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jr377 replied to the topic Drugs banned in US but not in other countries in the forum Regulatory Basics for Medical Devices 7 years ago
I am perfectly fine with the US not following other countries standards when it comes to allowing drugs to enter the market. I will expand upon jz365 and manolo’s point. One of the best examples I can give is Thalidomide as a sleeping pill. Post world war two, sleeping pills became a big hit, for obvious reasons (after seeing unimaginable horrors, it was hard to fall asleep on your own) . It became commonly used all across Europe, and was marketed as being safe for all (including pregnant women). In the US, thalidomide wasn’t allowed by the FDA because of Dr. Frances Oldham Kelsey. She wanted more clinical evidence. She stuck to it, even under incredible pressure to allow it on the market. Soon after, a wave of severe birth defects hit the nations who allowed the drug. Thalidomide was found to be the reason why. Over 10,000 children were born with severe birth defects. This is why the FDA needs to have scientists who won’t be swayed by pressures, mostly political and financial. More importantly, the FDA needs to be independent from other countries own regulatory agencies. The FDA must run it’s own studies and experiments, because trusting that other countries will do it properly is asinine.
[1] http://broughttolife.sciencemuseum.org.uk/broughttolife/people/franceskelsey