4 ms·

Regardless of how you want to redefine the phrase trickle down, your use of it here betrays a fundamental misunderstanding of the subject. If it's possible to

Regardless of how you want to redefine the phrase trickle down, your use of it here betrays a fundamental misunderstanding of the subject. If it's possible to reduce the regulatory burden of the approval process for biosimilar insulin so as to allow generic makers to compete more easily, this will REDUCE the monopoly power of the large incumbent drug companies. I don't know if you're being deliberately obtuse, but I can't say this any more clearly. > Once again, it was one example, I was mainly thinking about hair loss or other male things caused by men, historically and still, earning more. Right, so it was a bullshit distraction that can safely be ignored. > My main point was that the profit motive causes this kind of skew... Which has exactly nothing to do with insulin, or the larger problem of building a manufacturing base for complex biosimilar medicines that's big, efficient, and safe enough to not bankrupt us. Regulations are necessary and powerful tools that, if wielded clumsily, can easily kill that manufacturing base. Making sure those regulations are suited to the task is not "trickle down" in any way whatsoever.

jahaja 7y ago
> Regardless of how you want to redefine the phrase trickle down, your use of it here betrays a fundamental misunderstanding of the subject Care to explain how it doesn't fit the template I described? > this will REDUCE the monopoly power of the large incumbent drug companies This is at best naive. The approval process isn't the problem. Government granted monopolies are. > Which has exactly nothing to do with insulin Uhm, yes, and that was in response to the free-market nonsense, not insulin.
- nate_meurer 7y ago
  > The approval process isn't the problem. Government granted monopolies are. You're still not understanding. Overly burdensome approval processes are part of what creates government granted monopolies. In other words, those two things go together. For example, if you're familiar with the approval pipeline for generics in the U.S., you'll remember that the main component of an ANDA filing is proving equivalence. Regulations require the evaluation to be based not just on the chemical description of the brand name medicine, but on actual physical samples. A separate regulation subjects any medicine with serious side effects to the REMS program, which restricts its distribution to narrow channels of the drug maker's choosing. Furthermore, the regulation allows companies to voluntarily subject a drug to REMS-type treatment even in the absence of serious side effects. The result of these twisted regulations is that a large incumbent drug maker can easily deprive smaller generic makers from getting the samples they need to pursue approval. This is just one example. REMS and other regulations allow incumbent drug makers other ways to block prospective generic makers. These abuses are common, and according to one study cited by the FTC, if we removed or reformed some these regulations, it would save Americans billions of dollars a year. [1] Now read this slowly and carefully: these government regulations help to preserve big pharma monopolies. Read the citation below. Read the paper cited earlier. Read anything. If you have any evidence of your own to support your positions -- studies, papers, anything -- I'd be interested to hear it. Otherwise I'm done with this. 1 - https://accessiblemeds.org/sites/default/files/2018-09/REMS_WhitePaper_September2018%5B2%5D.pdf https://accessiblemeds.org/sites/default/files/2018-09/REMS_...
  - jahaja 7y ago
    You couldn't make this up. The very group that ordered the report you are referring to, The Association for Accessible Medicines (AAM), is also appealing the introduction of a law in California that makes pay-for-delay deals with drug companies illegal. Do you understand why I'm calling it naive now? They clearly don't have the public interests in mind at all, just raking in profits, even if it's through mob-like protection fees with incumbents. "The Association for Accessible Medicines (AAM), which represents generic drugmakers, is appealing a December 31 decision by a federal judge that allows California’s new law barring pay-for-delay arrangements between brand-name and generic pharma firms to go forward." "AAM had argued that the law violated the federal government’s right to regulate interstate commerce and the scope of US patents" https://www.centerforbiosimilars.com/news/lobbying-group-appeals-decision-allowing-california-payfordelay-law-to-take-effect https://www.centerforbiosimilars.com/news/lobbying-group-app...

jahaja 7y ago

> Regardless of how you want to redefine the phrase trickle down, your use of it here betrays a fundamental misunderstanding of the subject Care to explain how it doesn't fit the template I described? > this will REDUCE the monopoly power of the large incumbent drug companies This is at best naive. The approval process isn't the problem. Government granted monopolies are. > Which has exactly nothing to do with insulin Uhm, yes, and that was in response to the free-market nonsense, not insulin.

nate_meurer 7y ago
> The approval process isn't the problem. Government granted monopolies are. You're still not understanding. Overly burdensome approval processes are part of what creates government granted monopolies. In other words, those two things go together. For example, if you're familiar with the approval pipeline for generics in the U.S., you'll remember that the main component of an ANDA filing is proving equivalence. Regulations require the evaluation to be based not just on the chemical description of the brand name medicine, but on actual physical samples. A separate regulation subjects any medicine with serious side effects to the REMS program, which restricts its distribution to narrow channels of the drug maker's choosing. Furthermore, the regulation allows companies to voluntarily subject a drug to REMS-type treatment even in the absence of serious side effects. The result of these twisted regulations is that a large incumbent drug maker can easily deprive smaller generic makers from getting the samples they need to pursue approval. This is just one example. REMS and other regulations allow incumbent drug makers other ways to block prospective generic makers. These abuses are common, and according to one study cited by the FTC, if we removed or reformed some these regulations, it would save Americans billions of dollars a year. [1] Now read this slowly and carefully: these government regulations help to preserve big pharma monopolies. Read the citation below. Read the paper cited earlier. Read anything. If you have any evidence of your own to support your positions -- studies, papers, anything -- I'd be interested to hear it. Otherwise I'm done with this. 1 - https://accessiblemeds.org/sites/default/files/2018-09/REMS_WhitePaper_September2018%5B2%5D.pdf https://accessiblemeds.org/sites/default/files/2018-09/REMS_...
- jahaja 7y ago
  You couldn't make this up. The very group that ordered the report you are referring to, The Association for Accessible Medicines (AAM), is also appealing the introduction of a law in California that makes pay-for-delay deals with drug companies illegal. Do you understand why I'm calling it naive now? They clearly don't have the public interests in mind at all, just raking in profits, even if it's through mob-like protection fees with incumbents. "The Association for Accessible Medicines (AAM), which represents generic drugmakers, is appealing a December 31 decision by a federal judge that allows California’s new law barring pay-for-delay arrangements between brand-name and generic pharma firms to go forward." "AAM had argued that the law violated the federal government’s right to regulate interstate commerce and the scope of US patents" https://www.centerforbiosimilars.com/news/lobbying-group-appeals-decision-allowing-california-payfordelay-law-to-take-effect https://www.centerforbiosimilars.com/news/lobbying-group-app...