At least on one issue.
A hearing-aid disruption is under way, with inexpensive hearing aids heading to drugstores and other retailers sometime next year. But if you’re experiencing hearing loss, doctors and hearing experts say it isn’t wise to just wait for them to arrive.
The Food and Drug Administration is expected in the next few months to finalize a rule it proposed in October allowing people to buy hearing aids without getting a medical exam first. The rule would take effect 60 days after it’s published, following a public comment period that ends next month.
This is from Julie Jargon, “Over-the-Counter Hearing Ads are Coming. Here’s How to Get Ready,” Wall Street Journal, December 11, 2021.
People would be allowed to buy something based on their own judgment? Watch for chaos to follow.
Jargon goes on to say that this could reduce the price of hearing aids from thousands to hundreds of dollars. It’s not clear from her article why this is so. For that, you need to go to her link to the FDA news release. Here’s one excerpt from that release:
Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.
Today’s action follows President Biden’s July Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter. This effort also builds on the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering medical care costs for the American public.
Score one for Biden.
I still wonder, though, why this would lead to such a substantial decline in price. Google “hearing aids” and you find lots of choices already available now for just hundreds of dollars. This one at Amazon is priced at under $100.
When I post on FDA restrictions on people’s freedom to choose their own health care, I often get pushback from defenders of FDA’s tight regulations. I’m wondering if they would say that the FDA should have had those restrictions on hearing aids as long as they did and if they would say that even if the FDA restrictions should be eliminated, the rule should take 60 days to take effect.
HT2 regular reader Mark Barbieri.
READER COMMENTS
Walter Boggs
Dec 11 2021 at 8:13pm
I think the cost reduction could be because consumers were formerly required to have the device professionally fitted and adjusted.
Dylan
Dec 11 2021 at 8:14pm
As one of those people that has often given you pushback on your FDA pieces, I can say that the hearing aid deregulation seems like a move in the right direction. However, I realize that I don’t know much about the hearing aid market* and I’d like to hear any good arguments from the current approach before committing too strongly to this position.
Because, my predisposition towards FDA regulation of drug approvals, started out much closer to your own position, until I spent a decade in the industry. Perhaps that biased me, but I don’t think so, since my role was more peripheral and I would likely have benefited from a major deregulation in drug approvals.
*I do have a friend that works for a DTC hearing aid company, and last I checked in they were trying to figure out if they were likely to be helped or hurt by this deregulation, but I didn’t get any arguments as to why this would be a net negative for patients.
Phil H
Dec 12 2021 at 7:54am
I’ll piggyback on this post as someone who also generally supports FDA regulation. I agree with Dylan. For me the 60 day thing is a non-issue; it’s just a weird byproduct of this particular system, and any system always throws up weird stuff. (A completely deregulated market in hearing aids would also throw up weird stuff.)
There is always a balance of which things should be regulated and which should not; and how much things should be regulated. I have no doubt that governments get this balance wrong frequently. This in itself is not a reason for mass deregulation.
Mark Barbieri
Dec 12 2021 at 3:57pm
As someone that is not a big fan of the FDA, I’d like to know why we can’t compromise. I’ll agree that we keep the FDA fully funded. They can still determine whether products are safe and effective. All I ask is that I have the ability to buy products that they have not determined to be safe and effective if I so choose. I’ll even agree to sign a waiver saying that I understand they haven’t been determined to be safe and effective. I’ll even agree to only have the ability to purchase them if at least one OECD country’s regulatory agency has approved them. I just don’t understand why people think that the FDA alone should be able to determine what I can choose.
Dylan
Dec 12 2021 at 5:39pm
I don’t have a problem with you being able to buy a drug that hasn’t been proven safe and effective, as long as you are directly paying for it and not lobbying insurance companies or Medicare to pay the cost.
And drug approval reciprocity can be a good idea. Here’s one piece that talks about a bill from a few years ago that was trying to do that. The authors opinion was that it was unlikely to be bad, but probably wouldn’t be much better than the status quo either.
For me, I think we just have to be very careful with unintended consequences of changes to the system that would disincentivize the need to do those long and expensive clinical trials because, so far, that’s the only way we know if a drug actually works. And, because they are so expensive to run, there is already a lot of incentive to try and take shortcuts. The FDA (and other regulatory agencies) have been a decent barrier to that. I’d like to think that private markets could also provide the right incentive structure here, but the nutritional supplement market doesn’t give me a lot of faith in that outcome.
David Henderson
Dec 12 2021 at 7:12pm
You write:
Are you sure you meant to specify that condition? You’re saying that for someone to be able to use a non-FDA-approved drug, he must give up his freedom of speech?
Dylan
Dec 13 2021 at 8:08am
You’re right that I wouldn’t want to limit free speech. My off the cuff comment wasn’t met so much as a policy proposal as it was trying to get at my preferences. For the record, I of course think people should be free to take anything they want, as long as the only person they’re hurting is themselves. The lobbying comment was in trying to take that principal and make sure it didn’t hurt the rest of us in the process, through higher premiums for having a ton of useless drugs on the formularly most directly…but also the harder to see impact it could have on the clinical trial process. Just one example, enrolling clinical trials is already difficult. The big carrot for many is that they might get access to an experimental drug that might help them. If instead, they could just go and buy the experimental drug for sure, I think many would do that instead, and it would take much longer and be more expensive to figure out if the drug actually works.
john hare
Dec 12 2021 at 6:30pm
From what I can tell, the majority of people are terrified of possibly being to blame for any bad outcome. By allowing an invasive regulatory system to referee, they all can deny any responsibility at all, even in their own minds. And a regulatory system by nature will stretch to control it all. With enough CYA paperwork required, there is virtually no possibility that any one person can be found liable. And if ten treatments are never submitted due to the expense of the process, no one’s career will even notice.
Or, a lot of people don’t want to be in the position of making a critical decision. One of the ways to accomplish that is to not allow anyone else to be in the position of having to make that decision. After all, if that guy can make that decision, sooner or later you may have to do the same.
Look at one of Alan’s comments. (AFAIK the most knowledgeable here on this issue) First he states that hearing aids are not a DIY project just before listing an example of ear buds that do exactly that. He also mentions over a decade to get the FDA to approve something he considered a no brainer. Are these the sentiments of someone that thinks people can make rational informed decisions on their own.
Phil H
Dec 13 2021 at 5:12am
“the majority of people are terrified of possibly being to blame for any bad outcome.”
This seems to me a nice example of how mixed up the rhetoric on this subject can be. In the case of medical drugs, one of those “bad outcomes” you’re talking about is death. And, yes, I’d say people are terrified of causing or being to blame for deaths. As they should be! It seems bizarre to me that you’re starting your argument by suggesting we should all be a little less worried about causing death.
I can’t tell for certain that the current regulatory arrangements are great. But nothing is going to be made better by trying less hard to avoid “bad outcomes”. Surely we can all agree that the point of any medical system is precisely to avoid them?
robc
Dec 13 2021 at 10:16am
Yes, but no one seems to want to take the blame for deaths caused due to lack of drug availability.
The people who are dead due to delay in drug approval are just as dead as the people who are dead due to an experimental drug that doesn’t work or that kills them. People value those deaths differently, but they shouldnt.
The seen and the unseen.
Dylan
Dec 13 2021 at 10:27am
@robc I think you’re making a bad assumption, that in the absence of FDA blocking drugs from the market, the patients would somehow know which drugs were good and take those and hence lives would be saved. More likely, IMO, is that patients will take one of the hundreds or thousands of other drugs that will be proposed for the same indication, many with plausible sounding mechanisms of action, but the vast majority of which won’t do what they are hoped to do (and quite a few will make things worse)
robc
Dec 13 2021 at 10:58am
I am making no such assumption. I am putting the responsibility in the hands of the person who is actually responsible.
My assumption is that some organization would still exist that would test the drugs and that insurance companies would require that organizations approval before they will approve the drug, but that people could still get the drug before that if they paid out of pocket. And some people would choose poorly. But some lives would be saved.
But honestly, this goes back to your original post that I didnt respond to — what is the deontological argument in favor of the FDA? I could care less about any utilitarian arguments.
Dylan
Dec 13 2021 at 12:21pm
I don’t think that is a good assumption, since insurance companies these days already cover treatments that have little to no evidence of effectiveness. If, we had good reason to expect that insurance companies would band together and create an organization for a quasi-approval, I wouldn’t be against that. However, I think that would tend to evolve to look pretty similar to the FDA and would only trade speed of approval at the expense of a decline in evidence.
On net? I mean, sure, maybe someone who would have died might live because they get lucky and somehow choose the right drug they wouldn’t have access to via the FDA. But, would that be greater than the number of lives lost, due to the lack of knowledge on effectiveness?
My argument is entirely utilitarian.
KevinDC
Dec 13 2021 at 12:47pm
Phil said:
It’s true that in the case of medical drugs, death is a bad outcome we want to avoid. It’s also true that preventing people from being able to access medical drugs (or procedures or devices or whatnot) can also result in death, which is a bad outcome we’d want to avoid as well. What John Hare was getting at was that the FDA is far less concerned about the latter, even when it vastly outweighs the former. Consider the two following scenarios:
Situation one: A much more lax system that makes medical advances much more quickly available, but more bad drugs slip through as well. In some given timeframe, 10,000 people die as a result of bad things on the market, but 1,000,000 people are saved by easier access to good things.
Situation two: A much more strict system that makes medical advances much less available, but also lets fewer bad drugs slip through. In the same given timeframe, only 50 people die from bad things on the market, and 10,000 lives are saved by new good things released on the market. However, 1,000,000 people die from inability to access good things they otherwise would have been able to access.
The idea here is that the FDA, given the institutional incentives it faces, will pick scenario two over scenario one ten times out of ten, and this is a terrible, awful, no good, very bad arrangement. The FDA isn’t incentivized to be concerned with “preventing death” in some overall sense – they are incentivized to prevent deaths that will cause problems for them, and to ignore an even greater number of deaths that don’t cause them any problems. As is often the case, Scott Alexander said it well:
robc
Dec 13 2021 at 1:13pm
I have a two word response to that, but it won’t get past the filters on this site.
robc
Dec 13 2021 at 1:17pm
And this is why I prefer the deontological argument: There is no moral reason I shouldn’t have access to the drugs, so no need for the FDA at all. And then the problem of them making bad decisions due to misaligned incentives doesnt even exist.
robc
Dec 13 2021 at 1:19pm
I realized after I posted that that could be misinterpreted, so to clear things up, the second word is “utilitarianism.”
Michael
Dec 12 2021 at 7:38am
Is David criticizing the 60-day delay? As I understand it, this is just the standard 60-day notice and comment period before new rules take effect. I think that all things equal, it is better to have the 60-day notice and comment period for all rules (including this one) than to not have it at all or to use it selectively.
This regulatory change has an interesting history. A bipartisan bill calling for the FDA to make hearing aids available over-the counter (lead sponsors Elizabeth Warren and Chuck Grassley) was passed and signed into law by President Trump in 2017. This bill called on the FDA to establish regulations for OTC sales of hearing aids.
In July, President Biden ordered the FDA to publish a rule for notice and comment within 120 days of Biden’s order (a window that would close on Nov 6th).
On October 14, Senators Warren and Grassley issued a press release calling on the FDA to hurry up and issue its rule, and on October 19 (per David’s link above) the FDA did.
David Henderson
Dec 12 2021 at 10:26am
You asked:
Yes.
You stated:
But then why do it? If people have 60 days to comment, but no matter what the comments the new rules take effect, why slow it by 60 days?
Alan Goldhammer
Dec 12 2021 at 11:46am
David writes,
The answer is simple, it is part of the Administrative Procedures Act and is an absolute requirement regardless of how simpleminded the proposed regulation is. Regulatory agencies are bound by it and it does not permit them to willy nilly waive it. In my career I probably filed over 150 comments with regulatory agencies and always welcomed the allowed time period in order to fully research and vet comments.
This is also a case of eliminating regulatory capture by eliminating the requirement that a licensed professional dispense hearing aids.
David Henderson
Dec 12 2021 at 11:54am
Thanks. So now I understand the answer to the “why do it” part.
It seems to me that the only reason that the APA would require it is that an agency might change its mind during the 60 days if enough comments go a certain way. Does that ever happen?
Alan Goldhammer
Dec 12 2021 at 1:59pm
The 60 day comment period is rarely an issue but rather the time it can take for a final rule to be promulgated by the regulatory agency. We had a no brainer project when I was at PhRMA regarding Rx drug labels. The old reg required a printed copy of the drug label (this is the leaflet containing the full prescribing information that you sometimes get in dispensed medication that is in the original packaging. With the arrival of the Internet we engaged FDA about using electronic transmission of drug labels to the pharmacy. We started the project in 1999 and in the early aughts ran a demonstration project with two vendors who developed software that would read the bar label on the medication and automatically pull up the label on their computer screen. It was a great success and the pharmacists really liked this as the label on the screen was in a font that was easily readable. FDA agreed with us that this was the way to go but it took them almost 10 years to promulgate the regulation. Even then there were some organizations that objected to it claiming it would put patients at risk which was weird.
The regulation was finally implemented and anyone can now go to DailyMed website and pull up the prescribing information on any Rx drug. It’s also the most current information as new changes to safety and efficacy information are incorporated quickly.
As Vivian mentions below anyone can file comments on proposed regulations and now it is easy to do as the agencies accept electronic filing. In the old days, we would work on our comments to almost the last day and send a printed copy by messenger up to the FDA.
Vivian Darkbloom
Dec 12 2021 at 1:21pm
Alan is correct, although while the 60-day period is not mandatory, it is the default period of notice and comment. Shorter or longer periods are possible under the APA if justified by the circumstances (for example interim final rules are possible, if warranted, and have with immediate effect). While the change regarding hearing aids strikes me as a good one, I haven’t read the proposed rules. At the same time, I would be very surprised if this change warrants emergency treatment under the APA.
Not only is the notice and comment period (generally) mandatory, it is a good policy. It is one of the few ways the public can have direct participation in the rule-making process. I would rather prefer this than rulemaking made solely behind closed doors by insiders.
My experience is primarly with tax regulations; however, like Alan, I’ve had the opportunity to participate in the process. It only makes sense that those writing rules have input from those that are directly affected by them in order to avoid unintended consequences, etc. Rule makers cannot anticipate all the problems that might be created by proposed rules. My experience is that those writing the tax regulations at Treasury quite welcome outside input and sincerely listen to and consider substantive suggestions. This isn’t merely a matter of “changing their minds”; rather, it is most often a matter of refining those proposed rules where warranted.
David, if you are interested in having a positive influence on these proposed rules, you are free to submit comments just like any other citizen. It’s likely that your particpation through those channels would be more effective than comments on this blog. The following link contains the procedures for submitting comments as well as the proposed rules.
https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
Alan Goldhammer
Dec 12 2021 at 8:26am
The FDA press statement is a bit misleading when they talk about the current need for a “medical exam.” Audiologists are not medical doctors and the exam that they conduct is a hearing exam. One of the things they do is analyze the person’s hearing by frequency. As people age, the response to different audible frequencies change. Some lose the ability to hear higher pitches on the audio spectrum while others may lose parts of the middle spectrum which is where voices are pitched.
Modern hearing aids can be adjusted by the audiologist to account for the differences in a person’s ability to hear. this is much different than having a simple hearing aid that just boosts all parts of the spectrum. this is pretty much what accounts for the price differential and why you need to visit an audiologist to get your hearing aid adjusted. This is not a home DIY activity and don’t expect for these hearing aids be part of this OTC availability.
There are a number of Bluetooth ear buds that can be tuned to improve the listening experience. I have a set of Sennheiser buds that I use with the TV and Jabra buds that I use with my phone for listening to music and podcasts (when is David going to enter the podcast arena?? I listen to every Conversations with Tyler episode!). Both of these will send pulses of spectral tones to the user over each ear and you react to the pulse of you hear it. this is then recorded in the app for the bud and, bingo, the buds are adjusted for your hearing.
It’s conceivable that such technology can be utilized for general hearing aids but I suspect an audiology exam will still be superior.
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