Category: Law
How to do regulatory reform (from my email)
“Philip Howard here. I enjoyed your discussion with Jen Pahlka. Here are a few notes:
1. This current system needs disrupting, but I fear DOGEs indiscriminate cuts are making the status quo look good. Here’s Peter Drucker, criticizing Gore’s reinventing got: “patching. It always fails. The next step is to rush into downsizing. Management picks up a meat-ax and lays about indiscriminately. …amputation before diagnosis.” (from Management, revised ed).
2. Most of the newcomers to the realization that govt is paralyzed (Ezra Klein, Dunkelman etc) think that the red tape jungle can be pruned, or organized with better feedback loops (Pahlka). This is falling into Gore’s pit. There’s a fatal defect: the operating system is designed around legal compliance–instead of human authority to make tradeoff judgments. Law should be a framework setting the boundaries of authority, not a checklist. That’s why some reforms I championed (page limits, time limits) haven’t worked; there’s always another legal tripwire. I describe what a new framework should look like in this recent essay. https://manhattan.institute/article/escape-from-quicksand-a-new-framework-for-modernizing-america
3. Public unions: Democracy loses its link to voters–quite literally–if elected executives lack managerial authority. The main tools of management– accountability, resource allocation, and daily direction–have been either removed by union controls or are subject to union veto. Government is more like a scrum than a purposeful organization. There’s a core constitutional principle –private nondelegation–that prevents elected officials from ceding their governing responsibility to private groups. Stone v Mississippi: “The power of governing is a trust…, no part of which can be granted away.” That’s the basis of the constitutional challenge we’re organizing. The Trump admin could transform state and local govt by invoking this principle.
Fwiw, I see these points– authority to make tradeoff judgments, authority to manage— as microeconomic necessities, not policy positions. Nothing can work sensibly until people are free to make things work. We’re organizing a forum at Columbia Law School, The Day After Doge, on the morning of April 23. Here’s the lineup. https://www.commongood.org/the-day-after-doge. Let me know if you’d like to weigh in.”
My Conversation with the excellent Jennifer Pahlka
Here is the audio, video, and transcript. Here is the episode summary:
Jennifer Pahlka believes America’s bureaucratic dysfunction is deeply rooted in outdated processes and misaligned incentives. As the founder of Code for America and co-founder of the United States Digital Service, she has witnessed firsthand how government struggles to adapt to the digital age, often trapped in rigid procedures and disconnected from the real-world impact of its policies. Disruption is clearly needed, she says—but can it be done in a way that avoids the chaos of DOGE?
Tyler and Jennifer discuss all this and more, including why Congress has become increasingly passive, how she’d go about reforming government programs, whether there should be less accountability in government, how AGI will change things, whether the US should have public-sector unions, what Singapore’s effectiveness reveals about the trade-offs of technocratic governance, how AI might fundamentally transform national sovereignty, what her experience in the gaming industry taught her about reimagining systems, which American states are the best-governed, the best fictional depictions of bureaucracy, how she’d improve New York City’s governance, her current work at the Niskanen Center, and more.
Excerpt:
COWEN: Does that mean we need something like DOGE? I’ve lived near DC for about 40 years of my life. I haven’t seen anyone succeed with regulatory reforms. You can abolish an agency, but to really reform the process hasn’t worked. Maybe the best iteration we can get is to break a bunch of things now. That will be painful, people will hate it, but you have a chance in the next administration to put some of them back together again.
Maybe it’s just in a large country, there’s no other way to do it. We have separation of powers. The first two years of DOGE will seem terrible, but 8, 12, 16 years from now, we’ll be glad we did it. Is that possible?
PAHLKA: I don’t know what’s going to happen. I do think this is the disruption that we’re getting, whether it’s the disruption we wanted. The question of whether it could have been done in a more orderly manner is a tough one. I just feel sad that we didn’t try.
COWEN: Are you sure we didn’t try?
PAHLKA: I don’t think we really tried.
COWEN: The second Bush presidency, people talked about this, what we need to do. Al Gore — some of that was good, in fact, reinventing government. We’ve been trying all along, but this is what trying looks like.
PAHLKA: Yes. I think reinventing government happened at a time when we were just at the beginning of this digital revolution. It was trying with a very 20th-century mindset. Fine, did well within that context, but we don’t need that again.
We need 21st century change. We need true digital transformation. We need something that’s not stuck in the industrial ways of thinking. I don’t think we tried that. I think the efforts have just been too respectful of old ways of working and the institutions. There was really not an appetite, I think, for what I would call responsible disruptive change. Would it have worked?
COWEN: Is there such a thing?
PAHLKA: I don’t know. [laughs]
COWEN: Say you’re approaching USAID, where I think the best programs are great. A lot of it they shouldn’t be doing. On net, it passes a cost-benefit test, but the agency internally never seemed willing to actually get rid of the bad stuff, all the contracting arrangements which made American Congress people happy because it was dollars sent to America, but way inflated overhead and fixed costs. Why isn’t it better just to blow that up — some of it is great — and then rebuild the great parts?
PAHLKA: It’s so hard to say. [laughs] I’ve had the same thought. In fact, before inauguration, I wrote about the Department of Defense. It’s the same thing. There’s a clear recognition by the people in the institution, as you saw with USAID, that this is not okay, that this is not working. It’s just strange to be in an institution that large where so many people agree that it’s not working, from the bottom to the top, and yet nobody can make really substantive change.
Of great interest, obviously.
One economist removed from the Naval library
Deirdre McCloskey, can you guess which book? See #197. I might add the text to that one is remarkably non-salacious, perhaps many readers were somewhat disappointed.
Via the excellent CW.
Federal Judge Rejects FDA Power Grab
In Don’t Let the FDA Regulate Lab Tests! and The New FDA and the Regulation of Laboratory Developed Tests I warned that the FDA’s power grab over laboratory developed tests was both unlawful and likely to result in deadly harm (as it did during COVID). Thus, I am pleased that a Federal judge has vacated the FDA’s rule entirely, writing:
…the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services.
…FDA’s asserted jurisdiction over laboratory-developed test services as “devices” under the FDCA defies bedrock principles of statutory interpretation, common sense, and longstanding industry practice.
The judge also noted some of the costs that I had pointed to:
…the Fifth Circuit has made clear that district courts should generally “nullify and revoke” illegal agency action, Braidwood, 104 F.4th at 951. The Court finds that such relief is appropriate here. The final rule will initially impact nearly 80,000 existing tests offered by almost 1,200 laboratories, and it will also affect about 10,013 new tests offered every year going forward. The estimated compliance costs for laboratories across the country will total well over $1 billion per year, and over the next two decades, FDA projects that total costs associated with the rule will range from $12.57 billion to $78.99 billion. FDA acknowledges that the enormous increased costs to laboratories may cause price increases and reduce the amount of revenue a laboratory can invest in creating and modifying tests.
… For these reasons, it is ORDERED that the Laboratory Plaintiffs’ Motions for Summary Judgment, (Dkt. #20, #27), are GRANTED. The final rule is hereby SET ASIDE and VACATED.
HHS head RFK Jr. should immediately instruct the FDA to halt any further efforts to regulate laboratory developed tests.
AI Discovers New Uses for Old Drugs
The NYTimes has an excellent piece by Kate Morgan on AI discovering new uses for old drugs:
A little over a year ago, Joseph Coates was told there was only one thing left to decide. Did he want to die at home, or in the hospital?
Coates, then 37 and living in Renton, Wash., was barely conscious. For months, he had been battling a rare blood disorder called POEMS syndrome, which had left him with numb hands and feet, an enlarged heart and failing kidneys. Every few days, doctors needed to drain liters of fluid from his abdomen. He became too sick to receive a stem cell transplant — one of the only treatments that could have put him into remission.
“I gave up,” he said. “I just thought the end was inevitable.”
But Coates’s girlfriend, Tara Theobald, wasn’t ready to quit. So she sent an email begging for help to a doctor in Philadelphia named David Fajgenbaum, whom the couple met a year earlier at a rare disease summit.
By the next morning, Dr. Fajgenbaum had replied, suggesting an unconventional combination of chemotherapy, immunotherapy and steroids previously untested as a treatment for Coates’s disorder.
Within a week, Coates was responding to treatment. In four months, he was healthy enough for a stem cell transplant. Today, he’s in remission.
The lifesaving drug regimen wasn’t thought up by the doctor, or any person. It had been spit out by an artificial intelligence model.
AI is excellent at combing through large amounts of data to find surprising connections.
Discovering new uses for old drugs has some big advantages and one disadvantage. A big advantage is that once a drug has been approved for some use it can be prescribed for any use–thus new uses of old drugs do not have to go through the lengthy and arduous FDA approval procedures. In essence, off-label uses have been safety-tested but not FDA efficacy-tested in the new use. I use this fact about off-label prescribing to evaluate the FDA. During COVID, for example, the British Recovery trial, discovered that the common drug, dexamethasone could reduce mortality by up to one-third in hospitalized patients on oxygen support that knowledge was immediately applied, saving millions of lives worldwide:
Within hours, the result was breaking news across the world and hospitals were adopting the drug into the standard care given to all patients with COVID-19. In the nine months following the discovery, dexamethasone saved an estimated one million lives worldwide.
New uses for old drugs are typically unpatentable, which helps keep them cheap—but the disadvantage is that this also weakens private incentives to discover them. While FDA trials for these new uses are often unnecessary, making development costs much lower, the lack of strong market protection can still deter investment. The FDA offers some limited exclusivity through programs like 505(b)(2), which grants temporary protection for new clinical trials or safety and efficacy data. These programs are hard to calibrate—balancing cost and reward is difficult—but likely provide some net benefits.
The NIH should continue prioritizing research into unpatentable treatments, as this is where the market is most challenged. More broadly, research on novel mechanisms to support non-patentable innovations is valuable. That said, I’m not overly concerned about under-investment in repurposing old drugs, especially as AI further reduces the cost of discovery.
Peter Marks Forced Out at FDA
Peter Marks was key to President Trump’s greatest first-term achievement: Operation Warp Speed. In an emergency, he pushed the FDA to move faster—against every cultural and institutional incentive to go slow. He fought the system and won.
I had some hope that FDA commissioner Marty Makary would team with Marks at CBER. Makary understands that the FDA moves too slowly. He wrote in 2021:
COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape.
Americans can now see why medical advances often move at turtle speed. We need fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.
This starts at the top. Our public health leaders have become too be accepting of the bureaucratic processes that would outrage a fresh eye. For example, last week the antiviral pill Molnupiravir was found to cut COVID hospitalizations in half and, remarkably, no one who got the drug died.
The irony is that Molnupiravir was developed a year ago. Do the math on the number of lives that could have been saved if health officials would have moved fast, allowing rolling trials with an evaluation of each infection and adverse event in real-time. Instead, we have a process that resembles a 7-part college application for each of the phase 1, 2, and 3 clinical trials.
A Makary-Marks team could have moved the FDA in a very promising direction. Unfortunately, disputes with RFK Jr proved too much. Marks was especially and deservedly outraged by the measles outbreak and the attempt to promote vitamins over vaccines:
“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in a resignation letter referring to HHS Secretary Robert F. Kennedy Jr.
Thus, as of now, the FDA is moving in the wrong direction and Makary has lost an ally against RFK.
In other news, the firing of FDA staff is slowing down approvals, as I predicted it would.
Rethinking regulatory fragmentation
Regulatory fragmentation occurs when multiple federal agencies oversee a single issue. Using the full text of the Federal Register, the government’s official daily publication, we provide the first systematic evidence on the extent and costs of regulatory fragmentation. Fragmentation increases the firm’s costs while lowering its productivity, profitability, and growth. Moreover, it deters entry into an industry and increases the propensity of small firms to exit. These effects arise from redundancy and, more prominently, from inconsistencies between government agencies. Our results uncover a new source of regulatory burden, and we show that agency costs among regulators contribute to this burden.
That is from a new paper by Joseph Kalmenovitz, Michelle Lowry, and Ekaterina Volkova, forthcoming in Journal of Finance. Via the excellent Kevin Lewis.
What Follows from Lab Leak?
Does it matter whether SARS-CoV-2 leaked from a lab in Wuhan or had natural zoonotic origins? I think on the margin it does matter.
First, and most importantly, the higher the probability that SARS-CoV-2 leaked from a lab the higher the probability we should expect another pandemic.* Research at Wuhan was not especially unusual or high-tech. Modifying viruses such as coronaviruses (e.g., inserting spike proteins, adapting receptor-binding domains) is common practice in virology research and gain-of-function experiments with viruses have been widely conducted. Thus, manufacturing a virus capable of killing ~20 million human beings or more is well within the capability of say ~500-1000 labs worldwide. The number of such labs is growing in number and such research is becoming less costly and easier to conduct. Thus, lab-leak means the risks are larger than we thought and increasing.
A higher probability of a pandemic raises the value of many ideas that I and others have discussed such as worldwide wastewater surveillance, developing vaccine libraries and keeping vaccine production lines warm so that we could be ready to go with a new vaccine within 100 days. I want to focus, however, on what new ideas are suggested by lab-leak. Among these are the following.
Given the risks, a “Biological IAEA” with similar authority as the International Atomic Energy Agency to conduct unannounced inspections at high-containment labs does not seem outlandish. (Indeed the Bulletin of Atomic Scientists are about the only people to have begun to study the issue of pandemic lab risk.) Under the Biological Weapons Convention such authority already exists but it has never been used for inspections–mostly because of opposition by the United States–and because the meaning of biological weapon is unclear, as pretty much everything can be considered dual use. Notice, however, that nuclear weapons have killed ~200,000 people while accidental lab leak has probably killed tens of millions of people. (And COVID is not the only example of deadly lab leak.) Thus, we should consider revising the Biological Weapons Convention to something like a Biological Dangers Convention.
BSL3 and especially BSL4 safety procedures are very rigorous, thus the issue is not primarily that we need more regulation of these labs but rather to make sure that high-risk research isn’t conducted under weaker conditions. Gain of function research of viruses with pandemic potential (e.g. those with potential aerosol transmissibility) should be considered high-risk and only conducted when it passes a review and is done under BSL3 or BSL4 conditions. Making this credible may not be that difficult because most scientists want to publish. Thus, journals should require documentation of biosafety practices as part of manuscript submission and no journal should publish research that was done under inappropriate conditions. A coordinated approach among major journals (e.g., Nature, Science, Cell, Lancet) and funders (e.g. NIH, Wellcome Trust) can make this credible.
I’m more regulation-averse than most, and tradeoffs exist, but COVID-19’s global economic cost—estimated in the tens of trillions—so vastly outweighs the comparatively minor cost of upgrading global BSL-2 labs and improving monitoring that there is clear room for making everyone safer without compromising research. Incredibly, five years after the crisis and there has be no change in biosafety regulation, none. That seems crazy.
Many people convinced of lab leak instinctively gravitate toward blame and reparations, which is understandable but not necessarily productive. Blame provokes defensiveness, leading individuals and institutions to obscure evidence and reject accountability. Anesthesiologists and physicians have leaned towards a less-punitive, systems-oriented approach. Instead of assigning blame, they focus in Morbidity and Mortality Conferences on openly analyzing mistakes, sharing knowledge, and redesigning procedures to prevent future harm. This method encourages candid reporting and learning. At its best a systems approach transforms mistakes into opportunities for widespread improvement.
If we can move research up from BSL2 to BSL3 and BSL4 labs we can also do relatively simple things to decrease the risks coming from those labs. For example, let’s not put BSL4 labs in major population centers or in the middle of a hurricane prone regions. We can also, for example, investigate which biosafety procedures are most effective and increase research into safer alternatives—such as surrogate or simulation systems—to reduce reliance on replication-competent pathogens.
The good news is that improving biosafety is highly tractable. The number of labs, researchers, and institutions involved is relatively small, making targeted reforms feasible. Both the United States and China were deeply involved in research at the Wuhan Institute of Virology, suggesting at least the possibility of cooperation—however remote it may seem right now.
Shared risk could be the basis for shared responsibility.
Bayesian addendum *: A higher probability of a lab-leak should also reduce the probability of zoonotic origin but the latter is an already known risk and COVID doesn’t add much to our prior while the former is new and so the net probability is positive. In other words, the discovery of a relatively new source of risk increases our estimate of total risk.
Not the precedent I have been looking for
The Federal Communications Commission is prepared to block mergers and acquisitions involving companies that continue promoting diversity, equity and inclusion policies, FCC Chairman Brendan Carr said Friday.
Why Spain’s transition to democracy remains controversial
New podcast series on Latin American political economy, with Rasheed Griffith and Diego Sánchez de la Cruz, all in English.
NIMBY contrarianism
The standard view of housing markets holds that the flexibility of local housing supply–shaped by factors like geography and regulation–strongly affects the response of house prices, house quantities and population to rising housing demand. However, from 2000 to 2020, we find that higher income growth predicts the same growth in house prices, housing quantity, and population regardless of a city’s estimated housing supply elasticity. We find the same pattern when we expand the sample to 1980 to 2020, use different elasticity measures, and when we instrument for local housing demand. Using a general demand-and-supply framework, we show that our findings imply that constrained housing supply is relatively unimportant in explaining differences in rising house prices among U.S. cities. These results challenge the prevailing view of local housing and labor markets and suggest that easing housing supply constraints may not yield the anticipated improvements in housing affordability.
That is from a new NBER working paper by Schuyler Louie, John A. Mondragon, and Johannes Wieland.
What Did We Learn From Torturing Babies?
As late as the 1980s it was widely believed that babies do not feel pain. You might think that this was an absurd thing to believe given that babies cry and exhibit all the features of pain and pain avoidance. Yet, for much of the 19th and 20th centuries, the straightforward sensory evidence was dismissed as “pre-scientific” by the medical and scientific establishment. Babies were thought to be lower-evolved beings whose brains were not yet developed enough to feel pain, at least not in the way that older children and adults feel pain. Crying and pain avoidance were dismissed as simply reflexive. Indeed, babies were thought to be more like animals than reasoning beings and Descartes had told us that an animal’s cries were of no more import than the grinding of gears in a mechanical automata. There was very little evidence for this theory beyond some gesturing’s towards myelin sheathing. But anyone who doubted the theory was told that there was “no evidence” that babies feel pain (the conflation of no evidence with evidence of no effect).
Most disturbingly, the theory that babies don’t feel pain wasn’t just an error of science or philosophy—it shaped medical practice. It was routine for babies undergoing medical procedures to be medically paralyzed but not anesthetized. In one now infamous 1985 case an open heart operation was performed on a baby without any anesthesia (n.b. the link is hard reading). Parents were shocked when they discovered that this was standard practice. Publicity from the case and a key review paper in 1987 led the American Academy of Pediatrics to declare it unethical to operate on newborns without anesthesia.
In short, we tortured babies under the theory that they were not conscious of pain. What can we learn from this? One lesson is humility about consciousness. Consciousness and the capacity to suffer can exist in forms once assumed to be insensate. When assessing the consciousness of a newborn, an animal, or an intelligent machine, we should weigh observable and circumstantial evidence and not just abstract theory. If we must err, let us err on the side of compassion.
Claims that X cannot feel or think because Y should be met with skepticism—especially when X is screaming and telling you different. Theory may convince you that animals or AIs are not conscious but do you want to torture more babies? Be humble.
We should be especially humble when the beings in question are very different from ourselves. If we can be wrong about animals, if we can be wrong about other people, if we can be wrong about our own babies then we can be very wrong about AIs. The burden of proof should not fall on the suffering being to prove its pain; rather, the onus is on us to justify why we would ever withhold compassion.
Hat tip: Jim Ward for discussion.
The Shortage that Increased Ozempic Supply
It sometimes happens that a patient needs a non-commercially-available form of a drug, a different dosage or a specific ingredient added or removed depending on the patient’s needs. Compounding pharmacies are allowed to produce these drugs without FDA approval. Moreover, since the production is small-scale and bespoke the compounded drugs are basically immune from any patent infringement claims. The FDA, however, also has an oddly sensible rule that says when a drug is in shortage they will allow it be compounded, even when the compounded version is identical to the commercial version.
The shortage rule was meant to cover rare drugs but when demand for the GLP-1 drugs like Ozempic and Zepbound skyrocketed, the FDA declared a shortage and big compounders jumped into the market offering these drugs at greatly reduced prices. Moreover, the compounders advertised heavily and made it very easy to get a “prescription.” Thus, the GLP-1 compounders radically changed the usual story where the patient asks the compounder to produce a small amount of a bespoke drug. Instead the compounders were selling drugs to millions of patients.
Thus, as a result of the shortage rule, the shortage led to increased supply! The shortage has now ended, however, which means you can expect to see many fewer Hims and Hers ads.
Scott Alexander makes an interesting point in regard to this whole episode:
I think the past two years have been a fun experiment in semi-free-market medicine. I don’t mean the patent violations – it’s no surprise that you can sell drugs cheap if you violate the patent – I mean everything else. For the past three years, ~2 million people have taken complex peptides provided direct-to-consumer by a less-regulated supply chain, with barely a fig leaf of medical oversight, and it went great. There were no more side effects than any other medication. People who wanted to lose weight lost weight. And patients had a more convenient time than if they’d had to wait for the official supply chain to meet demand, get a real doctor, spend thousands of dollars on doctors’ visits, apply for insurance coverage, and go to a pharmacy every few weeks to pick up their next prescription. Now pharma companies have noticed and are working on patent-compliant versions of the same idea. Hopefully there will be more creative business models like this one in the future.
The GLP-1 drugs are complex peptides and the compounding pharmacies weren’t perfect. Nevertheless, I agree with Scott that, as with the off-label market, the experiment in relaxed FDA regulation was impressive and it does provide a window onto what a world with less FDA regulation would look like.
Hat tip: Jonathan Meer.
Visits to the Doctor, Per Year
The number of times people visit the doctor per year varies tremendously across OECD countries from a low of 2.9 in Chile to a high of 17.5 (!) in Korea. I haven’t run the numbers officially but it doesn’t seem that there is much correlation with medical spending per capita or life expectancy.
Data can be found here. 
Hat tip: Emil Kirkegaard on X.
Sentences to ponder
The daughters of immigrants enjoy higher absolute mobility than daughters of locals in most destinations, while immigrant sons primarily enjoy this advantage in countries with long histories of immigration.
That is from a new and very interesting paper by Leah Boustan, et.al. You have pondered the implied policy recommendations, right?