WRFH/Radio Free Hillsdale 101.7 FM - Bautista Vivanco: Why Are Americans Still Waiting for Life-Saving Drugs?

Episode Date: September 26, 2025

While patients in Canada, Europe, and Australia access life-saving therapies, Americans are left waiting, sometimes decades, due to the FDA’s rigid bottleneck. Bautista Vivanco, a Young Voices contributor and Research Associate at the Department of Health Policy Studies, where he analyzes FDA drug approvals, the budgets of health-related government programs, and global health indicators, joins WRFH to discuss.

Hello and welcome. You're listening to WRFH Radio Free Hillsdale 101.7 FM. I'm Malia Tipido here today with Bautista Vianco, a young voices contributor who recently authored an article for the Cato Institute about how the U.S.'s drug approval process directly harms Americans. Hi, Batista. Thank you for joining today. Hi, Malia. Thank you very much for inviting me. Yeah. Could you tell us first a little bit about yourself and why you began researching this topic? Absolutely. So as you can probably note by the accent, I'm originally from Argentina, but I came to the United States to study political science and economics. I graduated about two years ago. And since then, I've started working on think tanks around the D.C. area, mostly free market areas. oriented think times. And I've been working on focusing on healthcare in particular for around the last year, I would say. And this topic, this article is the result of a study that I conducted from after getting access to the list of the entirety of all the drugs approved in Canada. that, I was able to obtain that and then contrast it with the list of all the drugs approved

by the FDA in the United States. And we obtained some pretty interesting results, I would say. Okay. So your results, if I'm getting ahead of you, are that the FDA doesn't approve a lot of the things that the rest of the world has already used for many years. Could you walk us through the process of why getting a new drug in the US is so much harder than the rest of the world? Absolutely. And yes, just if we want to get a little bit on the specifics, usually when you talk to people about how many medicines you think are available in Canada, which is just across the border that are not available in the United States, people would say, well, you know, maybe a few, perhaps a dozen. Well, we found 69 different drugs that range from things like more benign, I would say,

like sunscreen or anti-eaching medicine to things that can be truly life-saving or they can change the lives of patients, like the first ever once-weekly diabetes or insulin injection, medicine that is used for the treatment of to help with the treatment of Parkinson, some that are used for assistive reproductive therapy. So it's all across the board. And one of the reasons these drugs are available in Canada, not in the United States, is because regulators in America are much more, the burden of proof that is set for the manufacturer.

of drugs in the United States, it's set much higher than in other countries. That means that if you want to approve a drug in the United States, you usually have to met a much higher standard than you would need in other countries. So usually you would have to do at least two randomized control trials. And for the most part, regulars at the FDA would want you to use data only from American populations, so not from people from other countries. This, as well as the very, very, the length of this entire process, which can take many, many years, sometimes disincentivizes manufacturers to seek approval altogether. Okay.

So hearing that, on the surface, you might think, isn't that just a higher standard of proof necessary that would make American drugs safer. But what would you say about our approval process crosses the line from having high standard to prove safety? Like what crosses it to blocks proven medicines from being usable? Well, you would think that this is a good thing, that that means that American drugs are safer and that they're better. But the problem here is that we are talking about options of care for,

people. There are many, many, many patients in the United States that die before getting access to the care they need simply because regulators think that the treatment that might be used for their condition doesn't meet their standards. This is problematic because ultimately, I personally believe that patients should have the right to choose how they want to treat their condition. and how they could seek to improve their health. But the problem is that if bureaucrat, the FDA, doesn't believe so, that's not saying that it's important for you to access a certain treatment, then it's illegal for you to do that.

And so if you ask me, I would say it's a very grave infringement in the freedoms of these patients, many of whom could be even in experiencing terminal conditions. So it can be very sad. So about the FDA in their lengthy approval process, do you think that there's some effect that the FDA being a bureaucracy has on the length and the standard of proof that is necessary? Yes. So there are a number of policies that the FDA follows that is lead to this. burden of proof to be much higher than other countries, but in many cases, these are unnecessary burdens that don't really equate to gains in quality. I think I mentioned previously

how some of the, one of these requirements, for instance, is that the data I use for approving a drug in the United States has to come from an American population, has to come from trials perform on American patients. There is, beyond the higher consumption of maple syrup, Canadians are not that different from Americans in terms of their physiology. So it makes no sense that data from Canada cannot be used to also approve trucks in the United States, but bureaucrats seemingly arbitrarily chose to do that. And then there are other things like the, as I mentioned, the necessity of randomized controlled trials to prove both the safety and the efficacy of this trucks.

because the FDA doesn't just make sure that these drugs are safe. It also has to make sure that these drugs are efficacious. That is the legal mandate that it has. It's a whole other level of not just trying to protect the public, but just trying to get even beyond that. And that leads to some bad consequences, as I described here, meaning that other countries have treatments that are just not approved in the United States. What would you say that it takes for the FDA to change its rules and regulations regarding

like restrictions and banned medications? Well, I would say that ultimately this will require a very profound push by the patients. But it's tough, you know, because if whenever the FDA approves the drug that it's safe and efficacious and that patient, get access to a new treatment, usually nobody's there to pat these bureaucrats in their back. Nobody's there to give them a star and say, good job. But if they make a mistake and they approve a drug that is not efficacious or that it's not safe, then they need to go and talk to Congress and explain to the people why they make the mistake. And maybe some of them, some of these bureaucrats can lose their job for something like that.

So they have a real incentive to not approve as many drugs as they should because not a lot of people would go and complain to the FDA. It's a certain drug is not approved if a certain treatment option does not pass their standard. So the incentives are lined up incorrectly. And I would say that until patients across the United States realize at the real cost that the FDA inflicts on their liberties, on their freedoms, on their right to choose their own healthcare, then it's very unlikely that anything is going to change and improve regarding the FDA. Okay. So as you said before about the rigorous testing, many of the overseas medications you cited in your articles weren't approved because they decided. decided that the cost of the trials would just be too much for them. How would you propose we could solve this without compromising the safety standard?

And is that just bringing more awareness? Well, to be fair, we don't know exactly the reason why every single one of these drugs was not approved in the United States or why the companies chose or did not choose to seek approval in the United States. But I would say one of the reasons, one of the ways in which we could assist drug manufacturers to engage in producing more drugs and trying to seek approval is ultimately by streamlining the approval process, so that, for instance, it requires, it could be a little less strengthen, for instance, require only one randomized control trial instead of two.

but my favorite way in which we could very rapidly improve all this situation would be simply by accepting or recognizing drugs that have been approved in other countries and immediately granting those drugs approval in the United States. That is not unheard of. Israel, for instance, immediately approves drugs from Canada, the European Union, the United States, and I believe Australia as well. So this could be something that will be able to streamline the process a lot. And whenever a manufacturer gets safety approval from, we could be a country, any country from the OACD, it could be just Europe and Canada. Policymakers can choose what standard they prefer. But that would make it much, much easier for manufacturers.

Right. You're listening to WRFH Radio Free Hillsdale 101.7 FM. In case you missed it, I'm Malia Tibur with Bautista Vivianco, a young voices contributor who studies federal drug regulation at the Department of Health Policy Studies. I wanted to ask you because I'm really interested in the case of insulin iodic. You mentioned both in your article and a few minutes ago. Could you go over what it is and what caused the FDA to reject it specifically? Well, this is actually a really interesting drug. It's pretty revolutionary.

So I don't know if you have anybody in your family or if you know someone that suffers from diabetes. I believe it is people with type two diabetes that they need to take insulin shots. I could be mistaken that I'm not a physician. But ultimately, some people with diabetes that need to take regular shots of insulin. The manufacturer of this drug, Insulin IcoDec, is Novo Nordisk, and they were able to come out with a compound, which is an analog of insulin, that has the benefit that you can only, you can inject it only once per week, and it allows you to maintain regular levels of glucose of sugar in your blood. It is pretty remarkable.

it has gained approval in Europe, as I mentioned in Canada and in many other countries. The problem is that with this particular drug, whenever the manufacturer tried to seek approval in the United States, the FDA, the regulars at the FDA considered that the risk of, well, one of the possible side effects was that some of the patients in the study that they did were able to get, a small spike on their sugar levels of their glucose. And that was recent enough for the FDA to block the approval. It's interesting because after that, the manufacturer came to the FDA and said, well, we're willing to work with you to try to address this.

We could perhaps make sure to put on the box in indication saying that there might be some risk of spikes in glucose. we could make sure to educate the physicians so that the physicians were only prescribed this if they know that this spike in glucose would not be damaging for their patients. But they were really just trying to work it out. But the regulators just said, no, thank you. And so they sent them back to the drawing board. So this was a particularly, I would say, a terrible case of, over-regulation, if you ask me, especially since there were other ways in which we could have

educated the patients so that they would be able to understand the risk associated with this drug. So, yeah, it's very sad. Yeah. You talked about the right to try before, and I believe that has come up in the first Trump administration. Could you talk more about that? Yes. So the right to try is is this idea that patients should have, especially terminally ill patients, should have the right to try drugs, treatments, medicines for their conditions. Even if these drugs or medicines have not gained full regulatory approval, if all the agencies, including the FDA, have not given their complete approval for these. And so ultimately, this was a particularly strong movement that I think

got kickstarted during the AIDS epidemic in the 80s and 90s, and it ultimately concluded in the passing of the Right to Tri Act in 2018, which thankfully has given some flexibility to patients to be able to obtain the treatments that they need without being blocked by the government. On a more, I guess, politically philosophical level, you, in your article, cited a few Cato Institute publications, which argued that the FDA's existence itself infringes on your rights to self-medication. Could you go more into detail about that part? Correct. Well, I mean, I would have to disclose here that my opinions are not the ones of the Cato Institute, but I would be in full agreement with that statement. Because ultimately,

what we're talking here are risk assessments. Whenever you make a... any decision what it is to travel by car, to put a helpman whenever you're riding a bike, or to eat the sushi from a gas station, you are making a risk-benefit analysis. The problem of the FDA is that because of its existence indicates that the government is doing that selection for you, is weighing in and comparing the risk versus the benefits of you being able to take a certain medicine or a certain drug. So a decision that should be done at the personal level, maybe even with the consultation of a physician or someone that you trust, is ultimately done by someone that has, well, if they make the wrong decision, they don't have to pay the costs from that. So it's a complete infringement on your right to ultimately decide what path do you want your life to go.

And in this way, it quite literally is an infringement on your right to decide the treatments that you want for the conditions that may or may not be very, very impactful for your life. Right. This might subjectively have more value to you than it would to them. Well, I would say, for instance, that if you can ask a person with diabetes, how much would they value the possibility of have insulin ICOTEC and on. only have to take the, inject themselves with insulin only once a week instead of daily or multiple times a day. And I can guarantee you that they probably will have much, they will perceive more benefits from that than your average FDA regulator. Do you think that Big Pharma lobbying has anything or can be held to account on why it's so hard to get approval in the U.S.? I would say that that is a factor, yes, because ultimately

having these barriers of entry for the drug market being the FDA regulations ultimately end up benefiting the bigger players. We're talking about really big corporations that have a lot of money, lawyers, experience. They usually even hire people that used to work at the FDA to assist them in their process of approval. So they get a leg up on the system, whereas like more smaller, nimbleer, innovative startups, they usually don't have those benefits or those resources. So this is ultimately a system that ends up helping them the incumbent.

In these cases, the big drug manufacturing companies and ultimately harming innovation, but also the health of the American patients and consumers. Recently, Trump's appointment of RFK Jr. as Secretary of Health and Human Services has stirred up many. Do you think that this appointment will help or hurt American success with drug regulation? That is a really good question. I personally don't perceive RFK as being a particular fan of deregulation. I do not know how much Milton Friedman he has read, but I would not bank on that. But if anything, though, I would say maybe the greatest benefit that we might see from him being appointed the Secretary of Health and Human Services is that it has brought attention. Your average voter, your average person on the streets now has a much greater understanding of these agencies, the role they play.

and in many cases how government action on the health policy impacts them directly. So it has allowed more people to understand truly how this over-regulation and government meddling in this realm can impact them very, very directly. So hopefully this will lead to some positive changes in the future. Yeah. Thank you for joining us today, Batista. Where can people follow your work? Yeah. I am active on Twitter, threads, and Instagram.

You can follow me and you can find me as Bautista Vivanco. All righty. This has been Malia Tibido with Bautista Vivanco. Thank you for listening to WRFH Radio Free Hillsdale 101.7 FM.