Even after the CDC testing fiasco, the FDA stood in the way of independent testing.
"Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities," ProPublica reported at the end of February.
With the FDA hampering widespread testing and the production of protective gear, would it surprise you to know that it also bears some responsibility for the short supply of hand sanitizer?
The full cost of developing a single new drug and seeing it through to approval by the FDA is roughly $2.6 billion dollars in 2013 dollars, according to a 2014 study by the Tufts Center for the Study of Drug Development that was published in the Journal of Health Economics.
The Tufts researchers also found that drugs are having a tougher time than in the past in making it through the FDA approval process.
As a result, "Devices were available to U.S. citizens an average of two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country."
If the FDA and other regulatory agencies are to have any role, Flanigan reasons, it should be restricted to informational certification of drugs as being safe, while allowing patients and physicians to abide by or disregard such advisory certification as they please.
https://reason.com/2020/04/03/dump-the-fda-for-a-healthier-america/
"Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities," ProPublica reported at the end of February.
With the FDA hampering widespread testing and the production of protective gear, would it surprise you to know that it also bears some responsibility for the short supply of hand sanitizer?
The full cost of developing a single new drug and seeing it through to approval by the FDA is roughly $2.6 billion dollars in 2013 dollars, according to a 2014 study by the Tufts Center for the Study of Drug Development that was published in the Journal of Health Economics.
The Tufts researchers also found that drugs are having a tougher time than in the past in making it through the FDA approval process.
As a result, "Devices were available to U.S. citizens an average of two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country."
If the FDA and other regulatory agencies are to have any role, Flanigan reasons, it should be restricted to informational certification of drugs as being safe, while allowing patients and physicians to abide by or disregard such advisory certification as they please.
https://reason.com/2020/04/03/dump-the-fda-for-a-healthier-america/
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