4 ms·

I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the gener

I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.

gwbas1c 7y ago
Yes there is. It's primarily based around different characteristics of how the medication dissolves in the patient's stomach, or the differences between fillers and binders.
- MegaButts 7y ago
  Doesn't that mean they're not chemically equivalent?
  - mikeyouse 7y ago
    The active ingredient is the same - the binders and fillers and capsule materials are mostly inert. This isn't true for all drugs - for the blood thinner Coumadin, you're meant to stick to generic or brand name and not switch between the two since there are known differences in efficacy.
    - MegaButts 7y ago
      I understand that. OP said: > There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent. If they're not chemically equivalent and have different medicinal effects as a result, then it's much easier to justify a price difference. I understand chemistry is more than just a list of ingredients. It's how those ingredients are combined that gives them their unique interactions.
      - JMTQp8lwXL 7y ago
        For sake of the discussion here, bio-equivalence is the more helpful way for meaningfully comparing generic to brand names. The filler might be different, but if the biological effect is identical at half the cost, one would be prudent to chose the generic option.
        perl4ever 7y ago
        Yet we see drugs that are, say, 100 times the cost of the generic. So how can that happen; how is that sustainable? Presumably nearly everyone starts on the generic, and then switches to the brand name if they have problems with the generic. So there is actually not competition so much as price discrimination! You can't tell someone who the generic has failed that they are equivalent, because their only hope is that they are not! Not only is the generic no longer an alternative, but psychologically, it's easier to put your hope in a super-expensive option because of the cliche "you get what you pay for". So I think telling people continually that generics are identical is not helpful, because it's not information. It's an assumption, which might be true or it might not be, but is essentially never helpful to any individual in making a decision.
    - jsight 7y ago
      I do not think the results for Coumadin/Warfarin are at all clear: https://www.ncbi.nlm.nih.gov/pubmed/21449627 https://www.ncbi.nlm.nih.gov/pubmed/21449627
      - mikeyouse 7y ago
        Thanks for the update - interesting study.
  - thereisnospork 7y ago
    Chemically equivalent but formulated differently. Think hot dog vs. corn dog: the meat is the same but the packaging is slightly different. The packaging can have a surprisingly large effect on drug absorption, and therefore efficacy. Notably with difficult to dissolve drugs a lot of work typically goes into formulating them to be more efficiently processed by the intestinal tract.
    - refurb 7y ago
      The FDA approves generics based on bioequivalence, not just chemical composition. In order to be an "AB" rated generic (and used as a substitute for the branded product), the generic has to fall between 80-125% bioequivalence of the brand, which measure dissolution and absorption. The fillers in the generic don't have to be the same as the branded product, but the drug does have to behave the same as the branded product.
      - perl4ever 7y ago
        There was an issue I read about with a drug where they did not test all the different dosages of a generic, and I think the behavior of one of the doses was not as expected because it didn't dissolve well or something. This was a psychiatric drug, and so of course, reports of problems went unheeded for years because patients were assumed to be imagining things. Saying "the drug does have to behave the same as the branded product" is like saying "the product as delivered does have to match the spec".
        refurb 7y ago
        Yup. There have been a handful of approved generics that didn’t have bioequivalence to the branded. It’s not a perfect process, but it works in nearly all the cases.
        perl4ever 7y ago
        We don't know that "it works in nearly all the cases". We know that in nearly all the cases, any issues don't rise to the level where the FDA or the public identifies them. I doubt that the system is constructed in such a way that nearly all the problems are identified. It seems to me that because drugs are developed to meet the absolute minimum standards for proving efficacy and safety, there's inherently going to be little if any margin for error in the manufacturing process and hardly any way to analyze problems. When reporting potential side effects, most drugs are going to be just above the noise level in their principle effect, so how are you going to determine what is a random unrelated issue and what is a negative side effect, and what is the consequence of a QA or design failure?
  - Rychard 7y ago
    My understanding is that only the "active ingredient" is the same. Everything else is subject to cost-cutting, as there are many fillers and binders to choose from, and they're priced differently.
deleted 7y ago
[deleted]
o09rdk 7y ago
This another in a long string of failures in generic regulations that underscore broader problems pertaining to regulation in the US healthcare system. There's this theoretical land of regulation, what the consumers and citizens are encouraged to presume, and what actually happens. It's been common, for instance, for people to repeatedly be berated for paying more for name brand. Studies in fact, of the public health economics of it, why people pay more for name brands, trying to understand it as if there are deficiencies in consumer reasoning. This is despite repeated problems with generic suppliers overseas, mainly India, diluting medications. This was uncovered, problems were corrected, and then it happened again. And now this. So who exactly is the rational purchaser? The person who buys generics under the assumption that they are chemically equivalent, or the skeptic who prefers to have transparency about where their medications are coming from, and purchases brand names? My point isn't to berate the FDA as incompetent -- I think they're overburdened -- but I do think there are broader problems involving a disconnect between how we discuss regulatory systems in the US and what actually happens. To me, this is just the tip of the iceberg. My personal opinion is the FDA needs to focus solely on this kind of problem -- ensuring drugs are what they are labeled to be -- with maybe some substantial research into effectiveness -- and to drop its regulatory role as drug police.
- AstralStorm 7y ago
  I only buy generics from known reputable manufacturers, these are mostly locally made EU ones, bit more expensive than big pharma, say Teva or even maybe Sanofi (they're very likely local though) but at least predictable and it helps local business. (Polish, Czech and Slovakian.)
jessaustin 7y ago
"...pay a premium for brand name..." My physician had prescribed "Diovan, not Valsartan" last year because of this. My pharmacist called me up as I was driving home from the physician's office. He assured me that he wasn't buying anything from that Chinese company, and observed that I'd be going from $65 per three months to $365 per three months. OK, generic it is...

I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.

gwbas1c 7y ago

Yes there is. It's primarily based around different characteristics of how the medication dissolves in the patient's stomach, or the differences between fillers and binders.

MegaButts 7y ago
Doesn't that mean they're not chemically equivalent?
- mikeyouse 7y ago
  The active ingredient is the same - the binders and fillers and capsule materials are mostly inert. This isn't true for all drugs - for the blood thinner Coumadin, you're meant to stick to generic or brand name and not switch between the two since there are known differences in efficacy.
  - MegaButts 7y ago
    I understand that. OP said: > There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent. If they're not chemically equivalent and have different medicinal effects as a result, then it's much easier to justify a price difference. I understand chemistry is more than just a list of ingredients. It's how those ingredients are combined that gives them their unique interactions.
    - JMTQp8lwXL 7y ago
      For sake of the discussion here, bio-equivalence is the more helpful way for meaningfully comparing generic to brand names. The filler might be different, but if the biological effect is identical at half the cost, one would be prudent to chose the generic option.
      - perl4ever 7y ago
        Yet we see drugs that are, say, 100 times the cost of the generic. So how can that happen; how is that sustainable? Presumably nearly everyone starts on the generic, and then switches to the brand name if they have problems with the generic. So there is actually not competition so much as price discrimination! You can't tell someone who the generic has failed that they are equivalent, because their only hope is that they are not! Not only is the generic no longer an alternative, but psychologically, it's easier to put your hope in a super-expensive option because of the cliche "you get what you pay for". So I think telling people continually that generics are identical is not helpful, because it's not information. It's an assumption, which might be true or it might not be, but is essentially never helpful to any individual in making a decision.
  - jsight 7y ago
    I do not think the results for Coumadin/Warfarin are at all clear: https://www.ncbi.nlm.nih.gov/pubmed/21449627 https://www.ncbi.nlm.nih.gov/pubmed/21449627
    - mikeyouse 7y ago
      Thanks for the update - interesting study.
- thereisnospork 7y ago
  Chemically equivalent but formulated differently. Think hot dog vs. corn dog: the meat is the same but the packaging is slightly different. The packaging can have a surprisingly large effect on drug absorption, and therefore efficacy. Notably with difficult to dissolve drugs a lot of work typically goes into formulating them to be more efficiently processed by the intestinal tract.
  - refurb 7y ago
    The FDA approves generics based on bioequivalence, not just chemical composition. In order to be an "AB" rated generic (and used as a substitute for the branded product), the generic has to fall between 80-125% bioequivalence of the brand, which measure dissolution and absorption. The fillers in the generic don't have to be the same as the branded product, but the drug does have to behave the same as the branded product.
    - perl4ever 7y ago
      There was an issue I read about with a drug where they did not test all the different dosages of a generic, and I think the behavior of one of the doses was not as expected because it didn't dissolve well or something. This was a psychiatric drug, and so of course, reports of problems went unheeded for years because patients were assumed to be imagining things. Saying "the drug does have to behave the same as the branded product" is like saying "the product as delivered does have to match the spec".
      - refurb 7y ago
        Yup. There have been a handful of approved generics that didn’t have bioequivalence to the branded. It’s not a perfect process, but it works in nearly all the cases.
        perl4ever 7y ago
        We don't know that "it works in nearly all the cases". We know that in nearly all the cases, any issues don't rise to the level where the FDA or the public identifies them. I doubt that the system is constructed in such a way that nearly all the problems are identified. It seems to me that because drugs are developed to meet the absolute minimum standards for proving efficacy and safety, there's inherently going to be little if any margin for error in the manufacturing process and hardly any way to analyze problems. When reporting potential side effects, most drugs are going to be just above the noise level in their principle effect, so how are you going to determine what is a random unrelated issue and what is a negative side effect, and what is the consequence of a QA or design failure?
- Rychard 7y ago
  My understanding is that only the "active ingredient" is the same. Everything else is subject to cost-cutting, as there are many fillers and binders to choose from, and they're priced differently.

deleted 7y ago

[deleted]

o09rdk 7y ago

This another in a long string of failures in generic regulations that underscore broader problems pertaining to regulation in the US healthcare system. There's this theoretical land of regulation, what the consumers and citizens are encouraged to presume, and what actually happens. It's been common, for instance, for people to repeatedly be berated for paying more for name brand. Studies in fact, of the public health economics of it, why people pay more for name brands, trying to understand it as if there are deficiencies in consumer reasoning. This is despite repeated problems with generic suppliers overseas, mainly India, diluting medications. This was uncovered, problems were corrected, and then it happened again. And now this. So who exactly is the rational purchaser? The person who buys generics under the assumption that they are chemically equivalent, or the skeptic who prefers to have transparency about where their medications are coming from, and purchases brand names? My point isn't to berate the FDA as incompetent -- I think they're overburdened -- but I do think there are broader problems involving a disconnect between how we discuss regulatory systems in the US and what actually happens. To me, this is just the tip of the iceberg. My personal opinion is the FDA needs to focus solely on this kind of problem -- ensuring drugs are what they are labeled to be -- with maybe some substantial research into effectiveness -- and to drop its regulatory role as drug police.

AstralStorm 7y ago
I only buy generics from known reputable manufacturers, these are mostly locally made EU ones, bit more expensive than big pharma, say Teva or even maybe Sanofi (they're very likely local though) but at least predictable and it helps local business. (Polish, Czech and Slovakian.)

jessaustin 7y ago

"...pay a premium for brand name..." My physician had prescribed "Diovan, not Valsartan" last year because of this. My pharmacist called me up as I was driving home from the physician's office. He assured me that he wasn't buying anything from that Chinese company, and observed that I'd be going from $65 per three months to $365 per three months. OK, generic it is...