Do Americans Really Get Access to New Drugs First?

Ashish Jha: 00:00:06

Hey, everybody. Ashish Jha, here from a sunny, but cold or getting colder, Rhode Island, Providence, Rhode Island, for another episode of a moment in health where today we're going to talk about a data point, a study, and answer a question, exactly what we do every week. And I'm going to jump right into it. The data point I want to talk about is 70% seven out of 10, more than two thirds. What is that? 70% of parents are opposed to removing public school immunization requirements in their state. This is according to a Kaiser Family Foundation poll, with Florida becoming the first US state to announce plans to end immunization requirements for public schools. A vast majority of Americans, Democrats, Republicans, liberals, conservatives, still believe that immunization requirements are necessary. Look, most immunization requirements happen based on like at the state, or sometimes at the community level. And having a state say to a community you cannot do this is deeply irresponsible, and I think states should be allowed to make those decisions ultimately. But if you want to allow kids to be able to go to school safely, then immunization requirements are really important part of that we know that, especially since these vaccines have been widely tested and widely found to be safe and highly effective, we're talking about vaccines like against polio and measles and mumps and rubella and all that stuff. So it was interesting to hear that 70% of American adults don't just support use of vaccines. They oppose getting rid of immunization requirements. That's your number of the week.

Ashish Jha: 00:01:51

Okay, I want to stay on the vaccine theme and talk about the study of the week. The study of the week comes from the October 15 2025 issue of JAMA Network open, and it is entitled first trimester mRNA covid, 19 vaccination and risk of major congenital anomalies. So one of the fear sort of things that people have said is somehow vaccines are not safe in pregnant women. Even our Health Secretary has talked about not giving pregnant women Vax covid vaccines, unclear from him whether that's safety of the of the mom or the safety of the child that's driving his concern here that we know. We already know that pregnancy is a high risk moment in terms of covid and being vaccinated reduces the risk of getting seriously ill during pregnancy. This study looks at what happens to the babies, and it comes from a registry of all live births from the country of France, from France for pregnancies starting in April 2021, through January 2022, more than 527,000 eligible live born infants, half a million, about a quarter of whom were exposed to at least one vaccine during the first trimester. First trimester is critical, because that's usually the time where major organs form, and if the vaccines were going to be harmful in causing major congenital malformations, that's when you are likely to see it. What did they find? Well, they found that there was absolutely no association that the risk of or the prevalence of major congenital anomalies was 176 per 10,000 infants among those who got a vaccine, and 179 per 10,000 infants among babies whose moms did not get a vaccine, essentially an identical rate, actually a slightly smaller rate among vaccinated, but tiny and not statistically significant, suggesting that there is no relationship. And look, this is a very, very big study, 500,000 more than 500,000 infants. I think the quality of the study, the size of the cohort, should really put to an end any concerns that covid vaccines in the first trimester of pregnancy

Ashish Jha: 00:04:06

are going to cause any harm for babies, and in fact, all the evidence so far suggests that it's protective for moms, but not harmful to babies. So that's your study of the week.

Ashish Jha: 00:04:22

All right. And now for the question of the week and for the question of the week, we have a very special guest, my friend and colleague, Olivier Wouters, Professor, here at the Brown School of Public Health. Olivier, thanks for being on the show. Thanks. So my question for you is this, everybody's worried about high drug costs. And one of the things people say about high drug costs as well. It's true, Americans pay more. Everybody knows what. Americans pay more for drugs. But that's okay, because not only do we fund global innovation, but we also get access to drugs first. My sense is it's a bit more nuanced than that. Do Americans get access to drugs? New drugs? Innovative drugs much faster, much earlier than everybody else. Yeah, that

Unknown: 00:05:04

is true. I mean, if you look, and this is something we looked at our own research, how quickly new medicines make their way around the world, and it is true that in the study that we conducted, roughly 70% of drugs launched first in the US, ahead of any other country on Earth. Yeah, that's consistent with more recent data put out by the Food and Drug Administration. So every year, they put out a list of approvals that year, yeah, and they'll indicate which of the drugs they approved were first approved by the FDA ahead of any other regulator. Yeah, it is true that the law and share of new drugs 70% roughly, that's gonna give or take and yeah, come into medical use in the US ahead of other countries. Yeah, however. Oh, there's a however, that is obviously just part of the story. Yeah, we don't necessarily just care about whether a drug launches. We also care about, well, is there broad access? So once a drug makes it on, it makes its way into a country, makes it onto the market, is there broad access to folks to the therapy, or is it just, perhaps, the wealthier segment of society that's able to gain preferential access? Yes, these products, and that's where I think the US perhaps lags a bit behind some of its peers, where there is indeed quicker access, but when you look at how equitably drug uptake is, yeah, there are broader concerns raised.

Ashish Jha: 00:06:14

There got it. So that's an important caveat, right? That you can get the drug to market, but do a vast majority of Americans have access and there, the answer is, maybe not as much. Maybe it's because, and is part of your point that when it launches in other countries, it tends to be a broader launch kind of from day one.

Unknown: 00:06:32

That is correct. It depends how you define launch, but it depends from country to country, sure, sure, sure. But I'm from Sweden, and Sweden, a lot of other European countries, there will be a government agency or body, sorry, let me take a step back. There's two steps you can think of, market authorization. So getting the green light from a regulatory body like the FDA, like the European Medicines Agency in Europe, but in Europe, for instance, that's just the first step. So once you gain that initial green light from the regulator, you then still need to negotiate with individual countries and payers, often a single national payer, whether that drug is going to be covered by the national system. So that's the step where, once you are given the sort of go ahead in Sweden by the agencies called TLV, at that point, there is much broader access, because the Swedish authorities have determined this good drug is good value for money. Yeah, it's gotten the green light from regulator. But not only that, we're going to make sure that there's wide coverage. And so you do, again, not to say that everything's perfect in Europe, no, yeah, but you do tend to see broader access

Ashish Jha: 00:07:32

quicker. Excellent. One last clarifying point, my understanding, or thought would be that if a drug is approved by the FDA, then, does Medicare immediately cover it or not? Necessarily?

Olivier Wouters: 00:07:44

There are some protected classes of medicines that where Medicare is required to cover drugs, yeah. But even so, there can be a bunch of requirements put in place where folks have to try different therapies before they're able to to gain access to some new, really expensive drug, yeah. So there might be a variety of coverage restrictions, things like prior authorization rules, yeah, step therapy requirements that mean that, yeah. Even though on paper, you might think you'd have access to the drug, might take a while before you actually get your hands on a

Ashish Jha: 00:08:14

drug. Great. So bottom line maybe first across the regulatory hurdle, but if your metric is broad access to the population, it's far more nuanced and far more variable than Americans always get it first fair Fair enough. Hey, Olivier, thanks so much for coming by. That was very helpful. Thanks, Ashish.

Ashish Jha: 00:08:39

Okay, so there you have it, another episode of a moment in health where we talked about one data point, 70% 70% of adults oppose getting rid of school immunization requirements, saying that those are essential for keeping kids safe in school. I agree with that. I'm part of that 70% then the study of the week, which looked at first trimester, mRNA, covid 19 vaccines and the risk of major congenital anomalies in all live births in France over almost a one year period, 500,000 babies finding no impact whatsoever of getting a covid vaccine and any major congenital anomalies for babies. And then we talked to my colleague and friend, Olivier Wouters, who's a professor here at Brown originally from Sweden, as he told us, and we talked about drug access, Americans pay a lot more for drugs, and part of it has been, yes, we fund the global innovation of new drugs, which is good that we have innovation, but the other part of the benefit has always been that we get early access. And he confirmed that, in fact, 70% of drugs are first launched here in the United States. But made a really important point, that our complicated system makes access to those drugs much harder, especially in the early days. And so it turns out that if you look at when does everybody have. Have access to a medicine in a country we don't necessarily end up coming out ahead, that we may pay more, but access here maybe for some people can be early, but for a large majority of people can come quite late, given all the barriers we have to accessing expensive medicines, a subtle, important nuance point that says that our higher prices may not be providing as much additional access as we like. All right, that's the episode. Thanks so much for listening and our music by Katherine Beggs, thank you again, Katherine, for putting original music for us. I'll talk to all of you guys next week. Have a good week, folks. You you.