Category: Current Affairs
The New FDA and the Regulation of Laboratory Developed Tests
The FDA under President Trump and new FDA head Martin Makary should rapidly reverse the FDA’s powergrab on laboratory developed tests. To recap, laboratory developed tests (LDTs) are the kind your doctor orders, they are a service not a product and are not sold directly to patients. Congress has never given the FDA the authority to regulate LDTs. Indeed, in 2015, Paul Clement, the former US Solicitor General under George W. Bush, and Laurence Tribe, a leading liberal constitutional lawyer, wrote an article that rejected the FDA’s claims writing that the “FDA’s assertion of authority over laboratory-developed testing services is clearly foreclosed by the FDA’s own authorizing statute” and “by the broader statutory context.”
Moreover, in addition to legal reasons there are sound public policy reasons to reject FDA regulation of LDTs. Lab developed tests have never been FDA regulated, except briefly during the pandemic when the FDA used the declaration of emergency to issue so-called “guidance documents” saying that any SARS-COV-II test had to be pre-approved by the FDA. Thus, the FDA reversed the logic of emergency. In ordinary times, pre-approval was not necessary but when speed was of the essence it became necessary to get FDA pre-approval. The FDA’s pre-approval process slowed down testing in the United States and it wasn’t until after the FDA lifted its restrictions in March that tests from the big labs became available.
In a remarkably prescient passage, Clement and Tribe (2015, p. 18) had warned of exactly this kind of delay:
The FDA approval process is protracted and not designed for the rapid clearance of tests. Many clinical laboratories track world trends regarding infectious diseases ranging from SARS to H1N1 and Avian Influenza. In these fast-moving, life-or-death situations, awaiting the development of manufactured test kits and the completion of FDA’s clearance procedures could entail potentially catastrophic delays, with disastrous consequences for patient care.
We are seeing the same kind of FDA-caused delay for tests for bird-flu.
Moreover, unlike some of the proposals associated with incoming HHS head Robert Kennedy, reversing the FDA on lab-developed tests has significant support from a wide-variety of experts. Here, for example, is the American Hospital Association:
…we strongly believe that the FDA should not apply its device regulations to hospital and health system LDTs. These tests are not devices; rather, they are diagnostic tools developed and used in the context of patient care. As such, regulating them using the device regulatory framework would have an unquestionably negative impact on patients’ access to essential testing. It would also disrupt medical innovation in a field demonstrating tremendous benefits to patients and providers.
The Trump administration has a number of options:
…the LDT Final Rule was promulgated in time to escape Congressional Review Act scrutiny; however, the executive branch and a Republican-controlled Congress have other tools to limit or vitiate FDA’s authority. These include, in no particular order:
The U.S. Department of Health and Human Services (HHS) could revoke the LDT Final Rule. The recission of a rule is treated the same as the promulgation of a new rule. If HHS revokes the final rule, the cases will likely be dismissed as moot. The timing of such action is uncertain at this time.
FDA could extend or revise its policies of enforcement discretion. LDTs are currently subject to FDA’s phaseout policy which has five stages, the last of which begins in May 2028. Specific categories of IVDs will continue under an enforcement discretion policy indefinitely as described in the preamble to the final rule. HHS could quickly issue such a revised policy or policies without prior public comment if it determines such policy meets the threshold in 21 CFR 10.115(g)(2).
Congress could act. With a Republican-controlled House and Senate to start the new Trump administration, there is a chance that efforts to legislate the regulation of LDTs could be reignited. Based on prior congressional efforts, it is likely that such legislation would place LDTs under control by CMS and CLIA, rather than require LDTs to comply with FDA requirements.
HHS could let the litigation continue. The new administration may view the U.S. District Court for the Eastern District of Texas to be sympathetic to the Plaintiffs’ arguments and therefore proceed unabridged assuming the final rule will be struck-down, if that is indeed the deregulatory objective of the new administration.
The U.S. Department of Justice (DOJ) could act concerning the litigation. DOJ options are constrained by ethics rules but DOJ could request to amend its filings, pause the case pending rule-making proceedings, or take other actions intended to stall or moot the litigation in a deregulatory fashion.
Merry Christmas!
Wishing all our readers a wonderful day and New Year!
Jefferson’s DOGE (that was then, this is now)
Jefferson swiftly undid twelve years of Federalism. He allowed the Sedition Act to expire and adopted a more catholic naturalization law. He reduced the federal bureaucracy — small even by today’s standards — particularly in the Treasury Department (a slap at Hamilton, who had been Secretary under Washington), slashing the number of employees by 40 percent and eliminating tax inspectors and collectors altogether. He cut the military budget in half, which was then 40 percent of the overall federal budget. He eliminated all federal excise taxes, purging the government of what he called Hamilton’s “contracted, English, half-lettered ideas.” Reluctantly he kept the First Bank of the United States, but paid off nearly half the national debt. “No government in history,” the historian Gordon S. Wood has observed, “had ever voluntarily cut back on its authority.”
That is from the new and very good book Martin van Buren: America’s First Politician, by James M. Bradley. Later things were different:
Martin van Buren went into office deermined to avoid Andrew Jackson’s fateful staffing mistakes. The backbiting and intrigue wasted two years of Jackson’s presidency. This van Buren could not afford.
And a wee bit later:
Then the voters had their say. The November elections in New York were an absolute bloodbath for the Democrats. There were 128 elections for assembly in 1837, and the Whigs won 101 of them.
The book is well-written.
Stephen Miran nominated to head the CEA
Here is Stephen on Twitter, Harvard PhD, mostly he has been in the private sector. The NYT has further information.
Via Jon Hartley.
The show so far, DOGE edition
Round one is over, and so far no progress and indeed steps backwards:
President-elect Donald Trump’s last-minute demands for a congressional funding package were rejected by dozens of Republicans this week, foreshadowing the legislative challenges he could face next year — even with unified GOP control.
The Republicans also revealed they are not willing to shut down the government, and they do not have such a stable coalition in the House, and that is even before they lose some number of seats.
The package that passed the House includes more than $110 billion in disaster aid and a one-year farm bill extension but is stripped of Trump’s demand: a debt limit extension.
There was not an actual substantive win in the final outcome. Not surprisingly, the Democrats are touting it as a win for the Democrats.
And here Vivek concedes the loss.
I very much hope DOGE makes progress on its key issues — excess regulation and spending — but political change is tough and requires some highly unusual and idiosyncratic skills. Keep also in mind that while Trump has a mandate to attack Woke and secure the border, voters seem far less excited by cutting back on government spending and regulation (if anything the opposite?). Government spending is what “makes Washington go round,” and Reps love it, no matter what they may say in some of their more manufactured moments. So DOGE strategy will need to adjust accordingly.
*The Triumph of Politics*
The author is David A. Stockman, and the subtitle is Why the Reagan Revolution Failed. This is for me a re-read, all DOGErs and aspiring DOGErs should give this book an initial read, as it covers why the Reagan attempts to pare back government largely failed. Excerpt:
But I hadn’t recoked that there would be so much opposition on our side of the aisle. I was shocked to find that the Democrats were geting so much Republican help in their efforts to keep the pork barrel flowing and the welfare state intact. I had been worried because the votes didn’t add up, not the economic plan.
I had also come to realize that in my haste to get the Reagan Revolution launched in February, we had moved too fast. There were numerous loose ends. The spending reductions needed to pay for the tax cuts had turned out to be even bigger and tougher than I had originally thought.
And:
Over the next eight months, the President’s pen remained in his pocket. He did not veto one single appropriations bill, all of which combined came in $10 billion [sic] over the line. Come to think of it, he did use his pen — to sign them.
Stockman of course was what you might call the DOGE leader of the early 1980s. His final take is that the Reagan Revolution failed because it misunderstood what the American people truly want from their government. For better or worse, they want privilege and also protection from misfortune, not efficiency or maximum economic growth.
Essential reading, for some of you.
A nuclear fusion plant in Virginia?
A company pioneering the use of fusion for commercial energy plans to build the nation’s first grid-scale fusion power plant in Virginia by the early 2030s, Gov. Glenn Youngkin and other state and company officials said Tuesday.
Commonwealth Fusion Systems (CFS), based in Massachusetts, said it will invest billions of dollars to build the unique facility, which — if the technology can be proved — promises to supply about 400 megawatts of electricity, enough energy to power about 150,000 homes, according to a state news release.
Here is more from The Washington Post.
The epistemics of drone incursions
I do not pretend to know what is going on, nor do I think it is aliens. I do read:
The sprawling Wright Patterson Air Force Base in Ohio is the latest military installation to report mysterious drones flying over its airspace, The War Zone has learned.
“I can confirm small aerial systems were spotted over Wright Patterson between Friday night and Saturday morning,” base spokesman Bob Purtiman told The War Zone on Sunday in response to our questions about the sightings. “Today leaders have determined that they did not impact base residents, facilities, or assets. The Air Force is taking all appropriate measures to safeguard our installations and residents.”
The drones “ranged in sizes and configurations,” Purtiman said. “Our units are working with local authorities to ensure the safety of base personnel, facilities, and assets.”
The airspace over the base was closed for a while. My point here is to beware self-styled “debunkers,” who often acquire excess ownership in a schtick. Most of all I mean figures such as Mick West. It is easy enough to find stupid claims about drones (especially in New Jersey?) and counter them. The better way to proceed is to confront the strongest claims head on. The head of DHS is mystified, and a classified security briefing was held for Congress. Those are puzzles we should try to figure out. There is at least a reasonable probability that something interesting is going on here. Beware debunkers, very often they are not your epistemic friends.
Addendum: Here is an update from a man who receives high-level intelligence briefings.
Technological Disruption in the US Labor Market
Deming, Ong and Summers have a good overview of long-run and very recent changes in the US labor market. Using a measure of occupational titles the authors find:
The years spanning 1990-2017 were the most stable period in the history of the US labor market, going back nearly 150 years.
It’s a bit too early to distinguish an AI revolution from a COVID shock but the last four years look to be more disruptive than any since the 1970s and over a slightly longer period there are trends including a decline in retail, as consumers shift to online shopping and delivery, and a decline in office work, the latter especially suggesting an AI effect:
There were 850,000 fewer retail sales workers in the US in 2023 compared to 2013 even though the US economy added more than 19 million jobs over this period.
There are nearly five hundred thousand fewer secretaries and administrative assistants in the US labor force now than there were a decade ago. At the same time, management and business occupations have grown very rapidly. There were four million more managers and 3.5 million more business and financial operations jobs in the US in 2023 than there were in 2013.
Keep in mind that these changes are occurring as employment and wages overall are rising.
Jennifer Pahlka on DOGE
An excellent piece, one of the best I have read all year. Here is the concluding paragraph:
We can wish that the government efficiency agenda were in the hands of someone else, but let’s not pretend that change was going to come from Democrats if they’d only had another term, and let’s not delude ourselves that change was ever going to happen politely, neatly, carefully. However we got here, we may now be in a Godzilla vs Kong world. Perhaps we’re about to get a natural experiment in which Elonzilla faces off with Larry ElliKong. One of the things we need to be ready to learn is that Elonzilla could lose. Or worse, since Elon and Larry are friends, the expected disruptive could get co-opted. And what would that say about the problem? Conjuring Elon is not bringing a gun to a knife fight. It was never a knife fight.
Recommended.
Another look at the New Jersey drone evidence
Here is the chain of examples, one can assume not all are represented properly, nonetheless I remain stumped.
Tetlock on Testing Grand Theories with AI
Testing grand theories of politics (or economics) is difficult because such theories are always contingent on ceteris paribus assumptions but outside of a lab, all else is rarely the same. The great Philip Tetlock has run multi-decade forecasting experiments but these are time and resource consuming. Tetlock, however, now suggests that LLMs could speed the process of testing grand theories like Mearsheimer’s neo-realism theory of politics:
With current or soon to be available technology, we can instruct large language models (LLMs) to reconstruct the perspectives of each school of thought, circa 1990,and then attempt to mimic the conditional forecasts that flow most naturally from each intellectual school. This too would be a multi-step process:
1. Ensuring the LLMs can pass ideological Turing tests and reproduce the assumptions, hypotheses and forecasts linked to each school of thought. For instance, does Mearsheimer see the proposed AI model of his position to be a reasonable approximation? Can it not only reproduce arguments that Mearsheimer explicitly endorsed from 1990-2024 but also reproduce claims that Mearsheimer never made but are in the spirit of his version of neorealism. Exploring views on historical counterfactual claims would be a great place to start because the what-ifs let us tease out the auxiliary assumptions that neo-realists must make to link their assumptions to real-world forecasts. For instance, can the LLMs predict how much neorealists would change their views on the inevitability of Russian expansionism if someone less ruthless than Putin had succeeded Yeltsin? Or if NATO had halted its expansion at the Polish border and invited Russia to become a candidate member of both NATO and the European Union?
2. Once each school of thought is satisfied that the LLMs are fairly characterizing, not caricaturing, their views on recent history(the 1990-2024) period, we can challenge the LLMs to engage in forward-in-time reasoning. Can they reproduce the forecasts for 2025-2050 that each school of thought is generating now? Can they reproduce the rationales, the complex conditional propositions, underlying the forecasts—and do so to the satisfaction of the humans whose viewpoints are being mimicked?
3. The final phase would test whether the LLMs are approaching superhuman intelligence. We can ask the LLMs to synthesize the best forecasts and rationales from the human schools of thought in the 1990-2024 period, and create a coherent ideal-observer framework that fits the facts of the recent past better than any single human school of thought can do but that also simultaneously recognizes the danger of over-fitting the facts (hindsight bias). We can also then challenge these hypothesized-to-be-ideal-observer LLM s to make more accurate forecasts on out-of-sample questions, and craft better rationales, than any human school of thought.
La ciudad lineal
When does it make sense to organize most of your urban activity on a (more or less) straight line?
If land transport is very costly, as in much earlier times, and a river is available, you might build much of the town right on the river bank. You can see remnants of this if you travel along the Rhine, though those developments have since expanded in other directions. Volgograd partially matches this description as well, or so I am told. But since river transport has declined in importance, such modes of urban organization have fallen out of favor and for obvious reasons.
Might some new technology resurrect the relevance of linear spatial organization?
Perhaps a very rapid airport people mover can make linear organization non-crazy, but I do not see that it would privilege linear organization. Does not Istanbul airport have a fairly linear structure? But how scalable is that?
The Saudi plans for Neom attempt to resurrect a very strong and strict linear model, based on a new mode of transport. From Wikipedia:
The Line is eventually planned to be 170 kilometres (110 miles) long. It could stretch from the Red Sea approximately to the city of Tabuk and could have nine million residents, resulting in an average population density of 260,000 per square kilometre (670,000/sq mi)…Early plans proposed an underground railway with 510-kilometre-per-hour (317 mph) trains that could travel from one end of The Line to the other in 20 minutes.
Supposedly all the shops and sites would be within a five-minute walk of line stops.
Of course this plan may not happen. But the 317-mph train is essential to the idea. Just hop on, and travel at super-rapid speeds to where you want to go. Presumably there are enough tracks with enough stops, like those newish programmable elevators, that you won’t have to accelerate and decelerate too many times. But, as the number of desirable stops proliferates, that ends up translating into an impractical number of separate individual train tracks.
The core problem seems to be that a linear city requires both super-rapid transport and not too many desirable stops. It is hard to pull off that combination in the modern world.
Is Conakry the closest the world has to a truly linear city?
Probably that map is a bear sign for the idea.
To read about this topic, you might try:
von Thunen, The Isolated City.
Arturo Soria y Puig, La Ciudad Lineal.
Cerda, The Five Bases of the General Theory of Urbanization, edited by Arturo Soria y Puig.
N.A. Miliutin, Sotsgorod: The Problem of Building Socialist Cities.
And ask your local GPT.
Austin Vernon on drones (from my email)
The offensive vs. defensive framing seems wrong, at least temporarily. It should be motivated vs. unmotivated, with drones favoring the motivated.
A competent drone capability requires building a supply chain, setting up a small manufacturing/assembly operation, and training skilled operators. They need to manage frequencies and adjust to jamming. Tight integration of these functions is a necessity. That favors highly motivated groups with broad popularity (recruiting skilled talent!) even if they are nominally weak.
Conversely, it can be challenging for overly corrupt or complacent organizations to counter. They are also more likely to fracture and lose cohesion when under attack.
We’ve seen HTS, Burmese rebels, and Azerbaijan all have a lot of success with drones. Ukraine went from hopelessly behind in drone tech to leading Russia in innovation in many niches.
It seems reasonable that the barriers to entry for a motivated drone “startup” will go up. The US military has effective, expensive interceptors like Coyote Block II to counter small attacks in locations like Syria. Fighting larger entities requires pretty absurd scaling to match enemy numbers and the low per-flight success rate – Ukraine claims they might produce millions of drones this year. Hamas had initial success attacking Israel on Oct. 7 but didn’t have the magazine depth to defend themselves.
AI targeting, the necessity of specialized components to defeat electronic warfare, and cheaper drone interceptors are all factors that could upset this balance. Entities that have the scale to deploy an AI stack, true factories, and specialized components should gain the advantage if the rate of change slows.
Markets in everything, personal fire hydrant edition
The latest sought-after home amenity? Personal fire hydrants. The logic is that when there’s a major disaster there may not be enough fire engines to protect every house in an area. If homeowners have their own hydrant ready to go—along with hoses, nozzles and adapters—and are trained to use it all, that could help reduce the number of homes destroyed.
Real-estate agents say mentioning a personal fire hydrant in the marketing materials now helps sell homes. “People notice it. It’s definitely a plus,” says Stephen Kotsenburg of Christie’s International Real Estate, who has the listing for a four-bedroom, three-bathroom, 3,388-square-foot home in Park City, Utah. It’s on the market for $2.1 million and advertises a fire hydrant, which is painted bright red and is visible as you come up the driveway.
Victoria Waldorf is the listing agent for a five-bedroom, three-bathroom, 4,691-square-foot house that is for sale for $1.775 million in Agua Dulce, Calif. She says she points out the personal fire hydrant to everyone who comes through for a viewing. “There’s relief in people’s faces,” she says.
Here is more from the WSJ, via Daniel Lippmann.