On Tue, 12 Jan 2021 22:09:27 +0000, in
, Richard Kettlewell
 wrote:

>Jim H  writes:
>> Richard Kettlewell  wrote:
>>>Joe  writes:
>>>> Thalidomide was 'safe' and 'properly tested'.
>>>
>>>Not by modern standards it wasn’t. It was, famously, a trigger for
>>>tightening up the regulatory regimes.
>>
>> The refusal of the FDA to approve the drug suggests it didn't meet the
>> standards of the time... which have been tightened considerably since.
>
>Many other countries approved it (hence the subsequent disaster) - the
>FDA (or possibly just the specific officer assigned to the application)
>was clearly ahead of the rest of the world at that point.

The rest of the world should have demanded all of the test results...
which would have demonstrated the teratogenic side effects in certain
species of laboratory animals... suggesting either rejection of the
current application was necessary or else a LOT more testing in
animals, including pregnant ones, was required. Had that happened I
bet that a LOT more testing may have taken place, but would never have
resulted in another application. I don't recall if the company was
sued into oblivion, but it should have been.
--
Jim H

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