see how the pharmaceutical industry
• 2:48
  Speaker 2: has been reacting to some of our k Juner's actions
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  Speaker 2: with vaccines. But I would say the main trend and
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  Speaker 2: theme that I've been seeing as I am writing these
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  Speaker 2: stories and reactions to how industry is responding to President
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  Speaker 2: Donald Trump is there's a lot of uncertainty. And don't
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  Speaker 2: get me wrong, there's always uncertainty in the industry, but
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  Speaker 2: I think right now it's very present. It's very heightened
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  Speaker 2: because with this administration, we have little details on how
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  Speaker 2: these major things are going to affect the industry. So
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  Speaker 2: I think a lot of folks are on edge. But
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  Speaker 2: that's not to say that the industry is also appears
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  Speaker 2: to be optimistic to work with the administration. They seem
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  Speaker 2: to be clear about their concerns and uncertainty, but they're
• 3:35
  Speaker 2: also like, we look forward to working with the Trump administration. More.
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  Speaker 1: I think you hit on so much there that uncertainty.
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  Speaker 1: Here's why we on a regular basis turn to your work.
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  Speaker 1: I mean love reading the pieces you do. They're always
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  Speaker 1: so well sourced andsightful. How do you sift the news
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  Speaker 1: from the noise, especially in with President Trump. We can
• 4:00
  Speaker 1: see something announced and then it goes nowhere or is
• 4:03
  Speaker 1: it really going somewhere secretly behind the scenes. How are
• 4:07
  Speaker 1: you picking what to write about and what's real and
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  Speaker 1: what's maybe just an announcement that actually we're not seeing
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  Speaker 1: go anywhere.
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  Speaker 2: It's a good question. It's just a matter of keeping
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  Speaker 2: up with the industry. But I'm also watching very closely
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  Speaker 2: how they are responding to some of Trump's actions. A
• 4:27
  Speaker 2: couple of weeks ago, I just put out a story
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  Speaker 2: on pharma and bios lobbying efforts under the Trump administration,
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  Speaker 2: and there's been instances where they've quickly responded to some
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  Speaker 2: of the actions, for example MFN the vaccines, and then
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  Speaker 2: there's also been instances where they've kind of just been
• 4:44
  Speaker 2: like quiet. I think they're a little quiet on the
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  Speaker 2: vaccine stuff because Rfkjunior was moving so fast and they
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  Speaker 2: were like picking and choosing what they should publicly share
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  Speaker 2: Their concerns about So I would say that would be
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  Speaker 2: my news judgment is what is industry quickly responding to
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  Speaker 2: or what are they quiet about? Because if they're quiet
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  Speaker 2: about it, maybe they're kind of like holding back. And
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  Speaker 2: that's where I'm making my news judgment. I'm also seeing,
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  Speaker 2: you know, what exactly is the Trump administration focusing on
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  Speaker 2: most like with I also cover FDA, and you know
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  Speaker 2: there's a lot in the drug space there, but we
• 5:20
  Speaker 2: see that ARCA Junior is doing a lot with food.
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  Speaker 2: So I've also had to like shift my you know,
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  Speaker 2: might beat to more of like the food space as well.
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  Speaker 1: Yeah, you have to keep up with the policy makers
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  Speaker 1: and that is that's a dynamic field these days. You
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  Speaker 1: talked a little bit about the FDA, and I want
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  Speaker 1: to stay there for a second. This is a new FDA,
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  Speaker 1: no doubt about it. And we also saw recently the
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  Speaker 1: beginning of the conversations about the reauthorization of the FDA,
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  Speaker 1: some stakeholder meetings. You know, the early stage ecosystem definitely
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  Speaker 1: has thoughts about how the FDA can best serve the
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  Speaker 1: American people. But both I suppose, both in the macro
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  Speaker 1: and the micro. Where do you see the FDA going,
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  Speaker 1: what do you see Congress doing, if anything, to put
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  Speaker 1: their stamp on the agency or is it really under
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  Speaker 1: its new leadership, going somewhere that you hadn't anticipated.
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  Speaker 2: I think it's all of it. Like I see, I
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  Speaker 2: would say what I noticed quickly about this FDA particularly
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  Speaker 2: is one thing that they continue to say over and
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  Speaker 2: over again in you know, all their press releases or
• 6:36
  Speaker 2: when doctor McCarey, the FT Commissioner comes out and makes
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  Speaker 2: an announcement, is that they want to work with industry.
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  Speaker 2: They want to hear their problems, in their concerns. But
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  Speaker 2: I think industry is just kind of like, you know,
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  Speaker 2: feeling uneasy because they're moving so fast, you know, with
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  Speaker 2: these new policies, introducing changes through medical journals or you know,
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  Speaker 2: introducing things on X so I think they're a little
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  Speaker 2: worried about that. But FDA continues to do that. But
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  Speaker 2: I will say, you know, going back to my main
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  Speaker 2: point is that they want to work with industries. What
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  Speaker 2: it looks like. And we see Mancerrey, who recently did
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  Speaker 2: the CEO listening tour with the pharmaceutical industry, which is
• 7:17
  Speaker 2: a big deal, and he seems to be meeting with
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  Speaker 2: leaders on how to make FDA more efficient, and I
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  Speaker 2: think it also comes down to like what efficient means
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  Speaker 2: and who gets to say a FDA.
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  Speaker 1: Yeah, another sort of magic word that I hope folks
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  Speaker 1: take away listening to this is is efficiency and that access.
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  Speaker 1: I think you're right that the door has been open
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  Speaker 1: for conversations. Industry may not always love what they're hearing
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  Speaker 1: in those conversations, but the conversations are there. And then
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  Speaker 1: I think you said something earlier that I wanted to
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  Speaker 1: come back to of the little details are missing in
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  Speaker 1: your conversation with stakeholders industry vcs that how challenging is
• 8:01
  Speaker 1: it for them to react to these policies that may
• 8:05
  Speaker 1: be nothing more than a few sentences long at best,
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  Speaker 1: maybe even just a post on X proposing something that
• 8:11
  Speaker 1: would really shift their value chain. How is that frustration
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  Speaker 1: something you hear a lot.
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  Speaker 2: Yeah, the frustration is definitely there, and it was even
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  Speaker 2: there for me when I was writing my story about
• 8:24
  Speaker 2: you know, their reactions, because when I spoke with the industry,
• 8:27
  Speaker 2: they're like, well, we don't really have a reaction because
• 8:30
  Speaker 2: there's not much to react too. So I think the
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  Speaker 2: best that they you know what they're doing, best right
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  Speaker 2: now is you know, sitting back and trying to prepare
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  Speaker 2: as much as they can. I talked to a couple
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  Speaker 2: of stakeholders who are like, there's so many knowns and unknowns.
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  Speaker 2: I think right now they like labeled the Medicare DIRUCT
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  Speaker 2: price egotiation as like a known unknown, like they kind
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  Speaker 2: of are grasping it, they know how to deal with it.
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  Speaker 2: It looks like the TRP of administration is moving, you know,
• 9:00
  Speaker 2: ahead with it fully. But then there's also like the
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  Speaker 2: unknown with MFN and tariffs and just the other executive
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  Speaker 2: order that you know seeks to lower drug prices that
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  Speaker 2: Trump signed earlier this year.
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  Speaker 1: Yeah, there's there's so much to unpack and yet also
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  Speaker 1: so little. It's it's a paradox. Very grateful for the time.
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  Speaker 1: But before I let you go, maybe you could tease,
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  Speaker 1: are there a couple of things that you're working on
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  Speaker 1: that really have caught your attention or other places where
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  Speaker 1: you really want to dig deeper to understand this space more.
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  Speaker 2: Yeah, there's so many. It's been so busy this year,
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  Speaker 2: as you were aware. But I think one thing that
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  Speaker 2: you know, as you know, I'm a very big drug
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  Speaker 2: pricing nerd, and a lot of the stories I write
• 9:46
  Speaker 2: are very wonky, a niche for Bloomberg Law. But recently
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  Speaker 2: I've been digging deep into the draft guidance for the
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  Speaker 2: third cycle of the Medicare Drug Price Negotiation program. What's
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  Speaker 2: interesting about that is, you know, it's kind of trump
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  Speaker 2: first take and you know, of the program, or his
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  Speaker 2: administration's first take of the program. He's also taking on
• 10:08
  Speaker 2: a big cycle, a major cycle, because it's where we
• 10:12
  Speaker 2: introduce Part B renegotiations. He works a new ground when
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  Speaker 2: I say, hey, I really am talking about CMS, CMS
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  Speaker 2: broks new.
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  Speaker 1: Ground on it. All funnels up, yeah, on.
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  Speaker 2: Fixed dose combination drugs in the guidance. So I think
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  Speaker 2: we're really watching for how this will unravel, because I
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  Speaker 2: think this program is like one of the biggest, you know,
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  Speaker 2: things that the industry is watching for, and we'll know
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  Speaker 2: like by fall, this final guidance you know what's in
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  Speaker 2: there and how Trump will take on this program. It's
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  Speaker 2: also it's also going to be an interesting guidance because
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  Speaker 2: if I'm correct, I've heard from drug makers who say
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  Speaker 2: they're anticipating you know, information in there that will talk
• 10:55
  Speaker 2: about the Orphan Cures Act implementation and how they can
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  Speaker 2: move forward with that, which is you know, something we're
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  Speaker 2: watching for writing about as well.
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  Speaker 1: Yeah, I think we're so grateful how the quality of
• 11:08
  Speaker 1: the coverage you provide on things like ipay, And you're right,
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  Speaker 1: it is a pivotal moment we walk into Part B.
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  Speaker 1: Maybe i'll steal in another question of just saying with
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  Speaker 1: Part B, physicians take their seat at the table to
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  Speaker 1: some extent, and you know, at full transparency, Incubate was
• 11:27
  Speaker 1: opposed to this price control program. We also think even
• 11:31
  Speaker 1: if there's going to be one, it's got flaws the
• 11:34
  Speaker 1: pill penalty where glad orphan cures is done. Do you
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  Speaker 1: think the dynamic changes at all a little bit that
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  Speaker 1: the people being hurt by this program expand in twenty
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  Speaker 1: twenty eight to include physicians or do you not see
• 11:53
  Speaker 1: that as a tremendous factor.
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  Speaker 2: I think it's a big factor. I think a lot
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  Speaker 2: of the know. I've really spoken with attorneys in groups
• 12:02
  Speaker 2: about Part B because I was really the only writing
• 12:05
  Speaker 2: about Part D first, So this was like a steep
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  Speaker 2: learning curve for me to understand. You know, who are
• 12:11
  Speaker 2: the players in Part B. But you're bringing in more stakeholders,
• 12:13
  Speaker 2: You're bringing in new players in the drug supply chain.
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  Speaker 2: So I think the question is how is CMS going
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  Speaker 2: to take that, you know, take that into consideration and
• 12:25
  Speaker 2: get feedback from physicians and those who you know are
• 12:28
  Speaker 2: distributing these Part B drugs under the program. I think,
• 12:33
  Speaker 2: you know, if I'm correct, they plan on doing more
• 12:36
  Speaker 2: listening sessions, so I think and stakeholders are hoping that
• 12:40
  Speaker 2: they can share their concerns, questions, comments, and listening sessions,
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  Speaker 2: but we'll only see how CMS will react to that
• 12:47
  Speaker 2: through a final guidance.
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  Speaker 1: Yeah. Well, really appreciate your thoughts. Nothing happens in a vacuum,
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  Speaker 1: so CMS is going to be doing that while also
• 12:57
  Speaker 1: navigating a trillion dollars out of Medicaid and how's that
• 13:01
  Speaker 1: going to impact hospitals and of course orphan cures implementation.
• 13:06
  Speaker 1: So it is so much to cover, but we are
• 13:09
  Speaker 1: so grateful that you took time out of your busy
• 13:11
  Speaker 1: schedule to join us for a press pass episode and
• 13:14
  Speaker 1: really grateful you could be here today.
• 13:16
  Speaker 2: It was great chatting with you, John, Thank you so
• 13:18
  Speaker 2: much for having me.
• 13:19
  Speaker 1: That's all for this press pass episode of the Making
• 13:22
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• 13:26
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• 13:27
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