Ep. 118: Holly Fernandez on the Ethics and Practice of Pre-Approval Drug Access through Expanded Access vs. Right-to-Try

Niklas (0:01)

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All right. So today is September 24th in 2026, and my guest is Holly Fernandez Lynch. Holly is associate professor of medical ethics and law at the University of Pennsylvania, and one of the most influential voices in US bioethics. In questions around clinical trial ethics, patient access, and research participants' compensation and ethics. So we're starting off from different positions, right? Holly was an opponent of the Federal Right to Try Act, which I agree with in spirit, but it has not been very effective, I must admit. And I'm now actually working on state right to try laws like Montana's SB 535

Holly and I have been introduced by a mutual connection and really enjoyed each other's open-mindedness to discuss issues.

We initially disagree with on, but actually with a desire to find better policy solutions based on agreement. And we found ourselves actually in much agreement that we need fresh ideas in the current time, especially around patient pre-approval access, which is something Holly has worked a lot on. So in this conversation today, we'll debate first principles behind medical regulation, patient rights, and economic innovation. And we talk about past attempts and failures to develop fresh ideas for pre-approval access. So Holly, welcome to the show and feel free to add anything to your background that listeners should know about you.

Holly Fernandez Lynch (2:02)

I think you got it all. Thanks so much for having me. I'm looking forward to this conversation.

Niklas (2:06)

Fantastic. I'm just like hearing an echo on my side. Let's see if I can do echo cancellation here.

But as long as it's okay for you, it's okay for me.

Holly Fernandez Lynch (2:18)

I'm not hearing any echo.

Niklas (2:19)

Okay, good. Yeah, Holly. So what are you currently working on most?

Holly Fernandez Lynch (2:25)

So most of my time is spent working on FDA regulatory policy and thinking about what are the appropriate standards for approving new medical products. But I especially focus on rare disease drug development in the context of drugs that are being researched in order to address unmet treatment need. And that's where FDA has the hardest time because it has to make these trade-offs potentially between speed, getting promising products to patients as quickly as possible, and certainty. Some of these rare disease contexts or certain types of products, it's very difficult to study them in traditional trials.

So we might not have the perfect answers about safety or effectiveness before a product is allowed on the market. So I spend a lot of time thinking about that.

I'm thinking a lot about Montana these days and novel approaches to allowing patients to try things before they have FDA approval. And then my side work on the oversight of clinical research. So I think a lot about the quality of ethics review boards that are responsible for deciding what research is allowed to proceed.

Niklas (3:41)

For sure, we'll get to that. I'm curious to kind of understand a bit your environment, right? So you've been in this for a long time. You've seen many different administrations. Today, there was a hearing of a potentially new FDA commissioner, Heidi Overton, that I watched.

And I'm curious. So having seen many commissioners and administrations, how much does sort of the political preference or the current administration actually matter to FDA? Because FDA also has career bureaucrats that have been working on these issues often for decades.

Holly Fernandez Lynch (4:16)

Yeah, I'm so glad you asked about it, because who leads FDA matters a lot, as we've seen in this administration when we've had a few different leaders in place.

It matters in a couple of different ways. One is just the level of confidence industry has in FDA leadership to be consistent, fair, apply the law in a way that will be predictable.

So we know that when there's a lot of turmoil at the agency, that's difficult for regulated industry, which has to make judgment calls about what trials to do, how to design those trials, what evidence is going to be convincing to the regulator, right? They need to make those decisions over the course of more than a decade, right? And they need to know if we decide that we're going to take this approach and it's going to convince FDA at point zero, that when it comes time for those data to be submitted in a marketing application, they're not going to get the rug pulled out from under them. The other reason, I'm glad you asked this question, because the other reason that it matters is that I think there can sometimes be a misperception about what type of agency FDA is. And we saw this come about quite frequently in the context of COVID, where there was discussion and debate and you heard people say, like FDA should just follow the science, as though science could answer all of these difficult policy questions. Science is critically important to FDA's work. It shouldn't make decisions that are contrary to the science, but the scientific evidence does not tell us what policy decisions should necessarily be made. So if I'm studying a new drug for ALS, for example, I might have some helpful clinical trial data that points in a particular direction on this primary endpoint, but I've missed this other primary endpoint, and maybe I've got some good evidence on the exploratory endpoints, and I've also got patients who are saying, we're willing to accept uncertainty and risk, right? So the trial data do not necessarily tell FDA what it ought to be doing in any given case. So why am I mentioning that in response to your question about FDA leadership? It is the role of FDA leadership to set the tone for the entire agency about what trade-offs are appropriate, right? So we heard, at least, I didn't watch the hearing today, because I had other things going on, but I saw coverage of Heidi Overton's comments, and one of the things that she said was, the White House wants me to go fast.