3 ms·

The medical changes in the US take forever for change to occur. Even if greater access to some of these common medications is to happen, it will take close to

The medical changes in the US take forever for change to occur. Even if greater access to some of these common medications is to happen, it will take close to a decade or more to see it meaningfully impact the industry. There will likely be a few drugs that become available before that, but likely not many and not enough to change the cost basis much. The US medical and pharmaceutical community is a very powerful political lobbying group as a whole and while some of this might be good for them they are not great at change, so it will be fought for years to come. Medicine in the US may become more affordable, but will not lose its prestige or the solid return on investment for physicians overall, IMO.

jrochkind1 8y ago
I'd be pretty shocked if the pharmaceutical industry is against this. I would bet they _lobbied_ for it. They can already advertise direct to consumers, now those consumers will be able to go directly to purchasing medication with no intermediary (no "ask your doctor if X is right for you"). This seems like it's GREAT for them. I would expect marketing budgets to go up dramatically in pursuit of these disintermediated consumers, and those marketing dollars to have a great return on investment. Do you have any reason to think otherwise? Hmm, pharmaceutical industry lobbying seems to have had a significant bump in 2017, from $250 million to $280 million based on lobbying paperwork filed... https://www.opensecrets.org/lobby/indusclient.php?id=H04&year=2017 https://www.opensecrets.org/lobby/indusclient.php?id=H04&yea...
- ars 8y ago
  It's not as great as you think for the pharmaceutical industry. They can't charge as much for OTC drugs because people won't pay for it. If the drug (or a similar in class competitor) is available OTC then they also can't charge as much via prescription. So both ways, prices go down.
  - davismwfl 8y ago
    Many times they still charge more for the prescription med still. Great example I just saw. We all know ibuprofen has been available as an OTC for a long time. Cheap to buy too, < $10 gets you a 100 cnt of 200mg pills at most pharmacies OTC in the US. But a physician can and will still prescribe 800mg Ibuprofen tablets to a patient. That prescription for say 40 tablets may cost the consumer $5-10 co-pay, but insurance has paid $35 or more. So the price per pill is drastically different, you can take 4 of the OTC pills and get the same affect. The one difference in this example, the one 800mg pill is less harsh on the stomach than taking 4 of the 200mg pills. Which is the reasoning usually for this type of prescription, that and convenience for the patient.
    - ars 8y ago
      > but insurance has paid $35 or more Insurance does not actually pay that much. Because of drug rebates (paid by the drug manufacturer), clawbacks, and Co-Pays, in total the drug manufacturer gets about the same as they would for the OTC drug. See here: https://money.cnn.com/2018/05/07/news/economy/drug-prices-rebates/index.html https://money.cnn.com/2018/05/07/news/economy/drug-prices-re... (and that article barely scratches the surface). Destroying that entire money-network would be probably the #1 thing that could help US medical spending. And as much as people hate Trump, he's probably the only one with the actual ability, and desire to do something about it. Other presidents have cared, but they were too risk adverse, Trump would be like "hmm, looks good - do it and let's see what happens". That kind of risk taking gets him in a lot of trouble, but it's why he was elected, and why he still has support despite the INCREDIBLY stupid things he says.
      - davismwfl 8y ago
        Rebates and incentives are very common when a drug is on patent, but not once it is available as a generic. Insurers have to pay the generics generally and have no rebate for those, though I am sure there are exceptions. Even the article you linked points that out, and a drug like ibuprofen that is generic at this point, has no rebates or incentives, only a negotiated fee on the class of medication generally. When I worked on doing data analytics for one of the large speciality pharmacies a while back, some of their medications had rebates in the low 5 figure range, the medications were typically a low 6 figure prescription. But for the generic meds they carried, there was no rebate and insurance paid the full fair at whatever was negotiated for the class of medications. That was a fun/educational project but also a bit depressing seeing how the system works. The pharmacies are also in this weird middle position where they have to process a lot of the data (and business rules), but can easily get squeezed out of the profit if they aren't savvy. I am with you, destroying the supply chain money antics would be a huge benefit in the US to cutting down the waste and useless spending.
  - maxerickson 8y ago
    I dunno, the name brand for a generic I took costs ~$200 a month. The generic is $7.
    - ars 8y ago
      That a different thing, name brand vs generic. This is OTC vs. Prescription. Although I bet your insurance company doesn't actually pay $200 if they cover it - they probably get rebates that cover the difference, and then make you pay a higher co-pay.
      - maxerickson 8y ago
        It's not completely different, the branded drug faces pretty stiff competition and hasn't cut prices.
        ars 8y ago
        > and hasn't cut prices. They have - they are [often] the same ones who make the generic. They make both, and if someone is willing to pay them extra for the brand name, they'll take it.
- davismwfl 8y ago
  I can't say you are wrong. But also remember the industry is lobbing against many things right now which have come around in the past few years, including the perception of opiate prescriptions where they are trying to moderate the discussion. Hence spending has gone up considerably. My personal logic is they typically have lobbied to keep most drugs regulated (or split) so to keep their reimbursements as high as possible. Most drugs once they go into the OTC market drop in margin, and volume does pick up but only to a point plus it comes with increased competition now. The last few allergy medications like Zertec, Allegra, Claritin etc that were once prescription only went OTC and margins dropped for the OTC versions. However, you will find at least in the case of a couple of them the companies were pushing for them to be OTC from the beginning because they had developed the drug with the intent to be OTC. However, even if you look at OTC allergy meds, most can still be prescribed and hence paid for by medical insurance and the per pill price is drastically higher, but the out of pocket expense for the consumer is lower (which is just screwed up IMO). Last point on this, once it goes OTC the competition on manufacturing skyrockets, again driving down margins for everyone, similar to when a prescription med comes off patent initially. I could see an argument though where the AMA and other physician lobbying groups here may diverge from the pharmaceutical lobbying but in general from my knowledge they work pretty close together.
  - jrochkind1 8y ago
    It reads to me like these medications are _not_ going to be classified as "over the counter." Even though they will not require a prescription, that's the whole point. I wonder if the regulations are written in some way to allow them to keep charging prescription prices without a prescription. The article definitely suggests it's a new "status", not merely making more things OTC. From the OP: > Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years. > The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance." Note, since they aren't typically _covered by insurance_. A new designation that would be covered by insurance, fit into insurance schedules under "prescription", but not actually require a prescription -- hey, "everyone" wins! From: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u... "Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system. Today’s new FDA draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription." The (very brief) draft guidance itself: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613666.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...

jrochkind1 8y ago

I'd be pretty shocked if the pharmaceutical industry is against this. I would bet they _lobbied_ for it. They can already advertise direct to consumers, now those consumers will be able to go directly to purchasing medication with no intermediary (no "ask your doctor if X is right for you"). This seems like it's GREAT for them. I would expect marketing budgets to go up dramatically in pursuit of these disintermediated consumers, and those marketing dollars to have a great return on investment. Do you have any reason to think otherwise? Hmm, pharmaceutical industry lobbying seems to have had a significant bump in 2017, from $250 million to $280 million based on lobbying paperwork filed... https://www.opensecrets.org/lobby/indusclient.php?id=H04&year=2017 https://www.opensecrets.org/lobby/indusclient.php?id=H04&yea...

ars 8y ago
It's not as great as you think for the pharmaceutical industry. They can't charge as much for OTC drugs because people won't pay for it. If the drug (or a similar in class competitor) is available OTC then they also can't charge as much via prescription. So both ways, prices go down.
- davismwfl 8y ago
  Many times they still charge more for the prescription med still. Great example I just saw. We all know ibuprofen has been available as an OTC for a long time. Cheap to buy too, < $10 gets you a 100 cnt of 200mg pills at most pharmacies OTC in the US. But a physician can and will still prescribe 800mg Ibuprofen tablets to a patient. That prescription for say 40 tablets may cost the consumer $5-10 co-pay, but insurance has paid $35 or more. So the price per pill is drastically different, you can take 4 of the OTC pills and get the same affect. The one difference in this example, the one 800mg pill is less harsh on the stomach than taking 4 of the 200mg pills. Which is the reasoning usually for this type of prescription, that and convenience for the patient.
  - ars 8y ago
    > but insurance has paid $35 or more Insurance does not actually pay that much. Because of drug rebates (paid by the drug manufacturer), clawbacks, and Co-Pays, in total the drug manufacturer gets about the same as they would for the OTC drug. See here: https://money.cnn.com/2018/05/07/news/economy/drug-prices-rebates/index.html https://money.cnn.com/2018/05/07/news/economy/drug-prices-re... (and that article barely scratches the surface). Destroying that entire money-network would be probably the #1 thing that could help US medical spending. And as much as people hate Trump, he's probably the only one with the actual ability, and desire to do something about it. Other presidents have cared, but they were too risk adverse, Trump would be like "hmm, looks good - do it and let's see what happens". That kind of risk taking gets him in a lot of trouble, but it's why he was elected, and why he still has support despite the INCREDIBLY stupid things he says.
    - davismwfl 8y ago
      Rebates and incentives are very common when a drug is on patent, but not once it is available as a generic. Insurers have to pay the generics generally and have no rebate for those, though I am sure there are exceptions. Even the article you linked points that out, and a drug like ibuprofen that is generic at this point, has no rebates or incentives, only a negotiated fee on the class of medication generally. When I worked on doing data analytics for one of the large speciality pharmacies a while back, some of their medications had rebates in the low 5 figure range, the medications were typically a low 6 figure prescription. But for the generic meds they carried, there was no rebate and insurance paid the full fair at whatever was negotiated for the class of medications. That was a fun/educational project but also a bit depressing seeing how the system works. The pharmacies are also in this weird middle position where they have to process a lot of the data (and business rules), but can easily get squeezed out of the profit if they aren't savvy. I am with you, destroying the supply chain money antics would be a huge benefit in the US to cutting down the waste and useless spending.
- maxerickson 8y ago
  I dunno, the name brand for a generic I took costs ~$200 a month. The generic is $7.
  - ars 8y ago
    That a different thing, name brand vs generic. This is OTC vs. Prescription. Although I bet your insurance company doesn't actually pay $200 if they cover it - they probably get rebates that cover the difference, and then make you pay a higher co-pay.
    - maxerickson 8y ago
      It's not completely different, the branded drug faces pretty stiff competition and hasn't cut prices.
      - ars 8y ago
        > and hasn't cut prices. They have - they are [often] the same ones who make the generic. They make both, and if someone is willing to pay them extra for the brand name, they'll take it.
davismwfl 8y ago
I can't say you are wrong. But also remember the industry is lobbing against many things right now which have come around in the past few years, including the perception of opiate prescriptions where they are trying to moderate the discussion. Hence spending has gone up considerably. My personal logic is they typically have lobbied to keep most drugs regulated (or split) so to keep their reimbursements as high as possible. Most drugs once they go into the OTC market drop in margin, and volume does pick up but only to a point plus it comes with increased competition now. The last few allergy medications like Zertec, Allegra, Claritin etc that were once prescription only went OTC and margins dropped for the OTC versions. However, you will find at least in the case of a couple of them the companies were pushing for them to be OTC from the beginning because they had developed the drug with the intent to be OTC. However, even if you look at OTC allergy meds, most can still be prescribed and hence paid for by medical insurance and the per pill price is drastically higher, but the out of pocket expense for the consumer is lower (which is just screwed up IMO). Last point on this, once it goes OTC the competition on manufacturing skyrockets, again driving down margins for everyone, similar to when a prescription med comes off patent initially. I could see an argument though where the AMA and other physician lobbying groups here may diverge from the pharmaceutical lobbying but in general from my knowledge they work pretty close together.
- jrochkind1 8y ago
  It reads to me like these medications are _not_ going to be classified as "over the counter." Even though they will not require a prescription, that's the whole point. I wonder if the regulations are written in some way to allow them to keep charging prescription prices without a prescription. The article definitely suggests it's a new "status", not merely making more things OTC. From the OP: > Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years. > The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance." Note, since they aren't typically _covered by insurance_. A new designation that would be covered by insurance, fit into insurance schedules under "prescription", but not actually require a prescription -- hey, "everyone" wins! From: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u... "Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system. Today’s new FDA draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription." The (very brief) draft guidance itself: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613666.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...