Trump Plans to Fire FDA’s Makary After Tumult at Agency

0:00 The FDA since the, uh, change in administration.

0:04 And they are obviously the appointment of, uh, Robert Kennedy junior to HHS,

0:09 which oversees because some of this has been in quite a bit of flux.

0:15 Uh, the center for, uh, Drug Evaluation and Research Center,

0:19 which takes up to drug approvals, looks after drug approvals.

0:24 That head has changed.

0:25 The center for Biologics Evaluation and Research,

0:27 which takes up to it, looks after vaccines and gene therapies, etc..

0:31 Got a new head, uh, Vinay Prasad that had left or was fired which way he was.

0:37 And then he came back again and now he's going again.

0:39 So there's been a lot of flux.

0:41 And when you get flux, are they fired?

0:42 I don't know, 3000, 3500 individuals.

0:44 Um, maybe I don't have the exact number, but something in that sort of region,

0:49 you know, that's this is a lot of old time knowledge that's left at the agency.

0:54 Some refresh is pretty good, but that all of this has happened under the, um.

1:00 uh, the caretaker ship of mighty MacQuarrie.

1:05 And to all intents and purposes,

1:06 the folks I talk to say that he's a perfectly knowledgeable, wonderful man.

1:10 I have friends on this on the bi side who

1:14 say to me that he's been very good to them.

1:16 And then, on the other hand,

1:18 we hear all these issues and somebody takes having issues, etc.

1:21 so I wouldn't be surprised if there's something happening here.

1:24 What has Marty MacQuarrie done?

1:26 Well, I mean, I think about from a personal point of view,

1:29 he's made, uh, estrogen patches more accessible

1:31 for women who are suffering through menopause.

1:33 And that's something he's written about in his book as well.

1:36 What has he done that, you know,

1:38 will kind of service his legacy if he does end up leaving?

1:42 Well, I think what was what's been good is

1:46 that he's much more available for us to hear from.

1:49 You know what I mean?

1:50 He does Twitter videos,

1:52 sit down and discusses and brings ideas and wants to make animal testing less.

1:59 Uh, I required.

2:01 He wants to get drug development timelines shortened.

2:06 They've done some deals with, uh, fast Zeneca and one of the former company.

2:09 I'm gonna think, to try and reduce the time of drug development,

2:12 which gives pharma companies the ability

2:14 to bring drugs faster to, to to patients.

2:17 What the problem is, is that there's been all this upheaval

2:21 and issues with not knowing exactly what to expect.

2:25 Having had a deal with the FDA, when you go back with your data and, you know,

2:29 bring some of these things in to public conversation where it

2:31 shouldn't have been done so that there's pluses and minuses here, unfortunately.

2:36 And what the FDA now needs is a solid, a good,

2:40 solid pair of hands that just just gets the gets down

2:43 to the business of looking at the safety and efficacy of drugs.

2:48 Sam, if you know, you know, when you talk to your, uh,

2:51 pharma companies and biotech companies, is it harder to get stuff done today?

2:55 Um, under this administration,

2:57 easier about the same puts and takes kind of what's the overall view.

3:01 But yeah I would say puts and takes a it's

3:03 a perfect phrase here because it depends who you talk to.

3:06 It depends whether you talk to them in public or private.

3:09 If you talk to, you know, nobody wants to upset the agency because if you

3:12 already have some trouble or some problem or some friction,

3:15 why would you want to add to it?

3:16 So if you look at what companies are saying publicly, everything's fine.

3:20 But then companies go and say, well, you know,

3:24 we've had this drug discussion with the FDA.

3:26 This was what we were told to do.

3:27 We did it.

3:28 And now they say no.

3:29 So there's some of that going on, which of course is reality.

3:32 So I think it all depends on, uh,

3:35 on who you talk to when you talk to them in what setting?

3:39 You know, I think I think that folks would mind the change here.

3:43 Um, before we let you go, Sam, I got to ask you about the hunt of virus.

3:46 Um, that is a big issue with one of the cruise ships.

3:49 Um, we know that Gene Hackman's, uh, wife passed away from this as well.

3:54 And so this is something that's kind of been percolating.

3:56 But how concerned should we be about the hantavirus.

4:00 Yeah, and three people have perished on the boat, which is obviously very sad.

4:04 And, uh, at the with with the current knowledge that we

4:07 have about these viruses and there have been other outbreaks before 1993,

4:11 there have been transmissions to humans,

4:13 and it's a virus that doesn't transmit that easily.

4:17 It's not like Covid.

4:18 They just have to breathe someone's breath

4:20 that live in a restaurant and you catch it.

4:23 Um, this is this requires much closer contact,

4:26 a much higher duration of, uh, exposure.

4:28 And, uh, quarantine is the best way to to silence it and you.

4:33 But but you need a functioning CDC in the US that's on the ball,

4:38 finding people who've traveled back and isolating

4:42 them and finding their contacts and isolating them.

4:45 That's the best way to do it.

4:46 Don't forget though.

4:48 Scarlet viruses do have a nasty habit of, uh, mutating.

4:52 So we should always have that little thing in the back of our mind.

4:55 That's what we don't want to happen.

4:56 The more you allow it to transmit to people, the more chance it gets.