Some studies have estimated 5,000 to 10,000 lives saved each decade by preventing dangerous drugs from making it to market. This was done by looking at pre-FDA deaths in the US and deaths in foreign countries without an FDA.

In comparison, studies have shown that the added delays and cost of FDA regulatory hurdles range between 21,000 to 120,000 deaths per decade.

So the NET outcome of lives saved minus lives lost is likely between 11,000 and 115,000 additional deaths each decade due to added delays and costs of the regulatory process.

However, the FDA did not create its mandate which is:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

The FDA mandate does not state that it should maximize the overall health of the population. It just states that it should ensure safety and efficacy without concern for cost.

From an ethical standpoint, the politicians who created this mandate and continue to fund it are ultimately responsible for these deaths.



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©2020 Mike P. Sinn

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