Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12). #pharma #business More On These Topics From The Pink Sheet Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/ US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/ US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/ US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/

Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts

Citeline Podcasts

# Full Transcript

**Podcast:** Citeline Podcasts

## Participants

- **Derek Ingerie** (None)
- **Maisha Osman** (None)
- **Nielsen Hobbs** (None)

## Transcript

Hello and welcome to another edition of Drug Fix, the Pink Sheet's Pharma Regulatory Podcast. I'm Derek Ingerie, an Executive Editor at the Pink Sheet, and I'm joined by Senior Reporter Maisha Osman and Editor-in-Chief Nielsen Hobbs. Today is May 8th, 2026. FDA Commissioner Martin Makary had a busy week. Not only was he announcing several new initiatives in interviews and conference appearances, but he also was fighting for his job. We'll discuss all of it today.

First, we should tackle the vultures surrounding Makary. Reports surface that the White House is growing increasingly unhappy with McCary and his performance and that he should be fired in the coming weeks. The Wall Street Journal also piled on its opinion desk called for his removal in multiple editorials this week, criticizing his choice for acting CBER director, among other issues. Maisha, you were at the Food and Drug Law Institute's annual meeting where he was asked about this.

Did he offer any insights and how did you interpret what he said? Yeah, so, you know, after his panel, a bunch of reporters were there and he was asked whether he plans to remain at the FDA and his response was feeling good while giving a thumbs up.

So, it kind of, you know, it was an interesting response because he didn't exactly, to me, he didn't look very much sure about it. So, given all the Wall Street Journal editorials coming, and he mentioned that in his panel as well. So, like, they were about the editorials going after him.

So, yeah, we'll see because today also the White House is meeting with SBA Pro-Life America and they have been a big critique of McCary. So, we'll see. Yeah, I feel like Commissioner McCary has been embattled almost as long as he's been the commissioner.

Obviously, this is a very high-profile flashpoint at this juncture and there's a lot going on that could create pressure on him. You know, I honestly think that the Trump administration would not want to ask him to leave, you know, on abortion terms.

They don't want that news cycle going into the midterm. So, the more salience the abortion issue gets and the question is sort of why FDA hasn't banned Mr. Pristone and the law of pro-life activists.

I think that actually sort of could help him keep this job because, you know, from a political standpoint, it is not a topic that the Trump administration wants to bring more attention to. Yeah, then there is the Senate Appropriations Committee is holding a hearing and he will be there to testify. So, this will for sure come up.

And then I think his response might play out as well moving on. Yeah, I'm sure he's being well-briefed on how to respond to Mr. Pristone questions when he gets them next week. Yeah, I keep asking this. I'm going to keep asking it, actually. I've asked it. I'm going to keep asking it. Every time...

Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts

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Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.