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lol... public service... yes, they are greedy AF: https://www.medpagetoday.com/rheumatology/generalrheumatology/89927 https://www.medpagetoday.com/rheumatology

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.

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.