SLSteven
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Federal Government's New Drug Development Center
- Thread starter SLSteven
- Start date
tangent4ronpaul
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Gee - I wonder why development has slowed to a crawl...
http://www.fda.gov/drugs/developmentapprovalprocess/default.htm
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/default.htm
-t
http://www.fda.gov/drugs/developmentapprovalprocess/default.htm
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/default.htm
-t
Austrian Econ Disciple
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Cue Mises. One Government intervention begets another, begets another, until we have full blown socialism.
roho76
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And yet these drugs hit the market after "FDA approval" and kill more people than street drugs. Lifes medical problems can't be fixed with a pill (there are exception of course).
tangent4ronpaul
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Some great comments on this article:
"Every American should know from tv ads that the side effects of drugs are stroke, heart attack,four hour erections,blindness,cancer and death.The federal drug effort will save social security with the final solution of reducing life span with stronger medicine!"
"this beg's the question "why does it take so long to approve any drug in the first place?? because the government get's in the way!! so is this just a way around all the slow/down and feet dragginjg.. it seems that there is now more $$$ spent to get these drugs to market. is this another abomination thing, as with another stupid and useless non-things that have not happened the lass two years?? let capitalism work!! yours in christ."
"Every American should know from tv ads that the side effects of drugs are stroke, heart attack,four hour erections,blindness,cancer and death.The federal drug effort will save social security with the final solution of reducing life span with stronger medicine!"
"this beg's the question "why does it take so long to approve any drug in the first place?? because the government get's in the way!! so is this just a way around all the slow/down and feet dragginjg.. it seems that there is now more $$$ spent to get these drugs to market. is this another abomination thing, as with another stupid and useless non-things that have not happened the lass two years?? let capitalism work!! yours in christ."
tangent4ronpaul
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my comment:
Back in the early 1960's before the FDA got involved with drug approval drugs went from discovery to market in about 2 years at a cost of tens of thousands of dollars. They were unleashed on the market after the manufacturer tested it and was confident that it was safe enough that they would not get sued. Today that process takes 12 years and costs between 750 Million and 1.2 Billion per drug for a single intended use. If the drug is useful for another purpose, it has to be tested again before the drug company can claim it's useful for the second purpose, but once approved and available it's more common for a doctor to just use it “off label” for the second purpose.
The FDA does not actually test drugs, they just dictate what tests must be done and what forms and paperwork must be filled out how. Many approvals are delayed because they don't like how the paperwork is filled out. The FDA will review test results performed by private groups or universities and base their decisions on the results. These groups want to make the drug companies happy, and earn future contracts for testing. Some have been caught just making up results.
Many drugs are never developed as the target population is not rich enough to afford them or the disease is not widespread enough to be profitable.
Then there is the proprietary issue. A drug called Prilosec had a serious problem – it's patent was about to to expire, so the drug company came up with a designer drug that was similar called Nexium that it could patent anew and get a monopoly on sales from. Unfortunately, they got it right the first time, and the now generic, cheap and Over the Counter (OTC) drug Prilosec was superior. They buried 5 studies until they finally got one that showed a brief (few day) advantage for Nexium, which they based their “superior” ads on.
Always remember that the drug companies spend $2 for advertizing expensive new drugs for every $1 they spend on R&D. Also, that Americans are over medicated and take more drugs than anyone else in the world.
Back in the early 1960's before the FDA got involved with drug approval drugs went from discovery to market in about 2 years at a cost of tens of thousands of dollars. They were unleashed on the market after the manufacturer tested it and was confident that it was safe enough that they would not get sued. Today that process takes 12 years and costs between 750 Million and 1.2 Billion per drug for a single intended use. If the drug is useful for another purpose, it has to be tested again before the drug company can claim it's useful for the second purpose, but once approved and available it's more common for a doctor to just use it “off label” for the second purpose.
The FDA does not actually test drugs, they just dictate what tests must be done and what forms and paperwork must be filled out how. Many approvals are delayed because they don't like how the paperwork is filled out. The FDA will review test results performed by private groups or universities and base their decisions on the results. These groups want to make the drug companies happy, and earn future contracts for testing. Some have been caught just making up results.
Many drugs are never developed as the target population is not rich enough to afford them or the disease is not widespread enough to be profitable.
Then there is the proprietary issue. A drug called Prilosec had a serious problem – it's patent was about to to expire, so the drug company came up with a designer drug that was similar called Nexium that it could patent anew and get a monopoly on sales from. Unfortunately, they got it right the first time, and the now generic, cheap and Over the Counter (OTC) drug Prilosec was superior. They buried 5 studies until they finally got one that showed a brief (few day) advantage for Nexium, which they based their “superior” ads on.
Always remember that the drug companies spend $2 for advertizing expensive new drugs for every $1 they spend on R&D. Also, that Americans are over medicated and take more drugs than anyone else in the world.
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