Latest / BioSpace / Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay
Transcript
- BioSpace ediorial: Welcome to the Weekly By Biospace. FDA Commissioner Marty McCary could be out of a job, as President Trump has reportedly signed off on a plan for his removal. Meanwhile, one of McCary's signature programs to speed drug approvals hit a bump last week, as Sanofi has allegedly requested its application be removed. On the business side, Biospace unveils our annual compensation report. Was Eli Lilly's David Ricks the highest paid in 2025? Just a note, this conversation took place prior to reports that Marty McCary has decided to resign. We've kept that commentary because we feel it adds value. We hope you agree. Or was it J &J's Joaquin Duado? Stay tuned to find out. Hi. Hello. Just for our listeners out there, Jeff Axt is away in San Diego right now for a conference. So it is just Annali and I this week. Yeah, we're a small crew. So Annali, you had a couple of days off last week. How was that? It was awesome. My dad came up and we built my garden fence. I'm building like my dream garden in my backyard and it was a lot of manual labor. So I'm pretty happy to be back at my desk job this week, but it's been super, super fun. I have so much work to do. I'm just getting the soil today. So now it's now I just have to do it. Now I have to grow stuff. So is this going to be a vegetable garden? Both. I'm going to have flowers and vegetables. Nice. My mom is just itching to get started with hers, but we got frost this morning. Yeah. And for our listeners, it's a long weekend in Canada and this weekend is known as May long weekend. And it's supposed to be like across the country. It's supposed to be when you can plant your gardens. But this year we're going to go down to negative two, which is obviously freezing. So we can't plant and Canadians are very mad about that. Yeah, I mean, I guess it is a little earlier than the usual. I guess it's called the May 2, 4 weekend. I guess it's not May 24 yet. However, we are expecting, I think, 24 degrees Celsius. So I think my mom's going be able to plan this weekend. Yeah, I mean, it must have been just because it fell on like the second, I don't know, the way the weeks fell or something. it's early this year. We all feel like we should be camping and planting, but that will not be the case. Spring will get here. It just will. It has to. Well, for anyone who doesn't know Annali and I, I'm Heather McKenzie. I'm a senior editor here at Biospace and I curate the Clinica Space newsletter that hits your inboxes on Mondays. And I am Annali Armstrong. I am senior editor and I do the weekly Biofarm executive newsletter which covers everything you need to know in the C-suite. So Heather, while I was away, was there any news? That is an excellent question. So on Friday, we were we were all just wrapping up for the week and thinking about you and your garden. When we got word from the Wall Street Journal that on Friday afternoon that President Trump had signed off on a plan to remove Marty McCary from his position as FDA commissioner. This is Wild. I caught up on this report through you guys and you know, we had a text go out to those of us in the newsroom because you know, this is the kind of news we like to get out as soon as possible, even if it's over the weekend. Luckily that didn't happen. McCary stuck around for me to catch up on things better on Monday, but this is just so weird. Like the president has signed off on firing him, however he's still there. Like what do we know? Yeah, except that the president on Saturday morning said that he didn't know anything about this. So I guess he kind of talk-o'd if he had signed off on it before. The Wall Street Journal was saying according to anonymous sources, unable to speak because, you know, it's like for potential ramifications. So we don't really know if this is happening. McCary is still scheduled to testify tomorrow. And that says we record this on Tuesday. He's scheduled to testify on Wednesday before Congress. So we will see if that happens. It's on my schedule. Well, let's hope it goes forward. mean, no matter what, it's going to be interesting. imagine that's going to be question number one. Yeah. What else were we actually expecting from that hearing otherwise before this went down? Other than, know, are you still the commissioner? Yeah. I think he's, ⁓ know, rare disease has been a big focus and especially the kind of inconsistent approvals and rejections of recent rare disease drugs. So I have a feeling that will be on the agenda. But I'm going to get my popcorn and write ready to watch that at I think 1030 because that's going to be interesting. for sure. So I know that McCarrie potentially leaving. We also had the departure of CBER director Vinay Prasad apparently at the end of April. This is a lot of departure. These are really important offices. So what is happening? Yeah, you know, I was thinking I wrote an editorial and published it last week on transparency. I think it's the third one I've either written or co-written on transparency with the FDA or HHS in total in the past couple of years. But this right here, this speaks to the transparency issues that keep coming up with this administration again and again. Like, do we know one person, you know, three anonymous sources telling Wall Street Journal one thing and then... President Trump saying absolutely another thing on Saturday morning and FDA and press releases with McCary's quotes still in them. First, last month or in March, we had McCary telling us that Prasad was always supposed to be on a one year leave of absence from UCSF and that he was always leaving at the end of April. But they told us this, what, six weeks before he was to leave. So, and now we have this. Right. And like this all kind of speaks to like this regulatory chaos, this uncertainty that biopharma hates. How is the industry taking this right now? Yeah, well, Bevo Capital Markets said on Monday that it's a quote, likely a broad positive for biopharma. They attributed this to recent controversial decisions that I was just talking about ⁓ that appear to be inconsistent. had a quote, McCary's tenure has been anchored in trying to provide more transparency, but controversial decisions and inconsistency have mired this perception." End quote. Yeah. So if McCary is out, do we have any early names that are coming up as to who might fill this position? I don't know who'd want to with so much turnover at this agency, but somebody's got to be the FDA commissioner. Yeah, from what I've heard from different people, they're having trouble getting someone permanent at CBER. because of all the drama. But yeah, there have been several names floating around in the past few days, both as potential nominees for the actual commissioner position and to serve in an acting capacity. So on the nominee side, we have Stephen Hahn, who is an oncologist ⁓ who served, he served in the position before during Trump's first term. And Brett Giroir, a former acting FDA commissioner who also served under Trump. I remember both those names. I'm maybe more familiar with Stephen Hahn because I believe Brett Giroir was like, he was acting so he was kind of temporary. Yeah, I just can't see Stephen Hahn coming back to do this role again. know that might be a little wishful thinking on the parts of journalists who wrote that. This is according to rotors. And then in terms of the temporary potential replacements, we have FDA Deputy Commissioner Kyle Diamantis, who is in charge of the food part of the FDA right now, and Grace Graham, the agency's Deputy Commissioner in charge of policy, legislation, and international affairs. Sounds like a probably good title to have for that, good skills to have. And then Sarah Brenner is, well, now she's senior counselor to Secretary Kennedy, but Brenner has a bit of a sordid history. She was deputy FDA commissioner last April and she reportedly intervened in the review of Novavax's COVID-19 vaccine, if you remember that whole frouhaha. Yeah, that seems like a controversial choice as we know that the president has kind of said to Kennedy like, lay low on the vaccine stuff, know, take that kind of not behind the scenes, but he's told them to kind of lay off. putting someone like that in charge of the FDA would maybe fly in the face of that advice. Yeah, yeah, that would be an interesting choice for sure. But Kerry is indeed on his way out and they do go with one of these acting commissioners. It would be kind of fitting for the whole health department at the moment. So the leaders of the FDA's two key drug review divisions, CBER and CEDAR, are currently acting roles, as is the CDC director until Trump's most recent nominee is confirmed. It's really bizarre to think that you have that across those three key agencies at HHS. Like that kind of stuff happens when a transition is fresh, but we're like, what are we a year and a half almost into, not close to a year and half, into Trump's presidency and we still don't have permanent leadership at this agency. It's a little astonishing. know, Jeff wrote an editorial last week that's really excellent. It shows all the turnover that has happened in the past 15, 16 months at HHS. So check that out. It's really kind of a stark reminder of everything that's happened. So with all of this turmoil, are things proceeding normally at FDA? Well, they seem to be trying to make them proceed normally. had a couple of approvals in the past week. One of the CARES signature programs actually is the Commissioner's National Priority Review vouchers. ⁓ And this program ran into some bumps last week. Stat News reported that Sanofi has requested that TZLD, which is its diabetes delay drug, be removed from the program. And that's after Acting CDSEDER Director Tracy Beth Holt disagreed with staff that it should be approved for an expansion indication into adults and kids eight years and older with stage three type one diabetes. And that's when the body can't make enough insulin on its own and you might be getting to the point where you need insulin injections. do we have any indication of what happened behind the scenes there or like? Just another disagreement apparently with leadership and staff. Sanofi, I reached out to Sanofi, they would not confirm it. So this is just going by stats reporting. it's, yeah, you know, it's at the same time, though, the seventh drug did get approved under the CNPB program. So Partner Therapeutics, that's nice name, announced that it had received a voucher for bizengri to treat an ultra rare bile duct cancer. So it announces on Wednesday, and then on Friday, the FDA approved the drug in two days, apparently. Okay, interesting. Yeah, that's fast. I don't know if this is just a really, really late announcement ⁓ by partner or it's just somehow. I don't want to speculate, but yeah, that was seemingly a two day approval. And under this program, it's supposed to be shortens the review times from 10 to 12 months to one to two months, not one to two days though. So I don't know what happened there. Wow. So that is the FDA. But aside from all of that mess, we have another juicy report coming up this week. Yes. So I have spent the past couple of weeks behind the scenes digging through a company's proxy reports, which is my absolute least favorite thing to do, by the way. It's one of those things where I love, I love analyzing the data, but collecting it sucks. Cause it's just everybody reports their exact compensation differently, et cetera, et cetera. But anyways, I have done the analysis. am on the other side. So this week we're going to be kicking off our annual compensation report, which will end with. a special edition of the Biofarm executive newsletter later this month. You have to subscribe to get that. Please make sure you do. You can do that at the top of our website. There's a little white and red button that says subscribe. Make sure you're subscribed. So that is what you need to do if you want to get our compensation report. who is our top paid CEO? Wait, I bet I can guess. Is it David Ricks? Ding, ding, ding, ding. You have it right. Of course, it's David Ricks from Eli Lilly. He made $36.7 million, which is absolutely no surprise that they are just throwing buckets of money at this man. Lilly had a tremendous year in 2025. Their valuation briefly touched $1 trillion, which has never been done for a pharma company. So they are certainly happy with his leadership. One thing that's been pretty interesting is he's also been doing a victory lap. He's been doing a lot of media. He's really become the face of this kind of know, GLP one market. So yeah, this it's absolutely not surprising that he is the number one highest paid CEO in pharma. I am totally on board your yacht for an interview. Just so you know, that's yeah, yeah, We will come to your yacht. We will go on location, certainly. So and then in number two, we had Jane Jay's Jaqueen Duado. You know, he also made over $30 million. Again, there's no surprise. Jane Jay is the largest healthcare company. They have multiple units, so it's not just pharma. So largest healthcare company in the world, I believe. the CEO of J &J is always high paid. Another not surprise, we have more men named Robert than we do women, once again. never surprises me, but it always disappoints me. I know, I know. So if you're wondering, it's Amgen Merck. And who are the Roberts? But we did have two women. And actually some very interesting dynamic when we just look, we zoom out and look at the women. So GSK's Emma Walmsley was the highest paid women. She actually swapped places with Vertex's Reshma Kohler-Rahmani this year. This is interesting because Walmsley actually left her post at the end of 2025. She's been replaced by Luke Meals. But GSK made a really big effort throughout 2025 to get Walmsley's compensation up to better match her peers. So she did get a pretty big pay bump for 2025 and Meals, who has now taken over, is going to basically benefit from that. Although he's going to be paid less in his first couple of years, he's never had a CEO role before and they kind of, and whereas Walmsley had previously served as CEO. So kind of some interesting dynamics going on at GSK. Keep an eye out for Biofarm Executive this month as we will have more stories on the dynamics of CEO pay throughout the month. And again, make sure that you subscribe to ⁓ Biofarm Executive and all of our other newsletters so that you can get that special edition on executive compensation too. Well, that is it for us this week. We will be back with the whole team next week. And ⁓ yeah, enjoy your spring.