17 ms·

The FDA's Restrictive Regulation of Home-Testing Devices (2017)

114 points by apsec112 5y ago

transfire 5y ago
It's just an excuse to protect corporate interests. If they really cated about consumers they'd make testing as accessible as possible. Best case in point concerning these persevere motives is what they did to the X-Prize for the medical "tri-corder".
finolex1 5y ago
Rapid COVID tests were much more widely available in Europe than in the US this past year, owing to differences in regulation. Also related: https://www.propublica.org/article/this-scientist-created-a-rapid-test-just-weeks-into-the-pandemic-heres-why-you-still-cant-get-it https://www.propublica.org/article/this-scientist-created-a-... https://www.nytimes.com/2021/09/21/briefing/rapid-testing-covid-us.html https://www.nytimes.com/2021/09/21/briefing/rapid-testing-co...
- yosito 5y ago
  I was living in Hungary most of 2021. Any time I needed rapid tests, it took me no longer than 20 minutes to get as many as I needed from the nearest pharmacy. I had to pay ~$5/each for them, which was fine for me. On my way to the US, I stopped in Mexico for two weeks (there were no direct flights, so I decided to get some beach time in). Rapid tests were available on every block, and it took 5 minutes to get one any time. Now I'm in Ohio. A family member didn't test before our Christmas Eve gathering (in retrospect, I should have required it), and ended up symptomatic and testing positive yesterday. Today I was searching for tests from 8am, I checked literally every pharmacy in the county, called all of the county health department's testing centers, libraries, universities, etc. There was not a single rapid test available anywhere, at home or on-site. Finally at 1pm the county health department tweeted to me that they got a shipment and it was first come first serve, two tests per person. So I drove over, and by the time I got there, they were handing out the last tests in their box. I was able to get only two tests. They were free, though I would have happily paid for them. But I found it infuriating that it was so impossible to get a rapid test when needed. I still don't have as many as I should on hand. I don't know what kind of backward, shithole country this has become, where even basic healthcare services are unavailable, but I'm considering going back to Mexico or Hungary as soon as possible.
  - jessaustin 5y ago
    FDA tries to prevent anything that could lead to less money going to big pharma firms. The theory is that if lots of cheap tests had been available during the deepest depths of the pandemic, transmission would have dropped and fewer people would have consented to vaccination. https://www.bostonglobe.com/2021/12/22/nation/man-behind-rapid-test-crusade/ https://www.bostonglobe.com/2021/12/22/nation/man-behind-rap...
  - denton-scratch 5y ago
    UK here. There was a shortage of self-test lateral flow tests a couple of weeks ago, but that's over - they have plenty in stock now. I can go to the NHS website and order a pack of 7 tests, and they'll arrive the next day. They're free. Teachers and medical staff don't even have to order them; they're provided (required) at the place of work. I happen to be signed-up for a survey by the Office of National Statistics; they send someone round every week to get a swab from me for PCR testing. I get the result from that by email, the next day. I have more confidence in the LFT than the PCR test, because some of the PCR test labs have been shown to be dodgy. The ONS is doing PCR tests because the PCR test gives them information about variants, that you don't get from the LFT. The ONS cares about variants and how they are mutating and spreading; I don't. LFT is good enough for me. I'm going to do an LFT right now, because I'm about to attend a family gathering.
saurik 5y ago
The entire premise of protecting people from "their own reactions to test results" is so horribly infuriating :(. The context that is missing here, which I am super curious about: Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? Is there any real organized opposition at all to the FDA doing this that one can attach themselves to?
- pimlottc 5y ago
  This appears to be a thesis paper for a law degree.
  - huitzitziltzin 5y ago
    There is no such thing in the US. Law degrees do not require a thesis. It is an article written for submission to a law review.
    - rhino369 5y ago
      Most schools require a long paper from grads. You typically write one for the journal you work on or maybe for a class you take. Unlike real scholarship, legal "scholarship" is only reviewed by third year law students. It's pretty worthless stuff.
    - DannyBee 5y ago
      This is partially right. JD's generally do not require a thesis. However, LLM's do.
- rasengan 5y ago
  Agree, it is infuriating. > Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? This looks like a student's thesis. The author, also, appears to be in agreement with you and is hoping to push information to help cause a stand: From the conclusion: > These restrictions illustrate a disturbing trend with major consequences for current and future technologies. Ultimately, the FDA’s decision to act as gatekeeper, limiting consumers’ access to their medical information, is premised on an impermissible value judgment that significantly restricts individual autonomy.
baggy_trough 5y ago
- knodi123 5y ago
  They save a lot of lives too. Maybe you're too young to remember the days of literal snake oil, or radium water, or "vital rays". The real problem with the FDA is they use a one-size-fits-all approach that is optimized to be as conservative as possible.
  - baggy_trough 5y ago
jtdev 5y ago
zackify 5y ago
Interesting seeing an article about this. Just this week I was looking to get a continuous glucose monitor. I’ve heard it can really prevent diabetes and help you understand what foods spike your levels. The fda won’t allow anyone to get these if they aren’t already diabetic. There’s so many ways we aren’t “free” in this country to do what we want with our bodies.
- enchiridion 5y ago
  I agree. This overzealous attitude from health regulators not good. I see it as nothing more than authoritarians in the health domain. They know what’s best for everyone, and clearly don’t trust that freedom empowers people. This is at the heart of many of the issues the public has had with the US government’s response to the pandemic.
  - scoopertrooper 5y ago
    Yeah, the American public have really shown how rational they are during this pandemic. The government is giving out the best vaccine in the world for free (also the best against Omicron) and 27% of adults are still not fully vaccinated. And it took some harsh mandates and a crazy new mutation to get them even that far.
    - eru 5y ago
      Freedom includes the freedom for people to make choices that you (or me) disagree with. An individual getting vaccinated or not has some externalities for the rest of society. The answer from orthodox economics is to measure / estimate these externalities, and then apply taxes and/or subsidies appropriately. The vaccines are already free for the patient, that's a generous subsidy. If that's not enough, they could give everyone who gets vaccinated fifty bucks or tax unvaccinated people some extra fee. Another example: in Singapore the government used to cover everyone's covid hospitalization costs, recently they changed to only covering them for vaccinated people (or those with a medically valid excuse).
      - 5y ago
AtomicOrbital 5y ago
Michael Mina is an immunologist, epidemiologist, and physician at Harvard and an expert on rapid paper based COVID testing ... Listen to his interview with Lex Fridman entitled #146 – Michael Mina: Rapid Testing, Viruses, and the Engineering Mindset Lex Fridman Podcast where Mina details what the tests do and how horribly corrupt the US gov has mismanaged rapid self testing
- Karsteski 5y ago
  Excellent podcast. I'd recommend as well the most recent one with Michael Mina, which is focused on COVID testing. Link for those interested: https://youtu.be/80OvNaEgmmw https://youtu.be/80OvNaEgmmw
marsven_422 5y ago
In Sweden home tests have been available for some time. The effect on the masses is that if the test is negative they will send their children to school, use public transportation, go to work even if they are sick as a dog. It's not Corona so it's fine. The end result is none Corona "normal" winter flue/cold/infections are being spread like never before.
- denton-scratch 5y ago
  I understand that flu and cold infections are more widespread this year than last, because people havn't been mingling as much in the last year. So when they do mingle, they encounter flu/cold variants that they don't have resistance to.
- spurgu 5y ago
  Du har 99% döda kommentarer men bara -5 karma? Vad är din hemlighet? Jag sku finna dina kommentarer moderatligt underhållande om de var nån annanstans än på HN.
- Dylan16807 5y ago
  Do you have any stats on that? How are those disease frequencies compared to 2019? I found this page, which suggests a relatively normal flu season so far: https://www.icuregswe.org/en/about-sir/nyheter/influensasasongen-2021-2022/ https://www.icuregswe.org/en/about-sir/nyheter/influensasaso... I don't see any cold data. Though I found a chart for australia: https://www.iqvia.com/-/media/iqvia/images/body/blogs/2021/12/exhibit-2.svg https://www.iqvia.com/-/media/iqvia/images/body/blogs/2021/1...
Sebguer 5y ago
The author of this paper is currently a clerk for Supreme Court Justice Alito: https://law.duke.edu/news/baird-jdma-18-selected-clerk-supreme-court-associate-justice-samuel-alito-0/ https://law.duke.edu/news/baird-jdma-18-selected-clerk-supre...
walterbell 5y ago
https://www.vanityfair.com/news/2021/12/the-biden-administration-rejected-an-october-proposal-for-free-rapid-tests-for-the-holidays https://www.vanityfair.com/news/2021/12/the-biden-administra... > The Biden Administration Rejected an October Proposal for “Free Rapid Tests for the Holidays” ... The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide “Testing Surge to Prevent Holiday COVID Surge” ... An administration official who attended the meeting told Vanity Fair that, while everyone present shared the same goal of expanding rapid testing as soon as possible, the plan could not be implemented at that time: “We did not have capacity to manufacture over-the-counter tests at that scale.” The problem, in essence, was twofold: The FDA had authorized only a handful of different home tests, and those it had authorized could not increase manufacturing fast enough.
worik 5y ago
Is this an argument for business opportunity dressed in morality clothing?
musicale 5y ago
It makes sense to regulate 23andme since its business model was to gather DNA for one purported set of purposes (consumer information, ancestry, etc.) and then to construct a large genetic database for its own research and business purposes. 23andme also has privacy implications/externalities for close relatives to people in their database. Law enforcement usage of DNA databases has also been controversial.
- KennyBlanken 5y ago
  Yeah - once you know you have certain genetic predispositions, that has severe implications for insurance. Do not do any sort of genetic testing without fully understanding present and possible future consequences of doing so. The author's age really shows when she mentions AIDS tests. AIDS for a while was a near guaranteed death sentence and also carried incredible social stigma, and not just because of the assumptions about you made (ie that you were gay, or a drug user.) I don't think people younger than 40 or so understand how big a deal it was when Princess Diana shook the hand of a person with AIDS in front of TV cameras. Receiving a positive AIDS test result could be deeply traumatic, and reaction to it could be life-altering on its own. It was 100% a good idea to require counseling...especially when we progressed treatment to the point where it was no longer a death sentence.
bryan0 5y ago
I’ve been trying to get any rapid test for the past 2 days unsuccessfully. I live in the Bay Area. I made a reservation and pre-paid $$$ for a rapid antigen and pcr test from a private company, and after 1 hour of waiting found out they are not available. Went to another site where wait was 2+ hours and unclear if they could do rapid. I asked workers at the local pharmacies when they were getting more at-home tests and if any stores were getting more. They basically laugh and tell me they have no idea and no way to find out. Really sad we’re nearly 2 years into the pandemic and this is the state of things.
- knodi123 5y ago
  I checked about 5 stores near me (including 2 CVS stores), and they were all sold out and said they had no idea how to find out where to look. Then I saw a pic on my local subreddit from another CVS about 1 mile further out had a mountain of tests on a table. So the inventory and supply chain problems are deep, in addition to any other issues that may be going on.
kragen 5y ago
What does covid testing look like in the countries that have handled the pandemic successfully? Like, on https://en.wikipedia.org/wiki/COVID-19_pandemic_death_rates_by_country https://en.wikipedia.org/wiki/COVID-19_pandemic_death_rates_..., the US has 2452 covid deaths per million population; countries #130-216 on that list have less than a tenth of that, sadly no longer including Vietnam or Thailand. Some of those are countries that just aren't doing adequate testing to have confidence in their statistics, but does anyone here have experience with how covid testing works in Singapore, Japan, Norway, Iceland, South Korea, Australia, etc.?
fragsworth 5y ago
Is it possible that there is an ulterior motive to the FDA restricting at-home self-testing testing from 23andme? If people are allowed to learn about and act on their genetic risk factors, is it possible that certain medical practices stand to lose a lot of money? Is it possible that cheap preventive care could replace expensive procedures/drugs that you are forced to purchase later, once your diseases become unmanageable? I find it very strange, and incredibly hard to believe that the risk of people overreacting from their medical information outweighs the positive impacts of having the knowledge.

114 points by apsec112 5y ago

It's just an excuse to protect corporate interests. If they really cated about consumers they'd make testing as accessible as possible. Best case in point concerning these persevere motives is what they did to the X-Prize for the medical "tri-corder".

finolex1 5y ago

Rapid COVID tests were much more widely available in Europe than in the US this past year, owing to differences in regulation. Also related: https://www.propublica.org/article/this-scientist-created-a-rapid-test-just-weeks-into-the-pandemic-heres-why-you-still-cant-get-it https://www.propublica.org/article/this-scientist-created-a-... https://www.nytimes.com/2021/09/21/briefing/rapid-testing-covid-us.html https://www.nytimes.com/2021/09/21/briefing/rapid-testing-co...

yosito 5y ago
I was living in Hungary most of 2021. Any time I needed rapid tests, it took me no longer than 20 minutes to get as many as I needed from the nearest pharmacy. I had to pay ~$5/each for them, which was fine for me. On my way to the US, I stopped in Mexico for two weeks (there were no direct flights, so I decided to get some beach time in). Rapid tests were available on every block, and it took 5 minutes to get one any time. Now I'm in Ohio. A family member didn't test before our Christmas Eve gathering (in retrospect, I should have required it), and ended up symptomatic and testing positive yesterday. Today I was searching for tests from 8am, I checked literally every pharmacy in the county, called all of the county health department's testing centers, libraries, universities, etc. There was not a single rapid test available anywhere, at home or on-site. Finally at 1pm the county health department tweeted to me that they got a shipment and it was first come first serve, two tests per person. So I drove over, and by the time I got there, they were handing out the last tests in their box. I was able to get only two tests. They were free, though I would have happily paid for them. But I found it infuriating that it was so impossible to get a rapid test when needed. I still don't have as many as I should on hand. I don't know what kind of backward, shithole country this has become, where even basic healthcare services are unavailable, but I'm considering going back to Mexico or Hungary as soon as possible.
- jessaustin 5y ago
  FDA tries to prevent anything that could lead to less money going to big pharma firms. The theory is that if lots of cheap tests had been available during the deepest depths of the pandemic, transmission would have dropped and fewer people would have consented to vaccination. https://www.bostonglobe.com/2021/12/22/nation/man-behind-rapid-test-crusade/ https://www.bostonglobe.com/2021/12/22/nation/man-behind-rap...
- denton-scratch 5y ago
  UK here. There was a shortage of self-test lateral flow tests a couple of weeks ago, but that's over - they have plenty in stock now. I can go to the NHS website and order a pack of 7 tests, and they'll arrive the next day. They're free. Teachers and medical staff don't even have to order them; they're provided (required) at the place of work. I happen to be signed-up for a survey by the Office of National Statistics; they send someone round every week to get a swab from me for PCR testing. I get the result from that by email, the next day. I have more confidence in the LFT than the PCR test, because some of the PCR test labs have been shown to be dodgy. The ONS is doing PCR tests because the PCR test gives them information about variants, that you don't get from the LFT. The ONS cares about variants and how they are mutating and spreading; I don't. LFT is good enough for me. I'm going to do an LFT right now, because I'm about to attend a family gathering.

saurik 5y ago

The entire premise of protecting people from "their own reactions to test results" is so horribly infuriating :(. The context that is missing here, which I am super curious about: Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? Is there any real organized opposition at all to the FDA doing this that one can attach themselves to?

pimlottc 5y ago
This appears to be a thesis paper for a law degree.
- huitzitziltzin 5y ago
  There is no such thing in the US. Law degrees do not require a thesis. It is an article written for submission to a law review.
  - rhino369 5y ago
    Most schools require a long paper from grads. You typically write one for the journal you work on or maybe for a class you take. Unlike real scholarship, legal "scholarship" is only reviewed by third year law students. It's pretty worthless stuff.
  - DannyBee 5y ago
    This is partially right. JD's generally do not require a thesis. However, LLM's do.
rasengan 5y ago
Agree, it is infuriating. > Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? This looks like a student's thesis. The author, also, appears to be in agreement with you and is hoping to push information to help cause a stand: From the conclusion: > These restrictions illustrate a disturbing trend with major consequences for current and future technologies. Ultimately, the FDA’s decision to act as gatekeeper, limiting consumers’ access to their medical information, is premised on an impermissible value judgment that significantly restricts individual autonomy.

baggy_trough 5y ago

knodi123 5y ago
They save a lot of lives too. Maybe you're too young to remember the days of literal snake oil, or radium water, or "vital rays". The real problem with the FDA is they use a one-size-fits-all approach that is optimized to be as conservative as possible.
- baggy_trough 5y ago

jtdev 5y ago

zackify 5y ago

Interesting seeing an article about this. Just this week I was looking to get a continuous glucose monitor. I’ve heard it can really prevent diabetes and help you understand what foods spike your levels. The fda won’t allow anyone to get these if they aren’t already diabetic. There’s so many ways we aren’t “free” in this country to do what we want with our bodies.

enchiridion 5y ago
I agree. This overzealous attitude from health regulators not good. I see it as nothing more than authoritarians in the health domain. They know what’s best for everyone, and clearly don’t trust that freedom empowers people. This is at the heart of many of the issues the public has had with the US government’s response to the pandemic.
- scoopertrooper 5y ago
  Yeah, the American public have really shown how rational they are during this pandemic. The government is giving out the best vaccine in the world for free (also the best against Omicron) and 27% of adults are still not fully vaccinated. And it took some harsh mandates and a crazy new mutation to get them even that far.
  - eru 5y ago
    Freedom includes the freedom for people to make choices that you (or me) disagree with. An individual getting vaccinated or not has some externalities for the rest of society. The answer from orthodox economics is to measure / estimate these externalities, and then apply taxes and/or subsidies appropriately. The vaccines are already free for the patient, that's a generous subsidy. If that's not enough, they could give everyone who gets vaccinated fifty bucks or tax unvaccinated people some extra fee. Another example: in Singapore the government used to cover everyone's covid hospitalization costs, recently they changed to only covering them for vaccinated people (or those with a medically valid excuse).
    - 5y ago

AtomicOrbital 5y ago

Michael Mina is an immunologist, epidemiologist, and physician at Harvard and an expert on rapid paper based COVID testing ... Listen to his interview with Lex Fridman entitled #146 – Michael Mina: Rapid Testing, Viruses, and the Engineering Mindset Lex Fridman Podcast where Mina details what the tests do and how horribly corrupt the US gov has mismanaged rapid self testing

Karsteski 5y ago
Excellent podcast. I'd recommend as well the most recent one with Michael Mina, which is focused on COVID testing. Link for those interested: https://youtu.be/80OvNaEgmmw https://youtu.be/80OvNaEgmmw

marsven_422 5y ago

In Sweden home tests have been available for some time. The effect on the masses is that if the test is negative they will send their children to school, use public transportation, go to work even if they are sick as a dog. It's not Corona so it's fine. The end result is none Corona "normal" winter flue/cold/infections are being spread like never before.

denton-scratch 5y ago
I understand that flu and cold infections are more widespread this year than last, because people havn't been mingling as much in the last year. So when they do mingle, they encounter flu/cold variants that they don't have resistance to.
spurgu 5y ago
Du har 99% döda kommentarer men bara -5 karma? Vad är din hemlighet? Jag sku finna dina kommentarer moderatligt underhållande om de var nån annanstans än på HN.
Dylan16807 5y ago
Do you have any stats on that? How are those disease frequencies compared to 2019? I found this page, which suggests a relatively normal flu season so far: https://www.icuregswe.org/en/about-sir/nyheter/influensasasongen-2021-2022/ https://www.icuregswe.org/en/about-sir/nyheter/influensasaso... I don't see any cold data. Though I found a chart for australia: https://www.iqvia.com/-/media/iqvia/images/body/blogs/2021/12/exhibit-2.svg https://www.iqvia.com/-/media/iqvia/images/body/blogs/2021/1...

Sebguer 5y ago

The author of this paper is currently a clerk for Supreme Court Justice Alito: https://law.duke.edu/news/baird-jdma-18-selected-clerk-supreme-court-associate-justice-samuel-alito-0/ https://law.duke.edu/news/baird-jdma-18-selected-clerk-supre...

walterbell 5y ago

https://www.vanityfair.com/news/2021/12/the-biden-administration-rejected-an-october-proposal-for-free-rapid-tests-for-the-holidays https://www.vanityfair.com/news/2021/12/the-biden-administra... > The Biden Administration Rejected an October Proposal for “Free Rapid Tests for the Holidays” ... The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide “Testing Surge to Prevent Holiday COVID Surge” ... An administration official who attended the meeting told Vanity Fair that, while everyone present shared the same goal of expanding rapid testing as soon as possible, the plan could not be implemented at that time: “We did not have capacity to manufacture over-the-counter tests at that scale.” The problem, in essence, was twofold: The FDA had authorized only a handful of different home tests, and those it had authorized could not increase manufacturing fast enough.

worik 5y ago

Is this an argument for business opportunity dressed in morality clothing?

musicale 5y ago

It makes sense to regulate 23andme since its business model was to gather DNA for one purported set of purposes (consumer information, ancestry, etc.) and then to construct a large genetic database for its own research and business purposes. 23andme also has privacy implications/externalities for close relatives to people in their database. Law enforcement usage of DNA databases has also been controversial.

KennyBlanken 5y ago
Yeah - once you know you have certain genetic predispositions, that has severe implications for insurance. Do not do any sort of genetic testing without fully understanding present and possible future consequences of doing so. The author's age really shows when she mentions AIDS tests. AIDS for a while was a near guaranteed death sentence and also carried incredible social stigma, and not just because of the assumptions about you made (ie that you were gay, or a drug user.) I don't think people younger than 40 or so understand how big a deal it was when Princess Diana shook the hand of a person with AIDS in front of TV cameras. Receiving a positive AIDS test result could be deeply traumatic, and reaction to it could be life-altering on its own. It was 100% a good idea to require counseling...especially when we progressed treatment to the point where it was no longer a death sentence.

bryan0 5y ago

I’ve been trying to get any rapid test for the past 2 days unsuccessfully. I live in the Bay Area. I made a reservation and pre-paid $$$ for a rapid antigen and pcr test from a private company, and after 1 hour of waiting found out they are not available. Went to another site where wait was 2+ hours and unclear if they could do rapid. I asked workers at the local pharmacies when they were getting more at-home tests and if any stores were getting more. They basically laugh and tell me they have no idea and no way to find out. Really sad we’re nearly 2 years into the pandemic and this is the state of things.

knodi123 5y ago
I checked about 5 stores near me (including 2 CVS stores), and they were all sold out and said they had no idea how to find out where to look. Then I saw a pic on my local subreddit from another CVS about 1 mile further out had a mountain of tests on a table. So the inventory and supply chain problems are deep, in addition to any other issues that may be going on.

kragen 5y ago

What does covid testing look like in the countries that have handled the pandemic successfully? Like, on https://en.wikipedia.org/wiki/COVID-19_pandemic_death_rates_by_country https://en.wikipedia.org/wiki/COVID-19_pandemic_death_rates_..., the US has 2452 covid deaths per million population; countries #130-216 on that list have less than a tenth of that, sadly no longer including Vietnam or Thailand. Some of those are countries that just aren't doing adequate testing to have confidence in their statistics, but does anyone here have experience with how covid testing works in Singapore, Japan, Norway, Iceland, South Korea, Australia, etc.?

fragsworth 5y ago

Is it possible that there is an ulterior motive to the FDA restricting at-home self-testing testing from 23andme? If people are allowed to learn about and act on their genetic risk factors, is it possible that certain medical practices stand to lose a lot of money? Is it possible that cheap preventive care could replace expensive procedures/drugs that you are forced to purchase later, once your diseases become unmanageable? I find it very strange, and incredibly hard to believe that the risk of people overreacting from their medical information outweighs the positive impacts of having the knowledge.