Results for “fda” 324 found
Google searches for inequality (from my email)
From Jared Sleeper:
I was surprised to see this magnitude of effect. Google searches for “inequality” are twice as high during the academic year as they are during the summer. They double in September vs. August and then collapse by 50% in June vs. May.
Speeding Up Pharmaceutical Approvals by Recognizing Other Stringent Regulators
New Zealand’s ACT party has proposed that New Zealand speed up pharmaceutical approvals by recognizing the decisions of other stringent regulators, an idea I have long promoted .
The average time for Medsafe to consent an application for a high risk medicine is 630 days. For intermediate risk, it is 661 days and for lower risk it is 830 days8. The average time taken just for processing some lower risk categories is 176-210 days. This is an unacceptable length of time, given there other regulatory bodies replicating that exact same work overseas.
ACT says if a drug or medical device has been approved by any two reputable foreign regulatory bodies (such as Australia, United States, United Kingdom), it should be automatically approved in NZ as well within one week unless Medsafe can show extraordinary reason why it shouldn’t be.
This simple change would significantly improve access to medicines that have already been subject to rigorous testing and analysis through other regulatory regimes.
The ACT party is small but it has some seats and surprisingly the much larger National party is proposing a similar rule:
New Zealand’s slow approval process for medicines means Kiwis wait much longer than people in other countries to access potentially life-saving treatments. While it is essential that medicines and other treatments are subject to stringent scrutiny to ensure they are safe, there is no reason why New Zealanders should have to wait for our domestic medicines regulatory body, Medsafe, to conduct its own cumbersome process from scratch, when countries with health systems we trust have already gone through this exercise.
National will:…• Require Medsafe to implement even faster approvals processes for any medicines for use in New Zealand that have already been approved by at least two regulatory bodies that we currently recognise, including Australia, the EU, Singapore, the UK, Switzerland and the US.
New Zealand, by the way, already has a reciprocity agreement with the United States for food and it’s mutual–the FDA also recognizes New Zealand as a stringent food regulator–so the idea is not unprecedented.
Moreover, all of this comes on the tail of the UK actually adopting the idea via the “reliance procedure” which recognizes the EU as a stringent regulator and guarantees approval in the UK within 67 days for ay drug approved in the EU.
In the United States, even AOC has flirted with the idea, at least for sunscreens!
Thus, the reciprocity or recognition idea is starting to be adopted.
Hat tip: Eric Crampton who has some further comments.
Pharmaceutical Externalities
In my view, pharmaceuticals are undervalued and underinvested in because, despite high prices, pharmaceutical innovations earn only a fraction of the value that they create (Nordhaus finds that in general that innovations reap only a small share of the gains that they create). In 2014, for example, we got Harvoni a new treatment that offered a complete cure for hepatitis C (HCV) infection. In 2014, Harvoni cost over $1000 a pill and between $60,000 and $100,000 for a full treatment. In 2015 Medicaid spent more on Harvoni than on any other drug and there were calls for regulation and price controls. Studies showed, however, that even at that high price, Harvoni was value/cost-effective. Today, with more competition, there are equivalent versions of Harvoni available from Amazon for $12,869 (and 64 cents) which is still expensive but cheap for a cure for an often debilitating and sometimes life-threatening disease (and the price is less for a private insurance buyer or Medicare/Medicaid). In 2030, Harvoni will go generic and prices will fall much more.
Writing at their new substack, Random Acts of Medicine (based on their book of the same name which I reviewed at the WSJ), Chris Worsham and Bapu Jena point us to another side-benefit of Harvoni and similar hep-C drugs. By curing hep-C these drugs results in fewer liver transplants but that means more livers are available for transplant to other people on the waiting list.
One simple statistic suggests that indeed, treatment of HCV is freeing up donor livers for patients with other diseases: in 2022, patients with chronic HCV infection represented only 11% of liver transplants (1,029 of 9,528)—down from the 38% in 2013 when the new HCV drugs were approved.
Beyond this simple figure, a new working paper by economists Kevin Callison, Michael Darden, and Keith Teltser has taken a new, rigorous look at data from 2014 to 2019 to understand how these new drugs for HCV have impacted liver transplants after their first 5 years of broad use. There were a number of encouraging findings:
- Waiting lists for liver transplants were being occupied by fewer HCV-positive patients and more HCV-negative patients; this shift can be explained by an estimated 45% reduction in the addition of new HCV-positive patients to waiting lists
- Patients on the waiting list were healthier, likely because waiting times for livers have decreased with less demand from HCV-positive patients
- Compared to what would have been expected without the introduction of new HCV treatments, the researchers estimated a 39% decrease in transplants to HCV-positive patients coupled with a 36% increase in transplants to HCV-negative patients.
- Over the five year period, researchers estimated 5,682 livers were transplanted to HCV-negative patients as a result of the new HCV drugs, corresponding to an economic value of $7.5 billion.
These kinds of external benefits from pharmaceuticals are often undercounted and they are one reason why I think the pharmaceutical price controls in the Inflation Reduction Act are a very bad idea.
Sunday assorted links
1. “Mobility indicators measuring voluntary decisions to socially distance, comprising measures of visitors/visits to recreational locations, and mobility proxy measuring duration of hours away from home show that a lower prevalence of long-term orientation traits explains persistent resistance to social distancing.” Link here, speculative.
2. Neanderthal genes and Covid risk? (WSJ)
3. “Masked ‘Boot Girls’ Are Freeing Booted Cars All Over Atlanta.”
4. Victor Fuchs has passed away.
5. Why it took the FDA so long to review the disputed cold remedy (NYT). And flying taxi executive to head the FAA.
6. “Japan’s Productivity Ranks Lowest Among G7 Nations for 50 Straight Years.” Why hasn’t YIMBY done more to fix that?
Diego on gas station drugs
From my email:
The average gas station is now packed to the brim with drugs. This place had a Whip-it stand near the checkout, that I imagine is for recreational nitrous oxide users rather than whipped cream enjoyers, as well as a massive selection of kratom. ‘Whippets’ can cause irreversible brain damage and kratom has opiate-like effects, binding to the same receptors as morphine. There were also 3 stands near the checkout dedicated to weed-adjacent things including a mix of gummies, vapes, and flower bud containers. Unsure exactly what the weed-adjacent stuff was, some of it was Delta-8. Seems like a lot of these weed derivatives stemmed from the 2018 farm bill. The kratom proliferation has been insane. One of the main kratom brands, Botanic Tonics, sells super-popular small blue vials under the name ‘Feel Free’ that merely say ‘Plant-based herbal supplement’ on the front. Despite the FDA recently seizing $3M of kratom from Botanic Tonics as well as endless stories of addiction on the subreddit r/Quittingfeelfree, Botanic Tonics is an official sponsor of UT Austin and Florida State University and gives out free vials to students.
I do not personally have data on this question, but I thought this content was worth passing along.
Why I am not entirely bullish on brain-computer interface
I agree that miracles may well be possible for disabled individuals, but I am less certain about their more general applicability. Here is one excerpt from my latest Bloomberg column:
Another vision for this technology is that the owners of computers will want to “rent out” the powers of human brains, much the way companies rent out space today in the cloud. Software programs are not good at some skills, such as identifying unacceptable speech or images. In this scenario, the connected brains come largely from low-wage laborers, just as both social media companies and OpenAI have used low-wage labor in Kenya to grade the quality of output or to help make content decisions.
Those investments may be good for raising the wages of those people. Many observers may object, however, that a new and more insidious class distinction will have been created — between those who have to hook up to machines to make a living, and those who do not.
Might there be scenarios where higher-wage workers wish to be hooked up to the machine? Wouldn’t it be helpful for a spy or a corporate negotiator to receive computer intelligence in real time while making decisions? Would professional sports allow such brain-computer interfaces? They might be useful in telling a baseball player when to swing and when not to.
The more I ponder these options, the more skeptical I become about large-scale uses of brain-computer interface for the non-disabled. Artificial intelligence has been progressing at an amazing pace, and it doesn’t require any intrusion into our bodies, much less our brains. There are always earplugs and some future version of Google Glass.
The main advantage of the direct brain-computer interface seems to be speed. But extreme speed is important in only a limited class of circumstances, many of them competitions and zero-sum endeavors, such as sports and games.
Nonetheless I am glad to the FDA is allowing Neuralink’s human trials to proceed — I would gladly be proven wrong.
The Promising Pathway Act
The evident failures of the FDA and CDC during COVID have opened up new opportunities for reform. One of the most interesting is the Promising Pathway Act, sponsored by Sens. Mike Braun (R-Ind.) and Kirsten Gillibrand (D-N.Y.). As Bart Madden and I write, the Act would create a new form of approval, provisional approval.
The Hill: Here’s how the current version of the bill works: A new drug could secure provisional approval for serious or life-threatening health conditions via early-stage clinical investigations indicating that the new drug’s safety and efficacy compare favorably to approved drugs.
Importantly, provisional approval requires establishing patient registries for all such treatments and is not simply a matter of faster approval. Third-party, independent entities would manage these registries, tracking safety and effectiveness.
In order to speed up the use of this new knowledge, the de-identified, disaggregated databases would be accessible to approved researchers, medical professionals for public health research and biopharmaceutical industry researchers. Drug sponsors or the government would fund the registries, and the FDA would submit an annual report to Congress on provisionally approved drugs.
Thus, provisional approval would allow earlier access to not yet approved drugs but would require the creation of a patient registry and database that could be used by anyone to evaluate the drug. An interesting and important idea.
Peltzman Revisited
Casey Mulligan has an excellent new paper, Peltzman Revisited: Quantifying 21st-Century Opportunity Costs of Food and Drug Administration Regulation. What are the costs of delaying a new drug or a vaccine? Longer and bigger clinical trials increase safety but I’ve often made the point that the people who would have lived had a good drug been approved sooner are buried in an invisible graveyard and thus these costs are typically undercounted–the failure to see the invisible graveyard biases decisions in favor of delay. Mulligan makes a different and rarely considered point about substitution effects. If a vaccine isn’t available there are substitutes but these substitutes are themselves potentially unsafe and ineffective. But who is testing the substitures?
Many of these substitute interventions, such as remote work, closing schools, and canceling normal medical appointments, are beyond the jurisdiction of the FDA and can be utilized without any attempt to demonstrate their safety or efficacy.
If the substitutes work, the costs of delay are reduced. The FDA, for example, is right to prioritize drugs for which there are few alternative treatments. But the standards for many vaccine or drug substitutes are completely different than those used to approve a vaccine:
Closing schools to in-person learning is an important example of a prevention activity that was available, was applied to tens of millions of children in the United States, and was outside the FDA’s jurisdiction…Obviously the FDA’s effectiveness standard for vaccines differs from the effectiveness standard (if any) that school districts applied in deciding to close schools.
Where were the randomized controlled trials for closing schools, shutting the parks and beaches, and delaying medical appointments? Thus, it’s quite possible that greater safety of vaccines comes at the expense of greater time under less safe and possibly unsafe substitutes. As Mulligan concludes:
Approval delays for pandemic tests and vaccines pushed tens of millions of individuals and businesses into preventions and treatments that were both outside FDA jurisdiction and hardly safe or effective. The pandemic experience raises the question of whether, on the whole, consumers engage in more unsafe and ineffective practices than they would if FDA approval were not a prerequisite for pharmaceutical sales.
Addendum: Much else of interest in the paper including a calculation of the value of the vaccines in the hundreds of billions and trillions very much in line with work done by the AHT team, including myself ,in the AER PP (especially the appendix) and Science.
Yglesias on Operation Warp Speed and the Republicans
Here’s Yglesias on Operation Warp Speed and the Republicans:
The debate over Operation Warp Speed wasn’t just a one-off policy dispute. Long before the pandemic, there was a conservative critique that the Food and Drug Administration is too slow and too risk-averse when it comes to authorizing new medications. Alex Tabarrok, a George Mason University economist, wrote about the “invisible graveyard” that could have been avoided if the FDA took expected value more seriously and considered the cost of delay in its authorization decisions.
The pandemic experience validated this criticism, which came to be embraced by some on the left as well — and it was about more than just vaccines. When it came to home Covid tests, Ezra Klein noted in the New York Times in 2021, “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.”
And yet, just as the invisible graveyard was becoming seen and the debate was being won and just as a historical public-private partnership had sped vaccines to the public and saved millions, the Republicans abandoned the high ground:
…it’s not surprising that Democrats are comfortable with the bureaucratic status quo and hesitant to ruffle feathers at federal regulatory agencies. What’s shocking is that Republicans — the traditional party of deregulation, the party that argued for years that the FDA is too slow-footed, the party that saved untold lives by accelerating vaccine development under Trump — have abandoned these positions.
At the cusp of what should have been a huge policy victory, Republicans don’t brag about their success, and they have no FDA reform legislation to offer. Instead, they’ve taken up the old mantle of hard-left skepticism of modern science and the pharmaceutical industry.
It’s been painful to see all that has been gained now being lost. Libertarian economists and conservatives argued for decades that the FDA worried more about approving a drug that later turns out to be unsafe than about failing to approve a drug that could save lives; thus producing a deadly caution. But now the FDA is being attacked for what they did right, quickly approving safe vaccines. I hope that he is wrong but I fear that Yglesias is correct that the FDA may now get even slower and more cautious.
The irony of the present moment is that there is substantial backlash to the FDA’s approval of vaccines that haven’t turned out to be dangerous at all.
That’s only going to make regulators even more cautious. Right now the entire US regulatory state is taking essentially no heat for the slow progress on the next generation of vaccines, and an enormous amount of heat for the perfectly safe vaccines that it already approved. And the ex-president who pushed them to speed up their work on those vaccines is not only no longer defending them, he’s embarrassed to have ever been associated with the project.
Like I said, it’s a comical moment of Republican infighting. But it’s a very grim one for anyone concerned with the pace of scientific progress in America.
Testing Freedom
In the latest Discourse Magazine I discuss the FDA’s long-standing fear and antipathy toward personalized medical tests and how this violates the 1st Amendment.
In 1972, the FDA confiscated thousands of home pregnancy tests, declaring that they were “drugs” meant to diagnose a “disease” and thus fell under the FDA’s regulatory dominion. The case went to the U.S. District Court for the District of New Jersey, and Judge Vincent P. Biunno ruled that the FDA had overstepped. “Pregnancy,” he said, “is a normal physiological function of all mammals and cannot be considered a disease … a test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news….” As a result of Judge Biunno’s ruling, home pregnancy tests are easily available today from pharmacies, grocery stores and online shops without a prescription.
These days, debates over home pregnancy tests from the 1970s seem anachronistic and paternalistic. Yet the same paternalistic arguments appear again and again with every new testing technology. In the late 1980s, for example, the FDA simply declared that it would not approve at-home HIV tests, regardless of their safety or efficacy. As with pregnancy tests, the concern was that people could not be trusted with information about their own bodies…the first rapid at-home HIV test was developed and submitted to the FDA in 1987 [but] it took 25 years before the FDA would approve these tests. (Now, you can easily buy such a test on Amazon.)
…The FDA has a vital role in ensuring that tests are clinically accurate—tests should do what they say they do. Tests don’t need to be perfectly accurate to be useful (think of thermometers, personality tests and tire pressure gauges), but if a test advertises that it measures HDL cholesterol, it should do that within the tolerances the firm promises. The FDA has the technical knowledge to ensure that tests work, and that’s a skill that Americans value from the agency.
What Americans don’t want is to be told they can’t handle the truth. Yet when it came to at-home tests such as pregnancy tests, HIV tests and genetic tests, that’s exactly the reasoning the FDA used—and continues to use—to suppress information. The FDA should ensure that tests are safe, but “safety” means physical safety. The FDA may not declare a product unsafe because it might produce dangerous knowledge. Patients have a right to know about their own bodies. Our antibodies, ourselves. The FDA has authority over drugs and devices but not over patients.
Judge Biunno had it right back in 1972 when he said that diagnostic tests produce “news.” Test results, therefore, are a type of speech that fall under the First Amendment right to freedom of speech. The Supreme Court has repeatedly rejected restrictions on freedom of speech based on “a fear that people would make bad decisions if given truthful information”; thus, FDA restrictions on tests based on such fears are unconstitutional. The question of whether consumers will respond “safely” to test results is no more relevant to the FDA’s regulatory authority than the question of whether readers will respond safely to political news published in The New York Times. The FDA does not have the constitutional authority to regulate news.
Retrospective look at rapid Covid testing
To be clear, I still favor rapid Covid tests, and I believe we were intolerably slow to get these underway. The benefits far exceed the costs, and did earlier on in the pandemic as well.
That said, with a number of pandemic retrospectives underway, here is part of mine. I don’t think the strong case for those tests came close to panning out.
I had raised some initial doubts in my podcasts with Paul Romer and also with Glen Weyl, mostly about the risk of an inadequate demand to take such tests. I believe that such doubts have been validated.
Ideally what you want asymptomatic people in high-risk positions taking the tests on a frequent basis, and, if they become Covid-positive, learning they are infectious before symptoms set in (remember when the FDA basically shut down Curative for giving tests to the asymptomatic? Criminal). And then isolating themselves. We had some of that. But far more often I witnessed:
1. People with symptoms taking the tests to confirm they had Covid. Nothing wrong with that, but it leads to a minimal gain, since in so many cases it was pretty clear without the test.
2. Various institutions requiring tests for meet-ups and the like. These tests would catch some but not all cases, and the event still would turn into a spreader event, albeit at a probably lower level than otherwise would have been the case.
3. Nervous Nellies taking the test in low-risk situations mainly to reassure themselves and others. Again, no problems there but not the highest value use either.
So the prospects for mass rapid testing — done in the most efficacious manner — were I think overrated.
I recall the summer of 2022 in Ireland, which by the way is when I caught Covid (I was fine, though decided to spend an extra week in Ireland rather than risk infecting my plane mates). Rapid tests were available everywhere, and at much lower prices than in the United States. Better than not! But what really seemed to make the difference was vaccines. The availability of all those tests did not do so much to prevent Covid from spreading like a wildfire during that Irish summer. Fortunately, deaths rose but did not skyrocket.
The well-known Society for Healthcare Epidemiology just recommended that hospitals stop testing asymptomatic patients for Covid. You may or may not agree, but that is a sign of how much status testing has lost.
Some commentators argue there are more false negatives on the rapid tests with Omicron than with earlier strains. I haven’t seen proof of this claim, but it is itself noteworthy that we still are not sure how good the tests are currently. That too reflects a lower status for testing.
Again, on a cost-benefit basis I’m all for such testing! But I’ve been lowering my estimate of its efficacy.
Thursday assorted links
Saturday assorted links
3. Qatar bans beer at the World Cup (NYT).
4. Paris is banning e-scooters? Would the FDA approve them?
5. Future Fund and clawback issues with grants, noting that I see the risk of clawback as pretty low.
6. Podcast with John Ashmore about the British people and what they have done.
7. Ross Douthat on Effective Altruism (NYT).
*The Messenger*
The author is Peter Loftus, and the subtitle is Moderna, the Vaccine, and the Business Gamble That Changed the World. An excellent book, here is one very short excerpt:
The FDA usually follows a rigid process of interacting with the drug companies it regulates. Normally, it can take months for a company to schedule an in-person meeting with the FDA.
Culture dies hard, here is Alex on the Invisible Graveyard. And this:
…Moderna executives expressed confidence they could hit the enrollment targets without significantly slowing down overall enrollment. But Fauci and Slaoui said they actually wanted Moderna to slow down overall enrollment in order to ensure they enrolled more minorities.
The book estimates the delay here at three weeks — how many lives was that in winter of 2020/2021?
Labor Unions Reduce Product Quality
A very nice paper in Management Science by Kini, Shen, Shenoy and Subramanian finds that labor unions reduce product quality. Two strengths of the paper. First, the authors have relatively objective measures of product quality from thousands of product recalls mandated by the FDA, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration covering many different industries. Second the authors use 3 different methods. First, they find that unionized firms are more likely to have recalls than non-unionized firms (a simple difference in means subject to many potential cofounds but I still like to see the raw data), second they find that in a panel model with industry and year fixed effects and other controls that firms which are more unionized have a greater frequency of product recalls. Finally they find that firms where the union just barely won the vote are more likely to have subsequent product recalls than firms for which the union just barely lost the vote–a regression discontinuity study.
In this paper, we study the impact of labor unions on product quality failures. We use a product recall as our measure of quality failure because it is an objective metric that is applicable to a broad cross-section of industries. Our analysis employs a union panel setting and close union elections in a regression discontinuity design framework to overcome identification issues. In the panel regressions, we find that firms that are unionized and those that have higher unionization rates experience a greater frequency of quality failures. The results obtain even at a more granular establishment level in a subsample in which we can identify the manufacturing establishment associated with the recalled product. When comparing firms in close elections, we find that firms with close union wins are followed by significantly worse product quality outcomes than those with close union losses. These results are amplified in non–right-to-work states, where unions have a relatively greater influence on the workforce.
The authors put more weight on financial strains caused by unionization as a mechanism whereas my story would be that unionization prevents firms from disciplining shoddy workers and that leads to lower product quality. Note that my theory would also cover teachers unions which the author’s mechanism would not.
Hat tip: Luke Froeb.
Photo Credit: Joe Piette.