Results for “fda” 324 found
“Free-floating credibility” is underrated
The presence of a minuscule risk for some of the adenovirus platform Covid vaccines means that the FDA has put a hold on J&J and still won’t approve AstraZeneca.
In response to critics, the FDA says that their credibility is on the line. If they allow vaccine use to proceed, and a modest number of people die as a result (with a big increase in net lives saved), the FDA and its defenders claim that people will lose faith in the FDA. Yet that is exactly the wrong thing to say, it is self-serving, and it exacerbates the problem at hand.
When the FDA announces that they have to ban a vaccine because its credibility is on the line, that very announcement puts their credibility on the line. It is a simple two-line proof. Either they are lying about whether their credibility is on the line, in which case they have wrecked their credibility with the lie. Or they are telling the truth, in which case by definition their credibility is indeed on the line.
One lesson is that you should not try to extend your credibility too far, because you will end up unduly constrained.
For purposes of contrast, consider alcoholic beverages. At the federal level they are regulated by the Alcohol and Tobacco Tax and Trade Bureau (who are they again?), and also various state and local authorities.
As a result of this unusual, Prohibition-rooted distribution of authority, alcohol does not come with nutritional labeling.
Now, in that setting, if a bunch of kids die from binge drinking, the credibility of the Bureau is not much damaged. The Bureau does not have to ban alcohol on the grounds that if it does not, the credibility of the Bureau will be ruined. The Bureau simply never put its credibility on the line in this manner.
Now you might favor a tighter regulation of alcohol for some reason, but you could achieve such regulation without tying up the credibility of the ATTT Bureau in knots. Similarly, the Department of Transportation regulates road safety (again with state and local authorities as well), but it has not put its credibility on the line when 40,000 or so Americans die each year on the roads. Again, maybe they should enforce tougher safety standards, but they shouldn’t tie their credibility to getting road deaths down to one hundred, and indeed they do not. They end up with more degrees of regulatory freedom.
Let’s say I were to announce that my credibility as a public intellectual were to depend at how I would fare at darts on British pub night. That would be a big mistake, for multiple reasons. It is like with the FDA. If I am lying about that credibility tie, I hurt my credibility as a public intellectual. If somehow I am telling the truth, well let’s just hope everyone else stays home that evening because my credibility is going to take a beating.
What I call “free-floating credibility” is underrated.
And that is precisely what defenders of the FDA destroy when they…defend the FDA. They make the FDA worse.
NB: You are “out of your lane” commenting on this analysis unless you have studied game theory with Thomas Schelling.
Vaccine fact of the day
Moderna and BioNTech shares jumped 10.5 per cent and 6.1 per cent, respectively, on Tuesday as the vaccine makers benefited from news of the J&J pause.
Norway’s health authorities estimated that their vaccination plans could be delayed by eight to 12 weeks if they could not use either the J&J or the Oxford/AstraZeneca vaccine.
The biggest short-term loser here is Europe, not the United States. Nor will this help Australia reopen. But does the American median voter or median FDA senior bureaucrat care? What will the CVS liability lawyers advise from here on out? What will the French anti-vaxxers think?
Here is the full FT article.
What should I ask Daniel Carpenter?
I will be doing a Conversation with Daniel, who is a professor of political science at Harvard and one of the world’s leading experts on the history of regulation and also the FDA. Here is part of his bio:
Professor Carpenter’s previous scholarship on regulation and government organizations appears in Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, 2010), winner of the Allan Sharlin Memorial Award of the Social Science History Association; and of The Forging of Bureaucratic Autonomy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862-1928 (Princeton, 2001), winner of the Gladys Kammerer Prize of the American Political Science Association and the Charles Levine Prize of the International Political Science Association. With David Moss of Harvard Business School, he is the author and co-editor of Preventing Regulatory Capture: Special Interest Influence in Regulation and How to Limit It (Cambridge, 2013).
And coming out in May:
Professor Carpenter’s research on petitioning appears in his forthcoming book Democracy by Petition: Popular Politics in Transformation, 1790-1870 (Harvard University Press, 2021)
So what should I ask him?
Why vaccination passports probably won’t work well
That is the topic of my latest Bloomberg column, here is one excerpt:
One issue is what exactly constitutes proof of vaccination. For my vaccinations, I have been issued a rather flimsy, easy-to-forge paper document from the Centers for Disease Control. Unlike a passport or a dollar bill, it has no embedded watermarks or other protections. Anyone with a moderately sophisticated copy machine could create many fake documents, or perhaps steal an existing stash of these documents and sell them on the black market. Once you have the documents, you can simply note that you have been vaccinated, and it is not easy for outside parties to dispute such claims.
Soon enough, of course, it may be easier for most adults to get a vaccine than to forge a vaccine passport. Still, U.S. laws and regulations work better when they can refer to clear, verifiable standards of evidence. It is hard to imagine a set of laws or procedures based on criteria so loose that they basically allow anyone to claim they are vaccinated. A more stringent standard, however, would be hard for most vaccinated Americans to meet.
Another knotty question is which vaccines will count for the passport. Pfizer’s, Moderna’s and Johnson & Johnson’s for sure, but what if you are a U.S. citizen living in Canada who received AstraZeneca’s vaccine, which has been approved by some 15 nations but not the U.S.? Is the federal government willing to tell a whole class of responsible individuals that they cannot fly on U.S. planes? Or will the vaccine-passport bureaucracy be willing to approve vaccines that the Food and Drug Administration will not?
These dilemmas can become stickier yet. What about Sputnik, the Russian vaccine, or the numerous Chinese vaccines, which are being administered around the world, including in Mexico?
Do Americans really wish to create a country to which most foreigners would not be very welcome? Furthermore, what counts as proof of foreign vaccination? Some Asian countries, including China, are creating elaborate and supposedly secure vaccine verification systems, using advanced information technology. Good for them — but how would that connect with U.S. regulations? How many different passport systems would a flight attendant or gate agent have to read, interpret and render judgment upon?
The likely result of all this: Many foreign visitors to the U.S. would never quite know in advance whether they could board an airplane or attend a public event.
And how would the passport reflect any new vaccines deemed necessary? What if new Covid-19 strains require booster shots? What if you’ve had Covid and thus get only one shot for now rather than two, as many experts are recommending? What will happen as the number of vaccines around the world proliferates? Given the slowness of the FDA and CDC, it is hard to imagine any new U.S. approvals coming quickly. A vaccine passport system could end up being fetters not only for foreigners and anti-vaxxers but also for vaccinated Americans.
Recommended, there are additional arguments at the link.
Sins of omission vs sins of commission
That is the topic of my latest Bloomberg column, here is one excerpt:
To be clear, public health officials are encouraging additional vaccinations. But they don’t seem to realize how much their own ostensibly “careful” rhetoric makes vaccination sound unappealing. “Not talking up the vaccines” is a sin of omission, not a sin of commission, and so it is tolerated and is not a major issue for public debate.
Should public officials be allowed, indeed encouraged, to treat sins of commission and omission so differently, as private citizens (myself included) typically do?
I live near Arlington National Cemetery, where approximately 400,000 veterans (and family members) are buried. I suspect they would not care so much whether their deaths were the result of errors of commission or omission. Did a commanding general order a hill to be charged that should have been left alone? Or did he make the mistake of not charging a hill that could have been taken?
Most citizens care about the total number of military casualties from a battle and are only modestly concerned about the details of the mistakes that caused them. That seems like the right and rational attitude. Perhaps it is also the correct attitude for the war against the coronavirus — that is, an overriding concern with casualties and outcomes, regardless of the kind of error that led to them.
Recommended.
Against Regulatory Nationalism
I’ve long argued that if a drug or medical device is approved in another country with a Stringent Regulatory Authority it ought to be approved in the United States. But, of course, the argument is even stronger in the other direction. Drugs and devices approved in the United States ought to be approved elsewhere. Indeed, this is how much of the world actually works because most countries do not have capability to evaluate drugs and devices the way the FDA or say the EMA does. Although it’s the way the world works, few will admit it because that would violate pretensions of regulatory nationalism. Moreover, keeping up with pretenses means transaction costs and unnecessary delays.
The price of such regulatory nationalism can be very high as indicated in this interview with Adar Poonawalla, chief executive of the Serum Institute of India (SII), the world’s largest producer of vaccines.
Some people think the reason that rollout has been slow in many countries is because the developers who hold the patents on the vaccines have licensed too few manufacturers to make them. Do you agree?
No. There are enough manufacturers, it just takes time to scale up. And by the way, I have been blown away by the cooperation between the public and private sectors in the last year, in developing these vaccines. What I find really disappointing, what has added a few months to vaccine delivery – not just ours – is the lack of global regulatory harmonisation. Over the last seven months, while I’ve been busy making vaccines, what have the US, UK and European regulators been doing? How hard would it have been to get together with the World Health Organization and agree that if a vaccine is approved in the half-dozen or so major manufacturing countries, it is approved to send anywhere on the planet?
Instead we have a patchwork of approvals and I have 70m doses that I can’t ship because they have been purchased but not approved. They have a shelf life of six months; these expire in April.
Did you get that? Regulatory nationalism has added months to vaccine delivery and now threatens to put to waste millions of stockpiled doses.
Addendum: See also Scott Sumner on the costs of regulatory nationalism.
Friday assorted links
1. Ezra Klein on California (NYT), right on the mark.
2. Interview with Michael Mina, too much common sense for it ever to be heeded.
3. Developing versatile vaccine platforms.
4. The Biden Administration hesitates to name an FDA head.
5. Pigs can play video games with their snouts.
6. Father of Britney Spears must share conservatorship.
8. Military officials were unaware of danger to Pence’s nuclear football during the riots.
Sunday assorted links
1. The regulatory, status quo bias in public health commentary: “Do any of the experts arguing that it’s wrong for Americans to demand access to the AstraZeneca vaccine also advise residents of the UK, EU, and 15 other countries to delay taking it until our FDA grants authorization?”
3. People are fed up with broken vaccine appointment tools — so they’re building their own (Technology Review).
4. NASA prize to make food on the Moon, Mars.
5. The UK put a venture capitalist in charge of its vaccine procurement.
6. Cuba will allow more small business.
7. Ross Douthat on the Romney family plan (NYT).
8. It seems fear of kidnapping is severely limiting mobility in Haiti, even for the non-wealthy (NYT).
Saturday assorted links
1. Henry Farrell reviews Mike Konczal.
2. Wombats, Cowen’s Second Law, and to the benefit of all. It is an article that keeps on surprising you.
3. Why was autocratic rule more stable in China than in Europe?
4. One guy who helped to drive GameStop (WSJ).
5. A review of the definition of market manipulation, for those of us who need it.
6. Our FDA regulatory state is failing us against Curative as well.
7. Game theory and the search for life, clever.
The Invisible Graveyard is Invisible No More
We called it the invisible graveyard, the place they buried people killed by FDA delay. Back then only a few of us–mostly libertarians long practiced in seeing the invisible hand–could see the invisible graveyard. Normal people looked at us oddly and quickly ran away when we frantically pointed to the dead. “There! there! Can’t you see the bodies?” Now, however, the veil has been lifted and even normal people see.
Here is Ezra Klein writing in the NYTimes:
The problem here is the Food and Drug Administration. They have been disastrously slow in approving these tests and have held them to a standard more appropriate to doctor’s offices than home testing. “The F.D.A. needs to catch up to the science,” Mina said, frustration evident in his voice. “They are inadvertently killing people by not following the science.” On my podcast, I asked Vivek Murthy, President Biden’s nominee for surgeon general, whether the F.D.A. had been too cautious. “I do think we’ve been too conservative,” he told me. Murthy went on to argue that there’s a difference between the diagnostic testing doctors do and the surveillance testing the public could do and that the F.D.A. had failed to appreciate the difference. Speeding the F.D.A. on this issue will be an early, and crucial, test for the Biden administration. In this case, Democrats need to deregulate.
Even back in December when I was tweeting from the rooftops things like:
Your daily reminder that 14,696 people have died from COVID in the United States since Pfizer applied for an EUA from the FDA.
people argued that I was exaggerating the simple math of FDA delay. Today, however, the reality of deadly delay is almost conventional wisdom. Here’s Klein again:
The new strains spread quickly. The speed of our countermeasures will decide our fate. What feel like reasonable delays in our normal experience of time — a few weeks here for Congress to debate a bill, a few weeks there for the F.D.A. to hold meetings — could lead to the kind of explosive infections that overwhelm our hospitals and fill our morgues.
A legal and regulatory question about First Doses First
It isn’t clear to me who in the United States is legally entitled to make this decision. An FDA EUA is required before a vaccine can be used in the U.S. But once an EUA has been issued, is “off-label use” permitted? The CDC’s Advisory Committee on Immunization Practices recommends how scarce vaccine doses should be prioritized, but “states” (governors?) are free to make contrary prioritization decisions. Can states also decide to give half-doses or lengthen the interval between first and second doses? Can a hospital, a nursing home, or an individual doctor make such a decision? (If so, can it also deviate from its state prioritizations?) Can HHS or the President specify how these decisions must be made, or alternatively can they explicitly free lower-level decision-makers to use their own judgment?
You’re not a specialist in pharmaceutical law, I realize. But I doubt you’ll let that stop you! When you recommend a less risk-averse approach to COVID-19 vaccination, to whom are you addressing the recommendation? Who has a right to implement it?
That is from MR reader Peter Sandman. Can any MR reader inform us on this?
Tuesday assorted links
1. Comment on the electoral fraud result.
2. Sadie Alexander in Teen Vogue.
3. Saudi Arabia lifts blockade of Qatar.
4. Virginia just barely reaching twenty percent distribution.
5. Good Ivermectin results? And more here. Speculative.
6. A modeling exercise favoring First Dose First, the most extensive treatment I have seen to date.
Vaccinate, 24/7
On Christmas I tweeted:
Operation Warp Speed makes me think that America isn’t finished. We have now vaccinated more people than any other country in the world.
I hope Biden awards Slaoui, Perna, Marks and Bourla the Presidential Medal of Freedom.
and a bit later “Today we celebrate. Tomorrow back to demanding more, faster.” Well, it’s tomorrow and we do need to do more, faster. Israel, for example, is doing better than the United States on vaccinations per capita and they are rolling out 24/7 vaccination clinics.
Health Minister Yuli Edelstein called Thursday to keep the vaccine operation going 24 hours a day, 7 days a week, including on Shabbat.
Regarding the push to carry out vaccinations on Shabbat, Edelstein, who is Orthodox, cited the Jewish legal principle of saving a life, or “pikuah nefesh,” which trumps nearly all other religious requirements.
According to a Channel 12 report Saturday, Clalit, Israel’s largest health maintenance organization, will open 24/7 vaccination centers in Tel Aviv, Haifa and Herzliya in the coming days to help ramp up the pace of the vaccine drive. Additional centers are expected to be opened at a later date.
Israeli hospitals are also to join the vaccination effort next week, and hundreds of IDF medics will also participate, to help expedite the process.
Also, if Britain approves the AZ vaccine this week, as I think they will, it should be immediately approved in the United States, if not as part of Operation Warp Speed then on a right to try basis until fully FDA approved.
Dr. Fauci, Straussian
Recently, a figure to whom millions of Americans look for guidance — Dr. Anthony S. Fauci, an adviser to both the Trump administration and the incoming Biden administration — has begun incrementally raising his herd-immunity estimate.
In the pandemic’s early days, Dr. Fauci tended to cite the same 60 to 70 percent estimate that most experts did. About a month ago, he began saying “70, 75 percent” in television interviews. And last week, in an interview with CNBC News, he said “75, 80, 85 percent” and “75 to 80-plus percent.”
In a telephone interview the next day, Dr. Fauci acknowledged that he had slowly but deliberately been moving the goal posts. He is doing so, he said, partly based on new science, and partly on his gut feeling that the country is finally ready to hear what he really thinks.
Hard as it may be to hear, he said, he believes that it may take close to 90 percent immunity to bring the virus to a halt — almost as much as is needed to stop a measles outbreak.
Asked about Dr. Fauci’s conclusions, prominent epidemiologists said that he might be proven right…
Dr. Fauci said that weeks ago, he had hesitated to publicly raise his estimate because many Americans seemed hesitant about vaccines, which they would need to accept almost universally in order for the country to achieve herd immunity.
Here is the full NYT story. A few points:
1. Surely Straussianism by now should be persuasive as a general theory.
2. Fauci is idolized by many as a kind of anti-Trump, but he is a terrible risk communicator, as evidenced also by his recent attacks on some of the “lesser” vaccines (which still would work if applied collectively). Not to mention his earlier remarks on masks, and also the mid-March safety of cruises. How a person understands Fauci is in fact a pretty good litmus test.
3. Should you be trusting everything the insiders are telling you about FDA processes?
4. I genuinely do not know what the herd immunity threshold is, but I assure you I am trying to tell you the truth on this one (and other matters). My Straussianism is not a normative theory of my own communication, but rather a positive theory of how the world works, and it has been vindicated once again.
Les priorités
F.D.A. Wants to Stop Regulating French Dressing
The federal agency said it was seeking to revoke its definition for the carrot-colored dressing, effectively erasing a government-required list of ingredients at the request of an industry group…the federal government has shown great interest in the humble dressing, painstakingly regulating since 1950 the ingredients that it must contain and revising the rules at least five times since then…
The lengthy and legalistic regulations for French dressing require that it contain vegetable oil and an acid, like vinegar or lemon or lime juice. It also lists other ingredients that are acceptable but not required, such as salt, spices and tomato paste.
Ahem. Here is the full NYT story.
p.s. It is disgusting, and it is not even French.