Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

First up is the Office of Generic Drugs.

We scooped on October 14th that Elan Murphy, who has been OGD director for about three years, has decided to step down.

Murphy will transition to become the office's associate director of regulatory science, and OGD deputy director Darby Kozak will become acting OGD director on October 19th, according to an email to staff.

Aside from the decision to move to a different role in the same office, which is not a common occurrence, Murphy's reasons for making the change were a bit surprising.

A source familiar with the decision told us that Murphy made the move because of the political pressure that she was under, as well as exhausting shared services issues that quote, "Quadrupled the administrative burden on supervisors." So to provide a little context, Murphy gained some attention when OGD approved a mifepristone generic in 2025.

That wasn't the first generic of the, uh, abortion drug, but anti-abortion advocates were outraged that the FDA made the move despite HHS Secretary Robert F. Kennedy Jr.'s intentions to conduct a safety review of the abortifacient, which they hoped would lead to more restrictions.

And the shared services issue stemmed from Commissioner Martin Makary's decision to move HR, IT, travel, and other staff out of the individual centers and into one combined group.

It was an attempt to cut duplicative activities and part of the Trump administration efforts to shrink the size of the federal government.

But this is once again a senior leadership change made during the Trump administration, which has included multiple center director changes.

OGD is a super office in CDER and carries a lot of importance at the agency because most prescriptions are filled with generic drugs.

The office also plays an important role in efforts to lower drug prices, which is a, become a big issue for the Trump administration.

So I, I guess I can't say I was surprised at the reasons that Murphy decided to step down, but I was a bit surprised that she moved to a different job within OGD.

Um, I guess I'm curious what you all think if, you know, taking into consideration everything that's, that's kind of factored into this, um, do you think it's a concern, you know, for, um, you know, acting Commissioner Kyle Diamantas or CDER Director Mike Davis that, you know, this sort of, you know, move hap- hap, you know, happened and for the reasons it happened? I mean, they are in the midst of a hiring surge and, you know, we've talked about many times before in this podcast, they're, they're trying to stem the departure of some of its more experienced staff.

Well, it's hard to know, uh, you know, exactly the, uh, um, the precise motivations of any one, uh, uh, person when they make a, uh, a move.

Obviously, having a, uh, a headline about, uh, political pressure, um, you know, at this juncture is, is not great for the administration, uh, um, because they've really sort of, uh, tried to emphasize that, uh, things are back on an even keel, uh, um, with Diamantas, uh, as acting director at, uh, um, at FDA, so that can't be good for them.

Uh, you know, like this is just me speculating, but I'm not, uh, um, you know, sure what, uh, um, uh, Murphy's, uh, um, uh, you know, tenure at, uh, um, at FDA and throughout the federal government, uh, um, itself, uh, has been, uh, um, in terms of perhaps, uh, becoming eligible for, uh, uh, retirement benefits, uh, you know, with more years of service and, uh, and the like.

So there are probably sort of, uh, you know, uh, factors beyond just the, um, you know, uh, the, the, the apparent strangeness of kind of moving into a, uh, different post in the same, uh, um, uh, the same office, yeah.

I believe, Derek, didn't your, didn't your story say that she was gonna be working on drug repurposing efforts?

Yeah, that was one of the things that was mentioned in the email to staff that she would be doing.

A- and that's certainly become a priority issue, um, in this administration.

I mean, we saw that with the leukovorin labeling change, and there was a big meeting a couple weeks a- a couple months ago with the Reagan-Udall Foundation on, um, repurposing efforts.

That, that's something that could not only provide access to people with rare diseases who don't have other options, it's also, um...

I see it also as a, uh, drug cost, drug pricing, um, approach, [clears throat] especially if you can repurpose generic drugs, uh, for people who, who currently don't have any, uh, on-label treatment options.

Um, but I think the turnover, leadership turnover in that office is concerning because while the general public [chuckles] may not be really aware of the Office of Generic Drugs, it is very important office within that agency.

As you said, it's a super office, does a awful lot of work every year in terms of generic reviews and approvals, and it is really a critical part of the drug pricing issue in this country.