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FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having bee

FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval. There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name. In my opinion there two things going on here that I strongly feel are true. 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. 2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.

lotsofpulp 7mo ago
> The rules and laws are there for a good reason Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.
- deleted 7mo ago
  [deleted]
- Dylan16807 7mo ago
  If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad. The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
  - wmf 7mo ago
    I don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.
  - phil21 7mo ago
    Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet. From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved. This is about as Wild West as most of us have lived through for the U.S. drug market.
    - mullingitover 7mo ago
      > This is about as Wild West as most of us have lived through for the U.S. drug market. I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out. To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient. [1] https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-other-additives-are-causing-concerns-about-vaping-cannabis/ https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-...
      - phil21 7mo ago
        I wouldn’t put vapes in the same category as patented pharmaceuticals. They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age. Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose. This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything. FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.
ab_testing 7mo ago
I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.
- deleted 7mo ago
  [deleted]
- roywiggins 7mo ago
  It's basically a regulatory arbitrage, see here: https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how_does_hims_get_away_with_compounding_readily/ https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how... > they get away with it because: > In-house prescription > legally registered 503A compounding pharmacy that is not selling bulk (individual prescription quantities) > They can argue clinically distrinct compounding > FDA does limited enforcement unless its unsafe or mass bulk production Point 4 seems not to be holding anymore.
  - jfengel 7mo ago
    Any idea why they'd change their mind about point 4? The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?
    - phil21 7mo ago
      Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented. If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all. Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
    - 7mo ago
beejiu 7mo ago
> 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
- cowsandmilk 7mo ago
  GLP-1 drugs don’t require marketing. There are tons of people who have been prescribed them and aren’t being covered by insurance. Both Novo and Eli Lily are now selling them direct to consumers with prescriptions that don’t have insurance coverage.
  - Forgeties79 7mo ago
    But they still market regardless. They probably constitute 50% of the medical ads I see now
    - willis936 7mo ago
      Make sure to tune into the superbowl tomorrow.
      - Forgeties79 7mo ago
        At least I know kid rock won’t be there
        roamerz 7mo ago
        Thankfully we have options - Kid Rock will be performing an alternative half-time show and it's available on X and Youtube @ 8PM.
        mullingitover 7mo ago
        Is there a Kalshi bet going about whether he'll perform his song about preferring underage girls?
khuey 7mo ago
> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. Are we cutting off people's access to meds or do they just not want to pay what they cost?
- ronsor 7mo ago
  To be fair, most medication in the US is overpriced due to patents and what not. The "cost" is hardly the real, legitimate cost and generally inflated 1000%+ compared to other countries.
  - estearum 7mo ago
    This is not really the correct way to think about this. Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable. This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability. As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this. Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment. This is actually extremely important in the drug context due to the aforementioned abysmal profitability. Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere. But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.” Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development. It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.
terminalshort 7mo ago
Where is the evidence that anyone has been harmed by these unapproved GLP1s? Until I see that I will assume the government is 100% in the wrong.
- Fezzik 7mo ago
  I just started taking Wegovy. Went the regulated route through my doctor, getting a prescription. She’s been monitoring loads of patients and noted that some of her patients going the ‘compound’ route had, in fact, had allergic reactions to their shots, or experienced their shots being less effective, after months of no problems. Nothing life threatening. But the fact is there is no oversight to what the GLP-1 is compounded with.
  - terminalshort 7mo ago
    You had the choice to go the expensive route and you took it. Don't tell other people they can't make their own choices too.
    - Fezzik 7mo ago
      Can you quote from the five sentences I wrote where I said anything about telling people what to do? I simply noted that my medical provider has first-hand experience with people getting questionable results from unregulated GLP-1s.
    - phil21 7mo ago
      Personally I feel the hims etc of this world need to go away. They give a false sense of security and they mask an incredibly shady industry. I also think people should be able to source from the grey market if they can figure it out. This means they understand the risks and likely take measures like ensuring their compounds are properly tested before injecting them. I’d feel differently if I didn’t understand how the average medspa gets their product and the corners they cut. I honestly trust some outright black market dealers better than most of those shops. They actually do testing on their product before shipping it. Likely sourced from exactly the same manufacturer as the guy in the locker room buys from. So long as the choices are informed I agree. The issue is hims/hers puts a fancy veneer of “sanctioned medical system” on top of what amounts to a black market. They are laundering and obscuring the risk and many patients simply do not understand this fact. It’s the difference between buying Xanax from a legit pharmacy vs a street dealer. The street dealer transaction you understand the risks involved and are making an informed decision. If you thought you were buying from a legit pharmaceutical company but they ended up just rebranding the same shit the street dealer is selling from his wholesaler - that is not informed consent even a little bit. There is something in the middle here but some HLPC testing I’ve seen of supposed legit compounding pharmacies hasn’t been great for these drugs.
refurb 7mo ago
ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest. And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after. Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound. I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez
ekianjo 7mo ago
You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.
tossandthrow 7mo ago
> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc. But it is all the rage when a pill can undo people's bad habits.
hulitu 7mo ago
> The rules and laws are there for a good reason. "To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"

lotsofpulp 7mo ago

> The rules and laws are there for a good reason Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.

deleted 7mo ago
[deleted]
Dylan16807 7mo ago
If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad. The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
- wmf 7mo ago
  I don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.
- phil21 7mo ago
  Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet. From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved. This is about as Wild West as most of us have lived through for the U.S. drug market.
  - mullingitover 7mo ago
    > This is about as Wild West as most of us have lived through for the U.S. drug market. I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out. To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient. [1] https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-other-additives-are-causing-concerns-about-vaping-cannabis/ https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-...
    - phil21 7mo ago
      I wouldn’t put vapes in the same category as patented pharmaceuticals. They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age. Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose. This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything. FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.

ab_testing 7mo ago

I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.

deleted 7mo ago
[deleted]
roywiggins 7mo ago
It's basically a regulatory arbitrage, see here: https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how_does_hims_get_away_with_compounding_readily/ https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how... > they get away with it because: > In-house prescription > legally registered 503A compounding pharmacy that is not selling bulk (individual prescription quantities) > They can argue clinically distrinct compounding > FDA does limited enforcement unless its unsafe or mass bulk production Point 4 seems not to be holding anymore.
- jfengel 7mo ago
  Any idea why they'd change their mind about point 4? The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?
  - phil21 7mo ago
    Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented. If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all. Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
  - 7mo ago

beejiu 7mo ago

> 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.

cowsandmilk 7mo ago
GLP-1 drugs don’t require marketing. There are tons of people who have been prescribed them and aren’t being covered by insurance. Both Novo and Eli Lily are now selling them direct to consumers with prescriptions that don’t have insurance coverage.
- Forgeties79 7mo ago
  But they still market regardless. They probably constitute 50% of the medical ads I see now
  - willis936 7mo ago
    Make sure to tune into the superbowl tomorrow.
    - Forgeties79 7mo ago
      At least I know kid rock won’t be there
      - roamerz 7mo ago
        Thankfully we have options - Kid Rock will be performing an alternative half-time show and it's available on X and Youtube @ 8PM.
        mullingitover 7mo ago
        Is there a Kalshi bet going about whether he'll perform his song about preferring underage girls?

khuey 7mo ago

> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. Are we cutting off people's access to meds or do they just not want to pay what they cost?

ronsor 7mo ago
To be fair, most medication in the US is overpriced due to patents and what not. The "cost" is hardly the real, legitimate cost and generally inflated 1000%+ compared to other countries.
- estearum 7mo ago
  This is not really the correct way to think about this. Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable. This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability. As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this. Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment. This is actually extremely important in the drug context due to the aforementioned abysmal profitability. Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere. But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.” Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development. It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.

terminalshort 7mo ago

Where is the evidence that anyone has been harmed by these unapproved GLP1s? Until I see that I will assume the government is 100% in the wrong.

Fezzik 7mo ago
I just started taking Wegovy. Went the regulated route through my doctor, getting a prescription. She’s been monitoring loads of patients and noted that some of her patients going the ‘compound’ route had, in fact, had allergic reactions to their shots, or experienced their shots being less effective, after months of no problems. Nothing life threatening. But the fact is there is no oversight to what the GLP-1 is compounded with.
- terminalshort 7mo ago
  You had the choice to go the expensive route and you took it. Don't tell other people they can't make their own choices too.
  - Fezzik 7mo ago
    Can you quote from the five sentences I wrote where I said anything about telling people what to do? I simply noted that my medical provider has first-hand experience with people getting questionable results from unregulated GLP-1s.
  - phil21 7mo ago
    Personally I feel the hims etc of this world need to go away. They give a false sense of security and they mask an incredibly shady industry. I also think people should be able to source from the grey market if they can figure it out. This means they understand the risks and likely take measures like ensuring their compounds are properly tested before injecting them. I’d feel differently if I didn’t understand how the average medspa gets their product and the corners they cut. I honestly trust some outright black market dealers better than most of those shops. They actually do testing on their product before shipping it. Likely sourced from exactly the same manufacturer as the guy in the locker room buys from. So long as the choices are informed I agree. The issue is hims/hers puts a fancy veneer of “sanctioned medical system” on top of what amounts to a black market. They are laundering and obscuring the risk and many patients simply do not understand this fact. It’s the difference between buying Xanax from a legit pharmacy vs a street dealer. The street dealer transaction you understand the risks involved and are making an informed decision. If you thought you were buying from a legit pharmaceutical company but they ended up just rebranding the same shit the street dealer is selling from his wholesaler - that is not informed consent even a little bit. There is something in the middle here but some HLPC testing I’ve seen of supposed legit compounding pharmacies hasn’t been great for these drugs.

refurb 7mo ago

ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest. And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after. Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound. I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez

ekianjo 7mo ago

You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.

tossandthrow 7mo ago

> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc. But it is all the rage when a pill can undo people's bad habits.

hulitu 7mo ago

> The rules and laws are there for a good reason. "To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"