6 ms·

I'm seeing this amidst a lot of pundit complaints that the FDA and similar regulatory organizations are hopelessly restrictionist. Because of their incentives,

I'm seeing this amidst a lot of pundit complaints that the FDA and similar regulatory organizations are hopelessly restrictionist. Because of their incentives, because they only add new regulations and never remove old and ill-suited ones, etc. I'm not saying the pundits are wrong in general, but this seems to be an exception. What went right here and why? Is there anything to learn?

Tuna-Fish 3y ago
There has been very significant pushback against such restrictionism for more than a decade, and it has steadily won over support especially among doctors. This is FDA starting to go with the flow.
- civilized 3y ago
  By this do you mean that doctors are changing their minds, and since doctors do things like run advisory boards at the FDA, that causes the FDA to behave less restrictively? In other words, why would the FDA bother to go with any flow? On the view of some economists, bureaucrats should never deregulate because there's no incentive for them to, and mere cultural pressure shouldn't really be an incentive.
  - brundolf 3y ago
    Cultural pressure means political pressure and eventually that works its way through the system. It may be blunt and slow, but it gets there eventually.
    - civilized 3y ago
      I'm realizing that you can always spin a story either way. If regulation is restrictionist, you talk about the ratchet and the overriding aversion of the regulator to being blamed for anything. If regulation is lax and ineffective, you talk about the revolving door with industry and the reluctance of regulators to piss off companies they could later get lucrative consulting jobs at. There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.
  - dragonwriter 3y ago
    > On the view of some economists, bureaucrats should never deregulate because there’s no incentive for them to Well, so economists models of things outside their notional specialty aren’t any more connected to reality than those inside. That’s…to be expected, I guess.
    - concordDance 3y ago
      Economists model incentive structures, I'd expect them to actually model things that aren't traditional economics quite well. IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them
      - the88doctor 3y ago
        Traditional economists model traditional economic incentives. Behavioral economists try to understand all the gaps in traditional economic models such as why people don't steal as much as they can when there is 0% chance of getting caught or why people who choose In-and-Out when given an option between McDonalds and In-and-Out suddenly choose McDonalds when just asked to pick a restaurant for lunch. Humans are motivated by emotional incentives at least as much as economic incentives, and humans also have cognitive and memory constraints that aren't considered by traditional economists. All of which is to say that while there may not be an economic incentive for government regulators to de-regulate, that conclusion fails to consider that many government regulators actually have an emotional desire to feel like they are doing good in the world and that emotional incentive can sometimes be stronger than the traditional economic incentive to keep regulations in place.
cushpush 3y ago
Plans for open-source hearing aids have also been developed and released, like happened on HN a few years ago (amazing work by the gentleman @zdw) https://news.ycombinator.com/item?id=20604566 https://news.ycombinator.com/item?id=20604566. So, I think like someone else said, this is gov't catching up to the fact that market alternatives exist and are undercutting an industry that has celebrated regulatory shielding for a long time. Really, the hardware is less complex as time goes on, right? It makes sense that low-cost alternatives will bring quality up for consumers and prices down for consumers. Question, Hearing aids are considered medical gear and therefore the regulation?
- 14 3y ago
  I always was told that the heating aids need to match the user. By that it means heating is tested and what frequency loss the patient has the hearing aid will then take that frequency and alter it to one the client can hear. It’s not a matter of higher volume. It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.
  - carlmr 3y ago
    >It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid. I would bet a lot of things could be done by regular people with proper software support. Having licensed gatekeepers raises prices for the service. Since you're excluding a lot of supplierd from the market. The question is then why gatekeep at all? With antibiotics for example, abuse and misuse can cause a lot of harm, so having someone gatekeep them, even if this raises the price of service makes sense. But with a lot of licensed professions we're merely creating an artificial moat that increases prices in a market economy.
elliekelly 3y ago
I feel like there are a lot of similar examples they just don’t get a lot of press. Naloxone was recently approved for OTC and they also recently approved allowing Mifepristone prescriptions by mail. They’re considering allowing a new birth control to be sold over the counter. Maybe a decade or so ago Plan B was prescription only but they allow that to be sold over the counter now, too. And a lot of other drugs have made the jump in my adult memory: allergy drugs like Claritin and Flonase used to be prescription only as did just about every major antacid like Prilosec and Nexium. There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.
- loeg 3y ago
  > There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think. Diclofenac did, if that's the one you're thinking of. I was prescribed it for joint pain a few years ago and was pleasantly surprised when I was able to buy it OTC after a while.
  - vlovich123 3y ago
    I think only in topical cream form vs as a pill right?
armchairhacker 3y ago
Some things need to be over-regulated, like food (making sure companies don't put bad things in it or lie about what they're selling), or anything common for the matter. Some things ehh...like experimental drugs, which some argue need to be well-tested, but the alternative for some is dying or living in constant pain (personally, I think people should be able to sign up for anything as long as its, beyond doubt, under their own choice and they're fully aware of potential consequences) I just don't see the reason to regulate hearing aids. It's not like they'll blow up in your ear or translate people's everyday conversations into conspiracy theories, and hearing aids which don't work well are better than none at all.
- geraldwhen 3y ago
  As a counter example, sesame was recently made a major food allergen by the FDA, which caused many food makers to add sesame to their food. Adding sesame was easier than following the regulations to assert their foods were sesame free, so now food that used to be safe is now dangerous for anyone with a sesame allergy. https://www.fastcompany.com/90830854/sesame-seed-allergen-fda-food-law https://www.fastcompany.com/90830854/sesame-seed-allergen-fd...
  - deleted 3y ago
    [deleted]
  - bsder 3y ago
    And for those with a mild sesame allergy, things improved dramatically as they don't have to play roulette with how much "undetectable" sesame is in their food anymore. The amount of sesame is known, quantified, and reliable. Once they establish that a food is "safe", they can buy it going forward. What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?
  - Jochim 3y ago
    My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame" next to the rest of their allergen information. Wheat was already on the major allergens list, the regulatory burden of keeping aerosolised flour from contaminating other products doesn't seem to have been much of an issue. The article also seems to make the case that sesame allergens were making their way into foods, with presumably disastrous effects but that was fine because companies didn't have to think about it. The preferred solution to the intentional adulteration of products should be to fine the companies and throw their executives in jail. It might make them more amenable to complying with the spirit of the law. In fact, society would be better off in general if executives went to jail more often.
thaumasiotes 3y ago
https://news.ycombinator.com/item?id=35846202 https://news.ycombinator.com/item?id=35846202 > Congress actually passed a law in 2017 ordering them to sell them over the counter.
rocket_surgeron 3y ago
>I'm not saying the pundits are wrong in general The pundits are wrong. The FDA follows the instructions given to them by Congress. What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this. What went wrong was that covid delayed the rule making process by about 18 months. Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency. Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did. After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did. Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process. There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't. Many, though not all, pundits don't realize what the process is.
AbrahamParangi 3y ago
Congress passed a law that made them do this - in 2017! The FDA has been going slow on implementation till the Biden admin gave them another kick in the pants.
stainablesteel 3y ago
federal bureaucracy is slow to move, definitely afaik older hearing aids actually posed some harm to folks if they got the wrong kind new models basically make this kind of problem non-existent
voxic11 3y ago
https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_Act_of_2017 https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...
zosima 3y ago
FDA was pushed for, I think, over six years by laws to allow over-the-counter hearing aids. I don't know why they even started regulating them. There is no credit here, whatsoever, for FDA.

Tuna-Fish 3y ago

There has been very significant pushback against such restrictionism for more than a decade, and it has steadily won over support especially among doctors. This is FDA starting to go with the flow.

civilized 3y ago
By this do you mean that doctors are changing their minds, and since doctors do things like run advisory boards at the FDA, that causes the FDA to behave less restrictively? In other words, why would the FDA bother to go with any flow? On the view of some economists, bureaucrats should never deregulate because there's no incentive for them to, and mere cultural pressure shouldn't really be an incentive.
- brundolf 3y ago
  Cultural pressure means political pressure and eventually that works its way through the system. It may be blunt and slow, but it gets there eventually.
  - civilized 3y ago
    I'm realizing that you can always spin a story either way. If regulation is restrictionist, you talk about the ratchet and the overriding aversion of the regulator to being blamed for anything. If regulation is lax and ineffective, you talk about the revolving door with industry and the reluctance of regulators to piss off companies they could later get lucrative consulting jobs at. There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.
- dragonwriter 3y ago
  > On the view of some economists, bureaucrats should never deregulate because there’s no incentive for them to Well, so economists models of things outside their notional specialty aren’t any more connected to reality than those inside. That’s…to be expected, I guess.
  - concordDance 3y ago
    Economists model incentive structures, I'd expect them to actually model things that aren't traditional economics quite well. IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them
    - the88doctor 3y ago
      Traditional economists model traditional economic incentives. Behavioral economists try to understand all the gaps in traditional economic models such as why people don't steal as much as they can when there is 0% chance of getting caught or why people who choose In-and-Out when given an option between McDonalds and In-and-Out suddenly choose McDonalds when just asked to pick a restaurant for lunch. Humans are motivated by emotional incentives at least as much as economic incentives, and humans also have cognitive and memory constraints that aren't considered by traditional economists. All of which is to say that while there may not be an economic incentive for government regulators to de-regulate, that conclusion fails to consider that many government regulators actually have an emotional desire to feel like they are doing good in the world and that emotional incentive can sometimes be stronger than the traditional economic incentive to keep regulations in place.

cushpush 3y ago

Plans for open-source hearing aids have also been developed and released, like happened on HN a few years ago (amazing work by the gentleman @zdw) https://news.ycombinator.com/item?id=20604566 https://news.ycombinator.com/item?id=20604566. So, I think like someone else said, this is gov't catching up to the fact that market alternatives exist and are undercutting an industry that has celebrated regulatory shielding for a long time. Really, the hardware is less complex as time goes on, right? It makes sense that low-cost alternatives will bring quality up for consumers and prices down for consumers. Question, Hearing aids are considered medical gear and therefore the regulation?

14 3y ago
I always was told that the heating aids need to match the user. By that it means heating is tested and what frequency loss the patient has the hearing aid will then take that frequency and alter it to one the client can hear. It’s not a matter of higher volume. It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.
- carlmr 3y ago
  >It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid. I would bet a lot of things could be done by regular people with proper software support. Having licensed gatekeepers raises prices for the service. Since you're excluding a lot of supplierd from the market. The question is then why gatekeep at all? With antibiotics for example, abuse and misuse can cause a lot of harm, so having someone gatekeep them, even if this raises the price of service makes sense. But with a lot of licensed professions we're merely creating an artificial moat that increases prices in a market economy.

elliekelly 3y ago

I feel like there are a lot of similar examples they just don’t get a lot of press. Naloxone was recently approved for OTC and they also recently approved allowing Mifepristone prescriptions by mail. They’re considering allowing a new birth control to be sold over the counter. Maybe a decade or so ago Plan B was prescription only but they allow that to be sold over the counter now, too. And a lot of other drugs have made the jump in my adult memory: allergy drugs like Claritin and Flonase used to be prescription only as did just about every major antacid like Prilosec and Nexium. There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.

loeg 3y ago
> There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think. Diclofenac did, if that's the one you're thinking of. I was prescribed it for joint pain a few years ago and was pleasantly surprised when I was able to buy it OTC after a while.
- vlovich123 3y ago
  I think only in topical cream form vs as a pill right?

armchairhacker 3y ago

Some things need to be over-regulated, like food (making sure companies don't put bad things in it or lie about what they're selling), or anything common for the matter. Some things ehh...like experimental drugs, which some argue need to be well-tested, but the alternative for some is dying or living in constant pain (personally, I think people should be able to sign up for anything as long as its, beyond doubt, under their own choice and they're fully aware of potential consequences) I just don't see the reason to regulate hearing aids. It's not like they'll blow up in your ear or translate people's everyday conversations into conspiracy theories, and hearing aids which don't work well are better than none at all.

geraldwhen 3y ago
As a counter example, sesame was recently made a major food allergen by the FDA, which caused many food makers to add sesame to their food. Adding sesame was easier than following the regulations to assert their foods were sesame free, so now food that used to be safe is now dangerous for anyone with a sesame allergy. https://www.fastcompany.com/90830854/sesame-seed-allergen-fda-food-law https://www.fastcompany.com/90830854/sesame-seed-allergen-fd...
- deleted 3y ago
  [deleted]
- bsder 3y ago
  And for those with a mild sesame allergy, things improved dramatically as they don't have to play roulette with how much "undetectable" sesame is in their food anymore. The amount of sesame is known, quantified, and reliable. Once they establish that a food is "safe", they can buy it going forward. What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?
- Jochim 3y ago
  My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame" next to the rest of their allergen information. Wheat was already on the major allergens list, the regulatory burden of keeping aerosolised flour from contaminating other products doesn't seem to have been much of an issue. The article also seems to make the case that sesame allergens were making their way into foods, with presumably disastrous effects but that was fine because companies didn't have to think about it. The preferred solution to the intentional adulteration of products should be to fine the companies and throw their executives in jail. It might make them more amenable to complying with the spirit of the law. In fact, society would be better off in general if executives went to jail more often.

thaumasiotes 3y ago

https://news.ycombinator.com/item?id=35846202 https://news.ycombinator.com/item?id=35846202 > Congress actually passed a law in 2017 ordering them to sell them over the counter.

rocket_surgeron 3y ago

>I'm not saying the pundits are wrong in general The pundits are wrong. The FDA follows the instructions given to them by Congress. What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this. What went wrong was that covid delayed the rule making process by about 18 months. Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency. Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did. After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did. Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process. There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't. Many, though not all, pundits don't realize what the process is.

AbrahamParangi 3y ago

Congress passed a law that made them do this - in 2017! The FDA has been going slow on implementation till the Biden admin gave them another kick in the pants.

stainablesteel 3y ago

federal bureaucracy is slow to move, definitely afaik older hearing aids actually posed some harm to folks if they got the wrong kind new models basically make this kind of problem non-existent

voxic11 3y ago

https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_Act_of_2017 https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...

zosima 3y ago

FDA was pushed for, I think, over six years by laws to allow over-the-counter hearing aids. I don't know why they even started regulating them. There is no credit here, whatsoever, for FDA.