4 ms·

I have gout and have learned quite a bit about how fucked this whole system is. I will find some sources but if my recollection serves me right there was an art

I have gout and have learned quite a bit about how fucked this whole system is. I will find some sources but if my recollection serves me right there was an arthritis medication that was developed before FDA approvals. In order to bring it up to FDA approval, companies can assume the burden of approval (clinical trials, etc) and then they basically get the drug. Well, in the time since this has happened a common drug used by many people (many later in life) is now costing medicare tons of money because, well, people are greedy. I would say this system needs to change but considering the democrats can't even escape from a wet paper bag, i don't see that happening.

refurb 5y ago
People are greedy? The FDA asked that colchicine go through the FDA approval process. A company did so and footed the cost. That’s not greed, that’s a public service.
- cityzen 5y ago
  lol... public service... yes, they are greedy AF: https://www.medpagetoday.com/rheumatology/generalrheumatology/89927 https://www.medpagetoday.com/rheumatology/generalrheumatolog... Colchicine, the old gout drug often cited as a cheap anti-inflammatory, hasn't been such a good deal since FDA approval, a study showed. The inflation- and rebate-adjusted Medicaid price per pill jumped from $0.24 in 2008 to $4.20 after the FDA officially approved a branded form, Colcrys, through the agency's Unapproved Drug Initiative pathway in 2009. and Accordingly, Medicaid spending on single-ingredient colchicine rose 2833%," they wrote, and "58% of this increase was attributable to price increases alone." and "Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system," argued B. Joseph Guglielmo, PharmD, of the University of California San Francisco, in an accompanying editorial. "The current study findings illustrate that we can never allow such an egregious case to take place again." say what you will but this is just stupid american bullshit.
  - refurb 5y ago
    No, this was entirely intentional on behalf of the FDA. They wanted to move unapproved products out of the dark and move them through a formal approval process. As a part of that process, they offered market exclusivity as an incentive for a company to spend the time and money to do so. As I said in another response, the filing fee alone is $1.6M. It's not as expensive as a full NDA approval, but it's not free. And your article lays it all out. "Their study used Medicaid and Medicare data files through 2017, when combined Medicaid and Medicare claims exceeded $340 million for colchicine. "Colcrys's manufacturer, which conducted a 1-week trial (n=185), received 3 years' market exclusivity for treatment of acute gout, and the unapproved formulations were soon ordered off the market, resulting in a virtual monopoly," McCormick's group noted." So the price goes up for 3 years and as a result you get a fully FDA approved drug? Not worth that trade off?
    - cityzen 5y ago
      We can agree to disagree. I do not think it's worth it at all.
- cityzen 5y ago
  Another point of interest: https://www.the-rheumatologist.org/article/the-unapproved-drugs-initiative-is-coming-to-an-end/ https://www.the-rheumatologist.org/article/the-unapproved-dr... On Friday, Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published a Notice through the Federal Register announcing the withdrawal of guidance documents that established the Unapproved Drugs Initiative. This Notice brings to an end a 14-year-old program that has been blamed for significantly contributing to the rising cost. So... again, yes... greed.
  - refurb 5y ago
    Trying to get unapproved drugs through the FDA approval process is greed?
    - cityzen 5y ago
      you're either trolling or lazy... here's an excerpt from the article: In total, 34 previously unapproved drugs were addressed through the Unapproved Drugs Initiative. In a 2017 analysis, researchers found that 90% of those drugs were approved through the new drug application 505(b)(2) pathway.2 The 505(b)(2) pathway does not require new clinical trial evidence and can be based on literature reviews or bioequivalence studies alone. New market exclusivity for these drugs led to a median price increase of 37% (interquartile range [IQR] = 23–204%) within two years of approval. It also resulted in more supply shortages of these drugs after approval, and these shortages also lasted longer likely because of the exclusivity. it's greed my friend.
      - refurb 5y ago
        How is it greed that someone goes through the process of getting FDA approval (which is more than just running trials), sets up FDA approved manufacturing, does all the monitoring, etc, then charges for it? You realize the application fee alone for 505(b)(2) is $1.6M?[1] It's not like someone just emails a few papers with an application form to the FDA and gets FDA approval. [1]https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments https://www.fda.gov/industry/fda-user-fee-programs/prescript...

refurb 5y ago

People are greedy? The FDA asked that colchicine go through the FDA approval process. A company did so and footed the cost. That’s not greed, that’s a public service.

cityzen 5y ago
lol... public service... yes, they are greedy AF: https://www.medpagetoday.com/rheumatology/generalrheumatology/89927 https://www.medpagetoday.com/rheumatology/generalrheumatolog... Colchicine, the old gout drug often cited as a cheap anti-inflammatory, hasn't been such a good deal since FDA approval, a study showed. The inflation- and rebate-adjusted Medicaid price per pill jumped from $0.24 in 2008 to $4.20 after the FDA officially approved a branded form, Colcrys, through the agency's Unapproved Drug Initiative pathway in 2009. and Accordingly, Medicaid spending on single-ingredient colchicine rose 2833%," they wrote, and "58% of this increase was attributable to price increases alone." and "Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system," argued B. Joseph Guglielmo, PharmD, of the University of California San Francisco, in an accompanying editorial. "The current study findings illustrate that we can never allow such an egregious case to take place again." say what you will but this is just stupid american bullshit.
- refurb 5y ago
  No, this was entirely intentional on behalf of the FDA. They wanted to move unapproved products out of the dark and move them through a formal approval process. As a part of that process, they offered market exclusivity as an incentive for a company to spend the time and money to do so. As I said in another response, the filing fee alone is $1.6M. It's not as expensive as a full NDA approval, but it's not free. And your article lays it all out. "Their study used Medicaid and Medicare data files through 2017, when combined Medicaid and Medicare claims exceeded $340 million for colchicine. "Colcrys's manufacturer, which conducted a 1-week trial (n=185), received 3 years' market exclusivity for treatment of acute gout, and the unapproved formulations were soon ordered off the market, resulting in a virtual monopoly," McCormick's group noted." So the price goes up for 3 years and as a result you get a fully FDA approved drug? Not worth that trade off?
  - cityzen 5y ago
    We can agree to disagree. I do not think it's worth it at all.
cityzen 5y ago
Another point of interest: https://www.the-rheumatologist.org/article/the-unapproved-drugs-initiative-is-coming-to-an-end/ https://www.the-rheumatologist.org/article/the-unapproved-dr... On Friday, Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published a Notice through the Federal Register announcing the withdrawal of guidance documents that established the Unapproved Drugs Initiative. This Notice brings to an end a 14-year-old program that has been blamed for significantly contributing to the rising cost. So... again, yes... greed.
- refurb 5y ago
  Trying to get unapproved drugs through the FDA approval process is greed?
  - cityzen 5y ago
    you're either trolling or lazy... here's an excerpt from the article: In total, 34 previously unapproved drugs were addressed through the Unapproved Drugs Initiative. In a 2017 analysis, researchers found that 90% of those drugs were approved through the new drug application 505(b)(2) pathway.2 The 505(b)(2) pathway does not require new clinical trial evidence and can be based on literature reviews or bioequivalence studies alone. New market exclusivity for these drugs led to a median price increase of 37% (interquartile range [IQR] = 23–204%) within two years of approval. It also resulted in more supply shortages of these drugs after approval, and these shortages also lasted longer likely because of the exclusivity. it's greed my friend.
    - refurb 5y ago
      How is it greed that someone goes through the process of getting FDA approval (which is more than just running trials), sets up FDA approved manufacturing, does all the monitoring, etc, then charges for it? You realize the application fee alone for 505(b)(2) is $1.6M?[1] It's not like someone just emails a few papers with an application form to the FDA and gets FDA approval. [1]https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments https://www.fda.gov/industry/fda-user-fee-programs/prescript...