President Trump was a forceful advocate of nationalism. Many intellectuals (myself included) are strong opponents of nationalism. Indeed I view nationalism and communism as the two great evils of the 20th century. Thus it’s ironic to find many proponents of government regulation making essentially nationalistic arguments.
Alex Tabarrok recently pointed to the FDA’s scandalous refusal to allow the manufacture and sale of AstraZenaca vaccine in America:
By the way, the US failure to authorize the AstraZeneca vaccine in the midst of a pandemic when thousands are dying daily and a factory in Baltimore is warmed up and ready to run is a tragedy and dereliction of duty of epic proportions. The AZ vaccine should be given an EUA immediately and made available in pharmacies for anyone who wants it while continuing to prioritize Moderna and Pfizer for the elderly and essential workers.
When I advocate allowing people to be free to take a non-FDA approved drug or vaccine, the response is generally an argument relying on some form of paternalism. People are too poorly informed to be allowed to make these choices. They should not be allowed to take the drugs unless experts have verified that the drugs are safe and effective.
But that’s obviously not their actual motive. Experts in the UK have looked at the AstraZenaca vaccine and found it to be safe and effective. And yet Americans are still not allowed to use the product. So if paternalism is not the actual motive, why do progressives insist that Americans must not be allowed to buy products not approved by the FDA? What is the actual motive?
The answer is nationalism. The experts who studied the AstraZenaca vaccine were not American experts, they were British experts. Can this form of prejudice be justified on scientific grounds? Obviously not. There has been no double blind, controlled study of comparative expert skill at evaluating vaccines. We have no way of knowing whether the UK decision is wiser than the FDA decision. Instead, the legal prohibition is being done on nationalistic grounds. We are told to blindly accept the incompetence of British experts, without any proof. (And even if you believed there was solid evidence that one country’s experts were better than another, it would not explain why each developed countries relies on their own experts. They can’t all be best!)
These debates always end up being like a game of whack-a-mole. Shoot down one argument and regulation proponents will simply put forth another. Their minds are made up. You say people shouldn’t be allowed to take a vaccine unless experts find it to be safe and effective? OK, the UK experts did just that. You say that only the opinion of US experts counts because our experts are clearly the best? Really, where is the scientific study that shows that our experts are the best? I thought you said we needed to “trust the scientists”? Now you are saying we must trust the nationalists? Was Trump right about nationalism?
My dream of a completely free market in drugs will likely never happen. But what’s wrong with the following three-part system of regulation as a compromise solution:
1. FDA approved drugs can be consumed by anyone in America.
2. Drugs approved by any of the top 20 advanced countries (but not the FDA) can be consumed by anyone willing to sign a consent form indicating that they understand the FDA has not approved this product. I’ll sign for AstraZeneca. (The US government puts together a list of 20 reputable countries.)
3. Drugs approved by none of the top 20 developed economies will still be banned.
This is what regulation would look like if paternalism actually were the motivating factor. But it’s not. It’s Trump-style nationalism that motivates progressives to insist that only FDA approved drugs can be sold in America. They may look down their noses at Trump, but they implicitly share his nationalism.
READER COMMENTS
Floccina
Jan 28 2021 at 3:54pm
People who believe that our laws prevent people are protected much by the FDA should browse quackwatch a bit. There is no end to the quackery out there.
Then there is the other side people not taking stuff (vaccinations) that they should be taking.
In a free country you can only protect people so much.
Scott Sumner
Jan 28 2021 at 4:38pm
Good points.
Jon Murphy
Jan 28 2021 at 5:00pm
I’ve been reviewing the FDA reports from early in the pandemic for a paper I am writing. The nationalism of which you speak is pretty blatent. They do not come out and say they’re nationalist, but much of the rules enacted and rules not waived deal with reasons unrelated to expert verification.
Scott Sumner
Jan 28 2021 at 6:44pm
Interesting. Thanks.
Gordon
Jan 28 2021 at 5:12pm
I wonder if the Thalidomide scandal from the 1960s still influences US regulators as a cautionary tale. And there is a question as to whether AstraZenaca had a sufficient number of subjects over the age of 65 to provide enough assurance that it is safe and effective for that age group which EU regulators have raised as a concern. Also, some scientists believe that vaccines which use adenoviruses as a delivery mechanism (like the AstraZenaca one) may be more prone to adverse effects as the body may react to the adenovirus. That may be a sticking point if it’s felt that AZ did not recruit enough test subjects in key demographics.
Scott Sumner
Jan 28 2021 at 6:44pm
That may all be true, but it in no way changes my view of what’s going on in this case. Your points might explain why and FDA officials says to himself, “I think I’ll pass on AstraZenaca and wait for my Moderna shot”. It does not justify the FDA officials telling Americans they cannot choose to listen to British expert opinion.
The way we responded to the Thalidomide scandal probably cost far more lives than the drug itself, just as the way we respond to terrorism costs more lives than it saves.
Fazal Majid
Jan 28 2021 at 5:35pm
Is it nationalism or protectionism, or simple CYA?
For bureaucrats, of course, it is always less risky to say no, and given the existence of the Pfizer and Moderna virus, there is less pressure to approve a third vaccine as there would have been had it been the only game in town (despite the massive advantage of not requiring liquid-nitrogen cold storage).
Scott Sumner
Jan 28 2021 at 6:45pm
Yes, they prefer to make errors of omission. Classic example of the principal/agent problem.
D.O.
Jan 28 2021 at 5:45pm
I remember in Obama days there was talk about some big US-EU trade agreement, part of which was mutual recognition of safety certifications. The big agreement never happened, but that mutual recognition should get back on the agenda. And then, get on with the trade agreement.
There is probably a bit of favoring your own in the approval process. If the aproval leads to a big windfall, the local regulators will be under pressure to get an early or easy approval, but I guess, we can trust EU experts on UK vaccines (Germany approved them for under 65).
Scott Sumner
Jan 28 2021 at 6:45pm
I agree.
Daniel Kling
Jan 28 2021 at 7:35pm
I guess I am too much of a globalist utilitarian to get really worked up about the AZ non-approval. If the next 10 million or 100 million AZ doses go to the UK, EU, or especially to non-rich countries instead of the US, then from my perspective… ok? Obviously I’d like for myself and the people I know/love to be vaccinated as soon as possible, but I feel a little morally icky about rooting for a change that makes that happen for me and other young/healthy people in the US too much earlier than for healthcare workers and older folks across the world. I’ve generally made my peace with having the great luck to have been born in the US (funny how easy it is to accept inequality when you’ve got the long straw), but having a little empathy and awareness of that inequality makes it easier not to get unduly incensed about these perceived slights.
I’m not trying to say that the FDA or medical ethicists are being good or wise here, but I’m constantly confounded by how little marginal analysis some of my favorite economists seem to do when they’re being outraged. How much harm is there from distributing some quantity of vaccines from the US to other countries? Are there AZ factories that aren’t producing the vaccine because they’re waiting for US approval? If so, then that’s shameful and crazy and people should be explicit about that happening. But why should it matter to anyone who’s not an economics rube (or politician) if some vaccines are made here and shipped elsewhere while other vaccines are made elsewhere and shipped here?
Surely, if we changed lots of other things (like ditching the government monopsony like David recommends), then this might make a much bigger difference, because US approval and potential profits could incentivize more, faster production throughout the supply chain. But for a ceteris paribus US approval, how does that help us if we don’t value the utility of American strangers a lot more than the utility of foreign strangers? I’m not a politician, and the US seems to be getting as much vaccine supply as pretty much anywhere else, so I have trouble seeing how global utility is greatly harmed by this particular FDA sin. I very much doubt it would make my marginal harm top 20 list of bad aspects of the US government Covid response. Is there something I’m missing, or is all the frustration here just deontological outrage (odd) and/or regular nationalism (meh)?
bill
Jan 30 2021 at 7:39am
I thought similarly, but then realized that the factory in Baltimore is idle while we await the FDA.
Scott Sumner
Jan 30 2021 at 10:53am
You asked:
“Are there AZ factories that aren’t producing the vaccine because they’re waiting for US approval?”
Yes, see Bill’s comment.
Mark Z
Jan 30 2021 at 5:48pm
If one were to rank countries in terms of how much harm would be averted from allocating vaccines there, I think the US would be very close to the top of the list.
BC
Jan 29 2021 at 4:45am
Ironic that progressives of all people would elevate the FDA above UK regulators. Progressives are fond of arguing that we should follow “every other developed country” in guaranteeing health care as a basic right, our gun laws should be as restrictive as every other countries’, etc. So, progressive logic would normally imply that we should defer to foreign regulators even more than our own FDA.
Scott Sumner
Jan 30 2021 at 10:53am
Good point.
Dylan
Jan 29 2021 at 7:41am
Scott,
I disagree with you on a lot of your posts on this subject and I think you error by lumping all people who disagree with you into one bucket, but I’m all in favor of drug reciprocity in approvals, particularly now.
In general, I think that drug reciprocity is a good thing but it is unlikely to lead to faster approval times in the U.S. in the near term, as the FDA already has the shortest median approval times of the 6 major developed world drug agencies (and has for most of the last two decades).
Mark Z
Jan 29 2021 at 11:38am
The average of the minimum national approval time across drugs can in theory be lower than the minimum of the average approval time across countries, so it’s possible, strictly statistically speaking, for even the country that’s fastest on average to benefit from reciprocity, but you know much more about this topic than I do. Do drugs pretty consistently get approved first in the US? (Basically I’m just harping on the subtle distinction between minimum average and average minimum, which may be practically unimportant here.)
Dylan
Jan 29 2021 at 12:28pm
Absolutely. There is a lot of variability in approval times, so that kind of thing could happen, although there has been a trend toward approval time convergence in most of the major markets for a decade or so, so probably not likely recently.
Drugs do tend to get approved in the U.S. first, although that has more to do with market size than approval times. There are exceptions, the U.S. has been a laggard in biosimilars compared to Europe is one example. There’s also Japan, which is strict on safety for drugs but less so on efficacy, so there are a fair number of drugs on the market there that don’t really do anything (something we only know because of clinical trials run elsewhere).
As I said, I think drug approval reciprocity is a good idea overall. There’s a ton of inefficiency in the system and it would be good to have some incentives to get rid of some of that and speed up other aspects, but at least in the short term we shouldn’t expect it would lead to a bunch of efficacious drugs suddenly becoming available in the U.S.
Jon Murphy
Jan 30 2021 at 9:09am
That the US already has some of the shortest median approval times is irrelevant to the drug reciprocity argument. The idea is that the drug has already been approved elsewhere. So, there mere fact that the drug has to go through another approval process regardless of how short the process is means that approval times are slower without reciprocity agreements.
For example, let’s say that at a given date, X, there are two drugs. One has been approved by the US and one has been approved by the UK.
With a drug reciprocity agreement, both drugs are available on Day X.
Without a drug reciprocity agreement, one drug is available on Day X and the other drug doesn’t become available until Day X+n (where n is the length of the approval process). Thus, so long as n is positive (and it will be), no drug reciprocity agreement means that approval times will take longer than with a drug reciprocity agreement regardless of how small n is.
Dylan
Jan 30 2021 at 10:52am
The point being, from a U.S. perspective, there are few drugs that are approved elsewhere before they are approved here. You’re going to have a much bigger impact for the other countries that take part in reciprocity than you will for the U.S. That’s great, and one of the reasons I’m for it, but it won’t do much to the drug approval process here.
This piece is a bit old but is a good overview of some of the issues.
Jon Murphy
Jan 30 2021 at 11:20am
True, but again irrelevant. There are lots of times when its not the case, as this current pandemic when people are dying. These are mutually beneficial trades that are not coming about. The presumption that the US won’t gain as much as other countries is irrelevant to the point that the US will gain.
Matt C
Jan 29 2021 at 11:59am
Why would we trust the federal government on questions of health when their official nutritional guidelines are contradicted by pretty much every study done in the past 20 years?
I agree with Bryan overall, but I would like to point out that it’s not always a question of which experts are better. With drugs, vaccines, etc., we need to weigh the benefits against the risks. Each person has their own calculus on these margins, and (at least in theory) these calculi aggregate into a national view on risk vs. benefits. It is possible (though not likely) that the U.S. is more risk-averse than the U.K., so both groups of experts might agree on what the risks are with differing results in application.
Most of the preceding paragraph is as much devil’s advocacy as anything. The biggest factor here is likely political economy.
Andre
Jan 29 2021 at 9:34pm
Precisely. The government openly promotes and subsidizes the very products that account for most US morbidity and a very large chunk (and most of the top ten causes) of death. Way more deaths than Covid. Every single year.
A big part of the problem is that both nutrition guidelines and agricultural promotion fall under USDA jurisdiction. Whatever the FDA’s faults, if they were in charge of nutrition, the government advice would be far better.
Jon Murphy
Jan 30 2021 at 9:11am
Matt-
I think a lot of us would like to see the FDA become more advisory rather than regulatory, along the lines you seem to suggest. But that’s irrelevant to Scott’s point.
Conditional on the current status quo, a drug reciprocity agreement would be a positive step forward. The fact one does not exist is an interesting question.
Ilverin Curunethir
Jan 29 2021 at 12:33pm
Before the election, the FDA described the standard of efficacy they would require before approving a vaccine. We can debate why they chose such a high standard at the time (possibly to delay vaccinations until after the Presidential election), and we can debate that they should change their mind, but I think the FDA just wants to “appear consistent” so they don’t want to change their mind (meaning the FDA delay would not be due to nationalism, rather egocentrism)
Michael Sandifer
Jan 29 2021 at 1:38pm
Yes, we should hope that when the younger generations are running the world, they will trust patients to make more decisions.
Jason
Jan 30 2021 at 9:12am
I was flabbergasted by the controversy surrounding just distributing the AZ vaccine here in Denmark before the EU approved it, even though it was already approved in the UK.
Sam
Jan 30 2021 at 10:03am
Something similar is going to happen to the Novovax vaccine. The phase 3 trial in the UK indicates a very high efficacy, and even South Africa they meet the initial 60% efficacy that the FDA wanted. However, the early indications are that the FDA wants Novavax to use data from their phase 3 trial in the US which won’t be ready for another 2 – 3 months. They don’t want them to apply for approval based on data from the UK trial. Very likely the FDA will also approve Novavax months after the UK. Trial nationalism.
Enoch A Lambert
Jan 30 2021 at 10:32am
Why is this attributed to nameless progressives? Or, if you have a few names of people that are also progressive, besides being anecdotal, is there evidence that it is their progressivism that is causing this version of nationalism?
Lance Merritt
Jan 30 2021 at 1:51pm
Yes!! I agree about the vaccine nationalism problem, but please give the context to show that conservatives are clamoring for allowing us to use the AZ vaccine while progressives are opposing it. Otherwise this just sounds like typical knee jerk lib-bashing.
edgar
Jan 30 2021 at 2:01pm
The fact that Astrazeneca has not applied to the USA FDA as of yet possibly has something to do with it.
Chuck Han
Feb 11 2021 at 3:58am
AstraZeneca has not applied for EUA because they have been told the application would not be accepted without endpoint data from the US Phase III trials.
What is preventing the FDA from relying on approvals from MHRA, EMA, CDSCO, and other country agencies plus the impending WHO EUL?
Niko Davor
Jan 30 2021 at 2:34pm
The type of destructive over-regulation this article criticizes is what Trump and the Trump Administration were good at reforming. Scott Gottlieb was a notable skilled guy to reform the FDA. The Trump Administration didn’t fix everything, it does seem like the FDA should have given expedited approval to the AstraZenaca vaccine, and make better use of UK’s vaccine trials. But generally, this seems like an unreasonable criticism of the Trump Administration.
<blockquote>
Thus it’s ironic to find many proponents of government regulation making essentially nationalistic arguments.
</blockquote>
“nationalism” is a pretty arbitrary word. One could reasonably say that government regulation by the national government is nationalism. Or a government owned university, like GMU, that receives enormous amounts of money, power, and prestige from national government is a form of nationalism. The author is a government worker; which is arguably nationalistic, even if he is trying to spin the narrative otherwise.
Randall Parker
Jan 30 2021 at 3:58pm
I suspect that drug approval reciprocity would help especially for old drug generics that are available in other countries but not in USA.
For example, wouldn’t use of Canadian or British or EU approvals make insulin far cheaper in USA?
Randall Parker
Jan 30 2021 at 4:23pm
What source of info is there for the assertion that the Baltimore facility isn’t making AstraZeneca vaccine? The wait for approval did not delay start of either Pfizer or Moderna production. Why should this be any different?
Consider this https://www.baltimoresun.com/coronavirus/bs-hs-astra-zeneca-vaccine-20201123-gofgqt3jsngfhjadn7sognm7ny-story.html
ChrisA
Jan 31 2021 at 6:53am
I wonder how much behind the scenes lobbying is going on by the existing incumbent vaccine suppliers to slow approvals of new vaccines? I would guess that AZ vaccine being more easily delivered and much cheaper would quickly eat into the market share of the Pfizer vaccine. I don’t think it will be explicit bribery, just lets of negative briefings. I also wonder if this is a factor against the first dose first strategy, where the risk is that one dose is good enough after all again reducing demand. We saw Pfizer quickly increased effective prices when they saw the people were able to get six doses out of a vial and not five, so there are some very commercially minded people running these companies.
Pedro
Jan 31 2021 at 9:48am
I would say that the answer goes beyond nationalism and probably involves rent-seeking. See Stigler on economic regulation.
Aram
Jan 31 2021 at 11:18am
There is a lot of vaccine skepticism in the US. Oregon is already vaccinating the general public because they haven’t had enough demand in high-risk groups. Managing this skepticism is part of what is going on. We may well be better off with a more “buyer-beware” equilibrium but right now people expect that if the government lets medicine go on the market then that is a very strong signal. So a shift to this would have to be done gradually.
Nick
Feb 1 2021 at 12:36pm
I buy the nationalism argument within the FDA but view a lack of any political consequence for politicians as the bigger problem. I have seen a lot of complaining about delayed approval of the AZ vaccine here and on MR, but I am not aware of any organized attempt to hold politicians accountable for the delay. I would love to see letter campaigns, mass protests outside the White House and FDA headquarters and proceeding coverage in national media. So long as the delay remains a non-issue for the general public, politicians can hide behind “safety-first” arguments for not expediating approval.
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