FDA Commissioner Speech
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I found it a little more frightening and sad than anything.
I am reminded of something that Frédéric Bastiat wrote(in 1850):
"..it is indeed fortunate that Heaven has bestowed upon certain men — governors and legislators — the exact opposite inclinations, not only for their own sake but also for the sake of the rest of the world! While mankind tends toward evil, the legislators yearn for good; while mankind advances toward darkness, the legislators aspire for enlightenment; while mankind is drawn toward vice, the legislators are attracted toward virtue. Since they have decided that this is the true state of affairs, they then demand the use of force in order to substitute their own inclinations for those of the human race."
I am reminded of something that Frédéric Bastiat wrote(in 1850):
"..it is indeed fortunate that Heaven has bestowed upon certain men — governors and legislators — the exact opposite inclinations, not only for their own sake but also for the sake of the rest of the world! While mankind tends toward evil, the legislators yearn for good; while mankind advances toward darkness, the legislators aspire for enlightenment; while mankind is drawn toward vice, the legislators are attracted toward virtue. Since they have decided that this is the true state of affairs, they then demand the use of force in order to substitute their own inclinations for those of the human race."
Thanks for the link. Nothing really new, except for the rationale given for rolling back the compliance date to 2021. Wonder how many folks listening to that address went out afterwards and had a smoke? Think I'll go have a smoke.
After 42 years in pharmacy I could write a book on all the awful things that influenced the industry over the years.
I'll say without hesitation that all the current shortages and high prices area due to bad FDA regulations dating from the last half of the Bush administration and picking up steam all during the Obama years up to the present one. If in 2008 congress would have passed laws with incentives for small generic drug manufactures to modernize their production lines the situation would be much better now. Instead, a mandate was issued. Many companies went out of business or sold to investors such as the infamous Martin Shkreli. We went from having 4 suppliers of epinephrine to just one.
Another factor was the FDA suddenly requiring that medications that had been in production and routine use for many years be certified as "safe and effective" by going through the FDA drug approval process that costs millions of dollars. Once again, investor groups pounced on that opportunity.
When the FDA banned asthma inhalers that used chlorofluorocarbons in the propellant, they required all products go through recertification. Same situation there... production from all small generic companies ceased and investors grabbed the new patents. The results of this are always the same... shortages and high prices for consumers, all brought to you by the FDA.
The reports I'm getting now are that the FDA is putting tighter restrictions on the amount of raw materials that can be imported to make opioid pain killers. We already face shortages at the end of the year for those, but pharmacies are bracing for the worst this year.
Things are so bad now we are mixing our own IV solutions such as dextrose and water because we can't get them from our usual sources. There are times at work when I feel like I'm working in a third world environment.
I'll say without hesitation that all the current shortages and high prices area due to bad FDA regulations dating from the last half of the Bush administration and picking up steam all during the Obama years up to the present one. If in 2008 congress would have passed laws with incentives for small generic drug manufactures to modernize their production lines the situation would be much better now. Instead, a mandate was issued. Many companies went out of business or sold to investors such as the infamous Martin Shkreli. We went from having 4 suppliers of epinephrine to just one.
Another factor was the FDA suddenly requiring that medications that had been in production and routine use for many years be certified as "safe and effective" by going through the FDA drug approval process that costs millions of dollars. Once again, investor groups pounced on that opportunity.
When the FDA banned asthma inhalers that used chlorofluorocarbons in the propellant, they required all products go through recertification. Same situation there... production from all small generic companies ceased and investors grabbed the new patents. The results of this are always the same... shortages and high prices for consumers, all brought to you by the FDA.
The reports I'm getting now are that the FDA is putting tighter restrictions on the amount of raw materials that can be imported to make opioid pain killers. We already face shortages at the end of the year for those, but pharmacies are bracing for the worst this year.
Things are so bad now we are mixing our own IV solutions such as dextrose and water because we can't get them from our usual sources. There are times at work when I feel like I'm working in a third world environment.
"Instead, a mandate was issued."
Most of these "mandates" are based on false premises, or simply address the wrong problems. It reminds me of an infamous mandate that asked the question, "How do we remediate the damage done by a predatory industry while still making sure that that predatory industry still gets their cut?" The truth is, there is no good answer to an inherently flawed question.
Most of these "mandates" are based on false premises, or simply address the wrong problems. It reminds me of an infamous mandate that asked the question, "How do we remediate the damage done by a predatory industry while still making sure that that predatory industry still gets their cut?" The truth is, there is no good answer to an inherently flawed question.
"FDA is putting tighter restrictions on the amount of raw materials that can be imported to make opioid pain killers."
I was under the impression that all seized heroin was put to good use in the making of legitimate opioid painkillers.
I'm sure I read that quite recently though perhaps it only applied to Europe?
Regards,
Jay.
I was under the impression that all seized heroin was put to good use in the making of legitimate opioid painkillers.
I'm sure I read that quite recently though perhaps it only applied to Europe?
Regards,
Jay.
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